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Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Jueves 23 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 23 de octubre de 2025

Los 23 documentos que 22 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. COYACoya Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. ISPCiSpecimen Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…ended December 31, 2023 have been audited by Wolf & Company, P.C., our former independent registered public accounting firm, as stated in their report (which includes an explanatory paragraph relating to substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the financial statements), and are incorporated herein in reliance upon such report given on the authority of said firm as experts in accounting and auditing. WHERE YOU CAN FIND…
  3. VRDNViridian Therapeutics, Inc.\DE424B5Nueva emisión de acciones con precioEDGAR
  4. XFORX4 Pharmaceuticals, Inc424B5Nueva emisión de acciones con precioEDGAR
    En el documentoContrasplit de accionestexto original ▸…completed the business combination with X4 Therapeutics, Inc. (formerly X4 Pharmaceuticals, Inc.) and we completed our corporate rebranding, changing our name to X4 Pharmaceuticals, Inc. On April 28, 2025, we effected a 1-for-30 reverse stock split of our common stock (the “Reverse Stock Split”). All references to common stock share and per share amounts in this prospectus supplement are presented on a post-Reverse Stock Split basis. Our principal…
  5. XRTXXORTX Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR

Participaciones y control

  1. NEUPNeuphoria Therapeutics Inc.SC 13DCambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ENVBEnveric Biosciences, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
    En el documentoContrasplit de accionestexto original ▸…stated that, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Company was not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A) due to the fact that the Company has effected a reverse stock split over the prior one-year period. The Notice stated that unless the Company timely requests a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting…
  2. INBXInhibrx Biosciences, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma. Chondrosarcoma The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart…
    En el documentoDesignación de medicamento huérfanotexto original ▸…activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma. In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…INBRX-109) Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.…
  3. NXTSNexentis Technologies Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. AKTXAkari Therapeutics Plc8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Officers; Compensatory Arrangements of Certain Officers. Appointment of Interim Chief Financial Officer On October 22, 2025, the board of directors (the “Board”) of Akari Therapeutics, plc (the “Company”), appointed Kameel Farag to serve as the Company’s interim Chief Financial Officer, effective immediately. Mr. Farag will succeed the Company’s current Chief Financial Officer, Torsten Hombeck, whose departure the Company previously reported. Mr. Farag will serve as interim Chief Financial…
  5. GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
  6. GRCEGrace Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…the 60th day after the U.S. Food and Drug Administration’s (FDA) acceptance for review of the Company’s New Drug Application for GTx-104 has passed. The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of the Company’s NDA submission for GTx-104.The application seeks approval for GTx-104 for the treatment of patients with aSAH, and is supported by a comprehensive data package including…
  7. HRMYHarmony Biosciences Holdings, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated…
  8. MEDPMedpace Holdings, Inc.10-QInforme trimestralEDGAR
  9. MIRAMIRA PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
  10. 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 re-filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for…
    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…
  11. SLNSilence Therapeutics plc8-KOtros hechos relevantesEDGAR
  12. TNGXTango Therapeutics, Inc.8-KResultadosEDGAR
  13. VKTXViking Therapeutics, Inc.10-QInforme trimestralEDGAR
  14. VRDNViridian Therapeutics, Inc.\DE8-KNuevo acuerdo materialEDGAR
  15. VSTMVerastem, Inc.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. NAIINATURAL ALTERNATIVES INTERNATIONAL INCDEF 14AConvocatoria de junta de accionistasEDGAR
  2. SBFMSunshine Biopharma Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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