Portada›Jueves 4 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 4 de diciembre de 2025

Los 19 documentos que 16 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← miércoles 3 de diciembre de 2025 · viernes 5 de diciembre de 2025 →

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. CAPRCAPRICOR THERAPEUTICS, INC.424B5Nueva emisión de acciones con precioEDGAR
2. INTSINTENSITY THERAPEUTICS, INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …PROSPECTUS SUPPLEMENT No. 4 (To the Sales Agreement Prospectus dated July 11, 2024 and the Base Prospectus, dated July 11, 2024) INTENSITY THERAPEUTICS, INC. Up to $30,000,000 Common Stock We have previously entered into an at the market offering agreement (the “Offering Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) relating to shares of our common stock offered by this prospectus supplement and the sales agreement prospectus dated…
3. TARAProtara Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
4. PHIOPhio Pharmaceuticals Corp.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. NAMSNewAmsterdam Pharma Co N.V.SC 13D/ACambio en participación significativaEDGAR
2. TRIBTRINITY BIOTECH PLCSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. CBIOCRESCENT BIOPHARMA, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoAcuerdo de licencia o colaboracióntexto original ▸

   …Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) (the “Strategic Transaction”), each of which is described below. CR-001 License Agreement On December 2, 2025, Crescent OpCo and Kelun-Biotech entered into a License Agreement (the “CR-001 License Agreement”) under which Crescent OpCo granted Kelun-Biotech an exclusive, royalty-bearing license to research, develop, manufacture and commercialize CR-001, Crescent’s proprietary bispecific antibody directed to VEGF and PD-1, in greater China (including mainland China, Hong Kong…
2. DNLIDenali Therapeutics Inc.8-KOtros hechos relevantesEDGAR
   En el documentoParada clínica impuesta por la FDAtexto original ▸

   …in children. Under Section 529, the FDA administers the RPDD and PRV programs. DNL952 (ETV:GAA) — Pompe Disease The Investigational New Drug ("IND") application for the Phase 1 study of DNL952 has been placed on clinical hold. The FDA requested a protocol amendment to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments, and stopping rules. These requests are related to preclinical…

   En el documentoRevisión prioritaria de la FDAtexto original ▸

   …Robust data package supporting a target indication for the full MPS II phenotype spectrum PDUFA Target Action Date: April 5, 2026 Preparing for Commercial Launch • Filed BLA for accelerated approval; granted priority review • BLA includes data from open-label, global Phase 1/2 study (N=47) • Up to 18 years of age • Treatment duration up to five years • Measuring biomarkers, safety, and exploratory clinical outcomes • Randomized…

   En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

   …NfL – Neurofilament light chain; SOC – Standard of care 58 Tividenofusp Alfa Development and Regulatory Path Robust data package supporting a target indication for the full MPS II phenotype spectrum PDUFA Target Action Date: April 5, 2026 Preparing for Commercial Launch • Filed BLA for accelerated approval; granted priority review • BLA includes data from open-label, global Phase 1/2 study (N=47) • Up to 18 years of age • Treatment duration…
3. ATOSATOSSA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
4. BIOABioAge Labs, Inc.8-KOtros hechos relevantesEDGAR
5. DNLIDenali Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
   En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

   …Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. “We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the…
6. ESLAEstrella Immunopharma, Inc.8-KOtros hechos relevantesEDGAR
7. FHTXFoghorn Therapeutics Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On December 3, 2025, the Board of Directors of Foghorn Therapeutics Inc. (the “Company”) appointed Jeff Sacher as Treasurer and interim Chief Financial Officer (“CFO”), effective immediately. The Company is continuing its search for a permanent CFO. The Company previously entered into an agreement with Danforth Advisors, LLC (“Danforth”) pursuant to which Danforth…
8. INTSINTENSITY THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
9. MPLTMapLight Therapeutics, Inc.8-KResultadosEDGAR
10. MPLTMapLight Therapeutics, Inc.10-QInforme trimestralEDGAR
11. PALIPALISADE BIO, INC.8-KCambio de estatutosEDGAR
12. QUREuniQure N.V.8-KOtros hechos relevantesEDGAR
13. VNDAVanda Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …tradipitant in motion sickness. Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025, positioning tradipitant as potentially the first new pharmacologic treatment for motion sickness in over 40 years. “The swift and favorable resolution of this issue highlights the effectiveness of our…

← miércoles 3 de diciembre de 2025 · viernes 5 de diciembre de 2025 →

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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