Portada›Miércoles 19 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 19 de noviembre de 2025

Los 27 documentos que 23 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 18 de noviembre de 2025 · jueves 20 de noviembre 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. CMNDClearmind Medicine Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …covering the October 31, 2024 consolidated financial statements contains an explanatory paragraph that states that the Company’s recurring losses from operations and lack of sufficient resources 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. Such financial statements are incorporated in this prospectus supplement by…
2. IVVDInvivyd, Inc.424B5Nueva emisión de acciones con precioEDGAR
3. MDCXMedicus Pharma Ltd.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …brought to market, or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our business plans and results of operations. 10 There is substantial doubt about the Company's ability to continue as a going concern and if the Company is unable to obtain additional financing from outside sources and/or eventually generate enough revenues, it may be forced to curtail or discontinue its operations. The Company's auditor…

   En el documentoDebilidad material en el control internotexto original ▸

   …precision in the review of materials used to record transactions in accordance with U.S. GAAP, and lack of formalized or documented policies related to the overall IT system environment. Our management has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024, and that such controls and procedures remained ineffective as of September 30, 2025. To address our material weaknesses…
4. OLMAOlema Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR

Participaciones y control

1. DNTHDianthus Therapeutics, Inc. /DE/SC 13D/ACambio en participación significativaEDGAR
2. IVAInventiva S.A.SC 13D/ACambio en participación significativaEDGAR
3. IVAInventiva S.A.SC 13D/ACambio en participación significativaEDGAR
4. IVVDInvivyd, Inc.SC 13D/ACambio en participación significativaEDGAR
5. ZYMEZymeworks Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. FBLGFibroBiologics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. JAGXJaguar Health, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
3. NERVMinerva Neurosciences, Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …completion of one year of continuous service; an additional forty-five percent (45%) of the Consultant Option shall vest on the tenth day following the date of the Company’s public announcement that it has achieved, on a statistically significant basis, the primary endpoint of the Company’s Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week timepoint; and the remaining thirty percent (30%) of the Consultant Option shall vest on the tenth day following…
4. TPSTTempest Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Matt Angel, Ph.D. In connection with the Closing of the Contemplated Transaction, Dr. Angel will be appointed to serve as the Company’s President and Chief Executive Officer, replacing Mr. Brady in such capacities, and as a member of the Company’s board of directors. Dr. Angel, age 44, has served as Co-Founder, President, Chief Executive Officer and Chairman of the Board…
5. ALKSAlkermes plc.8-KNuevo acuerdo materialEDGAR
6. DCOYDecoy Therapeutics Inc.8-KCambio en el consejo o la direcciónEDGAR
7. ENTAENANTA PHARMACEUTICALS INC10-KInforme anualEDGAR
8. FENCFENNEC PHARMACEUTICALS INC.8-KNuevo acuerdo materialEDGAR
9. GILDGILEAD SCIENCES, INC.8-KCambio en el consejo o la direcciónEDGAR
10. GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
11. HCWBHCW Biologics Inc.8-KNuevo acuerdo materialEDGAR
12. HINDVyome Holdings, Inc8-KResultadosEDGAR
13. IVVDInvivyd, Inc.8-KNuevo acuerdo materialEDGAR
14. KALAKALA BIO, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …on Form 10-Q for the quarter ended September 30, 2025. See Note 16, “Subsequent Events” for more information about the Convertible Loan Agreement. As a result, the Company has concluded that there is a substantial doubt about its ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued. Subject to consummation of an additional financing transaction with the Individual Lender or another third…

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

    …consideration, Impairment of right-of-use assets, Interest income, Interest expense, Grant income and other expense, net. 16. SUBSEQUENT EVENTS Nasdaq Deficiency Notice On November 10, 2025, the “Company” received a deficiency letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule…
15. OLMAOlema Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
16. ONCBeOne Medicines Ltd.8-KNuevo acuerdo materialEDGAR
17. QCLSQ/C TECHNOLOGIES, INC.10-QInforme trimestralEDGAR
18. TARAProtara Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

← martes 18 de noviembre de 2025 · jueves 20 de noviembre de 2025 →

Esto mismo, cada mañana y solo de tus empresas. Sigue a las que te interesen y recibe en tu correo lo que presenten ante la SEC, en castellano. Crear una cuenta. ¿Ya tienes cuenta? Entrar.

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