Portada›Miércoles 10 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 10 de septiembre de 2025

Los 37 documentos que 30 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 9 de septiembre de 2025 · jueves 11 de septiembre de 2025 →

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Emisiones y dilución

1. ACTUACTUATE THERAPEUTICS, INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …objectives of our management for future operations; · future results of anticipated product development efforts; · our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we will require substantial additional capital to finance our operations; and · our ability to comply with evolving legal standards and regulations, particularly concerning requirements for being…
2. AMLXAmylyx Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
3. BBOTBridgeBio Oncology Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred net operating losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion…

   En el documentoDebilidad material en el control internotexto original ▸

   …these rules, BBOT is required to maintain effective disclosure and financial controls and to make a formal assessment of the effectiveness of BBOT’s internal control over financial reporting. BBOT has identified a material weakness in its internal controls over financial reporting. If BBOT is unable to maintain effective internal controls over financial reporting and disclosure controls and procedures, the accuracy and timeliness…
4. CTORCITIUS ONCOLOGY, 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, even after completion of this offering, and its ability to raise those funds; ● the ability of the Company to commercialize LYMPHIR, including covering…
5. CTORCITIUS ONCOLOGY, INC.424B3Prospecto suplementario o de reventaEDGAR
   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, even after completion of this offering, and its ability to raise those funds; ● the ability of the Company to commercialize LYMPHIR, including covering…
6. NCELNewcelX Ltd.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …defend against claims of misappropriating third-party confidential information; •Our financial statements for the year ended December31, 2024, contained a going concern disclosure in Note 1 regarding substantial doubt about our ability to continue as a going concern. This going concern disclosure in Note 1 of financial statements could prevent us from obtaining new financing on reasonable terms or at all and risk our ability to continue operating as a going concern…

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

   …requirements of Nasdaq in the future, including but not limited to the corporate governance requirements and the minimum closing bid price requirement or the minimum equity requirement. On March31, 2022, NLS received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying us that, based on NLS’s shareholders’ equity of $542,388 as of December31, 2021, NLS was no longer in compliance with the…
7. RAPPRapport Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
8. TLRYTilray Brands, Inc.424B5Nueva emisión de acciones con precioEDGAR
9. XFORX4 Pharmaceuticals, IncS-3Capacidad de emisión registradaEDGAR
   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 are presented on a post-Reverse Stock Split basis. Our principal executive…
10. ANIXAnixa Biosciences IncS-3Capacidad de emisión registradaEDGAR
11. CAPRCAPRICOR THERAPEUTICS, INC.S-3Capacidad de emisión registradaEDGAR

Informes y hechos relevantes

1. BTAIBioXcel Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and…
2. CAMPCamp4 Therapeutics Corp8-KVenta de acciones no registrada (colocación privada)EDGAR
3. CTORCITIUS ONCOLOGY, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
4. TLPHTALPHERA, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
5. ABCLAbCellera Biologics Inc.8-KOtros hechos relevantesEDGAR
6. ABUSArbutus Biopharma Corp8-KOtros hechos relevantesEDGAR
7. ACTUACTUATE THERAPEUTICS, INC.8-KNuevo acuerdo materialEDGAR
8. ALNYALNYLAM PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
9. ALZNAlzamend Neuro, Inc.10-QInforme trimestralEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …sufficient to fund its development and commercial operations during the twelve-month period subsequent to the issuance of the financial statements included in this Quarterly Report. These factors create substantial doubt about our ability to continue as a going concern. In order to continue as a going concern, the Company will need to raise additional funds. The Company plans to seek additional funding through public equity, private equity and debt financings. The terms…

   En el documentoDebilidad material en el control internotexto original ▸

   …material weakness previously identified and disclosed in the Company’s Annual Report on Form 10-K for the year ended April 30, 2025, the end of its most recent fiscal year. Specifically, management has identified the following material weakness: · We do not have sufficient resources in our accounting department, which restricts our ability to perform sufficient reviews and approval of manual journal entries posted to the general ledger and to…
10. AMLXAmylyx Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
11. ANIXAnixa Biosciences Inc10-QInforme trimestralEDGAR
12. ARTLARTELO BIOSCIENCES, INC.8-KCambio de estatutosEDGAR
13. CORTCORCEPT THERAPEUTICS INC8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …communications@corcept.com www.corcept.com FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif., September 10, 2025— Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic…
14. DRMADermata Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
15. DSGNDesign Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
16. GYREGYRE THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …Population Diagnosed Compensated F-2-F4 Hydronidone, a structural analog of pirfenidone, reverses fibrosis by modulating TGF-β / p38γ / Smad7 signaling pathway — a key driver of fibrosis progression. It received Breakthrough Therapy designation from PRC’s NMPA in 2021, enabling expedited review. Current standard of treatment, e.g. entecavir, tenofovir, focuses on only reducing liver inflamation. Patients with F2 - F4 fibrosis are at a high risk…
17. INTSINTENSITY THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
18. LITSLite Strategy, Inc.8-KCambio de estatutosEDGAR
19. PMVPPMV Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
20. PTNPALATIN TECHNOLOGIES INC8-KOtros hechos relevantesEDGAR
21. QCLSQ/C TECHNOLOGIES, INC.8-KNuevo acuerdo materialEDGAR
22. RAPPRapport Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
23. RVMDRevolution Medicines, Inc.8-KOtros hechos relevantesEDGAR
24. TLRYTilray Brands, Inc.8-KOtros hechos relevantesEDGAR
25. TVTXTravere Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (“FSGS”), an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (“PDUFA”) target action date of January 13, 2026. If approved, FILSPARI would be the first medication indicated for FSGS, a rare and serious kidney disorder driven by proteinuria that leads to progressive kidney function loss and kidney failure. FILSPARI…

Juntas de accionistas

1. IBACIB Acquisition Corp.DEF 14AConvocatoria de junta de accionistasEDGAR

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