Portada›Martes 14 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, martes 14 de octubre de 2025

Los 50 documentos que 41 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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Emisiones y dilución

1. ACONAclarion, Inc.424B5Nueva emisión de acciones con precioEDGAR

   Aclarion presentó un suplemento de prospecto para ofrecer 64.000 acciones ordinarias y 236.000 warrants prefinanciados para comprar acciones adicionales.

   Original en inglés · traducción revisada

   64,000 Shares of Common Stock 236,000 Pre-Funded Warrants to Purchase Shares of Common Stock 236,000 Shares of Common Stock Issuable Upon Exercise of the Pre-Funded Warrants

   Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.

2. ASMBASSEMBLY BIOSCIENCES, INC.S-3Capacidad de emisión registradaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Equity Agreements, Gilead made an upfront equity investment of $15 million by purchasing from us 13,073,668 shares at a purchase price of $1.16 per share (which was reduced to 1,089,472 shares when we effected a 1-for-12 reverse stock split in February 2024). As a part of the 2024 Financing 10 Transaction, we and Gilead entered into the 2024 Securities Purchase Agreement for the issuance and sale, in a private placement, of 179,500 shares…
3. LEXXLexaria Bioscience Corp.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …obtain additional equity, effect a collaborative or strategic partnership, reduce or contain expenditures, and, ultimately, to generate revenue. Based on these factors, management determined that there is substantial doubt as to our ability to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our audited financial statements, and it…
4. SYRESpyre Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …2023, and subsequently amended and restated on September 29, 2023 and May 14, 2024, by and among us, Paragon Therapeutics, Inc. and Parapyre Holding LLC. Please be advised that on September 8, 2023, we effected a reverse stock split of our common stock at a ratio of 1-for-25 (the “Reverse Split”). Except as indicated otherwise, all share numbers related to our common stock disclosed in this prospectus supplement have been adjusted…
5. SYRESpyre Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …2023, and subsequently amended and restated on September 29, 2023 and May 14, 2024, by and among us, Paragon Therapeutics, Inc. and Parapyre Holding LLC. Please be advised that on September 8, 2023, we effected a reverse stock split of our common stock at a ratio of 1-for-25 (the “Reverse Split”). Except as indicated otherwise, all share numbers related to our common stock disclosed in this prospectus supplement have been adjusted…
6. XBIOXenetic Biosciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
7. ORKAOruka Therapeutics, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
8. ORKAOruka Therapeutics, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
9. SCNXScienture Holdings, Inc.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. APGEApogee Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
2. NVAXNOVAVAX INCSC 13D/ACambio en participación significativaEDGAR
3. SCLXScilex Holding CoSC 13D/ACambio en participación significativaEDGAR
4. ZBIOZenas BioPharma, Inc.SC 13D/ACambio en participación significativaEDGAR
5. ZBIOZenas BioPharma, Inc.SC 13D/ACambio en participación significativaEDGAR
6. ZBIOZenas BioPharma, Inc.SC 13D/ACambio en participación significativaEDGAR

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. CADLCandel Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoDesignación de terapia avanzada (RMAT)texto original ▸

   …pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 (aglatimagene besadenovec) in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, Fast Track Designation in NSCLC and prostate cancer, and both…
3. CORTCORCEPT THERAPEUTICS INC8-KFin de acuerdo materialEDGAR
4. ACONAclarion, Inc.8-KNuevo acuerdo materialEDGAR
5. ALLOAllogene Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
6. ALZNAlzamend Neuro, Inc.8-KCambio de estatutosEDGAR
7. ARDXARDELYX, INC.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers On October 13, 2025, the board of directors (the “Board”) of Ardelyx, Inc. (the “Company”) appointed Sue Hohenleitner as chief financial officer (“CFO”) and principal financial officer, effective November 4, 2025. Ms. Hohenleitner, age 55, worked at Johnson & Johnson (“J&J”), a publicly traded pharmaceutical, biotechnology, and medical technologies…
8. ATOSATOSSA THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
9. BCRXBIOCRYST PHARMACEUTICALS INC8-KNuevo acuerdo materialEDGAR
10. BIIBBIOGEN INC.8-KResultadosEDGAR
11. BMRABIOMERICA INC10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …efforts to reduce costs, we have implemented significant cost-cutting measures in an attempt to extend our cash runway and work towards increasing revenues to cover overhead costs. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability depends on the successful execution of our strategic plans, securing additional near-term financing, and achieving profitable operations. Our consolidated financial statements as…
12. CINGCingulate Inc.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …1301 (dexmethylphenidate), the company’s lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review. A Key Regulatory Milestone Under the 505(b)(2) Pathway This marks a major…
13. CLNNClene Inc.8-KResultadosEDGAR
14. DCOYDecoy Therapeutics Inc.8-KOtros hechos relevantesEDGAR
15. ELUTELUTIA INC.8-KCambio en el consejo o la direcciónEDGAR
16. FATEFATE THERAPEUTICS INC8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Current Report on Form 8-K and is incorporated herein by reference. Except as described above, there are no understandings or arrangements between Mr. Adawi and any other person pursuant to which he was appointed as Chief Financial Officer of the Company, and Mr. Adawi has no material interest in any transaction or proposed transaction in which the Company is or is to be a party. Mr. Adawi has no family relationship with any director or…
17. GERNGERON CORP8-KCambio en el consejo o la direcciónEDGAR
18. INMInMed Pharmaceuticals Inc.8-KCambio en el consejo o la direcciónEDGAR
19. INMInMed Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
20. INMBInmune Bio, Inc.8-KOtros hechos relevantesEDGAR
21. KPTIKaryopharm Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
22. LRMRLarimar Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
23. PPCBPropanc Biopharma, Inc.8-KNuevo acuerdo materialEDGAR
24. RCKTROCKET PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …EXHIBIT 99.1 Exhibit 99.1 Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission of KRESLADI™ for the Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I) Prescription Drug User Fee Act (PDUFA) target action date is March 28, 2026 All primary and secondary endpoints were met, and KRESLADI™ was well tolerated Rocket is eligible for a Rare Pediatric Disease Priority Review Voucher, should KRESLADITM be approved CRANBURY, NJ – October…
25. RNAZTranscode Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
26. SRRKScholar Rock Holding Corp8-KOtros hechos relevantesEDGAR
27. SYRESpyre Therapeutics, Inc.8-KResultadosEDGAR
28. TELOTelomir Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
29. TRAWTraws Pharma, Inc.8-KOtros hechos relevantesEDGAR
30. TVRDTvardi Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

    El ensayo de Fase 2 REVERT IPF fue un ensayo clínico aleatorizado, doble ciego y controlado con placebo de TTI-101 solo o junto con nintedanib en pacientes con fibrosis pulmonar idiopática.

    Original en inglés · traducción automática

    The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial of TTI-101 alone or in addition to nintedanib (OFEV®) in patients with IPF.

    Traducción automática (claude-sonnet-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.

31. XBIOXenetic Biosciences, Inc.8-KNuevo acuerdo materialEDGAR

Juntas de accionistas

1. BNTCBenitec Biopharma Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
2. GOVXGeoVax Labs, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
3. INMBInmune Bio, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
4. ISPCiSpecimen Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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