Portada›Viernes 24 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, viernes 24 de octubre de 2025

Los 37 documentos que 31 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← jueves 23 de octubre de 2025 · lunes 27 de octubre 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. BCDABioCardia, Inc.424B5Nueva emisión de acciones con precioEDGAR
2. CNTXContext Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
3. GNPXGenprex, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …operations and expenses, which could have a material adverse effect on our financial position, results of operations, cash flows, and ability to achieve our intended business objectives. These matters raise substantial doubt about our ability to continue as a going concern, and if we are unable to raise required capital, we may be unable to continue the operation of our business as currently planned or to seek strategic alternative transactions. We are currently listed…

   En el documentoContrasplit de accionestexto original ▸

   …aggregate market value of $11,307,982 pursuant to General Instruction I.B.6. of Form S-3 during the prior 12 calendar month period that ends on, and includes, the date of this prospectus supplement. We effected a 1-for-50 reverse stock split effective as of 12:01 a.m. Eastern Time on October 21, 2025, pursuant to which every fifty shares of our issued and outstanding common stock were reclassified as one share of common stock (the “2025 Reverse…

   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …to us in the ordinary course of business, for which it may receive customary fees and commissions. As previously disclosed in our Current Report on Form 8-K filed with the SEC on December 13, 2023, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with the Placement Agent on December 13, 2023. Pursuant to the Sales Agreement, the Placement Agent serves as agent (the “Agent”) with respect to an at-the-market (“ATM…
4. GTBPGT Biopharma, Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …incorporated by reference herein. Going Concern We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue as a going concern. While it is very difficult to estimate our future liquidity requirements, we believe if we are unable to obtain additional financing, existing cash resources will not be sufficient to enable us to fund…
5. SCNXScienture Holdings, Inc.424B5Nueva emisión de acciones con precioEDGAR
6. TNGXTango Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
7. XFORX4 Pharmaceuticals, Inc424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …completed the business combination with X4 Therapeutics, Inc. (formerly X4 Pharmaceuticals, Inc.) and we completed our corporate rebranding, changing our name to X4 Pharmaceuticals, Inc. On April 28, 2025, we effected a 1-for-30 reverse stock split of our common stock (the “Reverse Stock Split”). All references to common stock share and per share amounts in this prospectus supplement are presented on a post-Reverse Stock Split basis. Our principal…

Participaciones y control

1. BMEABiomea Fusion, Inc.SC 13D/ACambio en participación significativaEDGAR
2. MXCTMAXCYTE, INC.SC 13DCambio en participación significativaEDGAR
3. TRIBTRINITY BIOTECH PLCSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. BFRIBiofrontera Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. CRISCURIS INC8-KAviso de incumplimiento de cotizaciónEDGAR
3. GNPXGenprex, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Equity Requirement”) for continued listing through October 31, 2025 (the “Exception”). Also as previously disclosed, to regain compliance with the Bid Price Requirement, on October 21, 2025, the Company implemented a one-for-fifty (1:50) reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding shares of Common Stock. To regain compliance with the Bid Price Requirement, the closing bid price of the Company’s Common Stock must…

   En el documentoDesignación de medicamento huérfanotexto original ▸

   …treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002…

   En el documentoDesignación de vía rápida (Fast Track)texto original ▸

   …lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion…
4. ORMPORAMED PHARMACEUTICALS INC.8-KFin de acuerdo materialEDGAR
5. RNTXRein Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
6. TNGXTango Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
7. AMPHAmphastar Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
8. APREAprea Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
9. ARVNARVINAS, INC.8-KOtros hechos relevantesEDGAR
10. BFRGBullFrog AI Holdings, Inc.8-KCambio en el consejo o la direcciónEDGAR
11. CNTXContext Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
12. FLNAFILANA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
13. IMMPIMMUTEP Ltd20-FInforme anual (emisor extranjero)EDGAR
14. INMInMed Pharmaceuticals Inc.10-K/AInforme anual (enmienda)EDGAR
15. KURAKura Oncology, Inc.8-KOtros hechos relevantesEDGAR
16. PLRXPLIANT THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
17. PMNProMIS Neurosciences Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …addition, because PMN310 may not be limited by off-target binding or side effects, PMN310 could potentially offer an improved efficacy profile over other amyloid-directed antibody therapeutics. PMN310 was granted Fast Track designation by the U.S. Food and Drug Administration in July 2025. Based on the encouraging results from the Phase 1a trial (NCT06105528) of PMN310, ProMIS initiated PRECISE-AD, a Phase 1b clinical trial in AD patients…
18. SCNXScienture Holdings, Inc.8-KNuevo acuerdo materialEDGAR
19. SILOSilo Pharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
20. SNDXSyndax Pharmaceuticals Inc8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML. Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation…

    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult…
21. TLPHTALPHERA, INC.8-KCambio en el consejo o la direcciónEDGAR
22. VTRSViatris Inc8-KCambio de estatutosEDGAR

Juntas de accionistas

1. AYTUAYTU BIOPHARMA, INCDEF 14AConvocatoria de junta de accionistasEDGAR
2. CNSPCNS Pharmaceuticals, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
3. CRMDCorMedix Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
4. SCNXScienture Holdings, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …factors include the negative perception of reverse stock splits held by many investors, analysts, and other stock-market participants, as well as the fact that the stock price of some companies that have effected reverse stock splits has subsequently declined back to pre-reverse stock split levels. In approving the Reverse Stock Split Charter Amendment to effect the Reverse Stock Split, the Board determined that the potential benefits of the Reverse Stock Split outweigh these potential negative…
5. VTRSViatris IncDEF 14AConvocatoria de junta de accionistasEDGAR

← jueves 23 de octubre de 2025 · lunes 27 de octubre de 2025 →

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