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Lunes 12 oct 2026SEC · NASDAQ biomédico

Portada›Lunes 17 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 17 de noviembre de 2025

Los 49 documentos que 38 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. ARTLARTELO BIOSCIENCES, INC.S-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…superior to those of our existing securityholders, which could adversely affect the market price of our common stock and the voting power of shares of our common stock. Our financial condition raises substantial doubt as to our ability to continue as a going concern. As of September 30, 2025, we had approximately $1.7 million in cash and cash equivalents, and working capital of negative $3.0 million, and we have incurred and expect to continue to incur significant…
  2. BYSIBeyondSpring Inc.424B5Nueva emisión de acciones con precioEDGAR
  3. 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…
  4. FENCFENNEC PHARMACEUTICALS INC.424B5Nueva emisión de acciones con precioEDGAR
  5. HYPDHYPERION DEFI, INC.S-3Capacidad de emisión registradaEDGAR
    En el documentoContrasplit de accionestexto original ▸…regained compliance with the Minimum Bid Price Requirement. Nasdaq Stock Market Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet the Minimum Bid Price Requirement 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…
  6. IVVDInvivyd, Inc.424B5Nueva emisión de acciones con precioEDGAR
  7. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…future products, which are critical to the realization of its business plan and the future operations of the Company. This uncertainty, along with the Company's history of losses, indicates that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company…
  8. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…future products, which are critical to the realization of its business plan and the future operations of the Company. This uncertainty, along with the Company's history of losses, indicates that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company…
  9. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…future products, which are critical to the realization of its business plan and the future operations of the Company. This uncertainty, along with the Company's history of losses, indicates that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company…
  10. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…future products, which are critical to the realization of its business plan and the future operations of the Company. This uncertainty, along with the Company's history of losses, indicates that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company…
  11. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…future products, which are critical to the realization of its business plan and the future operations of the Company. This uncertainty, along with the Company's history of losses, indicates that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company…
  12. RKTORocket One Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…the sole and exclusive forum for certain disputes which could limit shareholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents. ● We identified a material weakness in our internal control over financial reporting, which resulted in the restatement of certain or our financial statements. If we are unable to remediate this weakness, or if we fail to maintain an effective…
  13. TTRXTurn Therapeutics Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…operations through at least the next 12 months from the date that these unaudited condensed consolidated financial statements as of September 30, 2025 are issued based on our expected cash needs, which raises substantial doubt about our ability to continue as a going concern. 5 Turn Therapeutics Inc. Notes to Condensed Consolidated Financial Statements As we continue to pursue our business plan, we expect to finance our operations through potential public or private equity…
    En el documentoDebilidad material en el control internotexto original ▸…Rule 13a-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report. During the preparation of our financial statements for the year ended December 31, 2024, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties. A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial…
  14. TTRXTurn Therapeutics Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…operations through at least the next 12 months from the date that these unaudited condensed consolidated financial statements as of September 30, 2025 are issued based on our expected cash needs, which raises substantial doubt about our ability to continue as a going concern. 5 Turn Therapeutics Inc. Notes to Condensed Consolidated Financial Statements As we continue to pursue our business plan, we expect to finance our operations through potential public or private equity…
    En el documentoDebilidad material en el control internotexto original ▸…Rule 13a-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report. During the preparation of our financial statements for the year ended December 31, 2024, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties. A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial…
  15. VSTMVerastem, Inc.424B5Nueva emisión de acciones con precioEDGAR
  16. AKTXAkari Therapeutics PlcS-1Capacidad de emisión registradaEDGAR

Participaciones y control

  1. ALMSALUMIS INC.SC 13D/ACambio en participación significativaEDGAR
  2. COGTCogent Biosciences, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. DMRADamora Therapeutics, Inc.SC 13DCambio en participación significativaEDGAR
  4. HOWLWerewolf Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  5. MRKRMarker Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ENSCEnsysce Biosciences, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  2. IONSIONIS PHARMACEUTICALS INC8-KVenta de acciones no registrada (colocación privada)EDGAR

    Ionis anunció una oferta propuesta de bonos convertibles para refinanciar sus notas convertibles de 2026.

    Original en inglés · traducción automáticaIonis Announces Proposed Convertible Offering to Refinance 2026 Convertible Notes,” dated November 11, 2025. 99.2 Press release entitled “Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes,” dated November 12, 2025. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

    Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

  3. JAZZJazz Pharmaceuticals plc8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Important Safety Information for ZIIHERA WARNING: EMBRYO-FETAL TOXICITY Exposure to ZIIHERA during pregnancy can cause embryo…
    En el documentoAprobación acelerada de la FDAtexto original ▸…Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.5 The U.S. FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. The FDA granted Breakthrough Therapy designation for zanidatamab’s development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination…
  4. NXTCNextCure, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  5. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
  6. ZYMEZymeworks Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: https://pp.jazzpharma.com/pi…
    En el documentoAprobación acelerada de la FDAtexto original ▸…BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from the NMPA in China, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. The FDA granted Breakthrough Therapy designation for zanidatamab’s development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination…
  7. AKBAAkebia Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
  8. CURXCuranex Pharmaceuticals Inc10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…the Company’s short and long-term operating budgets, expected profitability, investment and financing activities, and strategic planning. In prior periods, the Company disclosed conditions that raised substantial doubt about its ability to continue as a going concern. Management has re-evaluated the Company’s liquidity and capital resources in accordance with ASC 205-40, Presentation of Financial Statements Going Concern, for the twelve-month period following the…
    En el documentoContrasplit de accionestexto original ▸…September 30, 2025, including an aggregate of 4,340,812 shares of common stock issued during the quarter ended September 30, 2025. 18 Reverse Stock Split Effective November 19, 2024, the Board of Directors approved a three-for-five reverse stock split of the Company’s issued and outstanding common stock. The par value of $0.0001 per share was not affected. All share and per-share amounts for all periods presented have been retroactively adjusted to…
  9. ENTAENANTA PHARMACEUTICALS INC8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…business and development programs into fiscal 2029. Virology • Enanta’s virology pipeline includes the leading portfolio in development for RSV treatment, consisting of zelicapavir and EDP-323, both of which received Fast Track designation from the U.S. Food and Drug Administration. o In September, Enanta reported data on zelicapavir, an oral, once-daily RSV N-protein inhibitor, which was evaluated in RSVHR, a Phase 2b, randomized, double…
  10. FBIOFortress Biotech, Inc.8-KOtros hechos relevantesEDGAR
  11. FDMT4D Molecular Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  12. FENCFENNEC PHARMACEUTICALS INC.8-KNuevo acuerdo materialEDGAR
  13. GELSGelteq Ltd20-FInforme anual (emisor extranjero)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…statements for the years ended June 30, 2025 and 2024, the Company is in a current liability position as of June 30, 2025 and 2024, and has suffered recurring losses from operations. These conditions raise substantial doubt on our ability to continue as a going concern. The report of our independent registered public accounting firm M&K CPAS PLLC on the financial statements for the year ended June 30, 2025 and 2024 includes an explanatory paragraph on the doubt of our…
  14. GRCEGrace Therapeutics, Inc.10-Q/AInforme trimestral (enmienda)EDGAR
  15. HYPDHYPERION DEFI, INC.8-KNuevo acuerdo materialEDGAR
  16. IBIOiBio, Inc.10-Q/AInforme trimestral (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…September 30, 2024. ​ The history of significant losses, the negative cash flow from operations, and the dependence by the Company on its ability to obtain additional financing to fund its operations raised substantial doubt about the Company's ability to continue as a going concern. In August 2025, the Company closed on an underwritten public offering raising gross proceeds of approximately $50 million. (See Note 15 – Stockholders’ Equity for additional information.) Based on the…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Agreement); provided that sixty (60) days after the Effective Date entering into an at-the-market facility shall not be deemed a Variable Rate Transaction. ​ ATM Agreement ​ On July 3, 2024, the Company entered into the ATM Agreement with its Sales Agents providing for the issuance and sale by the Company of its Common Stock, from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may…
  17. IBIOiBio, Inc.8-KOtros hechos relevantesEDGAR
  18. ISPCiSpecimen Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…ability to continue as a going concern. If the Company does not generate enough revenue to provide an adequate level of working capital, its business plan will be scaled down further. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year from the date these unaudited condensed financial statements are issued. Management’s plan to mitigate the conditions that raise substantial doubt includes generating additional…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…Company’s audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Reverse Stock Split On October 9, 2023, the Company received a notification from Nasdaq that its Common Stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market. On July 19, 2024, the Company’s stockholders approved a proposal to amend the Company…
    En el documentoContrasplit de accionestexto original ▸…outstanding shares of common stock, as well as any shares of common stock held by the Company in treasury, at a ratio in the range from 1-for-10 to 1-for-20. On August 19, 2024, the Company’s board of directors approved a one-for-twenty (1:20) reverse stock split of the Company’s issued and outstanding shares of common stock (the “Reverse Stock Split”). On September 13, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate…
    En el documentoDebilidad material en el control internotexto original ▸…to remediate the related control deficiencies that led to the material weakness. In response to these deficiencies, management, with the oversight of the Audit Committee of the Board of Directors, has identified and implemented steps to remediate the material weakness. The Company began implementing the remediation plan during the second quarter of fiscal year 2023 and this remediation is ongoing as of the filing date of this Quarterly Report. The following remedial…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…The Private Placement closed on August 4, 2025. We incurred offering costs of approximately $100,000, resulting in net proceeds of approximately $1,649,998. At the Market Offering On March 5, 2024, we entered into the ATM Agreement with Rodman & Renshaw LLC as agent (the “Sales Agent”) pursuant to which we may issue and sell shares of our common stock, having an aggregate offering price of up to $1,500,000, from time to time through…
  19. MIRMMirum Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
  20. ORMPORAMED PHARMACEUTICALS INC.8-KNuevo acuerdo materialEDGAR
  21. ORMPORAMED PHARMACEUTICALS INC.8-KResultadosEDGAR
  22. QNRXQuoin Pharmaceuticals Ltd.8-KCambio en el consejo o la direcciónEDGAR
  23. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR
  24. TWSTTwist Bioscience Corp10-KInforme anualEDGAR
  25. VSTMVerastem, Inc.8-KOtros hechos relevantesEDGAR
  26. XCUREXICURE, INC.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. ACETAdicet Bio, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  2. AKTXAkari Therapeutics PlcDEF 14AConvocatoria de junta de accionistasEDGAR

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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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