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Domingo 11 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 31 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 31 de diciembre de 2025

Los 21 documentos que 18 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. CELUCelularity IncS-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…our inception, have no cellular therapeutic candidates approved for commercial sale and we anticipate that we will incur substantial net losses in the future. ● Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern. ● We will need substantial additional financing to develop our therapeutics and implement our operating plans. If we fail to obtain additional financing, we may be unable to complete the development…
  2. DMRADamora Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…audited by EY Godkendt Revisionspartnerselskab, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as 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…
  3. ENVBEnveric Biosciences, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…any revisions to any of the forward-looking statements contained herein to reflect future events or developments. iv SELECTED FINANCIAL DATA REFLECTING THE REVERSE STOCK SPLIT On October 23, 2025, we effected a 1-for-12 reverse stock split (the “Reverse Stock Split”), which began trading on a split-adjusted basis on October 28, 2025, pursuant to which every 12 shares of our issued and outstanding shares of Common Stock were reclassified…
  4. IMNNImunon, Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. VRAXVirax Biolabs Group Ltd424B3Prospecto suplementario o de reventaEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…15,950. In addition, we will issue warrants to Wainwright or its designees to purchase up to an aggregate of 513,850 ordinary shares at an exercise price of $0.36675 per share. On January 22, 2024, we entered into an At-the-Market Offering Agreement (the “Sales Agreement”) with Wainwright, acting as the Company’s sales agent, pursuant to which we may offer and sell, from time to time, through the sales agent, our ordinary shares. As of…

Participaciones y control

  1. SCLXScilex Holding CoSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. BCABBioAtla, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…longevity technologies). Pursuant to the Investment Agreement, an initial investment into Inversagen AI will be led by AIRC. As previously disclosed in the Company’s filings, BioAtla entered into an exclusive license agreement with Inversagen, LLC, as amended in July 2020, in which BioAtla granted Inversagen, LLC an exclusive, worldwide, royalty-bearing license under certain patents and know-how controlled by BioAtla to develop, make, have made, sell, have sold, offer for sale and import CAB-antibodies for the field of diseases associated with…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…ROR2 expression. As such, there is potential to expand the application of Oz-V more broadly beyond OPSCC to all HPV+ cancers, which represents a market opportunity of over $7 billion worldwide. The FDA granted Fast Track Designation to Oz-V for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In addition, the company has secured a partnership with an unnamed commercial manufacturer…
  2. CORTCORCEPT THERAPEUTICS INC8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)…
  3. NMADNOMAD POWER SOLUTIONS, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. ALDXAldeyra Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  5. ATAIAtaiBeckley Inc.8-K12BNuevo acuerdo materialEDGAR
  6. AXSMAxsome Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…living with this debilitating condition, if approved.” AXS-12’s clinical development program in narcolepsy includes three controlled efficacy trials, and a completed long-term safety trial. AXS-12 has been granted Orphan Drug Designation for the treatment of narcolepsy. Orphan Drug Designation is granted to promising drugs intended for the safe and effective treatment of rare diseases, defined as those affecting fewer than 200,000 people…
  7. CLYMClimb Bio, Inc.8-KOtros hechos relevantesEDGAR
  8. HCWBHCW Biologics Inc.8-KOtros hechos relevantesEDGAR
  9. IMNNImunon, Inc.8-KNuevo acuerdo materialEDGAR
  10. ORMPORAMED PHARMACEUTICALS INC.8-KOtros hechos relevantesEDGAR
  11. ORMPORAMED PHARMACEUTICALS INC.8-KCambio en el consejo o la direcciónEDGAR
  12. VNDAVanda Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
  13. VSTMVerastem, Inc.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. DMRADamora Therapeutics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  2. TPSTTempest Therapeutics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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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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