Portada›Martes 16 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, martes 16 de septiembre de 2025

Los 20 documentos que 20 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← lunes 15 de septiembre de 2025 · miércoles 17 de septiembre de 2025 →

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

Emisiones y dilución

1. GNPXGenprex, Inc.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …reference, our independent registered public accounting firm, in its audit report to the financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, expressed substantial doubt about our ability to continue as a going concern. See also our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025, as incorporated by reference into this prospectus, including the discussion therein under “Management’s Discussion…

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

   …organization collaborators presented a poster on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments. 4 Recent Developments ATM Sales On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an ATM offering program under which we may offer and sell through the Agent, from time to…
2. REVBREVELATION BIOSCIENCES, INC.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …have been audited by Baker Tilly US, LLP, an independent registered public accounting firm, as stated in their report thereon (which report includes an explanatory paragraph regarding the existence of substantial doubt about the Company’s ability to continue as a going concern), incorporated herein by reference, and have been incorporated in this prospectus and registration statement in reliance upon such report and upon the authority of such firm as experts in accounting and…
3. TTRXTurn Therapeutics Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …development. We expect to incur additional losses for the foreseeable future, and it is possible we may never achieve or maintain profitability. Our consolidated financial statements therefore express substantial doubt about our ability to continue as a going concern. ​ • We have a limited operating history and there are inherent uncertainties and risks in pharmaceutical and medical device product development and commercialization. ​ • If we fail to obtain or generate…

   En el documentoDebilidad material en el control internotexto original ▸

   …that competes against large, well-established companies with long-standing relationships, extensive clinical data, and recognized brands, as well as against new companies with innovative products. ​ • We identified a material weakness in our internal control over the accuracy of our financial reporting. Any failure to maintain an effective control over financial reporting may result in material misstatements of our consolidated financial…
4. BCDABioCardia, Inc.S-1Capacidad de emisión registradaEDGAR

Informes y hechos relevantes

1. BFRGBullFrog AI Holdings, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. NEUPNeuphoria Therapeutics Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
3. PCSAProcessa Pharmaceuticals, Inc.8-K/ACambio de estatutosEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Adjournment Proposal”): Shares For Against Abstain 14,039,730 2,563,581 524,527 Although the Adjournment Proposal was approved, the adjournment of the Special Meeting was not necessary because the shareholders approved the Charter Proposal, the Reverse Stock Split Proposal, and the OIP Proposal. Item 9.01(d) Financial Statements and Exhibits 3.1 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation 104 Cover Page Interactive Data…
4. ADILADIAL PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
5. APVOAptevo Therapeutics Inc.8-KOtros hechos relevantesEDGAR

   Aptevo anunció una tasa de remisión del 100% en la cohorte 3 de su ensayo RAINIER de fase 1b/2 con mipletamig, en combinación con venetoclax y azacitidina, en pacientes con leucemia mieloide aguda recién diagnosticada.

   Original en inglés · traducción automática

   today announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, the Company’s first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax + azacitidine for newly diagnosed patients with acute myeloid leukemia (AML) unfit for intensive chemotherapy.

   Traducción automática (claude-sonnet-5-5). 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.

   Mipletamig ha recibido la designación de medicamento huérfano para la leucemia mieloide aguda (AML) conforme a la Orphan Drug Act.

   Original en inglés · traducción automática

   Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantages—including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits—mipletamig has been evaluated in more than 100 patients over three trials to date.

   Traducción automática (claude-sonnet-5-5). 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.

6. CRBPCorbus Pharmaceuticals Holdings, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoDesignación de vía rápida (Fast Track)texto original ▸

   …- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. A Fast Track designation…
7. CYTKCYTOKINETICS INC8-KOtros hechos relevantesEDGAR
   En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

   …aficamten and received communications from FDA that no observations were noted. There have been no Good Manufacturing Practice (“GMP”) inspections for aficamten scheduled. The Prescription Drug User Fee Act (“PDUFA”) target action date for the NDA for aficamten remains December 26, 2025. In addition, the Company recently submitted responses to Day 120 List of Questions from the Committee for Medicinal Products for Human Use (“CHMP”) from European Medicines Agency (“EMA”) with respect…
8. DYAIDYADIC INTERNATIONAL INC8-KNuevo acuerdo materialEDGAR
9. KTTAPasithea Therapeutics Corp.8-KOtros hechos relevantesEDGAR
10. LGNDLIGAND PHARMACEUTICALS INC8-KNuevo acuerdo materialEDGAR
11. LYELLyell Immunopharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
12. OCGNOcugen, Inc.8-KNuevo acuerdo materialEDGAR
13. OVIDOvid Therapeutics Inc.8-KOtros hechos relevantesEDGAR
14. RLMDRELMADA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
15. RPRXRoyalty Pharma plc8-KNuevo acuerdo materialEDGAR
16. TENXTENAX THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR

← lunes 15 de septiembre de 2025 · miércoles 17 de septiembre de 2025 →

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