Portada›Jueves 30 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 30 de octubre de 2025

Los 60 documentos que 45 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← miércoles 29 de octubre de 2025 · viernes 31 de octubre de 2025 →

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. CRBPCorbus Pharmaceuticals Holdings, Inc.424B5Nueva emisión de acciones con precioEDGAR
2. SVRASavara Inc424B5Nueva emisión de acciones con precioEDGAR
3. VERUVERU INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …claims for fraud. The amended complaint also alleges that we are responsible to indemnify the Purchaser for a pre-closing tax liability of approximately $137,000. Reverse Stock Split On August 8, 2025, we effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of our issued and outstanding common stock. As a result of the Reverse Stock Split, each 10 shares of issued and outstanding common stock were automatically converted into…
4. IMAImageneBio, Inc.424B3Prospecto suplementario o de reventaEDGAR
5. NBPNovaBridge Biosciences424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. ABVXAbivax S.A.SC 13D/ACambio en participación significativaEDGAR
2. COCPCocrystal Pharma, Inc.SC 13D/ACambio en participación significativaEDGAR
3. RANIRani Therapeutics Holdings, Inc.SC 13DCambio en participación significativaEDGAR
4. TCRTAlaunos Therapeutics, Inc.SC 13DCambio en participación significativaEDGAR
5. VORVor 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. COCPCocrystal Pharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
3. INMBInmune Bio, Inc.8-KResultadosEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …to anti-amyloid therapies. ● The company is on track to request an End of Phase 2 meeting with the FDA which is anticipated to occur in Q1, 2026. INKmune® Platform: ● Concluded that the CARE-PC trial met its primary endpoint and 2 of the 3 secondary endpoints. Analysis of the first 9 patients treated showed evidence of NK cell proliferation in vivo and generation of functional, memory-like NK cells in 4 of 6 patients at the…
4. INSMINSMED Inc8-KResultadosEDGAR
   En el documentoLa FDA aprueba el fármacotexto original ▸

   …new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026. Brensocatib • In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI™ (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S. • In October 2025,…
5. LNAILunai Bioworks Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
6. ABVCABVC BIOPHARMA, INC.8-KCambio en el consejo o la direcciónEDGAR
7. AGIOAGIOS PHARMACEUTICALS, INC.8-KResultadosEDGAR
8. AGIOAGIOS PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
9. ALNYALNYLAM PHARMACEUTICALS, INC.8-KResultadosEDGAR
10. ALNYALNYLAM PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
11. AMRXAmneal Pharmaceuticals, Inc.8-KResultadosEDGAR
12. APVOAptevo Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
13. ARDXARDELYX, INC.8-KResultadosEDGAR
14. ARDXARDELYX, INC.10-QInforme trimestralEDGAR
15. BCDABioCardia, Inc.8-KOtros hechos relevantesEDGAR
16. BCYCBICYCLE THERAPEUTICS PLC8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …due to increased clinical program expenses for zelenectide pevedotin development, discovery, platform and other expenses, and higher personnel-related costs, including severance-related expenses of our workforce reduction in August 2025, offset by decreased clinical program expenses for Bicycle TICA® molecules. · General and administrative expenses were $18.9 million for the three months ended September 30, 2025, compared…

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

    …Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration (FDA) previously granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and NSCLC. · BT5528, a potential first-in…
17. BCYCBICYCLE THERAPEUTICS PLC10-QInforme trimestralEDGAR
18. BIIBBIOGEN INC.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …October 2025. FDA rolling submission underway for LEQEMBI IQLIK treatment initiation •Today announced that high dose nusinersen (SPINRAZA) in SMA was successfully resubmitted with the FDA with an updated PDUFA date of April 3, 2026 •Today announced both litifilimab Phase 3 studies for systemic lupus erythematosus fully enrolled with expected data readout for both studies now accelerated to H2 2026 •New analysis of dapirolizumab…
19. BIIBBIOGEN INC.10-QInforme trimestralEDGAR
20. CRBPCorbus Pharmaceuticals Holdings, Inc.8-KOtros hechos relevantesEDGAR
21. CTNMContineum Therapeutics, Inc.8-KResultadosEDGAR
22. CTNMContineum Therapeutics, Inc.10-QInforme trimestralEDGAR
23. DBVTDBV Technologies S.A.8-KCambio en el consejo o la direcciónEDGAR
24. ELABPMGC Holdings Inc.8-KNuevo acuerdo materialEDGAR
25. FHTXFoghorn Therapeutics Inc.8-KOtros hechos relevantesEDGAR
26. GILDGILEAD SCIENCES, INC.8-KResultadosEDGAR
27. IBIOiBio, Inc.8-KOtros hechos relevantesEDGAR
28. INDVIndivior Pharmaceuticals, Inc.8-KResultadosEDGAR
29. INDVIndivior Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
30. INMBInmune Bio, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …equivalents, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern. In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to…

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

    …shares of common stock at an average price of $10.56 per share under the ATM program. The aggregate net proceeds were approximately $2.0 million after commission expenses. During August 2024, the Company entered into an amended and restated at-the-market sales agreement with RBC Capital Markets LLC and BTIG (together, the “Sales Agents”) relating to the offer and sale of shares of our common stock with an aggregate offering price of up to $75.0 million. This amended…
31. INSMINSMED Inc10-QInforme trimestralEDGAR
32. IVVDInvivyd, Inc.8-KOtros hechos relevantesEDGAR
33. IXHLIncannex Healthcare Inc.8-KOtros hechos relevantesEDGAR
34. LITSLite Strategy, Inc.8-KCambio en el consejo o la direcciónEDGAR
35. LQDALiquidia Corp8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸

    …with interstitial lung disease (PH-ILD) and (ii) that Vectura shall be responsible for manufacturing and supplying Liquidia Technologies with clinical and commercial supplies of the Device. Under the License Agreement, Liquidia Technologies shall pay to Vectura (i) an upfront payment of $2,000,000 in connection with the execution of the License Agreement, (ii) certain development milestone payments of up to $12,000,000 upon achievement of certain development milestones; (iii…
36. NEOGNEOGEN CORP8-KCambio en el consejo o la direcciónEDGAR
37. PHATPhathom Pharmaceuticals, Inc.8-KResultadosEDGAR
38. PHATPhathom Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
39. RAREUltragenyx Pharmaceutical Inc.8-KOtros hechos relevantesEDGAR
40. RNACCartesian Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
41. SCNXScienture Holdings, Inc.8-KOtros hechos relevantesEDGAR
42. SVRASavara Inc8-KNuevo acuerdo materialEDGAR
43. TECXTectonic Therapeutic, Inc.8-KOtros hechos relevantesEDGAR
44. TVTXTravere Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …customary closing conditions. FILSPARI® (sparsentan) – FSGS •The Company’s supplemental New Drug Application (sNDA) for FILSPARI in FSGS 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 and only FDA-approved medicine for FSGS. In September 2025, the FDA informed the Company that following further review of the sNDA, an advisory committee is no…
45. TVTXTravere Therapeutics, Inc.10-QInforme trimestralEDGAR
46. VERUVERU INC.8-KNuevo acuerdo materialEDGAR
47. VNDAVanda Pharmaceuticals Inc.10-QInforme trimestralEDGAR
48. WVEWave Life Sciences, Inc.8-K/AOtros hechos relevantesEDGAR

Juntas de accionistas

1. CELZCREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.DEF 14AConvocatoria de junta de accionistasEDGAR
2. NEUPNeuphoria Therapeutics Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

← miércoles 29 de octubre de 2025 · viernes 31 de octubre de 2025 →

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