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Lunes 12 oct 2026SEC · NASDAQ biomédico

Portada›Lunes 15 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 15 de diciembre de 2025

Los 44 documentos que 37 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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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. FBLGFibroBiologics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. 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 registration statement, 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 one or more offerings under this prospectus or through other means, then in connection with the future filing of our Annual Report on Form 10-K for the year…
  3. IMNMImmunome Inc.424B5Nueva emisión de acciones con precioEDGAR
  4. KODKodiak Sciences Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. KYTXKyverna Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  6. NTHINEONC TECHNOLOGIES HOLDINGS, INC.S-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…report of our independent registered public accounting firm on our financial statements as of and for the year ended December 31, 2024 and 2023 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. See Note 1 to our annual financial statements appearing at the end of this prospectus for additional information on our assessment. In December 2022, the Company signed a Letter of Intent (“LOI”) with…
  7. VRCAVerrica Pharmaceuticals Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…2024 financial statements contains an explanatory paragraph that states that the Company has incurred substantial operating losses since inception and has negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of that uncertainty. WHERE YOU CAN FIND ADDITIONAL INFORMATION This prospectus is part of the registration statement…
  8. OVIDOvid Therapeutics Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. CLYMClimb Bio, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. ELUTELUTIA INC.SC 13D/ACambio en participación significativaEDGAR
  3. KYMRKymera Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. PAHCPHIBRO ANIMAL HEALTH CORPSC 13D/ACambio en participación significativaEDGAR
  5. PLURPluri Inc.SC 13D/ACambio en participación significativaEDGAR
  6. TRIBTRINITY BIOTECH PLCSC 13D/ACambio en participación significativaEDGAR
  7. WVEWave Life Sciences, Inc.SC 13D/ACambio en participación significativaEDGAR
  8. ZNTLZentalis Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. CGCCanopy Growth Corp8-KVenta de acciones no registrada (colocación privada)EDGAR
  2. FBIOFortress Biotech, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  3. FBLGFibroBiologics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. HUMAHumacyte, Inc.8-KFin de acuerdo materialEDGAR
  5. HUMAHumacyte, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  6. IMNMImmunome Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸EX-99.1 2 d793961dex991.htm EX-99.1 Exhibit 99.1 Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors Registrational trial met primary endpoint, with varegacestat significantly improving progression-free survival vs. placebo (hazard ratio = 0.16, p<0.0001) Trial also met all key secondary endpoints, with varegacestat delivering an objective response…
  7. JBIOJade Biosciences, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  8. ARCTArcturus Therapeutics Holdings Inc.8-KCambio en el consejo o la direcciónEDGAR
  9. BYSIBeyondSpring Inc.8-KOtros hechos relevantesEDGAR
  10. CINGCingulate Inc.8-KCambio en el consejo o la direcciónEDGAR
  11. CSBRCHAMPIONS ONCOLOGY, INC.8-KResultadosEDGAR
  12. CSBRCHAMPIONS ONCOLOGY, INC.10-QInforme trimestralEDGAR
  13. CTNMContineum Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
  14. FBIOFortress Biotech, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101; AAV-ATP7A gene therapy is currently in pre-clinical development and has received FDA Orphan Drug Designation. Cyprium was founded by, and is a majority-owned subsidiary of, Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.cypriumtx.com. ​ About Fortress Biotech Fortress Biotech, Inc. (…
    En el documentoRevisión prioritaria de la FDAtexto original ▸…PRV”), and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129 million in aggregate development and sales milestones from Sentynl. ​ The CUTX-101 NDA was initially granted Priority Review by the FDA and is supported by positive topline clinical efficacy results for CUTX-101, demonstrating significant improvement in overall survival for Menkes disease subjects who received early treatment…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸EX-99 2 fbio-20251215xex99.htm EX-99 Exhibit 99.1 ​ Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission ​ New PDUFA Target Action Date of January 14, 2026 set by FDA ​ ​ Miami, FL – December 15, 2025 – Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U…
  15. IBRXImmunityBio, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…as Chief Executive Officer of Scientific Protein Laboratories, LLC from December 2014 to June 2015. Prior to this, having served in roles of increasing responsibility at Abraxis BioScience, LLC, he was appointed Vice Chairman and Chief Executive Officer, overseeing the commercialization of Abraxane® and leading the negotiations that culminated in the acquisition of the company by Celgene Corporation in 2010. He began his 14 years at Bristol-Myers Squibb…
  16. INDVIndivior Pharmaceuticals, Inc.8-KCambio de estatutosEDGAR
  17. INMInMed Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
  18. KTTAPasithea Therapeutics Corp.8-KOtros hechos relevantesEDGAR
  19. LPCNLipocine Inc.8-KCambio en el consejo o la direcciónEDGAR
  20. MISTMilestone Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
  21. PCSAProcessa Pharmaceuticals, Inc.8-KCambio de estatutosEDGAR
  22. PVLAPALVELLA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
  23. RLMDRELMADA THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
  24. SLNSilence Therapeutics plc8-KCambio en el consejo o la direcciónEDGAR
  25. SPRBSPRUCE BIOSCIENCES, INC.8-KCambio en el consejo o la direcciónEDGAR
  26. TARAProtara Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  27. ZBIOZenas BioPharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
  28. ZNTLZentalis Pharmaceuticals, Inc.8-KCambio en el consejo o la direcciónEDGAR

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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.

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