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Domingo 11 oct 2026SEC · NASDAQ biomédico

Portada›Lunes 29 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 29 de diciembre de 2025

Los 40 documentos que 33 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. AGENAGENUS INCS-3ASRCapacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…report covering the December 31, 2024 consolidated financial statements contains an explanatory paragraph that states that the Company’s recurring losses from operations and net capital deficiency raise substantial doubt about the entity’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. 13 Table of Contents WHERE YOU CAN FIND MORE INFORMATION We file annual, quarterly…
  2. IBRXImmunityBio, Inc.424B5Nueva emisión de acciones con precioEDGAR
  3. QUCYQuantum Cyber N.V.424B5Nueva emisión de acciones con precioEDGAR
  4. QUCYQuantum Cyber N.V.424B5Nueva emisión de acciones con precioEDGAR
  5. SABSSAB Biotherapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…December 31, 2024, have been audited by EisnerAmper LLP, independent registered public accounting firm, as set forth in their report (which report includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern), and have been incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing. LEGAL MATTERS If and when the securities being…
  6. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…additional funding, which may not be available to us on acceptable terms, or at all. 14 Table of Contents • Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern. Risks Related to our Commercial Operations and Product Development • We obtain, or historically have obtained, our commercial supply of certain of our products, the clinical supply of our product candidates…
    En el documentoContrasplit de accionestexto original ▸…Warrants”. Our Common Stock is listed on the Nasdaq Capital Market under the symbol “SCLX”. On December 26, 2025, the last reported sales price per share of our Common Stock was $14.10. On April 15, 2025, we effected a reverse stock split of our Common Stock at a ratio of 1-for-35 (the “Reverse Stock Split”). Unless otherwise noted, the share and per share information in this prospectus reflects the effect of the Reverse Stock Split. We…
    En el documentoDebilidad material en el control internotexto original ▸…timely and accurately report ourfinancial results and such material weaknesses may result in a material misstatement of our financial statements.” above for additional information regarding a previously identified material weakness. These reporting and other obligations place significant demands on our management and administrative and operational resources, including accounting resources. In addition, changing laws, regulations…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Riley Purchase Agreement. On, and effective as of, February 16, 2024, we and B. Riley mutually agreed to terminate the B. Riley Purchase Agreement. At-the-Market Sales Agreement On December 22, 2023, we entered into a Sales Agreement (the “ATM Sales Agreement”) with B. Riley Securities, Inc., Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC (the “Sales Agents”), which agreement was voluntarily terminated by us effective as of March 5, 2025. Pursuant…
  7. TNXPTonix Pharmaceuticals Holding Corp.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated herein by reference, which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s ability to continue as a going concern. Such financial statements are incorporated herein by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing. WHERE YOU CAN FIND MORE INFORMATION…
  8. VBIOValion Bio, Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Company’s financial statements at December 31, 2024 and 2023, and for the years then ended, 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), which is incorporated herein by reference. Such financial statements are incorporated herein by reference in reliance on Rosenberg Rich Baker Berman, P.A.’s report, given on the authority of such firm…
    En el documentoContrasplit de accionestexto original ▸…All exercises are subject to certain beneficial ownership limitations, as set forth in the Note Offering Warrant. Reverse Stock Splits Reverse Stock Split - 2025 Effective March 7, 2025, the Company implemented a reverse stock split of the Company’s issued and outstanding shares of common stock at a ratio of 1-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the…
  9. VBIOValion Bio, Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Company’s financial statements at December 31, 2024 and 2023, and for the years then ended, 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), which is incorporated herein by reference. Such financial statements are incorporated herein by reference in reliance on Rosenberg Rich Baker Berman, P.A.’s report, given on the authority of such firm…
    En el documentoContrasplit de accionestexto original ▸…Warrants. As of December 29, 2025, all 12,000 of the Initial Tranche Preferred Shares and Warrants remain outstanding. Reverse Stock Splits Reverse Stock Split - 2025 Effective March 7, 2025, the Company implemented a reverse stock split of the Company’s issued and outstanding shares of common stock at a ratio of 1-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the…
  10. CVKDCadrenal Therapeutics, Inc.S-1Capacidad de emisión registradaEDGAR
  11. LEXXLexaria Bioscience Corp.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. HOWLWerewolf Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. INABIN8BIO, INC.SC 13D/ACambio en participación significativaEDGAR
  3. IVVDInvivyd, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. NEUPNeuphoria Therapeutics Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ACETAdicet Bio, Inc.8-KCambio de estatutosEDGAR
    En el documentoContrasplit de accionestexto original ▸…at its 2025 Special Meeting of Stockholders held on December 19, 2025 (the “Special Meeting”), and upon the recommendation of the Company’s Board of Directors (the “Board”), the Company’s stockholders approved a certificate of amendment to effect a reverse stock split of the Common Stock at a ratio ranging from any whole number between 1-for-5 and 1-for-30, as determined by the Board in its discretion, subject to the Board’s authority to abandon such amendment (the…
  2. APVOAptevo Therapeutics Inc.8-KCambio de estatutosEDGAR
    En el documentoContrasplit de accionestexto original ▸…amendments and the abandonment of the other amendments, or the abandonment of all amendments, to be determined by the Board in its sole discretion following the Special Meeting. On December 17, 2025, the Board approved an amendment to the Certificate of Incorporation to effect a reverse stock split of its common stock at the reverse split ratio of 1-for-18 (the “Reverse Stock Split”). Accordingly, on December 29, 2025, the Company filed a Certificate of Amendment of Amended and Restated Certificate…
  3. DRMADermata Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. DYAIDYADIC INTERNATIONAL INC8-KAviso de incumplimiento de cotizaciónEDGAR
  5. MREOMereo BioPharma Group plc8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸EX-99.1 2 mreo-ex99_1.htm EX-99.1 Exhibit 99.1 Mereo BioPharma Announces Phase 3 ORBIT and COSMIC Results for Setrusumab (UX143) in Osteogenesis Imperfecta Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC) Both studies achieved secondary endpoint of improvements in bone mineral density with strong statistical…
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…oncology product candidates, etigilimab, an anti-TIGIT; and navicixizumab for the potential treatment of late-line ovarian cancer. Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties. All statements other than statements of historical…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…imperfecta from the European Commission (“EC”) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which…
  6. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  7. SILOSilo Pharma, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
  8. DYAIDYADIC INTERNATIONAL INC8-KNuevo acuerdo materialEDGAR
  9. IBACIB Acquisition Corp.10-KInforme anualEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…considered to be at least one year from the date that the financial statements are issued as it expects to continue to incur significant costs in pursuit of its acquisition plans. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management plans to address this uncertainty through a Business Combination. There is no assurance that the Company’s plans to raise capital or to consummate a Business Combination will be successful…
  10. IBRXImmunityBio, Inc.8-KNuevo acuerdo materialEDGAR
  11. ICCCIMMUCELL CORP /DE/8-KOtros hechos relevantesEDGAR
  12. INOINOVIO PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…efficacy, which could make it an important therapeutic option for a majority of RRP patients. The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations. The European Commission granted INO-3107 Orphan Drug designation. In addition, INOVIO has CE-marked its CELLECTRA® delivery device in the EU, which allows INOVIO to commercialize the device in the EU and other geographies that recognize CE-marking. The United Kingdom…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. INOVIO…
  13. IPSCCentury Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  14. KALAKALA BIO, Inc.8-KCambio en el consejo o la direcciónEDGAR
  15. OMEROMEROS CORP8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…under review by the European Medicines Agency (EMA) with a decision expected in mid-2026. YARTEMLEA has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA, and the EMA has granted it orphan drug designation in hematopoietic stem-cell transplantation. YARTEMLEA is the first and only approved therapy for TA-TMA. About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy Hematopoietic stem…
  16. ORGOOrganogenesis Holdings Inc.8-KNuevo acuerdo materialEDGAR
  17. PRAXPraxis Precision Medicines, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…pursuant to Section 13(a) of the Exchange Act. ☐ Item 8.01. Other Events. On December 29, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (“BTD”) for ulixacaltamide for the treatment of patients with essential tremor (“ET”). The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition…
  18. PTCTPTC THERAPEUTICS, INC.8-KNuevo acuerdo materialEDGAR
  19. RAREUltragenyx Pharmaceutical Inc.8-KOtros hechos relevantesEDGAR
  20. SABSSAB Biotherapeutics, Inc.8-KOtros hechos relevantesEDGAR
  21. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR
  22. TNXPTonix Pharmaceuticals Holding Corp.8-KNuevo acuerdo materialEDGAR

Juntas de accionistas

  1. FBLGFibroBiologics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
    En el documentoContrasplit de accionestexto original ▸…Company and our stockholders and is likely to improve the trading price of our Common Stock and improve the likelihood that we will be allowed to maintain our listing on Nasdaq. Accordingly, our Board approved the Reverse Stock Split Amendment as being in the best interests of the Company. Risks Associated with the Reverse Stock Split The Reverse Stock Split May Not Increase the Price of our Common Stock over the Long-Term and our…
  2. GRIGRI Bio, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  3. KTTAPasithea Therapeutics Corp.DEF 14AConvocatoria de junta de accionistasEDGAR

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