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Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Jueves 6 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 6 de noviembre de 2025

Los 237 documentos que 126 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

·

El día, bloque a bloque

Va en color lo que cambia el capital o avisa de un riesgo: las emisiones con precio (424B1, 424B2, 424B4 y 424B5), los 8-K con item 1.02, 1.03, 2.04, 3.01, 3.02 y 4.02, y cualquier documento en el que haya aparecido una frase vigilada, que va citada debajo. Lo demás va en tinta normal. Una cita marcada «por primera vez» es una frase que no estaba en el informe previo del mismo tipo de esa empresa. La etiqueta del formulario lleva a su explicación.

Emisiones y dilución

  1. ALTAltimmune, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. BHSTBIOHARVEST SCIENCES INC.424B7Prospecto de reventa de tenedoresEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Company, or otherwise at least as favorable to the Company as those previously obtained, or at all. Importantly, the inclusion in note 1B to the audited annual consolidated financial statements and in “Substantial Doubt About the Company’s Ability to Continue as a Going Concern” in the report thereto of Ziv Haft Certified Public Accountants (Isr.) (PCAOB ID# 1185) of disclosure regarding the Company’s ability to continue as a going concern may negatively impact the Company’s…
  3. CALCCalciMedica, Inc.424B5Nueva emisión de acciones con precioEDGAR
  4. FDMT4D Molecular Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. HINDVyome Holdings, IncS-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Haskell & White LLP, an independent registered public accounting firm, as stated in their report thereon (which report expresses an unqualified opinion and includes an explanatory paragraph relating to substantial doubt about ReShape Lifesciences Inc’s ability to continue as a going concern), and incorporated by reference in this Prospectus and Registration Statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing. The consolidated financial…
    En el documentoContrasplit de accionestexto original ▸…with the Company. The Selling Stockholders’ resale of these shares is registered on the registration statement of which this prospectus forms a part. Reverse Stock Split On August 15, 2025, the Company effected a 1-for-4 reverse stock split of its Common Stock (the “Reverse Stock Split”). On July 24, 2025, the stockholders of the Company approved the proposal to authorize the Board of Directors of the Company (the “Board”), in its discretion…
  6. IRDOpus Genetics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  7. LXRXLEXICON PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
  8. MTVAMetaVia Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…424B5 TABLE OF CONTENTS Filed Pursuant to Rule 424(b)(5)​ Registration No. 333-278646​ PROSPECTUS SUPPLEMENT (To prospectus dated April 23, 2024) Up to $2,300,000 of Common Stock METAVIA INC. We have entered into an At The Market Offering Agreement, (“Sales Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg” or the “Agent”), relating to the sale of shares of our common stock, par value $0.001 per share (the “Common Stock”), offered…
  9. OKUROnKure Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…liability company and a direct, wholly owned subsidiary of Reneo (“Merger Sub II”), and OnKure, Inc., a Delaware corporation (“Legacy OnKure”). Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10 (the “Reverse Stock Split”), (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as Class A Common…
  10. OKUROnKure Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoContrasplit de accionestexto original ▸…liability company and a direct, wholly owned subsidiary of Reneo (“Merger Sub II”), and OnKure, Inc., a Delaware corporation (“Legacy OnKure”). Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10, (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as “Class A common stock”, and (iv) Merger…
  11. VBIOValion Bio, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Company’s financial statements at December 31, 2024 and 2023, and for the years then ended, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern), which is incorporated herein by reference. Such financial statements are incorporated herein by reference in reliance on Rosenberg Rich Baker Berman, P.A.’s report, given on the authority of such firm…
    En el documentoContrasplit de accionestexto original ▸…registered hereunder. As of October 15, 2025, all 1,750 of the Fourth Tranche Preferred Shares remain outstanding. Reverse Stock Splits Reverse Stock Split - 2025 Effective March 7, 2025, the Company implemented a reverse stock split of the Company’s issued and outstanding shares of common stock at a ratio of 1-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the…
  12. ALTAltimmune, Inc.S-3Capacidad de emisión registradaEDGAR
  13. MAZEMaze Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
  14. MBXMBX Biosciences, Inc.S-3Capacidad de emisión registradaEDGAR
  15. REPLReplimune Group, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
  16. TRDAEntrada Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
  17. URGNUroGen Pharma Ltd.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

  1. HOWLWerewolf Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ALTAltimmune, Inc.8-KFin de acuerdo materialEDGAR
  2. ATYRaTYR PHARMA INC8-KResultadosEDGAR
    En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸…and provided a corporate update. “In September, we announced results from our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). While we did not meet the primary endpoint, efzofitimod is the first investigational therapy to exhibit improvements in quality of life across multiple disease-related health outcomes while also reducing steroid burden in patients with pulmonary…
  3. CRISCURIS INC8-KFin de acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…and the Fourth Amendment to the Collaborative Research, Development and License Agreement, between the Company and Genentech effective as of January 1, 2012, the “License Agreement”). Pursuant to the License Agreement, the Company is entitled to royalty on net sales of Erivedge that ranges from 5% to 7.5%. The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances. Upon closing of…
    En el documentoDesignación de medicamento huérfanotexto original ▸…the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL. •Curis is initiating a Phase 2 clinical study of emavusertib in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL), with dosing of the first…
  4. CURXCuranex Pharmaceuticals Inc8-KAviso de incumplimiento de cotizaciónEDGAR
  5. LNAILunai Bioworks Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
  6. LONALeonaBio, Inc.8-KResultadosEDGAR
    En el documentoContrasplit de accionestexto original ▸…statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in various models of ALS. Corporate Updates • In September 2025, Athira implemented a 10-for-1 reverse stock split of Athira’s issued and authorized common stock. The reverse stock split became effective on September 17, 2025 at 5:00 p.m., Eastern Time. • Athira continues to explore strategic alternatives focused…
  7. NTLAIntellia Therapeutics, Inc.8-KResultadosEDGAR

    Intellia finalizó el tercer trimestre con aproximadamente 670 millones de dólares en efectivo, equivalentes y valores negociables.

    Original en inglés · traducción automáticaEnded third quarter with approximately $670 million in cash, cash equivalents and marketable securities; expected to fund operations into mid-2027 • Conference call today at 6:00 p.m.

    Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

    ...tras una sola dosis. Intellia lidera el desarrollo y la comercializacion de nex-z en colaboracion con Regeneron Pharmaceuticals, Inc. El 29 de octubre de 2025, la Administracion de Alimentos y Medicamentos de Estados Unidos (FDA) impuso una suspension clinica (clinical hold)… Sigue en la ficha

    Original en inglés · traducción revisadaafter a single dose. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. On October 29, 2025, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.

    Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.

  8. PHIOPhio Pharmaceuticals Corp.8-KVenta de acciones no registrada (colocación privada)EDGAR
  9. YARWYarrow Bioscience, Inc.8-KResultadosEDGAR
    En el documentoParada clínica impuesta por la FDAtexto original ▸…hematological cancers with limited effective treatment options. 1 •Phase 1b trial in subjects with moderate-to-severe plaque psoriasis. In April 2025, the U.S. Food and Drug Administration (FDA) verbally placed a clinical hold on the Company’s Phase 1b trial evaluating VYN202 in subjects with moderate-to-severe plaque psoriasis following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202…
  10. ZLABZai Lab Ltd8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…Taiwan, collectively). –Seronegative gMG: In August 2025, Zai Lab partner argenx announced topline data from the pivotal ADAPT SERON study of VYVGART in patients with AChR-Ab seronegative gMG. The study met its primary endpoint (p-value=0.0068) and it is the first global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative. Zai Lab participated…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…functional recovery. China’s NMPA accepted the New Drug Application (NDA) for the treatment of schizophrenia in January 2025. •Povetacicept: InSeptember 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to povetacicept for the treatment of IgA nephropathy (IgAN). Subsequently, the FDA also granted a rolling review of the Biologics License Application (BLA) submission for povetacicept for this indication…
  11. ZYMEZymeworks Inc.8-KResultadosEDGAR
    En el documentoAprobación acelerada de la FDAtexto original ▸…BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from the NMPA in China, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or…
  12. AARDAardvark Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  13. ABCLAbCellera Biologics Inc.8-KResultadosEDGAR
  14. ABCLAbCellera Biologics Inc.10-QInforme trimestralEDGAR
  15. ACADACADIA PHARMACEUTICALS INC10-QInforme trimestralEDGAR
  16. ACHVACHIEVE LIFE SCIENCES, INC.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced its financial results for third quarter 2025 and confirmed its Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026, for cytisinicline for treatment of nicotine dependence for smoking cessation. “The FDA’s acceptance of our NDA for cytisinicline in smoking cessation is an important milestone for Achieve, reflecting…
  17. ACHVACHIEVE LIFE SCIENCES, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…cash used in operating activities was $31.5 million. For the nine months ended September 30, 2024, we incurred a net loss of $27.5 million and net cash used in operating activities was $20.6 million. Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our ability to obtain additional financing. While we have historically financed our operations through equity…
  18. ACRSAclaris Therapeutics, Inc.8-KResultadosEDGAR
  19. ACRSAclaris Therapeutics, Inc.10-QInforme trimestralEDGAR
  20. ALECAlector, Inc.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…Based on these results, the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued. Corporate News • In October 2025, the company implemented a reduction in force of approximately 47% intended to focus the company’s resources on its highest-priority programs, to ensure continued progress across its portfolio, and extend cash runway through 2027. Third Quarter 2025…
  21. ALECAlector, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…share of $6.57, resulting in aggregate net proceeds of $71.1 million, after deducting underwriting discounts and commissions and offering costs. At-the-Market Offering On November 7, 2023, the Company entered into an at-the-market sales agreement with TD Securities (USA) LLC (TD Securities, formerly known as Cowen and Company, LLC) pursuant to which the Company may offer and sell from time to time through TD Securities up to $125,000,000 of shares…
  22. ALGSAligos Therapeutics, Inc.8-KResultadosEDGAR
  23. ALGSAligos Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…may require additional time and cost, may impose operational restrictions on us, and may not be available on attractive terms. Our recurring losses from operations and negative cash flows have raised substantial doubt regarding our ability to continue as a going concern. Our recurring losses from operations and negative cash flows raise substantial doubt about our ability to continue as a going concern. We have devoted our resources to our research and development activities…
  24. ALLOAllogene Therapeutics, Inc.8-KResultadosEDGAR
  25. ALLOAllogene Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation. In the past, we have identified a material weakness in our internal control over financial reporting, and if we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in the…
  26. ALTAltimmune, Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…ahead of schedule, signaling significant interest from patients and providers in potential new AUD therapies o Topline results from the RECLAIM trial are expected in 2026 o In August 2025, the Company was granted Fast Track Designation from the FDA for pemvidutide in AUD ​ Alcohol-associated Liver Disease (ALD) ● Announced initiation of RESTORE, a Phase 2 trial of pemvidutide in ALD o The RESTORE trial is a 48-week study evaluating…
  27. ALTAltimmune, Inc.10-QInforme trimestralEDGAR
  28. AMLXAmylyx Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…the Company anticipates biomarker data will be available in the coming months and expects to present these at a medical meeting in the first half of 2026. In June 2025, Amylyx announced that the FDA granted Fast Track designation to AMX0114. Financial Results for the Third Quarter Ended September 30, 2025 R&D Expenses: Research and development expenses for the third quarter of 2025 were $19.9 million, compared to $21.2 million…
  29. AMLXAmylyx Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  30. AMPHAmphastar Pharmaceuticals, Inc.8-KResultadosEDGAR
  31. AMPHAmphastar Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  32. AMRXAmneal Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  33. APVOAptevo Therapeutics Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator…
  34. APVOAptevo Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…amendments and the abandonment of the other amendments, or the abandonment of all amendments, to be determined by the Board in its sole discretion 10 following the Special Meeting. On May 21, 2025, the Board approved an amendment to the Certificate of Incorporation to effect a reverse stock split of our common stock at the reverse split ratio of 1-for-20 (the “Reverse Stock Split”). Accordingly, on May 23, 2025, the Company filed a Certificate of Amendment of Amended and Restated Certificate of…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…under the SEPA for aggregate gross proceeds of $15.0 million. As of September 30, 2025, the remaining availability under the SEPA is $10.0 million. At The Market Offering Agreement On April 28, 2025, we entered into an At The Market Offering Agreement with Roth for an aggregate offering price of $50.0 million, pursuant to which we may offer and sell shares of our common stock from time to time through Roth. The compensation to Roth for the…
  35. ATYRaTYR PHARMA INC10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…regard to legal fees, such as attorney fees related to this matter or any other legal matters, we recognize such costs as incurred. 5. Stockholders’ Equity At the Market Offering Programs In April 2022, we entered into an Open Market Sale AgreementSM with Jefferies implementing the Jefferies ATM Offering Program. In December 2024, we amended the Jefferies ATM Offering Program. Under the Jefferies ATM Offering Program we may offer and sell, from time to time and at our option, up to an aggregate of $215…
  36. AVTXAvalo Therapeutics, Inc.8-KResultadosEDGAR
  37. AVTXAvalo Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…D and Series E Preferred Stock are redeemable at par value outside the control of the Company, they are recognized outside of permanent equity. At-the-Market Offering Program In June 2025, the Company entered into an “at-the-market” sales agreement with TD Securities (USA) LLC (“TD Cowen”), pursuant to which the Company may sell, from time to time, shares of its common stock having an aggregate offering price of up to $75.0 million through TD Cowen…
  38. BDTXBlack Diamond Therapeutics, Inc.8-KResultadosEDGAR
  39. BDTXBlack Diamond Therapeutics, Inc.10-QInforme trimestralEDGAR
  40. BIOABioAge Labs, Inc.8-KResultadosEDGAR
  41. BIOABioAge Labs, Inc.10-QInforme trimestralEDGAR
  42. CALCCalciMedica, Inc.8-KOtros hechos relevantesEDGAR
  43. CAMPCamp4 Therapeutics Corp8-KResultadosEDGAR
  44. CAMPCamp4 Therapeutics Corp10-QInforme trimestralEDGAR
  45. CBIOCRESCENT BIOPHARMA, INC.8-KResultadosEDGAR
  46. CBIOCRESCENT BIOPHARMA, INC.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…the Reverse Stock Split) was 0.1445 shares of GlycoMimetics common stock for each share of Crescent common stock. Reverse Stock Split Immediately prior to the consummation of the Merger, GlycoMimetics effected a 1-for-100 reverse stock split of GlycoMimetics common stock, which became legally effective on June 13, 2025 (the “Reverse Stock Split”). The Company common stock commenced trading on a post-Reverse Stock Split, post-Merger basis…
  47. CCCCC4 Therapeutics, Inc.8-KResultadosEDGAR
  48. CCCCC4 Therapeutics, Inc.10-QInforme trimestralEDGAR
  49. CGEMCullinan Therapeutics, Inc.8-KResultadosEDGAR
  50. CGEMCullinan Therapeutics, Inc.10-QInforme trimestralEDGAR
  51. CGTXCOGNITION THERAPEUTICS INC8-KResultadosEDGAR
  52. CGTXCOGNITION THERAPEUTICS INC10-QInforme trimestralEDGAR
  53. CHRSCoherus Oncology, Inc.8-KResultadosEDGAR
  54. CHRSCoherus Oncology, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be detected or prevented on a timely basis. During the year ended December 31, 2024, we identified a material weakness in the operating effectiveness of our procedures related to documentation and review of certain inventory account reconciliations. The lack of sufficient evidence of the review performed over these accounting…
  55. CLYMClimb Bio, Inc.8-KResultadosEDGAR
  56. CLYMClimb Bio, Inc.10-QInforme trimestralEDGAR
  57. COLLCOLLEGIUM PHARMACEUTICAL, INC8-KResultadosEDGAR
  58. COLLCOLLEGIUM PHARMACEUTICAL, INC10-QInforme trimestralEDGAR
  59. CRDFCardiff Oncology, Inc.10-QInforme trimestralEDGAR
  60. CRDFCardiff Oncology, Inc.8-KResultadosEDGAR

    CRDF reportó resultados financieros para el tercer trimestre finalizado el 30 de septiembre de 2025 y destacó datos del ensayo CRDF-004 que evalúa onvansertib en combinación con el estándar de atención para cáncer colorrectal metastásico con mutación RAS en primera línea.

    Original en inglés · traducción automáticatoday announced financial results for the third quarter ended September 30, 2025, and provided a business update. “This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC.

    Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

  61. CRISCURIS INC10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements. •We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. •We have incurred substantial losses, expect to continue to incur substantial losses for the foreseeable future and may never generate significant revenue or achieve or maintain profitability. •We will…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…various additional requirements. In the past we have, from time to time, received deficiency letters from Nasdaq as a consequence of our failure to satisfy such requirements. On February 21, 2025, we received a deficiency letter from Listing Qualifications Department, or Staff, of Nasdaq notifying us that the market value of our listed securities had closed for the last 30 consecutive business days below the minimum $35,000,000…
  62. CRNXCrinetics Pharmaceuticals, Inc.8-KResultadosEDGAR
  63. CRNXCrinetics Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  64. CRONCronos Group Inc.8-KResultadosEDGAR
  65. CRONCronos Group Inc.10-QInforme trimestralEDGAR
  66. CTMXCytomX Therapeutics, Inc.10-QInforme trimestralEDGAR
  67. CTMXCytomX Therapeutics, Inc.8-KResultadosEDGAR
  68. CUECue Biopharma, Inc.8-KNuevo acuerdo materialEDGAR
  69. CYRXCryoport, Inc.10-QInforme trimestralEDGAR
  70. DFTXDefinium Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…dosing day and consistent with the mechanism of action of lysergide D-tartrate (LSD). These results represent a substantial improvement over currently approved therapies for GAD, which led to MM120 being granted Breakthrough Therapy Designation (BTD) from FDA in March 2024. Program Status and Anticipated Milestones MM120 ODT (lysergide D-tartrate) for GAD • Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the treatment of…
  71. DFTXDefinium Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…proceeds from the March 2024 Offering and the March 2024 Private Placement for the research and development of our product candidates and working capital and general corporate purposes. On June 28, 2024, we entered into a sales agreement with Leerink Partners LLC (the "Sales Agreement") to create an at-the-market equity program under which we from time to time may offer and sell the ATM Shares (as defined below), through or to the Agent. We also filed a prospectus supplement on June 28, 2024 allowing for up to $150.0 million…
  72. DMRADamora Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…September 30, 2025 will be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of these financial statements. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these financial statements are issued. The Company has developed plans to mitigate this risk, which primarily consist of raising additional capital through…
    En el documentoContrasplit de accionestexto original ▸…Company’s cash and cash equivalents amounted to $14.2 million, current assets amounted to $16.8 million, and current liabilities amounted to $1.2 million. Reverse Stock Split On August 29, 2024, the Company effected a 1-for-25 reverse stock split of its issued and outstanding common stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have…
  73. DNLIDenali Therapeutics Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date was extended from January 5, 2026, to April 5, 2026. The extension follows Denali’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and…
  74. DNLIDenali Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…our private placement through the sale of approximately 3.2 million shares of common stock andpre-funded warrants to purchase approximately 26.0 million shares of our common stock. In February 2025, we established a registered “at-the-market” facility for the potential future sale of up to $400.0 million of shares of common stock from time to time by entering into an equity distribution agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC…
  75. DWTXDogwood Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…Halneuron® and SP16 IV. Our lead product candidate, Halneuron®,is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the Food and Drug Administration (“FDA”) for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known…
  76. ELUTELUTIA INC.8-KResultadosEDGAR
  77. ESLAEstrella Immunopharma, Inc.8-KOtros hechos relevantesEDGAR
  78. ETONEton Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…sequential product sales growth ● Q3 2025 basic and fully diluted GAAP EPS of $(0.07), non-GAAP fully diluted EPS of $0.04, and Adjusted EBITDA of $2.9 million ● ET-600 NDA accepted for review, assigned PDUFA date of February 25, 2026 ● GALZIN® launch ahead of plan; exceeded previous year-end target of 200 active patients ● Held positive FDA meeting clarifying pathway to KHINDIVI™ label expansion ● Submitted proposed clinical study…
  79. ETONEton Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  80. EWTXEdgewise Therapeutics, Inc.8-KResultadosEDGAR
  81. EWTXEdgewise Therapeutics, Inc.10-QInforme trimestralEDGAR
  82. FDMT4D Molecular Therapeutics, Inc.8-KResultadosEDGAR
  83. GLUEMonte Rosa Therapeutics, Inc.8-KResultadosEDGAR
  84. GLUEMonte Rosa Therapeutics, Inc.10-QInforme trimestralEDGAR
  85. GPCRStructure Therapeutics Inc.8-KResultadosEDGAR
  86. GPCRStructure Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…proceeds from the Follow-On Offering were approximately $512.7 million after deducting underwriting discounts and commissions and estimated offering costs. At-the-Market Offering In August 2025, the Company entered into a sales agreement (the “ATM Sales Agreement”) with Leerink Partners LLC and Cantor Fitzgerald & Co. (the “ATM Sales Agents”), pursuant to which the Company may, 12 Table of Contents STRUCTURE THERAPEUTICS INC. NOTES TO UNAUDITED CONDENSED CONSOLIDATED…
  87. IMCRImmunocore Holdings plc8-KResultadosEDGAR
  88. IMCRImmunocore Holdings plc10-QInforme trimestralEDGAR
  89. IMNMImmunome Inc.8-KResultadosEDGAR
  90. IMNMImmunome Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…$7.75 per share, for net proceeds of $161.7 million, after deducting underwriting discounts and commissions and offering expenses. 16 Table of Contents 2024 ATM Agreement On May 14, 2024, the Company entered into an “at the market” sales agreement, or the 2024 ATM Agreement, with TD Securities (USA) LLC, or TD Cowen, as sales agent, pursuant to which the Company may offer and sell from time to time shares of its common stock having an aggregate…
  91. INABIN8BIO, INC.8-KResultadosEDGAR
  92. INABIN8BIO, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…audited annual financial statements as of and for the years ended December 31, 2024 and 2023, our independent auditors included an explanatory paragraph regarding our ability to continue as going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock and we may have a more difficult time obtaining financing. Further, the perception that we may be unable to continue as a going…
    En el documentoContrasplit de accionestexto original ▸…Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a reverse stock split at a ratio of one-for-thirty (the "Reverse Stock Split"). On June 5, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise or vesting of all outstanding stock options and warrants…
  93. INMInMed Pharmaceuticals Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…timing of the Company’s operating expenses. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. The Company expects to continue to seek additional funding through equity financings, debt financings or…
  94. INTSINTENSITY THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…balances. Liquidity and Capital Resources Our financial statements have been prepared assuming we will continue as a going concern. We have incurred losses from operations and negative cash flows that raise substantial doubt about our ability to continue as a going concern. Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…costs $ 481 $ 374 Accrued employee compensation-related expenses 15 56 Accrued other 65 78 Total $ 561 $ 508 Note 7. Stockholders’ Equity At The Market Offering Agreement On July 3, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may sell and issue, from time to time, up to $15.0 million of shares of its common stock…
  95. INTSINTENSITY THERAPEUTICS, INC.8-KResultadosEDGAR
  96. IOVAIOVANCE BIOTHERAPEUTICS, INC.8-KResultadosEDGAR
  97. IOVAIOVANCE BIOTHERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. For example, in August 2025, we entered into a Sale Agreement with Jefferies with respect to an at the market offering program, under which we may, from time to time, issue and sell up to $350.0 million of our common stock, and we may offer additional shares under our automatic shelf registration statement in the future…
  98. IRDOpus Genetics, Inc.8-KOtros hechos relevantesEDGAR
  99. IRDOpus Genetics, Inc.8-KNuevo acuerdo materialEDGAR
  100. IRONDisc Medicine, Inc.8-KResultadosEDGAR
  101. IRONDisc Medicine, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…volatile. • We have incurred and will continue to incur increased costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies. • We have identified a material weakness in our internal controls over financial reporting and may identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, which may result…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…48.9999 per pre-funded warrant. As of September 30, 2025, none of the 204,081 pre-funded warrants had been exercised. ATM Programs Cantor Fitzgerald & Co. (“Cantor”) On November 15, 2024, the Company entered into a Controlled Equity Offering Sales Agreement (the “Cantor ATM Agreement”) with Cantor, pursuant to which the Company may, from time to time in its sole discretion, issue and sell to or through Cantor, acting as sales agent, shares of the Company’s common stock, par value…
  102. IVVDInvivyd, Inc.8-KResultadosEDGAR
  103. IVVDInvivyd, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…and compliance-reporting capabilities. It is uncertain when, if ever, the Company will generate substantial revenue from product sales to be able to fund its operating expenses and capital requirements. Substantial Doubt about Ability to Continue as a Going Concern The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in…
  104. JANXJanux Therapeutics, Inc.8-KResultadosEDGAR
  105. JANXJanux Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…can be reasonably estimated. As of September 30, 2025, the Company is not currently party to any material legal proceedings. 4. Stockholders’ Equity Shelf Registration Statement In May 2023, the Company entered into an ATM Equity OfferingSM Sales Agreement (“Sale Agreement”) with BofA Securities, Inc. (“BofA”) to sell shares of common stock, from time to time, through an “at the market offering” program having an aggregate offering price of up to $150.0…
  106. KYNBKYNTRA BIO, INC.8-KOtros hechos relevantesEDGAR
  107. LBRXLB PHARMACEUTICALS INC8-KResultadosEDGAR
  108. LBRXLB PHARMACEUTICALS INC10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…a net loss of $3.6 million and $13.7 million, respectively, and used $17.1 million of cash in operating activities for the nine months ended September 30, 2025. In prior periods, these factors raised substantial doubt about the Company’s ability to continue as a going concern. Based on the Company’s current operating plan, management estimates that its existing cash, cash equivalents and marketable securities of $314.5 million as of September 30, 2025, will be sufficient to…
  109. LFCRLIFECORE BIOMEDICAL, INC. \DE\8-KResultadosEDGAR
  110. LFCRLIFECORE BIOMEDICAL, INC. \DE\10-QInforme trimestralEDGAR
  111. LGNDLIGAND PHARMACEUTICALS INC8-KResultadosEDGAR
  112. LNTHLantheus Holdings, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…384.0 million, GAAP fully diluted earnings per share of $0.41, adjusted fully diluted earnings per share of $1.27 and free cash flow of $94.7 million • Separately announced upcoming retirement of CEO, departure of President and appointment of prior CEO to Executive Chairperson; Board conducting CEO search • Announced PDUFA dates for its new formulation of piflufolastat F 18 PSMA PET imaging agent; for MK-6240, its F 18 tau-targeted positron emission…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…and pediatric patients. • In October, the Company announced the FDA has accepted its New Drug Application (NDA) for MK-6240, the Company’s F 18-labeled tau-targeted PET imaging agent. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics. The FDA has set a PDUFA target action date of August 13, 2026. • In August, the Company announced the…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…tau-targeted PET imaging agent. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics. The FDA has set a PDUFA target action date of August 13, 2026. • In August, the Company announced the FDA acceptance of its NDA for a new formulation of piflufolastat F 18 PSMA PET imaging agent. In addition to increasing batch size – potentially enabling increased…
  113. LNTHLantheus Holdings, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…holding a cumulative 19.90% of the outstanding Perspective Shares (or 17.35% on a fully diluted basis) after giving effect to the closing of the private placement transaction. On June 14, 2024, Perspective effected a 1-for-10 reverse stock split, after which the Company held 11,677,339 shares of Perspective’s common stock. At September 30, 2025, the Company held 11,677,339 Perspective Shares, which represents approximately 16.0% of Perspective…
  114. LONALeonaBio, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…equity 26,786 44,841 Total liabilities and stockholders' equity $ 30,033 $ 58,779 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. (1)The Company effected a reverse stock split of its outstanding shares of common stock on September 17, 2025 where every ten shares of its common stock issued and outstanding was converted into one share of common stock. Any fractional post-split…
  115. LPCNLipocine Inc.10-QInforme trimestralEDGAR
  116. LPCNLipocine Inc.8-KResultadosEDGAR
  117. LSTALISATA THERAPEUTICS, INC.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, RNA-based therapeutics, and Antibody-Drug Conjugates (“ADCs”) in solid tumor models. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received…
  118. LSTALISATA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…lease payments — Less: Amounts representing interest — Present value of lease liabilities $ — Note 9 – Stockholders' Equity Equity Issuances At The Market Offering Agreement On June 4, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent, in connection with an “at the market offering” under which the Company from time to time may offer and sell shares of its…
  119. LXRXLEXICON PHARMACEUTICALS, INC.8-KResultadosEDGAR
  120. LXRXLEXICON PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
  121. LXRXLEXICON PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
  122. MAZEMaze Therapeutics, Inc.8-KResultadosEDGAR
  123. MAZEMaze Therapeutics, Inc.10-QInforme trimestralEDGAR
  124. MBXMBX Biosciences, Inc.8-KResultadosEDGAR
  125. MBXMBX Biosciences, Inc.10-QInforme trimestralEDGAR
  126. MRNAModerna, Inc.8-KResultadosEDGAR
  127. MRNAModerna, Inc.10-QInforme trimestralEDGAR
  128. MRVIMARAVAI LIFESCIENCES HOLDINGS, INC.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…research and development funding caused by changes in U.S. public health policy and the spending priorities of the U.S. federal government. •Unintended consequences from our recent organizational changes and workforce reduction. •Use of Maravai’s products by customers in the production of vaccines and therapies, some of which represent relatively new and still-developing modes of treatment, and the impact of unforeseen adverse…
  129. MTVAMetaVia Inc.8-KResultadosEDGAR
  130. MTVAMetaVia Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…2025. Due in large part to the ongoing clinical trials, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these condensed consolidated financial statements. We plan to continue to fund our operations from equity offerings, debt financing, exercise of existing warrants…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Equity Securities and Use of Proceeds None. ​ Item 3.Defaults Upon Senior Securities None. ​ Item 4.Mine Safety Disclosures Not applicable. ​ Item 5.Other Information On November 6, 2025, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with Ladenburg Thalmann & Co. Inc., as sales agent and/or principal (“Ladenburg”), pursuant to which the Company may offer and sell, from time to time through or to Ladenburg…
  131. MTVAMetaVia Inc.8-KOtros hechos relevantesEDGAR
  132. NAGENiagen Bioscience, Inc.8-KOtros hechos relevantesEDGAR
  133. NATRNATURES SUNSHINE PRODUCTS INC10-QInforme trimestralEDGAR
  134. NATRNATURES SUNSHINE PRODUCTS INC8-KResultadosEDGAR
  135. NKTRNEKTAR THERAPEUTICS8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…rezpegaldesleukin in atopic dermatitis in a late-breaker oral presentation at European Academy of Dermatology and Venereology (EADV) 2025 Congress. · In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very-severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. · In July of 2025, Nektar…
  136. NMRANeumora Therapeutics, Inc.8-KResultadosEDGAR
  137. NMRANeumora Therapeutics, Inc.10-QInforme trimestralEDGAR
  138. NTHINEONC TECHNOLOGIES HOLDINGS, INC.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced that its Board of Directors has appointed Amir Heshmatpour as Chief Executive Officer. Mr. Heshmatpour, who was appointed President in April, will assume the CEO role effective immediately, continuing to serve as Executive Chairman of the Board. Dr. Thomas Chen, the company’s founder,…
  139. NTLAIntellia Therapeutics, Inc.10-QInforme trimestralEDGAR
  140. NVAXNOVAVAX INC10-QInforme trimestralEDGAR
  141. NVAXNOVAVAX INC8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…distribution of our COVID-19 vaccine. 2.Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to our license partners. 3.Sanofi includes revenue recognized under our license agreement including upfront payments, milestones, royalties and transition services reimbursement. 4.Other Partners include upfront payments, royalties and milestone revenue under our licensing agreements including Serum Institute…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…U.S. markets. •In October 2025, Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid™ in combination with both Fluzone High-Dose and Flublok. Both programs have received Fast Track designation from the U.S. Food and Drug Administration (FDA). 1 •In August 2025, the FDA approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years…
  142. OKUROnKure Therapeutics, Inc.8-KResultadosEDGAR
  143. OKUROnKure Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…liability company and a direct, wholly owned subsidiary of Reneo (“Merger Sub II”), and OnKure, Inc., a Delaware corporation (“Legacy OnKure”). Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10 (the “Reverse Stock Split”), (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as Class A Common…
  144. OKUROnKure Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
  145. ONCBeOne Medicines Ltd.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…the treatment of first-line gastric cancer (GC). •Achieved submission in Japan for the treatment of first-line GC. Exhibit 99.1 Select Clinical-Stage Programs Hematology •Sonrotoclax (BCL2 inhibitor): ◦Received FDA Breakthrough Therapy Designation as a treatment for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). ◦Completed enrollment of Phase 2 trial for the treatment of adult patients with R/R Waldenstrom’s macroglobulinemia…
  146. ONCBeOne Medicines Ltd.10-QInforme trimestralEDGAR
  147. ORGOOrganogenesis Holdings Inc.8-KResultadosEDGAR
  148. ORGOOrganogenesis Holdings Inc.10-QInforme trimestralEDGAR
  149. PBYIPUMA BIOTECHNOLOGY, INC.8-KResultadosEDGAR
  150. PBYIPUMA BIOTECHNOLOGY, INC.10-QInforme trimestralEDGAR
  151. PCRXPacira BioSciences, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…million of expense will be recognized and paid over three years pursuant to a key employee holdback agreement in increments of 50%, 30% and 20% at each year’s respective anniversary. (10) The Company appointed a new chief executive officer (“CEO”) effective January 2, 2024. During the three and nine months ended September 30, 2024, CEO transition costs included compensation costs related to the transition of the former CEO. (11) In July…
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you…
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve…
  152. PCRXPacira BioSciences, Inc.10-QInforme trimestralEDGAR
  153. PCSAProcessa Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…statements are available to be issued based on the timing and amount of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result, substantial doubt exists about our ability to continue as a going concern within one year after the date that these consolidated financial statements are available to be issued. The accompanying consolidated financial statements do not include any adjustments to reflect the…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…trading market for our shares; ● a limited amount of news and analyst coverage; and ● a decreased ability to issue additional securities or obtain additional financing in the future. On February 4, 2025, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) notifying us that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock has been below the minimum…
    En el documentoContrasplit de accionestexto original ▸…regain compliance with Rule 5550(a)(2). On August 7, 2025, Nasdaq granted us an additional 180 calendar days, or through February 2, 2026, to regain compliance. On September 11, 2025, our stockholders approved a reverse stock split of our common stock in order to attempt to regain compliance with Rule 5550(a)(2). We may be unable to complete the Reverse Stock Split, and even if we do, we may still be unable to meet the minimum bid…
  154. PLRXPLIANT THERAPEUTICS, INC.8-KResultadosEDGAR
  155. PLRXPLIANT THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion on the effectiveness of our internal control, including as a result of any identified material weakness, we could lose investor confidence in the accuracy and completeness of our financial reports, which would cause the 67 price of our common stock to decline, and we may be subject to investigation or sanctions…
  156. PRTAPROTHENA CORP PUBLIC LTD CO8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…NCT06268886) •Bristol Myers Squibb is also conducting a Phase 1 open-label single-dose clinical trial to assess a subcutaneous administration; primary completion expected in 2H 2025 (NCT06955741) •BMS-986446 granted Fast Track designation by U.S. FDA as a treatment for Alzheimer’s disease PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb. •Bristol Myers Squibb obtained…
  157. PRTAPROTHENA CORP PUBLIC LTD CO10-QInforme trimestralEDGAR
  158. PTGXProtagonist Therapeutics, Inc8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…oral presentation of the durability of response and safety results through week 52 from the VERIFY study. · On August 25th, the Company and its partner Takeda Pharmaceuticals announced rusfertide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with PV. · Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals…
  159. PTGXProtagonist Therapeutics, Inc10-QInforme trimestralEDGAR
  160. PTNPALATIN TECHNOLOGIES INC8-KNuevo acuerdo materialEDGAR
  161. QDELQuidelOrtho Corp10-QInforme trimestralEDGAR
  162. QNRXQuoin Pharmaceuticals Ltd.8-KResultadosEDGAR
  163. QNRXQuoin Pharmaceuticals Ltd.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…regained compliance with Listing Rule 5550(a)(2) and the matter was closed. Nasdaq Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet the Minimum Bid Price Requirement and has effected a reverse stock split over the prior one-year period, or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, will not be eligible for an automatic…
  164. RANIRani Therapeutics Holdings, Inc.8-KResultadosEDGAR
  165. RANIRani Therapeutics Holdings, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…2025, had negative cash flows from operations of $19.0 million. As of September 30, 2025, cash, cash equivalents, and restricted cash equivalents totaled $4.6 million. While these factors had raised substantial doubt about our ability to continue as a going concern, after September 30, 2025, as disclosed in more detail in Note 16, the Company entered into various financing agreements and a license and collaboration agreement in October 2025. The Company believes…
  166. RAPPRapport Therapeutics, Inc.8-KResultadosEDGAR
  167. RAPPRapport Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…entered into a common stock sales agreement, dated July 1, 2025, by and between the Company and Leerink Partners LLC and Cantor Fitzgerald & Co., acting as sales agents (the “Sales Agreement”), which established an at-the-market offering program pursuant to which the Company may offer and sell shares of its common stock from time to time (the “ATM Program”). In connection with the ATM Program, the Company also filed a prospectus with…
  168. RCKTROCKET PHARMACEUTICALS, INC.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…of the BLA for KRESLADITM (marnetegragene autotemcel; marne-cel) for the treatment of severe leukocyte adhesion deficiency-I (LAD-I). o In October, KRESLADITMreceived a Prescription Drug User Fee Act (PDUFA) target action date for March 28, 2026. o Rocket is eligible for a Rare Pediatric Disease Priority Review Voucher (PRV), with the approval of KRESLADI™. • Leadership updates with several key appointments to support Rocket’s transition toward…
  169. RCKTROCKET PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
  170. REPLReplimune Group, Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Company announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the BLA resubmission of RP1 for the treatment of advanced melanoma with a Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026. The resubmission is considered by the FDA to be a complete response to the complete response letter received on July 21, 2025. In the Type A meeting minutes, the FDA indicated that the IGNYTE-3 trial…
  171. REPLReplimune Group, Inc.10-QInforme trimestralEDGAR
  172. REVBREVELATION BIOSCIENCES, INC.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…California. The Company’s common stock and public warrants are listed on the Nasdaq Capital Market under the symbols “REVB” and “REVBW”, respectively. Reverse Stock Split On January 28, 2025, the Company effected the approved 1-for-16 reverse stock split of our shares of common stock. On July 7, 2025, the Company effected the approved 1-for-3 reverse stock split of our shares of common stock. Unless specifically provided otherwise herein, the share and…
  173. REVBREVELATION BIOSCIENCES, INC.8-KResultadosEDGAR
  174. RGNXREGENXBIO Inc.10-QInforme trimestralEDGAR
  175. RGNXREGENXBIO Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…functional outcomes across multiple natural history methods of measurement, when decline is expected • Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; PDUFA date February 8, 2026 • Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy for chronic retinal disease o Enrollment completed in pivotal trials evaluating subretinal delivery of sura-vec in wet…
  176. RLAYRelay Therapeutics, Inc.8-KResultadosEDGAR
  177. RLAYRelay Therapeutics, Inc.10-QInforme trimestralEDGAR
  178. RLYBRallybio Corp8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…primarily due to a decrease in development costs related to RLYB212 and other program candidates, in addition to a decrease in payroll and personnel-related expenses, largely related to the Company's workforce reduction announced in May 2025; offset by an increase in development costs related to RLYB116. •General & Administrative (G&A) Expenses: G&A expenses were $3.0 million for the third quarter of 2025, compared to…
  179. RLYBRallybio Corp10-QInforme trimestralEDGAR
  180. RNACCartesian Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis…
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a…
  181. RNACCartesian Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…at a ratio in the range of 1-for-20 and 1-for-30, with such ratio to be determined at the discretion of the Company’s board of directors, or the Board of Directors. The Board of Directors subsequently approved a final reverse stock split ratio of 1-for-30, and the Company effected the Reverse Stock Split on April 4, 2024. As a result of the Reverse Stock Split, all figures in this Quarterly Report on Form 10-Q relating to shares of the…
  182. RZLTRezolute, Inc.8-KResultadosEDGAR
  183. RZLTRezolute, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…of the 2024 Private Placement occurred in July 2024, resulting in net proceeds of $6.0 million. Jefferies Open Market Sales Agreement On November 14, 2023, the Company and Jefferies LLC (the “Agent”) entered into an open market sales agreement (the “Sales Agreement”) that provides for an “at the market” offering for the sale of up to $50.0 million in shares of the Company’s common stock (the “Placement Shares”) through the Agent. The Agent was acting as sales agent and was required to use commercially reasonable…
  184. SANASana Biotechnology, Inc.8-KResultadosEDGAR
  185. SANASana Biotechnology, Inc.10-QInforme trimestralEDGAR
  186. SIGASIGA TECHNOLOGIES INC8-KResultadosEDGAR
  187. SIGASIGA TECHNOLOGIES INC10-QInforme trimestralEDGAR
  188. SLNSilence Therapeutics plc8-KResultadosEDGAR
  189. SLNSilence Therapeutics plc10-QInforme trimestralEDGAR
  190. SRPTSarepta Therapeutics, Inc.10-QInforme trimestralEDGAR
  191. STROSUTRO BIOPHARMA, INC.8-KResultadosEDGAR
  192. STROSUTRO BIOPHARMA, INC.10-QInforme trimestralEDGAR
  193. STTKShattuck Labs, Inc.8-KResultadosEDGAR
  194. STTKShattuck Labs, Inc.10-QInforme trimestralEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…to commercialize our product candidates. In addition, we may not be profitable even if we commercialize any of our product candidates. Recent Developments As previously reported, on August 8, 2025, we received written notice from Nasdaq that we were not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on Nasdaq for failure to maintain a minimum closing bid price of $1.00 per share. To regain compliance, the closing bid price…
  195. STTKShattuck Labs, Inc.8-K/AResultadosEDGAR
  196. SUPNSUPERNUS PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
  197. TECXTectonic Therapeutic, Inc.8-KResultadosEDGAR
  198. TECXTectonic Therapeutic, Inc.10-QInforme trimestralEDGAR
  199. TKNOAlpha Teknova, Inc.8-KResultadosEDGAR
  200. TRDAEntrada Therapeutics, Inc.8-KResultadosEDGAR
  201. TRDAEntrada Therapeutics, Inc.10-QInforme trimestralEDGAR
  202. URGNUroGen Pharma Ltd.8-KResultadosEDGAR
  203. URGNUroGen Pharma Ltd.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…legally available, when and if declared by the Board of Directors (the “Board”). Since the Company's inception, the Board has not declared any dividends. ATM Sales Agreement In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with Cowen and Company, LLC (“Cowen”) pursuant to which the Company may from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $100.0 million. During…
  204. VCELVericel Corp8-KResultadosEDGAR
  205. VCELVericel Corp10-QInforme trimestralEDGAR
  206. VERAVera Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  207. VIVSVivoSim Labs, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…and cost of commercializing drug candidates and may affect the prices that can be charged if drug candidates are approved for commercialization. • Management has performed an analysis and concluded that substantial doubt exists about our ability to continue as a going concern. Separately, our independent registered public accounting firm has included in its opinion for the year 28 ended March 31, 2025 an explanatory paragraph expressing substantial doubt in our ability to…
  208. VTRSViatris Inc8-KResultadosEDGAR
  209. VTRSViatris Inc10-QInforme trimestralEDGAR
  210. VTVTvTv Therapeutics Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). Cadisegliatin is under investigation, and the safety and efficacy have not been established. There is no guarantee that this product will receive health…
  211. VTVTvTv Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…TD Cowen ATM Offering for net proceeds of $2.5 million. As of the issuance date of the Company’s June 30, 2025 Form 10-Q, the Company disclosed, as required under applicable accounting standards, that substantial doubt existed surrounding the Company’s ability to continue as a going concern within one year of the issuance date of the June 30, 2025, condensed consolidated financial statements. Based on the cash and cash equivalents currently available to the Company as discussed above, the…
  212. WHWKWhitehawk Therapeutics, Inc.8-KResultadosEDGAR
  213. WHWKWhitehawk Therapeutics, Inc.10-QInforme trimestralEDGAR
  214. XERSXeris Biopharma Holdings, Inc.8-KResultadosEDGAR
  215. XERSXeris Biopharma Holdings, Inc.10-QInforme trimestralEDGAR
  216. YARWYarrow Bioscience, Inc.10-QInforme trimestralEDGAR
  217. ZLABZai Lab Ltd10-QInforme trimestralEDGAR
  218. ZYMEZymeworks Inc.10-QInforme trimestralEDGAR

Juntas de accionistas

  1. JUNSJUPITER NEUROSCIENCES, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

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