Portada›Jueves 8 de enero de 2026

Biomédicas del NASDAQ ante la SEC, jueves 8 de enero de 2026

Los 50 documentos que 45 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← miércoles 7 de enero de 2026 · viernes 9 de enero de 2026 →

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. ALMSALUMIS INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …marketable securities as of December 31, 2025, will not be sufficient to meet our operating and capital requirements for at least 12 months from the date of issuance of this prospectus supplement and there is substantial doubt about our ability to continue as a going concern. Corporate Information Alumis was incubated by Foresite Labs, LLC (“Foresite Labs”) and incorporated on January 29, 2021 as a Delaware corporation under the name FL2021-001, Inc. In March 2021, FL2021…
2. CELUCelularity Inc424B3Prospecto suplementario o de reventaEDGAR
   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…
3. GNLXGENELUX Corp424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …offering program. Any future sales could significantly dilute your investment in this offering. Our independent registered public accounting firm has indicated that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. The report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2024 and 2023 included an explanatory paragraph indicating that…
4. KALAKALA BIO, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …balance of approximately $21.1 million as of September 30, 2025. Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable…

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

   …Agreement have been satisfied and the aggregate liability due Oxford of approximately $10.6 million has been settled and released. Nasdaq Market Value of Listed Securities Deficiency On November 10, 2025, we received a deficiency letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market notifying us that the listing of our common stock was not in compliance with Nasdaq Listing Rule 5550…

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

   424B5 1 kalabio_424b5.htm 424B5 Filed pursuant to Rule 424(b)(5) Registration Statement No. 333-270263 PROSPECTUS SUPPLEMENT (To prospectus dated May 11, 2023) Up to $15,000,000 Common Stock We have entered into an At the Market Offering Agreement (the “Sales Agreement”), with H.C. Wainwright & Co., LLC (“Wainwright” or the “sales agent”) relating to the sale of shares of our common stock, par value $0.001 per share (the “common stock…
5. PHATPhathom Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
6. AVTXAvalo Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
7. GTBPGT Biopharma, Inc.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. DRMADermata Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
2. SCLXScilex Holding CoSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. CGCCanopy Growth Corp8-KVenta de acciones no registrada (colocación privada)EDGAR
2. CRISCURIS INC8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoDesignación de medicamento huérfanotexto original ▸

   …monotherapy and combination studies in acute myeloid leukemia (AML), with additional resources we plan to continue development of emavusertib as a monotherapy and in combination in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery…
3. GRIGRI Bio, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …collagen turnover, lung tissue repair, and improvements in pulmonary function, further strengthening the overall clinical proof-of-concept for GRI-0621.” The Company previously reported that the study met its primary endpoint, demonstrating a safety and tolerability profile differentiated from that of existing treatment options. The study also met secondary endpoints suggestive of disease-modifying activity, reversal of fibrosis…
4. IPSCCentury Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
5. MLTXMoonLake Immunotherapeutics8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All…
6. NEUPNeuphoria Therapeutics Inc.8-KFin de acuerdo materialEDGAR
7. SPRBSPRUCE BIOSCIENCES, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
8. TCRTAlaunos Therapeutics, Inc.8-KFin de acuerdo materialEDGAR
9. ACRVAcrivon Therapeutics, Inc.8-KResultadosEDGAR
10. AGENAGENUS INC8-KNuevo acuerdo materialEDGAR
11. AMLXAmylyx Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …200 worldwide* worldwide term through 2043 if granted • Granted US patent rights through • Granted US patent rights • Positioned for NCE 2037** through 2040 exclusivity • Positioned for NCE exclusivity• Granted Orphan Drug Designation for the treatment • Granted Orphan Drug of Wolfram syndrome Designation for the treatment of hyperinsulinemic hypoglycemia * Includes in-licensed patents ** Additional patent term potentially available…

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

    …AMX0114 Amyotrophic LUMINA trial ASO targeting calpain-2, a Lateral Sclerosis LUMINA PHASE 1 CLINICAL TRIAL protein involved in axonal • Began enrolling cohort 2 (n=12) in December 2025 (ALS) degeneration • Granted FDA Fast Track designation • As part of research collaboration with Gubra, AMX0318 demonstrated a robust chemical stability profile, strong in vitro potency, evidence of AMX0318 in vivo efficacy and tolerability, high solubility…

    En el documentoRevisión prioritaria de la FDAtexto original ▸

    …medical meeting • Early data from LUMINA show AMX0114 was generally well-tolerated for participants enrolled in cohort 1 (n=12), with no treatment-related SAEs Fully enroll cohort 2 (n=12) 2026 • The FDA granted Fast Track designation to AMX0114 in May 2025 providing eligibility for Priority Review if relevant criteria continue to be met ALS=amyotrophic lateral sclerosis; mRNA=messenger ribonucleic acid; SAE=serious adverse event; 1. Brown, R. H., Al-Chalabi A. N Engl J Med. 2017;377(2):162-172…
12. AMRNAMARIN CORP PLC\UK8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …previously forecasted. We believe we are on track for sustainable positive annual cash flow in 2026, driven by continued efficient revenue generation across all markets, a full year of cost savings from our restructuring plan, and the fact that the majority of the expenses associated with that plan were incurred in 2025. We have a robust cash position and debt-free balance sheet and are actively pursuing additional ways to…
13. ARDXARDELYX, INC.8-KResultadosEDGAR
14. ATAIAtaiBeckley Inc.8-KCambio en el consejo o la direcciónEDGAR
15. AVIRAtea Pharmaceuticals, Inc.8-KResultadosEDGAR
16. CGEMCullinan Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …development of velinotamig in autoimmune diseases. Oncology • CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) o In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer…
17. CLYMClimb Bio, Inc.8-KOtros hechos relevantesEDGAR
18. COYACoya Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
19. CRMDCorMedix Inc.8-KResultadosEDGAR
20. DCOYDecoy Therapeutics Inc.8-KCambio de estatutosEDGAR
21. GNLXGENELUX Corp8-KOtros hechos relevantesEDGAR
22. ICCCIMMUCELL CORP /DE/8-KResultadosEDGAR
23. INDPIndaptus Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
24. IVVDInvivyd, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …or severe AEs reported; all AEs, including headache and injection site pain, were deemed unrelated to study drug. • In December 2025, Invivyd announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for VYD2311. • Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If…
25. JSPRJasper Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
26. KALAKALA BIO, Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 1.01. Entry into a Material Definitive Agreement. On January 8, 2026, KALA BIO, Inc. (the “Company”), entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) providing for the sale and issuance by the Company of shares of its common stock, par value $0.001 per share (the “Common…
27. LABSTANDARD BIOTOOLS INC.8-KResultadosEDGAR
28. NEOGNEOGEN CORP8-KResultadosEDGAR
29. NEOGNEOGEN CORP10-QInforme trimestralEDGAR
30. PCRXPacira BioSciences, Inc.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you…

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

    …Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve…
31. PHATPhathom Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
32. PRAXPraxis Precision Medicines, Inc.8-KCambio en el consejo o la direcciónEDGAR
33. SLSSELLAS Life Sciences Group, Inc.8-KResultadosEDGAR
34. TLRYTilray Brands, Inc.8-KResultadosEDGAR
35. TLRYTilray Brands, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸

    …eliminated on consolidation. A complete list of our subsidiaries that existed as of our most recent fiscal year end is included in the Annual Report. Reverse Stock Split Effective December 2, 2025, the Company implemented a reverse stock split of its outstanding shares of Common Stock, at a ratio of one-for-ten (the “Reverse Stock Split”). No fractional shares were issued in connection with the Reverse Stock Split. Fractional shares resulting…
36. TNGXTango Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Transition: Barbara Weber to Retire, Malte Peters Appointed Successor - Founding CEO Barbara Weber, M.D. to become executive chair of the board of directors - - Malte Peters, M.D., current board member, appointed President and Chief Executive Officer, effective immediately – BOSTON, January 8, 2026 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation…
37. TRDAEntrada Therapeutics, Inc.8-KResultadosEDGAR
38. VNDAVanda Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
39. XERSXeris Biopharma Holdings, Inc.8-KResultadosEDGAR
40. XLOXilio Therapeutics, Inc.8-KResultadosEDGAR
41. XNCRXencor Inc8-KResultadosEDGAR

← miércoles 7 de enero de 2026 · viernes 9 de enero de 2026 →

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