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Miércoles 14 oct 2026SEC · NASDAQ biomédico

Portada›Martes 7 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, martes 7 de octubre de 2025

Los 36 documentos que 26 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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Por qué unas líneas van en color

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. ACETAdicet Bio, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. BMEABiomea Fusion, Inc.424B5Nueva emisión de acciones con precioEDGAR
  3. HUMAHumacyte, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Stock Purchase Agreement will not be sufficient to fund our operations, as currently planned, for more than one year beyond the filing date of this prospectus supplement, we have determined that there is substantial doubt regarding our ability to continue as a going concern. If we do not raise sufficient funds through this offering or through other means, then in connection with the future filing of our Annual Report on Form 10-K for the year ending December 31, 2025 (the…
  4. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…82. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On October 6, 2025, the closing sale price per warrant of our Public Warrants was $0.14. 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. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…82. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On October 6, 2025, the closing sale price per warrant of our Public Warrants was $0.14. 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…
  6. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…82. Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On October 6, 2025, the closing sale price per warrant of our Public Warrants was $0.14. 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…
  7. TVRDTvardi Therapeutics, Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR

    La compañía indica que su situación financiera genera dudas sustanciales sobre su capacidad para continuar como negocio en marcha.

    Original en inglés · traducción revisadaThe Company’s financial condition raises substantial doubt as to its ability to continue as a going concern. ● The Company will require substantial additional capital to fund its operations.

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

    Cara cambió su nombre a Tvardi Therapeutics y, según el acuerdo de fusión, en la fecha de cierre realizó un desdoblamiento inverso de sus acciones de 1 por 3 y aumentó sus acciones comunes autorizadas a 150.000.000.

    Original en inglés · traducción automáticaCara effected a 1-for-3 reverse stock split of its common stock (the “Reverse Stock Split”), (ii) Cara increased its authorized shares of common stock to 150,000,000

    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. CRMDCorMedix Inc.S-3ASRCapacidad de emisión registradaEDGAR
  9. KZIAKAZIA THERAPEUTICS LTD424B3Prospecto suplementario o de reventaEDGAR
  10. KZIAKAZIA THERAPEUTICS LTD424B3Prospecto suplementario o de reventaEDGAR
  11. KZIAKAZIA THERAPEUTICS LTD424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

  1. ALZNAlzamend Neuro, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. AMRXAmneal Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. CLYMClimb Bio, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. SRRKScholar Rock Holding CorpSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ACETAdicet Bio, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
  2. JBIOJade Biosciences, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…pre-funded warrants, in each case without regard to beneficial ownership limitations. BAFF-R License Agreement On October 3, 2025, the Company and Paragon Therapeutics, Inc. (“Paragon”), entered into a license agreement (the “License Agreement”), pursuant to which Paragon granted the Company a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting BAFF-R in the field of prophylaxis, palliation, treatment…
  3. ABUSArbutus Biopharma Corp8-KOtros hechos relevantesEDGAR
  4. ACETAdicet Bio, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…approximately two hours after the event. About ADI-001 ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV lupus nephritis (LN), refractory systemic lupus erythematosus (SLE) with extrarenal…
  5. ACETAdicet Bio, Inc.8-KNuevo acuerdo materialEDGAR
  6. ACHVACHIEVE LIFE SCIENCES, INC.8-KCambio en el consejo o la direcciónEDGAR
  7. BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
  8. BMEABiomea Fusion, Inc.8-KNuevo acuerdo materialEDGAR
  9. BMRNBIOMARIN PHARMACEUTICAL INC8-KResultadosEDGAR
  10. DYAIDYADIC INTERNATIONAL INC8-KOtros hechos relevantesEDGAR
  11. ELUTELUTIA INC.8-KNuevo acuerdo materialEDGAR
  12. HUMAHumacyte, Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For uses other than the FDA approval in the extremity vascular trauma indication…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment…
  13. ICCCIMMUCELL CORP /DE/8-KResultadosEDGAR
  14. IDXXIDEXX LABORATORIES INC /DE8-KCambio en el consejo o la direcciónEDGAR
  15. LXEOLexeo Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  16. MYGNMYRIAD GENETICS INC8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Separation Agreement and Release of Claims (the “Separation Agreement”) with Scott J. Leffler, the Company’s former Chief Financial Officer. As previously disclosed, the Company announced Mr. Leffler’s departure as Chief Financial Officer of the Company, effective August 15, 2025. Mr. Leffler’s separation from employment occurred at the close of business on September 2, 2025 (the “Separation Date”). The Separation Agreement becomes effective…
  17. NVAXNOVAVAX INC8-KOtros hechos relevantesEDGAR
  18. SCLXScilex Holding Co8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Vice President of Finance from January 2022 to April 2023. Mr. Ma has more than 15 years of finance and operational expertise across pharmaceuticals and venture backed biotechnology companies. Mr. Ma was appointed as Chief Financial Officer of Semnur Pharmaceuticals, Inc. (OTC: SMNR) on September 22, 2025. He previously served as Director of Finance and Operations for Anwita Biosciences, Inc., a clinical stage company, from August 2019 to…
  19. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. PRTAPROTHENA CORP PUBLIC LTD CODEF 14AConvocatoria de junta de accionistasEDGAR
  2. RZLTRezolute, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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