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Lunes 12 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 10 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 10 de diciembre de 2025

Los 34 documentos que 25 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. ADXNAddex Therapeutics Ltd.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Pursuant to Rule 424(b)(5)​ Registration No. 333-291644​ PROSPECTUS SUPPLEMENT (To prospectus dated December 5, 2025) Up to $3,300,000 American Depositary Shares Representing Ordinary Shares ​ We have entered into an At The Market Offering Agreement, or the sales agreement, dated January 30, 2024, with H.C. Wainwright & Co., LLC, or H.C. Wainwright, relating to offer and sale of American Depositary Shares, or ADSs, each representing one…
  2. CCCCC4 Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  3. CTORCITIUS ONCOLOGY, INC.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…addition, such statements could be affected by risks and uncertainties related to: ● our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern; ● our need for substantial additional funds, even after completion of this offering, and its ability to raise those funds; ● our ability to successfully commercialize LYMPHIR, including covering the…
  4. DNLIDenali Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. DYNDyne Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  6. ENVBEnveric Biosciences, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸…any revisions to any of the forward-looking statements contained herein to reflect future events or developments. iv SELECTED FINANCIAL DATA REFLECTING THE REVERSE STOCK SPLIT On October 23, 2025, we effected a 1-for-12 reverse stock split (the “Reverse Stock Split”), which began trading on a split-adjusted basis on October 28, 2025, pursuant to which every 12 shares of our issued and outstanding shares of Common Stock were reclassified…
  7. EVAXEvaxion A/S424B5Nueva emisión de acciones con precioEDGAR
  8. GPCRStructure Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
  9. HURATuHURA Biosciences, Inc./NV424B5Nueva emisión de acciones con precioEDGAR
  10. INKTMiNK Therapeutics, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…December 31, 2024 consolidated financial statements contains an explanatory paragraph that states that the Company has suffered recurring losses from operations and has a net capital deficiency that raises 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. 25 Table of Contents $150,000,000 Common Stock Preferred Stock Warrants Debt…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…relates to the issuance and sale of up to $50,000,000 of our common stock, $0.00001 par value per share, from time to time through our sales agent, B. Riley Securities, Inc. (the “Sales Agent”). We have entered into an At Market Issuance Sales Agreement (the “ATM Sales Agreement”) with the Sales Agent relating to shares of our common stock offered by this prospectus supplement and the accompanying prospectus. In accordance with the terms of the ATM Sales Agreement, we may offer…
  11. KYMRKymera Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  12. VERAVera Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  13. GRIGRI Bio, Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
  14. PRLDPrelude Therapeutics IncS-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. INDVIndivior Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. PBMPSYENCE BIOMEDICAL LTD.SC 13DCambio en participación significativaEDGAR
  3. TRIBTRINITY BIOTECH PLCSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. CTORCITIUS ONCOLOGY, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
  2. GRIGRI Bio, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸EX-99.1 2 ex991_pressreleasetoplined.htm EX-99.1 Exhibit 99.1 GRI Bio Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) Study met its primary endpoint demonstrating that GRI-0621 was well tolerated over 12 weeks of treatment, with no drug-related severe or serious adverse events and no increase in GI issues when used with existing approved treatments…
  3. HYPDHYPERION DEFI, INC.8-KOtros hechos relevantesEDGAR
    En el documentoContrasplit de accionestexto original ▸…notified by Nasdaq that we had regained compliance with the Minimum Bid Price Rule. Nasdaq Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet the Minimum Bid Price Rule and has effected a reverse stock split over the prior one-year period, or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, will not be eligible for an automatic…
  4. INMBInmune Bio, Inc.8-KFin de acuerdo materialEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 1.02Termination of a Material Definitive Agreement. As previously disclosed, on August 9, 2024, INmune Bio Inc. (the “Company”) entered into an Amended and Restated At-The-Market Sales Agreement (the “Sales Agreement”) with RBC Capital Markets, LLC (“RBC”) and BTIG, LLC (“BTIG”), pursuant to which the Company could offer and sell shares of its common stock, par value $0.001 per share (“Common…
  5. MBRXMoleculin Biotech, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  6. AARDAardvark Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS. ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage…
  7. DNLIDenali Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
  8. DYNDyne Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
  9. FDMT4D Molecular Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  10. GPCRStructure Therapeutics Inc.8-KOtros hechos relevantesEDGAR
  11. HURATuHURA Biosciences, Inc./NV8-KNuevo acuerdo materialEDGAR
  12. KYMRKymera Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
  13. ONCOOnconetix, Inc.8-KNuevo acuerdo materialEDGAR
  14. ONCOOnconetix, Inc.8-KCambio en el consejo o la direcciónEDGAR
  15. RIGLRIGEL PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…Phase 1b Study of R289, a Dual IRAK 1/4 Inhibitor, in Patients with Relapsed/Refractory (R/R) Lower Risk Myelodysplastic Syndrome (LR-MDS) Presenter: Guillermo Garcia-Manero, M.D. R289 was previously granted Orphan Drug designation for the treatment of myelodysplastic syndromes and granted Fast Track designation for the treatment of previously-treated transfusion dependent lower-risk MDS by the FDA. About R289 R289 is a prodrug…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…Phase 1b Study of R289, a Dual IRAK 1/4 Inhibitor, in Patients with Relapsed/Refractory (R/R) Lower Risk Myelodysplastic Syndrome (LR-MDS) Presenter: Guillermo Garcia-Manero, M.D. R289 was previously granted Orphan Drug designation for the treatment of myelodysplastic syndromes and granted Fast Track designation for the treatment of previously-treated transfusion dependent lower-risk MDS by the FDA. About R289 R289 is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to…
  16. VERAVera Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. LEXXLexaria Bioscience Corp.DEF 14AConvocatoria de junta de accionistasEDGAR

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