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

Portada›Lunes 10 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 10 de noviembre de 2025

Los 130 documentos que 87 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. ACXPAcurx Pharmaceuticals, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…share. We are an “emerging growth company” under applicable Securities and Exchange Commission rules and, as such, we are subject to reduced public company reporting requirements. On August 4, 2025, we effected a 1-for-20 reverse stock split pursuant to which every 20 shares of our issued and outstanding common stock were reclassified as one share of common stock (the “Reverse Stock Split”). The Reverse Stock Split had no impact on the par…
  2. BHSTBIOHARVEST SCIENCES INC.424B5Nueva emisión de acciones con precioEDGAR
    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. CAMPCamp4 Therapeutics CorpS-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…2024, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon (which includes an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern described in Note 1 to the consolidated financial statements), included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in reliance…
  4. GNPXGenprex, Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. ONCOOnconetix, Inc.424B3Prospecto suplementario o de reventaEDGAR
    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. 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…
  6. PTNPALATIN TECHNOLOGIES INC424B4Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…statements include, but are not limited to, statements about: ● our significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern; ● our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of economic disruptions; ● our expectation…
    En el documentoContrasplit de accionestexto original ▸…Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-50 reverse stock split of the outstanding shares of our common stock. The Company’s stockholders previously approved the Reverse Stock Split at our annual meeting of stockholders held on July 25, 2025. The Reverse Stock Split became effective after market on August 11, 2025 with the Company’s Common Stock trading on the OTCQB on a split-adjusted…
  7. VORVor Biopharma Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, as set forth in their report (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements), which is incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial statements are incorporated…
    En el documentoContrasplit de accionestexto original ▸…registration statement will not be reviewed or be subject to further review. On August 25, 2025, we held a special meeting of our stockholders and received Stockholder Approval. On September 18, 2025, we effected a reverse stock split of our common stock at a ratio of 1-for-20, without any adjustment to the total number of shares of common stock authorized by our certificate of incorporation. The registration statement of which this…
  8. VORVor Biopharma Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, as set forth in their report (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements), which is incorporated by reference in this prospectus supplement. Our financial statements are incorporated by reference in reliance on…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…preliminary unaudited cash and cash equivalents was approximately $160.5 million. Subsequent to September 30, 2025, we issued and sold 1,370,111 shares pursuant to our “at-the-market” facility that we entered into in December 2022 (the “ATM Facility”) with Stifel, Nicolaus & Company, Incorporated, as sales agent, for net proceeds of $49.8 million. This preliminary financial information reflects our preliminary estimate, based on currently available…
  9. MLYSMineralys Therapeutics, Inc.S-3ASRCapacidad de emisión registradaEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…solicitation. 33 Common Stock Preferred Stock Debt Securities Warrants Units PROSPECTUS November 10, 2025 PROSPECTUS SUPPLEMENT (To Prospectus Dated November 10, 2025) $300,000,000 Common Stock We have entered into an ATM Equity Offering Sales Agreement (the Sales Agreement), with BofA Securities, Inc., Evercore Group L.L.C. and Goldman Sachs & Co. LLC (each, a Sales Agent, and collectively, the Sales Agents), relating to the sale of…
  10. VYGRVoyager Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. BNTCBenitec Biopharma Inc.SC 13D/ACambio en participación significativaEDGAR
  2. IBRXImmunityBio, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. LENZLENZ Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. LGNDLIGAND PHARMACEUTICALS INCSC 13D/ACambio en participación significativaEDGAR
  5. MBXMBX Biosciences, Inc.SC 13D/ACambio en participación significativaEDGAR
  6. MLTXMoonLake ImmunotherapeuticsSC 13D/ACambio en participación significativaEDGAR
  7. NEUPNeuphoria Therapeutics Inc.SC 13D/ACambio en participación significativaEDGAR
  8. PCRXPacira BioSciences, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ANABANAPTYSBIO, INC8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…600mg Q2W: p=0.0062 • 400mg Q4W: p=0.0016 • 100mg Q4W: p=0.0092 ** ** * * Mean Change in DAS28-CRP Over Time MMRM analysis on ITT population (N=424 total; n=106 placebo, n=318 rosnilimab) Rosnilimab met primary endpoint of mean change from baseline in DAS28-CRP at Week 12 for all active doses Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W Placebo • All dose arms demonstrated statistically significant…
  2. APGEApogee Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…APG777 observed statistically significant improvement in itch within 48 hours, as measured by mean percent change in I-NRS from baseline, and remained significant through Week 16. In July, APEX Part A met its primary endpoint, with APG777 demonstrating an EASI reduction from baseline of 71.0% compared to placebo at 33.8% (p < 0.001). APG777 was well tolerated with a safety profile consistent with other agents in the class…
  3. DMRADamora Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. IONSIONIS PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR

    Los resultados del estudio pivotal de olezarsen para hipertrigliceridemia severa mostraron una reducción media ajustada por placebo de hasta el 72% en los niveles de triglicéridos en ayunas a los seis meses, sostenida hasta los 12 meses.

    Original en inglés · traducción automáticaUp to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months

    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.

    Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) anunció hoy resultados positivos de los estudios pivotales de Fase 3 CORE y CORE2 de olezarsen en personas con hipertrigliceridemia severa (sHTG). Los estudios cumplieron el objetivo principal, con olezarsen logrando una reducción media… Sigue en la ficha

    Original en inglés · traducción automáticaIonis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG). The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The reductions were sustained through 12 months.

    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.

  5. KALAKALA BIO, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  6. LYELLyell Immunopharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…cell clinical development to rapidly progress this program, as well as our two pivotal clinical trials evaluating ronde-cel for patients with relapsed or refractory large B-cell lymphoma.” LYL273 was granted Fast Track designation for the treatment of mCRC by the U.S. Food and Drug Administration. The Phase 1 clinical trial is continuing to enroll patients with refractory mCRC to determine the recommended Phase 2 dose. The next…
  7. NTLAIntellia Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

    Intellia presentó datos clínicos positivos de un análisis conjunto de pacientes que recibieron una dosis de 50 mg de lonvo-z en un ensayo de fase 1/2 para angioedema hereditario.

    Original en inglés · traducción automáticapresented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg) dose of lonvo-z in the company’s ongoing Phase 1/2 clinical trial in patients with hereditary angioedema (HAE).

    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.

    La FDA impuso una suspensión clínica a los ensayos MAGNITUDE y MAGNITUDE-2 el 29 de octubre de 2025.

    Original en inglés · traducción revisadaOn October 29, 2025, the United States Food and Drug Administration placed a clinical hold on the investigational new drug applications for the MAGNITUDE and MAGNITUDE-2 trials.

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

    Lonvo-z ha recibido cinco designaciones regulatorias, incluidas Orphan Drug y RMAT de la FDA.

    Original en inglés · traducción automáticaLonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K.

    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.

  8. PPCBPropanc Biopharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  9. QUREuniQure N.V.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…following (data cutoff as of June 30, 2025): o A statistically significant 75% slowing in disease progression measured by the composite Unified Huntington’s Disease Rating Scale (cUHDRS) was observed which met the primary endpoint compared to a propensity score-matched external control (p=.003). ​ o A key secondary endpoint of Total Functional Capacity (TFC) demonstrated a statistically significant 60% slowing of disease progression…
  10. ABOSAcumen Pharmaceuticals, Inc.8-KCambio en el consejo o la direcciónEDGAR
  11. AGENAGENUS INC8-KResultadosEDGAR
  12. AGENAGENUS INC10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…registration and launch strategy for botensilimab/balstilimab. However, because the completion of cash funding transactions is not entirely within our control, and in accordance with accounting standards, substantial doubt continues to exist about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and…
  13. AKBAAkebia Therapeutics, Inc.8-KResultadosEDGAR
  14. AKBAAkebia Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…financial reporting described below. As previously disclosed in our Annual Report on Form 10-K, that was filed with the SEC on March 13, 2025, or 2024 Form 10-K, as of December 31, 2024, our management identified a material weakness in our internal control over financial reporting. Specifically, we did not effectively document controls that operated with a sufficient level of precision to evaluate the completeness, accuracy and reasonableness…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…undesignated preferred stock, $0.00001 par value per share, of which no shares were issued and outstanding as of September 30, 2025 and December 31, 2024. At-the-Market Facility On April 7, 2022, the Company entered into an at-the-market, or ATM, sales agreement, or the Original Sales Agreement, with Jefferies LLC, or Jefferies, as the Company's sales agent, under which the Company could offer and sell from time to time up to $26.0 million of shares of its common…
  15. ANIPANI PHARMACEUTICALS INC8-KResultadosEDGAR
  16. ANNXAnnexon, Inc.8-KResultadosEDGAR
  17. ANNXAnnexon, Inc.10-QInforme trimestralEDGAR
  18. APGEApogee Therapeutics, Inc.10-QInforme trimestralEDGAR
  19. ARCTArcturus Therapeutics Holdings Inc.8-KResultadosEDGAR
  20. ASMBASSEMBLY BIOSCIENCES, INC.8-KResultadosEDGAR
  21. ASMBASSEMBLY BIOSCIENCES, INC.10-QInforme trimestralEDGAR
  22. AVBPArriVent BioPharma, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation.” Dr. Yao continued, “Our antibody-drug conjugate (ADC) portfolio is also advancing with our lead candidate ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal…
  23. AVBPArriVent BioPharma, Inc.10-QInforme trimestralEDGAR
  24. BCAXBicara Therapeutics Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸EX-99.1 2 pressreleaseq32025.htm EX-99.1 Bicara Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Granted FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in…
  25. BCAXBicara Therapeutics Inc.10-QInforme trimestralEDGAR
  26. BCDABioCardia, Inc.8-KOtros hechos relevantesEDGAR
  27. BFRIBiofrontera Inc.8-KOtros hechos relevantesEDGAR
  28. BIVIBIOVIE INC.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…SEC on August 15, 2025 (the “2025 Form 10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2025 Form 10-K. Reverse stock split The Company effected a 1:10 reverse stock split of the issued and outstanding shares of its Common Stock on July 7, 2025 which was approved by the board of directors prior to shareholders’ approval at the special meeting on June 23, 2025. All historical…
  29. BTAIBioXcel Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  30. CABACabaletta Bio, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications. In addition, the FDA has granted new regulatory designations to rese-cel, including Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of systemic lupus erythematosus and lupus nephritis and Fast Track Designation for generalized myasthenia gravis. • FDA alignment on additional registrational cohort…
  31. CABACabaletta Bio, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…success depends in part upon our ability to retain our key employees, consultants and advisors and to attract, retain and motivate other qualified personnel. • We have identified conditions that raise substantial doubt about our ability to continue as a going concern. If we are unable to secure additional funding beyond our current cash position that enables our operations into the second half of 2026, we may be forced to delay, reduce or discontinue our product development…
  32. CAPRCAPRICOR THERAPEUTICS, INC.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials. Deramiocel has received Orphan Drug Designation for the treatment of Duchenne Muscular Dystrophy (DMD) from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation…
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…trials. Deramiocel has received Orphan Drug Designation for the treatment of Duchenne Muscular Dystrophy (DMD) from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher…
  33. CAPRCAPRICOR THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…operations, the Company does not have sufficient cash on hand to support current operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. Therefore, there is a substantial doubt about the Company’s ability to continue as a going concern. The Company’s plan to address its financial position may include potentially seeking additional financing primarily from, but not limited to, the sale and issuance of equity or debt securities, the licensing…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…for resale the shares sold in the Private Placement, which registration statement was declared effective on November 8, 2024. ATM Programs September 2025 ATM Program On September 10, 2025, the Company established an at-the-market offering under a prospectus supplement for aggregate sales proceeds of up to $150.0 million (the “September 2025 ATM Program”), pursuant to an Equity Distribution Agreement with Piper Sandler and Oppenheimer…
  34. CINGCingulate Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…following the U.S. Food and Drug Administration’s (FDA) acceptance of Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) and assignment of a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. Cingulate also announced it has completed a $6 million financing transaction, further strengthening its balance sheet and extending its cash runway into the second quarter of 2026, as the company prepares…
  35. CLDXCelldex Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…statement with the SEC to register for sale any combination of the types of securities described in the shelf registration statement, including shares of its common stock. On February 26, 2024, the Company entered into a controlled equity offering sales agreement (“ATM Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock from time to time through Cantor, acting as agent. Also on February 26, 2024, the Company terminated…
  36. CLDXCelldex Therapeutics, Inc.8-KResultadosEDGAR
  37. COGTCogent Biosciences, Inc.8-KOtros hechos relevantesEDGAR
  38. CRSPCRISPR Therapeutics AG8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…observed. CTX340 is currently in IND/CTA-enabling studies. Autoimmune Disease and Immuno-Oncology • CTX112™, targeting CD19, is being developed for autoimmune disease and hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma. A Phase 1 clinical trial in autoimmune disease…
  39. CRSPCRISPR Therapeutics AG10-QInforme trimestralEDGAR
  40. CRVOCervoMed Inc.8-KResultadosEDGAR
  41. CVKDCadrenal Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…financings on terms acceptable to the Company or at all. As a result, there is uncertainty in the Company’s ability to meet its current operating and capital expenses. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date the accompanying financial statements are issued. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced…
    En el documentoContrasplit de accionestexto original ▸…Company’s stockholders approved an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its shares of common stock, and its Board of Directors subsequently approved a final reverse stock split ratio of 1-for-15. The reverse stock split became effective on August 20, 2024 (the “Effective Date”). On the Effective Date, every 15 shares of issued and outstanding common stock were combined and converted…
  42. CVKDCadrenal Therapeutics, Inc.8-KResultadosEDGAR
  43. DTILPRECISION BIOSCIENCES INC8-KOtros hechos relevantesEDGAR
  44. EDITEditas Medicine, Inc.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…impairment charges for the nine months ended September 30, 2025 were related to the discontinuation of the clinical development of the Company’s reni-cel program initiated in December 2024, the related workforce reduction, associated impairment charges for laboratory and manufacturing equipment related to the reni-cel program, and the acceleration in expense due to changes in useful life estimates for leasehold improvements…
  45. EDITEditas Medicine, Inc.10-QInforme trimestralEDGAR
  46. EWTXEdgewise Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Nofi is expected to enter into an indemnification agreement on the Company’s standard form. There are no arrangements or understandings between Mr. Nofi and any other persons pursuant to which he was appointed Chief Financial Officer. There are no family relationships between Mr. Nofi and any director or executive officer of the Company and the Company has not entered into any transactions with Mr. Nofi that are reportable pursuant…
  47. FDMT4D Molecular Therapeutics, Inc.8-KResultadosEDGAR
  48. FDMT4D Molecular Therapeutics, Inc.10-QInforme trimestralEDGAR
  49. HROWHARROW, INC.8-KResultadosEDGAR
  50. HROWHARROW, INC.10-QInforme trimestralEDGAR
  51. IMDXInsight Molecular Diagnostics Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…implemented within one year after the date that such financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about our ability to continue as a going concern within one year after the date that such financial statements are issued. In performing this analysis, we excluded certain elements of our operating plan that cannot be considered probable. Our expectation…
  52. IMDXInsight Molecular Diagnostics Inc.8-KResultadosEDGAR
  53. IMVTImmunovant, Inc.8-KResultadosEDGAR
  54. IMVTImmunovant, Inc.10-QInforme trimestralEDGAR
  55. INOINOVIO PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…medicines and proprietary device technology, which may prove difficult or costly to obtain. •We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern. •If we are unable to obtain FDA approval of our proprietary devices and DNA medicine candidates, we will not be able to commercialize them in the United States. In particular, because our product candidates…
  56. INOINOVIO PHARMACEUTICALS, INC.8-KResultadosEDGAR
  57. IRWDIRONWOOD PHARMACEUTICALS INC10-QInforme trimestralEDGAR
  58. IRWDIRONWOOD PHARMACEUTICALS INC8-KResultadosEDGAR
  59. JSPRJasper Therapeutics, Inc.8-KResultadosEDGAR
  60. JSPRJasper Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. In performing this analysis, the Company excluded certain elements of its operating plan that cannot be…
    En el documentoContrasplit de accionestexto original ▸…of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. Reverse Stock Split On January 4, 2024, the Company effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of its common stock. The par value per share and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of common stock underlying…
  61. KYNBKYNTRA BIO, INC.8-KResultadosEDGAR
  62. KYNBKYNTRA BIO, INC.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…otherwise noted, discussion in the notes to the condensed consolidated financial statements, relates to solely to the Company’s continuing operations. Reverse Stock Split On June 16, 2025, the Company effected a 1-for-25 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split reduced the number of issued and outstanding shares of common stock from approximately 101.1 million shares to approximately 4.0 million shares. Proportionate…
  63. LRMRLarimar Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  64. LXRXLEXICON PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
  65. MGTXMeiraGTx Holdings plc8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…ophthalmology. Lilly also has a right of first negotiation for use of the Company’s proprietary riboswitch technology in the field of ophthalmological gene editing. Financial Terms Under the terms of the Collaboration Agreement, MeiraGTx will receive an upfront payment of $75 million after signing the Collaboration Agreement and will be eligible to receive up to over $400 million in total milestone payments, including up to $135 million in other potential near…
  66. MLYSMineralys Therapeutics, Inc.8-KResultadosEDGAR
  67. MLYSMineralys Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes. At Market Equity Offering Sales Agreement On March 21, 2024, the Company entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc. and Evercore Group L.L.C. as the Company’s sales agents (the Agents) and/or principals. Pursuant to the terms of the ATM Agreement, the Company…
  68. MNKDMANNKIND CORP8-KOtros hechos relevantesEDGAR
  69. MREOMereo BioPharma Group plc10-QInforme trimestralEDGAR
  70. MREOMereo BioPharma Group plc8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…oncology product candidates, etigilimab, an anti-TIGIT; and navicixizumab for the potential treatment of late-line ovarian cancer. Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties. All statements other than statements of historical…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…imperfecta from the European Commission (“EC”) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which…
  71. NKTRNEKTAR THERAPEUTICS8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…modulating cells known as regulatory T cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance. In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription…
  72. NKTXNkarta, Inc.8-KResultadosEDGAR
  73. NKTXNkarta, Inc.10-QInforme trimestralEDGAR
  74. NRIXNurix Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  75. OLMAOlema Pharmaceuticals, Inc.8-KResultadosEDGAR
  76. OLMAOlema Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  77. PALIPALISADE BIO, INC.10-QInforme trimestralEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…stock price beyond this ten-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). As of October 15, 2025, the bid price of our common stock again closed above $1.00 for 10 consecutive days and we received a minimum bid price compliance 48 letter from Nasdaq confirming that we regained compliance with Listing Rule 5550(a)(2), and that the matter is now closed. We can provide no assurances that we will continue to comply with…
    En el documentoContrasplit de accionestexto original ▸…shares of $0.01 par value common stock. Each share of common stock entitles the holder thereof to one vote on each matter submitted to a vote at a meeting of stockholders. On April 5, 2024, the Company effected a 1-for-15 reverse stock split of its issued and outstanding common stock (the "Reverse Stock Split"). Accordingly, each of the Company’s stockholders received one share of the Company's common stock for every 15 shares of the Company…
    En el documentoDebilidad material en el control internotexto original ▸…assurance level as a result of the material weakness that existed in our internal control over financial reporting, as described below. However, our management, including our Chief Executive Officer, has concluded that, notwithstanding the identified material weakness in our internal control over financial reporting, the condensed consolidated financial statements in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position…
  78. PASGPassage BIO, Inc.8-KResultadosEDGAR
  79. PASGPassage BIO, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…Company’s stockholders provided authorization for the Company’s Board of Directors to effect a reverse stock split to regain compliance with Nasdaq’s listing requirements. On July 14, 2025, the Company effected a 1-for-20 reverse stock split of its common stock, or the Reverse Stock Split. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who were otherwise entitled to receive fractional shares received…
  80. PDSBPDS Biotechnology Corp8-KOtros hechos relevantesEDGAR
  81. PROKPROKIDNEY CORP.10-QInforme trimestralEDGAR
  82. PROKPROKIDNEY CORP.8-KResultadosEDGAR
  83. PVLAPALVELLA THERAPEUTICS, INC.8-KResultadosEDGAR
  84. QUREuniQure N.V.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…proceeds after related offering expenses upon the underwriters’ exercise of their option to purchase an additional 0.7 million ordinary shares at the public offering price. ​ In July 2025, the Company entered into a Sales Agreement with Leerink Partners LLC (“Leerink Partners”) with respect to an at-the-market (“ATM”) offering program, under which the Company may, from time to time and at the Company’s sole discretion, offer and sell through Leerink Partners, acting as agent, the Company’s ordinary shares, up to an aggregate…
  85. ROIVRoivant Sciences Ltd.8-KResultadosEDGAR
  86. ROIVRoivant Sciences Ltd.10-QInforme trimestralEDGAR
  87. SEPNSepterna, Inc.8-KResultadosEDGAR
  88. SEPNSepterna, Inc.10-QInforme trimestralEDGAR
  89. SKYESkye Bioscience, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…CBeyond studies for obesity through the 52-week Phase 2a extension data. However, additional funding will be required to support subsequent studies for the development of nimacimab. In May 2024 the Company entered into an Equity Distribution Agreement (the "ATM Agreement") under which the Company may sell up to $100,000,000 of shares of common stock. The Company has not sold any shares under the ATM Agreement as of the date hereof and is not obligated to, and cannot provide…
  90. SKYESkye Bioscience, Inc.8-KResultadosEDGAR
  91. SPRBSPRUCE BIOSCIENCES, INC.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸EX-99.1 2 sprb-ex99_1.htm EX-99.1 Exhibit 99.1 Spruce Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Updates Granted Breakthrough Therapy Designation for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfillipo Syndrome Type B (MPS IIIB) Biologics License Application Submission of TA-ERT for the Treatment of MPS IIIB on…
  92. SPRBSPRUCE BIOSCIENCES, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…control. Some of the material risks associated with our business include the following: • We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern. • We will need substantial additional financing to develop our product candidates and implement our operating plan. If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate…
    En el documentoContrasplit de accionestexto original ▸…minimum bid price requirement under Nasdaq. As a result, the Company’s common stock began trading publicly on the over-the-counter market on April 29, 2025 under its symbol “SPRB”. Subsequently, the Company effected a one-for-seventy-five (1:75) reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Company's common stock began trading on the OTCQB on a split-adjusted basis on August 7, 2025 (the “Effective Date”) under the ticker symbol…
  93. SPRYARS Pharmaceuticals, Inc.8-KResultadosEDGAR
  94. SPRYARS Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. On January 31, 2025, we entered into a Controlled Equity OfferingSM Sales Agreement (the “ATM Sales Agreement”) pursuant to which we may from time to time offer and sell our common stock to or through Cantor Fitzgerald & Co., acting as sales agent, in any manner deemed to be an “at-the market offering”. We have…
  95. TARAProtara Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first U.S. Food and Drug Administration (FDA) approved IV choline formulation for PS patients. It has been granted Orphan Drug Designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and has been granted Fast Track Designation as a source of choline when oral or enteral nutrition is not…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…approved IV choline formulation for PS patients. It has been granted Orphan Drug Designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and has been granted Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition…
  96. TARAProtara Therapeutics, Inc.10-QInforme trimestralEDGAR
  97. TBPHTheravance Biopharma, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the U.S., the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication…
  98. TELOTelomir Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…generate losses and have insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date the financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months from the issuance date of this report. Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…million was received, for the issuance of 666,667 shares. ATM Agreement On February 14, 2025, the Company filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At The Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC under which the Company may offer and sell shares of its Common Stock, with an aggregate offering amount sold of up to $100,000,000. During the…
  99. TNXPTonix Pharmaceuticals Holding Corp.8-KResultadosEDGAR
  100. TNXPTonix Pharmaceuticals Holding Corp.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2025. On February 5, 2025, the Company effected a 1-for-100 reverse stock split of its issued and outstanding shares of common stock. On June 10, 2024, the Company effected a 1-for-32 reverse stock split of its issued and outstanding shares of common stock. The Company accounted…
  101. TNYATenaya Therapeutics, Inc.8-KResultadosEDGAR
  102. TNYATenaya Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…shares and included in other non-current liabilities within the condensed balance sheets. The Lender Warrant expires on August 6, 2034. 17 “At-the-Market” Equity Offering On August 10, 2022, the Company entered into a sales agreement (the Sales Agreement) with Leerink Partners LLC to establish an “at-the-market” (ATM) offering defined in Rule 415 under the Securities Act. Pursuant to the Sales Agreement, the Company is permitted to offer and sell, from time to time, shares of its common stock having a maximum aggregate offering…
  103. VYGRVoyager Therapeutics, Inc.8-KResultadosEDGAR
  104. VYGRVoyager Therapeutics, Inc.10-QInforme trimestralEDGAR
  105. WVEWave Life Sciences, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…boys with Duchenne muscular dystrophy amenable to exon 53 skipping. WVE-N531 was designed using Wave’s best-in-class oligonucleotide chemistry modifications, including PN backbone chemistry. WVE-N531 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food & Drug Administration. • In a positive Phase 2, open label clinical trial, boys receiving WVE-N531 for 48 weeks had a statistically significant…
  106. WVEWave Life Sciences, Inc.10-QInforme trimestralEDGAR
  107. ZNTLZentalis Pharmaceuticals, Inc.8-KResultadosEDGAR
  108. ZNTLZentalis Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s tangible assets are held in the United States. Liquidity Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the…

Juntas de accionistas

  1. JAGXJaguar Health, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  2. ONCOOnconetix, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
    En el documentoContrasplit de accionestexto original ▸…regarding our common stock that may be issued under the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) and the Company’s 2022 Equity Incentive Plan (the “2022 Plan”). 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 numbers shown reflect numbers on a post-split basis. Plan category: Number of Securities to be issued…
  3. REVBREVELATION BIOSCIENCES, INC.DEF 14AConvocatoria de junta de accionistasEDGAR
  4. ZYMEZymeworks Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

·

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.