Portada›Martes 28 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, martes 28 de octubre de 2025

Los 33 documentos que 27 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← lunes 27 de octubre de 2025 · miércoles 29 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. GNTAGenenta Science S.p.A.424B5Nueva emisión de acciones con precioEDGAR
2. PREPrenetics Global Ltd424B5Nueva emisión de acciones con precioEDGAR
3. TLPHTALPHERA, INC.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

1. CGONCG Oncology, Inc.SC 13D/ACambio en participación significativaEDGAR
2. NERVMinerva Neurosciences, Inc.SC 13DCambio en participación significativaEDGAR
3. RNAZTranscode Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. CELUCelularity Inc8-KVenta de acciones no registrada (colocación privada)EDGAR
2. EDSAEdesa Biotech, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation (“IMV”). Paridiprubart in the most conservative intention-to-treat (“ITT”) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments (“SOC”) had a lower…
3. INCYINCYTE CORP8-KResultadosEDGAR
   En el documentoLa FDA aprueba el fármacotexto original ▸

   …Monjuvi®) as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing, with data anticipated around year-end 2025. Inflammation and Autoimmunity (IAI) Ruxolitinib cream ▪In September, the FDA approved the supplemental New Drug Application (sNDA) for Opzelura for pediatric atopic dermatitis (AD). Opzelura is now indicated for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric…

   En el documentoAprobación acelerada de la FDAtexto original ▸

   …lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising…
4. AKBAAkebia Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
5. ALDXAldeyra Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
6. ALKSAlkermes plc.8-KResultadosEDGAR
7. ALKSAlkermes plc.10-QInforme trimestralEDGAR
8. ARQTArcutis Biotherapeutics, Inc.8-KResultadosEDGAR
9. ARQTArcutis Biotherapeutics, Inc.10-QInforme trimestralEDGAR
10. BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
11. BMRNBIOMARIN PHARMACEUTICAL INC10-QInforme trimestralEDGAR
12. DBVTDBV Technologies S.A.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …sufficient to fund its operations into the third quarter of 2026. As such, cash and cash equivalents are not sufficient to fund operations for the next 12 months, and these conditions and events raise substantial doubt about the Company's ability to continue as a going concern Management is also actively pursuing financing options including additional sales under the ATM program, potential warrant exercises, and strategic transactions. These Condensed Consolidated Financial…
13. GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
14. INCYINCYTE CORP10-QInforme trimestralEDGAR
15. INMBInmune Bio, Inc.8-KOtros hechos relevantesEDGAR
16. JAZZJazz Pharmaceuticals plc8-KCambio en el consejo o la direcciónEDGAR
17. KNSAKiniksa Pharmaceuticals International, plc8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …– ARCALYST® (rilonacept) Q3 2025 net product revenue of $180.9 million, representing 61% year-over-year growth – – ARCALYST 2025 expected net product revenue raised to $670 - $675 million – – KPL-387 granted Orphan Drug Designation for the treatment of pericarditis – – Cash balance increased by $44.3 million in Q3 2025 to $352.1 million – – Conference call and webcast scheduled for 8:30 am ET today – London – October 28, 2025 –…

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

    …recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults…
18. KNSAKiniksa Pharmaceuticals International, plc10-QInforme trimestralEDGAR
19. NBIXNEUROCRINE BIOSCIENCES INC8-KResultadosEDGAR
20. NBIXNEUROCRINE BIOSCIENCES INC10-QInforme trimestralEDGAR
21. NEOGNEOGEN CORP8-K/ACambio en el consejo o la direcciónEDGAR
22. REGNREGENERON PHARMACEUTICALS, INC.8-KResultadosEDGAR
23. REGNREGENERON PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
24. RGENREPLIGEN CORP8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …during 2025 including severance, employee-related and facility exit costs. Cost of goods sold includes the benefit received from the sale of inventory that had previously been reserved as part of the restructuring plan of $975 and $572 for the three months ended September 30, 2025 and 2024, respectively, and $3,268 and $3,607 for the nine months ended September 30, 2025 and 2024, respectively. (2) Includes $17,379 and…
25. TTRXTurn Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
26. UNCYUnicycive Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. Preliminary Financial Information…

Juntas de accionistas

1. PALIPALISADE BIO, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

← lunes 27 de octubre de 2025 · miércoles 29 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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