Saltar al contenido
PivotalWire
Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Martes 4 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, martes 4 de noviembre de 2025

Los 103 documentos que 62 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. ONCOOnconetix, Inc.S-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…assurance that additional capital will be available to us on acceptable terms, or at all, or that we will ever generate revenue sufficient to provide self-sustaining cash flows. These circumstances raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements incorporated by reference in this prospectus do not include any adjustment that might be necessary if the Company is unable to continue as a going concern…
    En el documentoContrasplit de accionestexto original ▸…in this prospectus do not include any adjustment that might be necessary if the Company is unable to continue as a going concern. 2 Recent Developments Reverse Stock Split On June 13, 2025, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-eighty-five (1:85). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards…
  2. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…86. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On November 3, 2025, the closing sale price per warrant of our Public Warrants was $0.22. On April 15, 2025, we effected a reverse stock split of our Common Stock at a ratio of 1-for-35 (the “Reverse Stock Split”). Unless otherwise noted, the share and per share information in the Prospectuses and this prospectus supplement reflects the effect…
  3. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…86. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On November 3, 2025, the closing sale price per warrant of our Public Warrants was $0.22. On April 15, 2025, we effected a reverse stock split of our Common Stock at a ratio of 1-for-35 (the “Reverse Stock Split”). Unless otherwise noted, the share and per share information in the Prospectuses and this prospectus supplement reflects the effect…
  4. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…86. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On November 3, 2025, the closing sale price per warrant of our Public Warrants was $0.22. On April 15, 2025, we effected a reverse stock split of our Common Stock at a ratio of 1-for-35 (the “Reverse Stock Split”). Unless otherwise noted, the share and per share information in the Prospectuses and this prospectus supplement reflects the effect…
  5. SPRCSciSparc Ltd.424B3Prospecto suplementario o de reventaEDGAR
  6. TSHATaysha Gene Therapies, Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

  1. DBVTDBV Technologies S.A.SC 13D/ACambio en participación significativaEDGAR
  2. HOWLWerewolf Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. MIRMMirum Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. MPLTMapLight Therapeutics, Inc.SC 13DCambio en participación significativaEDGAR
  5. NAMSNewAmsterdam Pharma Co N.V.SC 13D/ACambio en participación significativaEDGAR
  6. PHATPhathom Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. AMGNAMGEN INC8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…Biosimilars •A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) in patients with resected stage III or stage IV melanoma in the adjuvant setting met the primary endpoint of pharmacokinetic similarity. •A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma. •A…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…submission of DeLLphi 304 a global Phase 3 confirmatory study evaluating IMDELLTRA vs. standard of care in subjects with relapsed ES-SCLC after platinum-based first-line chemotherapy was accepted with a PDUFA date of December 18, 2025. Regulatory reviews are also underway in a number of additional geographies. •The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage…
  2. HRMYHarmony Biosciences Holdings, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸…encephalopathies (DEEs) confirmed via non-clinical and clinical data ● Currently in the IND-enabling stage ​ Neurobehavioral Franchise ​ ZYN002 ● The ZYN002 phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate; a review of the full data set is ongoing ● The ZYN002 development program in 22q11.2 deletion syndrome…
    En el documentoDesignación de medicamento huérfanotexto original ▸…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS. About Fragile X Syndrome ​ ​ ​ ​ ​ Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited…
  3. PRLDPrelude Therapeutics Inc8-KVenta de acciones no registrada (colocación privada)EDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers On November 4, 2025, the Company announced that Jane Huang, M.D. resigned as the President and Chief Medical Officer of the Company, effective on November 3, 2025 (the “Separation Date”). Dr. Huang’s resignation was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies…
  4. TARSTarsus Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular…
  5. AARDAardvark Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  6. ABSIAbsci Corp8-KNuevo acuerdo materialEDGAR
  7. ANABANAPTYSBIO, INC8-KResultadosEDGAR
  8. ANABANAPTYSBIO, INC10-QInforme trimestralEDGAR
  9. AUPHAurinia Pharmaceuticals Inc.10-QInforme trimestralEDGAR
  10. AUPHAurinia Pharmaceuticals Inc.8-KResultadosEDGAR
  11. BCRXBIOCRYST PHARMACEUTICALS INC10-QInforme trimestralEDGAR
  12. BEAMBeam Therapeutics Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…in the first cohort in Part B of the trial, designed to evaluate AATD patients with mild to moderate liver disease with or without lung disease. • In August, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101 for the treatment of SCD. The designation is designed to support the development and evaluation of regenerative medicines, with the intention of addressing serious or life…
  13. BEAMBeam Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…underwriting discounts, commissions and approximately $0.8million related to legal, accounting and other fees in connection with the offering. Refer to Note 9 for further information. The Company has entered into an at the market sales agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, pursuant to which the Company is entitled to offer and sell, from time to time at prevailing market prices, shares of its common stock having…
  14. BMEABiomea Fusion, Inc.8-KResultadosEDGAR
  15. BMEABiomea Fusion, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…political conditions, inflationary pressures, increases in interest rates and disruptions to and volatility in the credit and financial markets in the United States and worldwide or other factors. There is substantial doubt about our ability to continue as a going concern. To date, we have not generated any revenues from product sales and have incurred significant operating losses in each year since our inception and we anticipate that losses may continue for the next…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…2.50 23,000,000 23,550,000 There were no warrants exercised during the three and nine months ended September 30, 2025. ATM Offering Agreement with Piper Sandler & Co. On November 25, 2022, the Company entered into an equity distribution agreement (the 2022 ATM Agreement) with Piper Sandler & Co. (Piper Sandler), as sales agent, with respect to an ATM offering program (the 2022 ATM Offering Program). Pursuant to the prospectus supplement relating to the Offering (as defined…
  16. CMPSCOMPASS Pathways plc8-KResultadosEDGAR
  17. CMPSCOMPASS Pathways plc10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…dated October 8, 2021, through February 27, 2025, the Company sold 5,491,836 ADSs under the Company’s ATM offering program, resulting in $54.8 million in net proceeds. On February 27, 2025, the Company entered into a new Sales Agreement to govern the Company’s ATM offering program with TD Cowen, or the Sales Agreement, under which the Company may issue and sell from time to time up to $150.0 million of our ADSs, subject to the terms of the Sales Agreement. Sales of its…
  18. CORTCORCEPT THERAPEUTICS INC8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Development “We are approaching important clinical development milestones,” said Dr. Belanoff. “Our New Drug Application (NDA) for relacorilant in hypercortisolism has a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025. The PDUFA date for our NDA for relacorilant in platinum-resistant ovarian cancer is July 11, 2026. We believe both deadlines will be met. In addition, our clinical studies will soon produce important…
  19. CORTCORCEPT THERAPEUTICS INC10-QInforme trimestralEDGAR
  20. CPIXCUMBERLAND PHARMACEUTICALS INC8-KResultadosEDGAR
  21. CRVOCervoMed Inc.8-KOtros hechos relevantesEDGAR
  22. CRVSCorvus Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…at all. Failure to manage discretionary spending or raise additional capital, as needed, may adversely impact the Company’s ability to achieve its intended business objectives. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that…
  23. CRVSCorvus Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. The final data from the Company…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. The final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients…
  24. CYRXCryoport, Inc.8-KResultadosEDGAR
  25. EXELEXELIXIS, INC.8-KResultadosEDGAR
  26. EXELEXELIXIS, INC.10-QInforme trimestralEDGAR
  27. GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
  28. HOWLWerewolf Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…clinical programs, WTX-124 and WTX-330, and our first INDUCER T-cell engager candidate, WTX-1011,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. “For WTX-124, which received Fast Track Designation last month, we plan to provide an update later in the fourth quarter of 2025 on the path to a registration-enabling trial based on interim Phase 1/1b clinical trial data and feedback from an End of Phase…
  29. HOWLWerewolf Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…concern for at least twelve months from the date these condensed consolidated financial statements are issued in this Form 10-Q. We are currently evaluating plans to mitigate the conditions which raise substantial doubt about our ability to continue as a going concern. We will be required to raise additional funds through an additional public equity financing, establish collaborations with or license our technology to other companies, or seek alternative means of financial…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…the Nasdaq Stock Market LLC, or Nasdaq, including, among other things, maintaining a minimum closing bid price of $1.00 per share, referred to as the minimum bid price requirement. On May 13, 2025, we received a deficiency letter from the Nasdaq Listing Qualifications Department notifying us that we had failed to meet the bid price requirement. Subsequently, the closing bid price of our common stock was at least $1.00 per share…
  30. HRMYHarmony Biosciences Holdings, Inc.10-QInforme trimestralEDGAR
  31. HRTXHERON THERAPEUTICS, INC. /DE/8-KResultadosEDGAR
  32. HRTXHERON THERAPEUTICS, INC. /DE/10-QInforme trimestralEDGAR
  33. HURATuHURA Biosciences, Inc./NV8-KNuevo acuerdo materialEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 1.01. Entry into a Material Definitive Agreement. On November 3, 2025, TuHURA Biosciences, Inc. (the “Company”) entered into an At The Market Offering Agreement (the “Offering Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) with respect to an at the market offering program under which the Company may offer and sell shares of its common stock…
  34. IBIOiBio, Inc.8-KOtros hechos relevantesEDGAR
  35. ICCCIMMUCELL CORP /DE/8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…on Form 8-K filed on September 30, 2025, the Company elected Olivier te Boekhorst to serve as its President and Chief Executive Officer starting on November 1, 2025. As of that date, Michael F. Brigham stepped down as President, CEO, Secretary, and Treasurer and assumed the position of Special Advisor to the CEO. In connection with the foregoing changes, the Company’s Board of Directors voted on October 29, 2025 to expand the size…
  36. IDYAIDEAYA Biosciences, Inc.8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…clearance for IDE892 (PRMT5) received in 3Q 2025; IND filing for IDE034 (B7H3/PTK7 bispecific TOP1i ADC) complete, with IND filing for IDE574 (KAT6/7) on track for year-end 2025 • Entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States; IDEAYA received $210 million upfront and is eligible for up to $320 million in milestone payments • ~$1.14 billion of cash, cash equivalents, and marketable securities as of September 30, 2025; expected to fund operations into 2030 SOUTH…
  37. IDYAIDEAYA Biosciences, Inc.10-QInforme trimestralEDGAR
  38. KTTAPasithea Therapeutics Corp.8-KOtros hechos relevantesEDGAR
  39. KURAKura Oncology, Inc.8-KResultadosEDGAR
  40. KURAKura Oncology, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…As of September 30, 2025, pre-funded warrants to purchase 6,478,301 of such shares of common stock from the Private Placement had been exercised and 840,585 remained outstanding. In November 2023, we entered into the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our…
  41. KYMRKymera Therapeutics, Inc.8-KResultadosEDGAR
  42. KYMRKymera Therapeutics, Inc.10-QInforme trimestralEDGAR
  43. LABSTANDARD BIOTOOLS INC.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…results for the quarter ended September 30, 2025. Recent Highlights: • Third quarter 2025 total combined company revenue of $46.2 million; Revenue from continuing operations of $19.6 million • Implemented restructuring plan expected to deliver over $40 million in annualized cost savings; On track to achieve positive adjusted EBITDA target in 2026 • $217.0 million in cash & cash equivalents as of September 30, 2025; Approximately…
  44. LABSTANDARD BIOTOOLS INC.10-QInforme trimestralEDGAR
  45. LFVNLifevantage Corp10-QInforme trimestralEDGAR
  46. LFVNLifevantage Corp8-KResultadosEDGAR
  47. LGVNLongeveron Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. 2. Summary of Significant Accounting Policies Basis of Presentation: The condensed financial statements of the Company were prepared in accordance with U.S. GAAP. Certain reclassifications have been…
    En el documentoContrasplit de accionestexto original ▸…used in the current period presentation. These reclassifications had no impact on net loss, stockholders’ equity or cash flows as previously reported. Reverse Stock Split: On March 26, 2024, the Company effected a reverse stock split of the outstanding shares of its Class A common stock and Class B common stock on a one-for-10 (1:10) basis (the “Reverse Stock Split”). The Reverse Stock Split became effective at 11:59 p.m. Eastern…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…gross proceeds to the Company from the offering were approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. On September 19, 2025, we entered into an At The Market Offering Agreement (the “ATM Agreement”) providing for the sale and issuance by the Company of shares of Class A common stock from time to time, through or to H.C. Wainwright & Co., LLC (“Wainwright) as the Company…
  48. LGVNLongeveron Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…an additional $12.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants. ● In September, the Company announced key leadership updates with Than Powell being appointed Interim Chief Executive Officer, and Dr. Joshua Hare being appointed Executive Chairman of the Board of Directors. ● In October, the Company announced that George Paletta, Jr., MD, MBA, has been elected to the Longeveron Board of Directors…
    En el documentoDesignación de medicamento huérfanotexto original ▸…the trial experienced 100% transplant-free survival up to five years of age after receiving laromestrocel compared to approximate 20% mortality rate observed from historical control data. ● The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…the trial experienced 100% transplant-free survival up to five years of age after receiving laromestrocel compared to approximate 20% mortality rate observed from historical control data. ● The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited…
  49. LPCNLipocine Inc.8-KOtros hechos relevantesEDGAR
  50. MDGLMADRIGAL PHARMACEUTICALS, INC.8-KResultadosEDGAR
  51. MDGLMADRIGAL PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Warrants may increase or decrease this percentage, but not in excess of 19.99%, by providing at least 61 days prior notice to the Company. At-The-Market Issuance Sales Agreement In May 2024, the Company entered into an at-the-market sales agreement (the “2024 Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company could, from time to time, issue and sell shares of its common stock. Pursuant to the 2024 Sales Agreement…
  52. MIRMMirum Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…and improvements in fatigue for patients treated with volixibat. No new safety signals were observed, and the most common adverse event was diarrhea with all cases mild to moderate. Volixibat has been granted breakthrough therapy designation for the treatment of PBC. About CHOLBAM® (cholic acid) capsules The FDA approved CHOLBAM (cholic acid) capsules in March 2015, the first FDA-approved treatment for pediatric and adult patients with bile…
  53. MIRMMirum Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  54. MYGNMYRIAD GENETICS INC8-K/AResultadosEDGAR
  55. MYGNMYRIAD GENETICS INC10-QInforme trimestralEDGAR
  56. NAGENiagen Bioscience, Inc.10-QInforme trimestralEDGAR
  57. NAGENiagen Bioscience, Inc.8-KResultadosEDGAR
  58. NVAXNOVAVAX INC8-KOtros hechos relevantesEDGAR
  59. NVCTNuvectis Pharma, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Statement, we may offer and sell securities having an aggregate public offering price of up to $150.0 million. In connection with the 22 Table of Contents filing of the Registration Statement, we also entered into a at-the-market sales agreement with H. C. Wainwright & Co. (the “Sales Agent”), pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $40.0 million under an at-the-market offering…
  60. NVCTNuvectis Pharma, Inc.8-KResultadosEDGAR
  61. OABIOmniAb, Inc.8-KResultadosEDGAR
  62. OABIOmniAb, Inc.10-QInforme trimestralEDGAR
  63. OCULOCULAR THERAPEUTIX, INC8-KResultadosEDGAR

    Ocular Therapeutix reportó un saldo de caja de 344,8 millones de dólares al 30 de septiembre de 2025, junto con ingresos netos de aproximadamente 445 millones de dólares de una oferta de acciones de octubre de 2025.

    Original en inglés · traducción automáticaCash balance of $344.8 million as of September 30, 2025, together with net proceeds of ~$445 million from October 2025 equity offering, with expected runway into 2028 BEDFORD, MA, November 04, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc.

    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.

  64. OCULOCULAR THERAPEUTIX, INC10-QInforme trimestralEDGAR
  65. PAHCPHIBRO ANIMAL HEALTH CORP8-KOtros hechos relevantesEDGAR
  66. PCVXVaxcyte, Inc.8-KResultadosEDGAR
  67. PCVXVaxcyte, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…stock with $0.001 par value per share, of which 130,029,111 and 124,893,034 shares were issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. ATM Program In July 2021, we entered into an Open Market Sales AgreementSM (the “Original ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), to issue and sell, from time to time at our discretion, shares of our common stock at an aggregate 14 Table of Contents offering price up to $150.0 million through…
  68. PHATPhathom Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
  69. PTCTPTC THERAPEUTICS, INC.8-KResultadosEDGAR
  70. PTCTPTC THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…connection with the Company’s strategic pipeline prioritization and discontinuation of its preclinical and early research programs in its gene therapy platform. 6. Capitalization In August 2019, the Company entered into an At the Market Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald and RBC Capital Markets, LLC (together, the “Sales Agents”), pursuant to which, the Company may offer and sell shares of its common stock…
  71. RAREUltragenyx Pharmaceutical Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…Ltd. (“KKC”) based on net sales of Crysvita® in the United States and Canada under the terms of the Company’s Collaboration and License Agreement with KKC dated as of August 29, 2013, as amended (the “License Agreement”) from and after January 1, 2028 and (ii) 30% of the future royalty payments due to the Company from KKC based on net sales of Crysvita® in the United States and Canada under the terms of the Company’s License Agreement, from and after the date on which the Royalty Cap…
  72. RGENREPLIGEN CORP10-QInforme trimestralEDGAR
  73. RIGLRIGEL PHARMACEUTICALS INC10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…the structure of healthcare payment systems; ● litigation or arbitration; ● economic and other external factors or other disaster or crisis; and ● period-to-period fluctuations in financial results. We completed a reverse stock split of our shares of common stock, which may reduce and may limit the market trading liquidity of the shares due to the reduced number of shares outstanding and may potentially have an anti-takeover effect…
  74. RIGLRIGEL PHARMACEUTICALS INC8-KResultadosEDGAR
  75. RLMDRELMADA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
  76. RYTMRHYTHM PHARMACEUTICALS, INC.8-KResultadosEDGAR
    En el documentoRevisión prioritaria de la FDAtexto original ▸…U.S. Food and Drug Administration (FDA) accepted for filing the Company’s sNDA for setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. The FDA granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2025.Additionally, the European Medicines Agency (EMA) confirmed validation of the Type II variation submission…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. The FDA granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2025.Additionally, the European Medicines Agency (EMA) confirmed validation of the Type II variation submission to the Marketing Authorization Application (MAA) for setmelanotide for the same indication.…
  77. RYTMRHYTHM PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
  78. SCLXScilex Holding Co8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…infrastructure for a secure, efficient Biotech Exchange, allowing for the tokenization, valuation, and seamless trading of biotech data assets while maintaining compliance and privacy standards. According to the licensing agreement, Scilex shall pay a non-refundable upfront license fee in four equal installments of $2.5 million each on or before December 31, 2025, March 31, 2026, June 30, 2026, and September 30, 2026. DataVault will earn sales milestone payments of up to…
  79. STOKStoke Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…protein expression with the aim to maintain or improve vision in patients with ADOA. Stoke has generated preclinical data demonstrating proof-of-mechanism and proof-of-concept for STK-002. STK-002 has been granted orphan drug designation by the FDA as a potential new treatment for ADOA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. About Stoke Therapeutics Stoke Therapeutics (Nasdaq: STOK), is a biotechnology…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…improve neurodevelopment, cognition, and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen to develop and commercialize zorevunersen…
  80. STOKStoke Therapeutics, Inc.10-QInforme trimestralEDGAR
  81. SUPNSUPERNUS PHARMACEUTICALS, INC.8-KResultadosEDGAR
  82. SYRESpyre Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…financial condition and results of operations in a timely and accurate manner, decrease investor confidence in us, and reduce the value of our common stock. For example, in the fourth quarter of 2024, we identified a material weakness in our internal control over financial reporting which resulted in restatements of our previously-issued financial statements to amend certain net loss per share disclosures. •Our business could be adversely…
  83. SYRESpyre Therapeutics, Inc.8-KResultadosEDGAR
  84. TARSTarsus Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies. The 2023 ATM Prospectus covers the sale of up to $100.0 million of our common stock pursuant to an Open Market Sales AgreementTM we entered into with Jefferies in 2021 (the “ATM Sales Agreement”). Under the terms of the 2023 ATM Prospectus and ATM Sales Agreement, Jefferies will act as the Company's sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds…
  85. TNGXTango Therapeutics, Inc.10-QInforme trimestralEDGAR
  86. TNGXTango Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…of malignant glioma • TNG456 is a potent, highly MTAP selective brain-penetrant PRMT5 inhibitor in development for glioblastoma, currently enrolling patients in a Phase 1/2 study. • In October, the FDA granted Orphan Drug Designation (ODD) to TNG456 for the treatment of malignant glioma. This designation provides for a seven-year marketing exclusivity period upon regulatory approval, as well as certain incentives, including federal…
  87. TSHATaysha Gene Therapies, Inc.10-QInforme trimestralEDGAR
  88. TSHATaysha Gene Therapies, Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸EX-99.1 4 d17004dex991.htm EX-99.1 Exhibit 99.1 Taysha Gene Therapies Reports Third Quarter 2025 Financial Results and Provides Corporate Update TSHA-102 granted Breakthrough Therapy designation by FDA Finalized FDA alignment on REVEAL pivotal trial protocol and SAP, including 6-month interim analysis that may expedite BLA submission, which was enabled by the rigorous developmental milestone…
  89. VRTXVERTEX PHARMACEUTICALS INC / MA10-QInforme trimestralEDGAR
  90. VSTMVerastem, Inc.8-KResultadosEDGAR
  91. VSTMVerastem, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…costs related to research and development of its product candidates and commercial activities. As a result of the assessment in accordance with the applicable accounting standards, these conditions raise substantial doubt about the Company’s ability to continue as a going concern for 12 months after the date the condensed consolidated financial statements are issued. The Company expects to finance its operations with its existing cash, cash equivalents and investments, through…

·

Esto mismo, cada mañana y solo de tus empresas. Sigue a las que te interesen y recibe en tu correo lo que presenten ante la SEC, en castellano. Crear una cuenta. ¿Ya tienes cuenta? Entrar.

Esto no son recomendaciones de inversión. Son hechos públicos verificables en su fuente. Lee siempre el documento original antes de decidir nada. Aviso legal.