Portada›Martes 21 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, martes 21 de octubre de 2025

Los 23 documentos que 20 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← lunes 20 de octubre de 2025 · miércoles 22 de octubre de 2025 →

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

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. CTXRCitius Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …addition, such statements could be affected by risks and uncertainties related to: ● our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern; ● the Company’s need for substantial additional funds and its ability to raise those funds; ● our ongoing evaluation of strategic alternatives; ● the ability of Citius Oncology to commercialize LYMPHIR…
2. DCOYDecoy Therapeutics Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …reserves. •The pendency of the Merger could have an adverse effect on the trading price of Salarius’ common stock and its business, financial condition and prospects. •Decoy’s financial condition raises substantial doubt regarding its ability to continue as a going concern. 19 •Decoy has never generated revenue from product sales and all of Decoy’s product candidates are currently in the preclinical stage, and Decoy may continue to incur significant losses for the foreseeable…

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

   …Decoy and their respective directors and executive officers may sell shares into the market, which could adversely affect the market price of shares of Salarius’ common stock. Salarius has previously entered into an At the Market Offering Agreement dated as of February 5, 2021, with the representative, pursuant to which, from time to time, Salarius may offer and sell shares of its common stock under an “at-the-market” offering program…
3. IRONDisc Medicine, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …investment. Please also carefully read the section titled “Cautionary Note Regarding Forward-Looking Statements.” 7 Table of Contents SELECTED FINANCIAL DATA Reverse Stock Split On December 29, 2022, we effected a 1-for-10 reverse stock split of our common stock. The total number of authorized shares of capital stock was amended from 260,000,000 to 110,000,000. The par value per common share remained unchanged. The audited consolidated financial…
4. VRDNViridian Therapeutics, Inc.\DE424B5Nueva emisión de acciones con precioEDGAR
5. RDHLRedHill Biopharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
6. ZBIOZenas BioPharma, Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

1. ARTLARTELO BIOSCIENCES, INC.SC 13D/ACambio en participación significativaEDGAR
2. IVAInventiva S.A.SC 13DCambio en participación significativaEDGAR

Informes y hechos relevantes

1. ALECAlector, Inc.8-KResultadosEDGAR
   En el documentoRecorte de plantilla o reestructuracióntexto original ▸

   …meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, workforce reduction, product candidates, research and preclinical pipeline, blood-brain barrier technology platform, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding…

   En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸

   …latozinemab (AL001) in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In the 96-week, double-blind INFRONT-3 trial, latozinemab, developed in collaboration with GSK, did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer’s Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB). Although…
2. GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 8.01 Other Events. As of 12:01 a.m. on October 21, 2025, Genprex, Inc., a Delaware corporation (the “Company”), effected the previously disclosed one-for-fifty (1:50) reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”). After giving effect to the Reverse Stock Split, as of October…
3. RZLTRezolute, Inc.8-KFin de acuerdo materialEDGAR
4. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KFin de acuerdo materialEDGAR
5. BKHABlack Hawk Acquisition Corp10-QInforme trimestralEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …Standard Board’s Accounting Standards Update (“ASU”) 2014-15, “Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern,” management has determined that these conditions raise substantial doubt about the Company’s ability to continue as a going concern. In addition, if the Company is unable to complete a Business Combination within the Combination Period, the Company’s board of directors would proceed to commence voluntary liquidation and thereby a…
6. CPIXCUMBERLAND PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
7. CTXRCitius Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
8. DCOYDecoy Therapeutics Inc.8-KCambio en el consejo o la direcciónEDGAR
9. ELABPMGC Holdings Inc.8-KNuevo acuerdo materialEDGAR
10. PRAXPraxis Precision Medicines, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …PATIENT-GUIDED Patient-guided development strategies to deliver on what patients actually need Four pillars guide how we develop medicines 5 Two platforms to generate optimized therapies * Relutrigine has received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the FDA, and ODD from the European Medicines Agency (EMA) for the treatment of SCN2A and SCN8A-DEE and RPD designation for Dravet Syndrome ^ PRAX…

    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …PATIENT-GUIDED Patient-guided development strategies to deliver on what patients actually need Four pillars guide how we develop medicines 5 Two platforms to generate optimized therapies * Relutrigine has received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the FDA, and ODD from the European Medicines Agency (EMA) for the treatment of SCN2A and SCN8A-DEE and RPD designation…
11. QNRXQuoin Pharmaceuticals Ltd.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead product candidate, QRX003, for the treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency (EMA) in May 2025…
12. QTTBQ32 Bio Inc.8-KOtros hechos relevantesEDGAR
13. RNACCartesian Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
14. SUPNSUPERNUS PHARMACEUTICALS, INC.8-KResultadosEDGAR
15. VRDNViridian Therapeutics, Inc.\DE8-KResultadosEDGAR

← lunes 20 de octubre de 2025 · miércoles 22 de octubre 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.

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