Portada›Lunes 8 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 8 de diciembre de 2025

Los 48 documentos que 32 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← viernes 5 de diciembre de 2025 · martes 9 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. DYNDyne Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
2. FULCFulcrum Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
3. GPCRStructure Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
4. GRIGRI Bio, Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …issue and sell all of the securities registered in this offering, we will require substantial additional capital to advance and complete a Phase 2b clinical trial of GRI-0621. •Our auditors have expressed substantial doubt about our ability to continue as a going concern, and we may not be able to continue as a going concern if we do not obtain additional financing. Risks Related to Research and Development and the Pharmaceutical Industry •Our business is highly dependent…

   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …there can be no assurance that the Panel will accept our Compliance Plan or that we will ultimately regain compliance with the Stockholders’ Equity Requirement. In addition, on September 10, 2024, we received a letter from the Staff of Nasdaq indicating that we no longer met the Minimum Bid Price Rule set forth in Nasdaq Listing Rule 5550(a)(2) because the closing bid price for our Common Stock was less than $1.00 for the 30 consecutive business days prior thereto. On February 19, 2025, we filed…

   En el documentoContrasplit de accionestexto original ▸

   …read this prospectus, together with additional information described under the heading “Where You Can Find More Information” carefully before you invest in any of our securities. On February 21, 2025, we effected a reverse stock split of our Common Stock at a ratio of one-for-17 (the “February 2025 Reverse Stock Split”). Unless otherwise indicated, all financial information, share numbers, option numbers, warrant numbers, other derivative…

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

   …derivative security numbers and exercise prices appearing in this prospectus have been adjusted to give effect to the February 2025 Reverse Stock Split. May 2024 At The Market Offering On May 20, 2024, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with Wainwright, pursuant to which we may sell and issue, subject to the limitations in the Sales Agreement, up to $10.0 million of shares of our Common Stock from time…
5. IMMXImmix Biopharma, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …and other serious diseases; and ● Pursue development of NXC-201 in other applicable indications where CAR-T is not an approved therapy today. Recent Developments ATM Program On June 3, 2025, the Company entered into an At The Market Offering Agreement (the “June 2025 ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”) under which the Company may offer and sell, from time to time at its sole discretion, up to $50 million shares…
6. KYMRKymera Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
7. VERAVera Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
8. WVEWave Life Sciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
9. GRIGRI Bio, Inc.424B3Prospecto suplementario o de reventaEDGAR
10. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
11. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
12. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
13. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
14. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
15. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. CBIOCRESCENT BIOPHARMA, INC.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. DYNDyne Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …htm EX-99.1 Exhibit 99.1 Dyne Therapeutics Announces Positive Topline Results from Phase 1/2 DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD) - Registrational Expansion Cohort (REC) met primary endpoint, demonstrating statistically significant increase in dystrophin to 5.46% at 6 months (muscle content-adjusted; p<0.0001), replicating the same 7-fold change from baseline previously observed at the registrational…
2. GPCRStructure Therapeutics Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …active:placebo) and started at 5 mg of aleniglipron (or placebo) with a 4-week titration schedule, reaching target doses of 45 mg, 90 mg or 120 mg once-daily. Each of the three doses in the ACCESS study achieved statistical significance on the primary endpoint and all key secondary endpoints. Primary efficacy estimandi results at 36 weeks are as follows: Aleniglipron 45 mg Aleniglipron 90 mg Aleniglipron 120 mg Placebo Mean percent change in body weight at…
3. GRIGRI Bio, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …) has received topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”). This topline data indicates that the trial met its primary endpoint and certain secondary endpoints that have been evaluated to date demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects…
4. GRMLGreenland Mines Ltd8-KVenta de acciones no registrada (colocación privada)EDGAR
5. IRONDisc Medicine, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoAprobación acelerada de la FDAtexto original ▸

   …/ Confirmatory DISC-0974‡ Anti-HJV monoclonal antibody Subcutaneous, once-monthly DISC-0998‡ Anti-HJV monoclonal antibody Extended half-life Erythropoietic Porphyrias (EPP and XLP) NDA Accepted; CNPV Received; Potential for Accelerated Approval; APOLLO study underway Anemia Associated with Inflammatory Diseases Iron Modulation Portfolio Program † Bitopertin in-licensed from Roche; ‡ DISC-0974 and DISC-0998 in-licensed from AbbVie; *DISC-3405…
6. MDCXMedicus Pharma Ltd.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5…
7. MIRMMirum Pharmaceuticals, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

   …virus (“HBV”). Target has designed brelovitug to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles. Brelovitug for the treatment of chronic HDV has received breakthrough therapy designation from the U.S. Food and Drug Administration (“FDA”), designation under the Priority Medicines (PRIME) scheme from the European Medicines Agency (“EMA”) and an orphan medicinal product designation by the…
8. ALLRAllarity Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
9. ARQTArcutis Biotherapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
10. ARVNARVINAS, INC.8-KOtros hechos relevantesEDGAR
11. ASMBASSEMBLY BIOSCIENCES, INC.8-KOtros hechos relevantesEDGAR
12. BCAXBicara Therapeutics Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …reverses the fibrotic and immune- excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose…
13. CGEMCullinan Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …AML 31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed CLN-049 recently granted Fast Track designation by the U.S. FDA Company to host in-person event on Monday, December 8, at 8:00 p.m. ET CAMBRIDGE, Mass., December 8, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage…
14. COGTCogent Biosciences, Inc.8-KOtros hechos relevantesEDGAR
15. DYNDyne Therapeutics, Inc.8-KDeuda nueva o compromiso financieroEDGAR
16. FULCFulcrum Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …cohort, pociredir was demonstrated to be generally well-tolerated in people with SCD with up to three months of exposure, with no treatment-related serious adverse events reported. Pociredir has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of SCD. To learn more about clinical trials of pociredir please visit ClinicalTrials.gov. About Sickle Cell Disease SCD is a genetic disorder of the red blood cells caused by a mutation…

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

    …cohort, pociredir was demonstrated to be generally well-tolerated in people with SCD with up to three months of exposure, with no treatment-related serious adverse events reported. Pociredir has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of SCD. To learn more about clinical trials of pociredir please visit ClinicalTrials.gov. About Sickle Cell Disease SCD is a genetic disorder of the red blood…
17. HALOHALOZYME THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
18. IMMXImmix Biopharma, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …therapy with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL Amyloidosis AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light…

    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸

    …therapy with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL Amyloidosis AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect…
19. IMMXImmix Biopharma, Inc.8-KNuevo acuerdo materialEDGAR
20. INKTMiNK Therapeutics, Inc.8-KResultadosEDGAR
21. INMBInmune Bio, Inc.8-KNuevo acuerdo materialEDGAR
22. KYMRKymera Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
23. LYELLyell Immunopharma, Inc.8-KOtros hechos relevantesEDGAR
24. ORICOric Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
25. PEPGPepGen Inc.8-KOtros hechos relevantesEDGAR
26. PLRXPLIANT THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
27. PRAXPraxis Precision Medicines, Inc.8-KOtros hechos relevantesEDGAR
28. RXRXRECURSION PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …eligibility from ≥55 to ≥18. This expansion was based on a thorough risk-benefit analysis, enabling evaluation of REC-4881 in younger patients who represent a substantial portion of FAP patients. REC-4881 has received Fast Track and Orphan Drug designations from the US FDA, as well as Orphan Drug designation from the European Commission. Results of the Phase 2 Data for Ongoing REC-4881 Trial Efficacy and Durability Findings As of the November 25, 2025 data cutoff in the open-label Phase 2 portion of TUPELO…
29. SRPTSarepta Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
30. TARAProtara Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
31. TBPHTheravance Biopharma, Inc.8-KOtros hechos relevantesEDGAR
32. WVEWave Life Sciences, Inc.8-KOtros hechos relevantesEDGAR

← viernes 5 de diciembre de 2025 · martes 9 de diciembre de 2025 →

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