Portada›Miércoles 17 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 17 de septiembre de 2025

Los 20 documentos que 18 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 16 de septiembre de 2025 · jueves 18 de septiembre de 2025 →

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Emisiones y dilución

1. BCDABioCardia, Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
2. PLURPluri Inc.S-3Capacidad de emisión registradaEDGAR
3. PMCBPharmaCyte Biotech, Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

1. HYPDHYPERION DEFI, INC.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. PGENPRECIGEN, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. ARVNARVINAS, INC.8-KOtros hechos relevantesEDGAR
   En el documentoRecorte de plantilla o reestructuracióntexto original ▸

   …efficiencies across the business. The Company continues to believe that its cash, cash equivalents and marketable securities as of June 30, 2025, together with the actions described above, including the workforce reduction, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the second half of 2028.The Company has based this estimate on assumptions that may prove to be…

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

   …development costs, commercialization expenses, and profits, including any costs, expenses and profits that arise due to the parties’ agreement to out-license commercialization rights. Vepdegestrant was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. About Arvinas 4 Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology…

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

   …epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. 2 Strategic Plan and Cost Optimization Measures Following the decision to monetize the value of vepdegestrant and out-license its rights to a third party, Arvinas management and its Board of Directors…
3. BIAFbioAffinity Technologies, Inc.8-KCambio de estatutosEDGAR
4. CGCCanopy Growth Corp8-KCambio en el consejo o la direcciónEDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …“Canopy Growth” or the “Company”) (TSX: WEED) (Nasdaq: CGC), a world-leading cannabis company dedicated to unleashing the power of cannabis to improve lives, today announced that Tom Stewart has been appointed Chief Financial Officer, effective immediately. Mr. Stewart’s appointment supports the continued execution of Canopy Growth’s fiscal year 2026 strategy, which is marked by structural efficiency, operational and commercial focus…
5. DRMADermata Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
6. ELABPMGC Holdings Inc.8-KCambio de estatutosEDGAR
7. ELTXElicio Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
8. PLURPluri Inc.10-KInforme anualEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …ended June 30, 2025, the accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern. Our recurring operating losses and negative cash flow raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. As of June 30, 2025, our cash balances (cash and cash equivalents, short-term bank deposits…

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

   …maintain the listing of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction. On November 25, 2024, we received a deficiency letter (the “Nasdaq Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (the “Nasdaq”), notifying us that we are not in compliance with the Stockholders’ Equity Requirement, which…

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

   …were included in the Company’s issued and outstanding shares as a result of rounding-up fractional shares into whole shares as a result of the reverse share split. b) On February 13, 2024 the Company entered into an At-The-Market Sales Agreement, or the Sales Agreement, with A.G.P., which provides that upon the terms and subject to the conditions and limitations set forth in the Sales Agreement, the Company may elect, from time to time, to offer…
9. RCKTROCKET PHARMACEUTICALS, INC.8-KNuevo acuerdo materialEDGAR
10. ROIVRoivant Sciences Ltd.8-KOtros hechos relevantesEDGAR
11. RZLTRezolute, Inc.8-KResultadosEDGAR
12. RZLTRezolute, Inc.10-KInforme anualEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …the derivative liability of $8.5 million was reclassified to shareholders’ equity on May 13, 2024. Jefferies Open Market Sales Agreement On November 14, 2023, the Company and Jefferies LLC (the “Agent) entered into an open market sales agreement (the “Sales Agreement”) that provides for an “at the market” offering for the sale of up to $50.0 million in shares of the Company’s common stock (the “Placement Shares”) through the Agent. The Agent is acting as sales agent and is required to use commercially reasonable…
13. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KCambio en el consejo o la direcciónEDGAR
14. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR
15. VORVor Biopharma Inc.8-KOtros hechos relevantesEDGAR
16. XFORX4 Pharmaceuticals, Inc8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Officer, and Natasha Thoren, the Company’s Chief Legal & Compliance Officer, in each case effective as of September 15, 2025. On September 16, 2025, Dr. Christophe Arbet-Engels informed the Company of his resignation as the Company’s Chief Medical Officer, effective as of September 16, 2025. Appointment of Chief Operating Officer On September 16, 2025, the Board appointed John Volpone as Chief Operating Officer of the Company, effective immediately. Mr…

    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …and align resources with the Company’s long‑term strategy to successfully complete the 4WARD Phase 3 trial in patients with moderate and severe chronic neutropenia. As part of this initiative, X4 will reduce its workforce by 50%, a step anticipated to result in annualized cost savings of approximately $13 million. Corporate Updates •John Volpone has been appointed Chief Operating Officer (COO), in addition to his current…

← martes 16 de septiembre de 2025 · jueves 18 de septiembre de 2025 →

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