Portada›Lunes 8 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 8 de septiembre de 2025

Los 28 documentos que 24 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← viernes 5 de septiembre de 2025 · martes 9 de septiembre de 2025 →

¿Lo quieres en tu correo cada mañana, y solo de tus empresas? Crear una cuenta.

Emisiones y dilución

1. DNTHDianthus Therapeutics, Inc. /DE/424B5Nueva emisión de acciones con precioEDGAR
2. IMAImageneBio, Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …issuance date of our unaudited condensed financial statement as of and for the six months ended June 30, 2025 (as filed as Exhibit 99.4 to our Form 8-K/A, filed with the SEC on August 12, 2025), which raises substantial doubt as to our ability to continue as a going concern. In July 2025, as further discussed above, Legacy Inmagene completed its Merger with Ikena, through which it received approximately $95.2 million in cash and cash equivalents from Ikena and aggregate…

   En el documentoContrasplit de accionestexto original ▸

   …to “Legacy Inmagene” refer to Inmagene Biopharmaceuticals together with its consolidated subsidiaries for periods prior to the Merger. Pursuant to the Merger Agreement, on the Closing Date, (i) Ikena effected a 1-for-12 reverse stock split of Ikena’s issued common stock (the “Reverse Stock Split”), (ii) Merger Sub I merged with and into Legacy Inmagene (the “First Merger”), with Legacy Inmagene surviving the First Merger as a wholly owned…

   En el documentoDebilidad material en el control internotexto original ▸

   …affect our financial condition following the Merger. For more information, please see the section titled “Unaudited Pro Forma Condensed Combined Financial Information” in this prospectus. Legacy Inmagene identified a material weakness in its internal control over financial reporting. If we fail to remediate this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective…
3. ISPCiSpecimen Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …profitability in subsequent periods. Our prior losses and expected future losses have had and will continue to have adverse effects on our stockholders’ equity (deficit) and working capital. There is substantial doubt about our ability to continue as a going concern. Our audited financial statements included in this Annual Report include an explanatory paragraph that indicates that they were prepared assuming that we would continue as a going concern. We have suffered…

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

   …Agreement. In connection with the ATM Offering, we incurred offering costs of approximately $255,000, resulting in net proceeds of approximately $1,239,000. 35 Reverse Stock Split On October 9, 2023, we received a notification from Nasdaq that our 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, our stockholders approved a proposal to amend our Fourth Amended…

   En el documentoContrasplit de accionestexto original ▸

   …our issued and 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 Board approved a one-for-twenty (1:20) reverse stock split of our issued and outstanding shares of common stock. On September 13, 2024, we filed with the Secretary of State of the State of Delaware a Certificate of Amendment to our Certificate of Incorporation…

   En el documentoDebilidad material en el control internotexto original ▸

   …recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. During the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate this…

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

   …exercisable for an aggregate of up to 65,625 shares of common stock, all of which were repurchased by us on February 13, 2024, and are no longer outstanding. At the Market Offering On March 5, 2024, we entered into an At the Market Offering Agreement (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…
4. LBRXLB PHARMACEUTICALS INCS-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …future and may never achieve or maintain profitability. • As a result of our history of losses and negative cash flows from operations, our consolidated financial statements contain a statement regarding a substantial doubt about our ability to continue as a going concern. • We will require substantial additional financing in addition to the proceeds of this offering to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms to us…
5. RAPPRapport Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
6. IMRXImmuneering Corp424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. MLYSMineralys Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
2. MLYSMineralys Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. HYPDHYPERION DEFI, INC.8-KAviso de incumplimiento de cotizaciónEDGAR
2. IMMXImmix Biopharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
3. RAPPRapport Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …precision medicines for patients with neurological or psychiatric disorders, today announced that the Phase 2a clinical trial of RAP-219(RAP-219-FOS-201) in patients with drug-resistant focal onset seizures met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period…
4. RAREUltragenyx Pharmaceutical Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …Metabolism 2025 in Kyoto, Japan. Participants achieved statistically significant and clinically meaningful reductions in cornstarch while maintaining glycemic control As previously reported, the study met its primary endpoint with patients treated with DTX401 (n=20) experiencing a mean reduction in cornstarch of 41% at Week 48 compared to 10% reduction in the placebo group (n=24) (p < 0.0001). Data at Week 96 showed even greater…
5. ANIPANI PHARMACEUTICALS INC8-KResultadosEDGAR
6. APREAprea Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
7. ATOSATOSSA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
8. BCYCBICYCLE THERAPEUTICS PLC8-KCambio en el consejo o la direcciónEDGAR
9. CHRSCoherus Oncology, Inc.8-KOtros hechos relevantesEDGAR
10. CYTKCYTOKINETICS INC8-K/AOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …relieves symptoms in patients with HCM. Aficamten was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China…

    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …investigational drug candidate currently under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additional Analysis from MAPLE-HCM Assesses Effect of Aficamten Compared to Metoprolol on Cardiac Structure and Function Dr. Sheila Hegde, M.D., M.P.H, Assistant Professor, UT Southwestern Medical Center…
11. DNTHDianthus Therapeutics, Inc. /DE/8-KOtros hechos relevantesEDGAR
12. EOLSEvolus, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Arrangements of Certain Officers. Appointment of Chief Financial Officer On September 8, 2025, Evolus, Inc. (the “Company”) announced that, effective September 8, 2025, its Board of Directors (the “Board”) appointed Tatjana Mitchell to serve as the Company’s Chief Financial Officer. Tatjana Mitchell, age 47, served as the Senior Vice President, Finance of Experian North America since April 2023. From May 2019 to March 2023, Ms. Mitchell served as the Chief Financial Officer for…
13. HROWHARROW, INC.8-KNuevo acuerdo materialEDGAR
14. IDYAIDEAYA Biosciences, Inc.8-KOtros hechos relevantesEDGAR
15. KROSKeros Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
16. NRXPNRX Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application…

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

    …disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has…
17. RAPPRapport Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
18. SDGRSchrodinger, Inc.8-KCambio en el consejo o la direcciónEDGAR
19. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KCambio en el consejo o la direcciónEDGAR
20. SMMTSummit Therapeutics Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery,…

← viernes 5 de septiembre de 2025 · martes 9 de septiembre 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.

Esto no son recomendaciones de inversión. Son hechos públicos verificables en su fuente. Lee siempre el documento original antes de decidir nada. Aviso legal.