Portada›Martes 6 de enero de 2026
Biomédicas del NASDAQ ante la SEC, martes 6 de enero de 2026
Los 38 documentos que 29 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.
← lunes 5 de enero de 2026 · miércoles 7 de enero de 2026 →
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
- ALMSALUMIS INC.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…securities as of December 31, 2025, will not be sufficient to meet our operating and capital requirements for at least 12 months from the date of issuance of this preliminary prospectus supplement and there is substantial doubt about our ability to continue as a going concern. Corporate Information Alumis was incubated by Foresite Labs, LLC (“Foresite Labs”) and incorporated on January 29, 2021 as a Delaware corporation under the name FL2021-001, Inc. In March 2021, FL2021…
- ESLAEstrella Immunopharma, Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing. The report of Macias Gini & O’Connell LLP contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. The financial statements of Estrella Biopharma, Inc. (now known as Estrella Immunopharma, Inc.) as of June 30, 2023 and for the year ended June 30, 2023, appearing in the Annual Report on Form 10-K of…
- PRAXPraxis Precision Medicines, Inc.424B5Nueva emisión de acciones con precioEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
- ENLVEnlivex Ltd.424B3Prospecto suplementario o de reventaEDGAR
- NERVMinerva Neurosciences, Inc.424B3Prospecto suplementario o de reventaEDGAR
Participaciones y control
- ANIXAnixa Biosciences IncSC 13D/ACambio en participación significativaEDGAR
- FBIOFortress Biotech, Inc.SC 13D/ACambio en participación significativaEDGAR
Informes y hechos relevantes
- ALKSAlkermes plc.8-KOtros hechos relevantesEDGAR
En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸
EX-99.1 2 alks-ex99_1.htm EX-99.1 Exhibit 99.1 Alkermes Contacts: For Investors: Sandy Coombs, +1 781 609 6377 For Media: Gretchen Murphy,+1 781 609 6419 Alixorexton Granted Breakthrough Therapy Designation by U.S. FDA for the Treatment of Narcolepsy Type 1 DUBLIN, Jan. 6, 2026 -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy…
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…phase 3 development later this quarter,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. In the Vibrance-1 phase 2 study, alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful and dose-dependent improvements from baseline compared to placebo in wakefulness on the Maintenance of Wakefulness…
- ASBPAspire-Lakewood Holdings, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- BRNSBarinthus Biotherapeutics plc.8-KAviso de incumplimiento de cotizaciónEDGAR
- DMRADamora Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- ESLAEstrella Immunopharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- IMUXIMMUNIC, INC.8-KAviso de incumplimiento de cotizaciónEDGAR
- KALAKALA BIO, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- MISTMilestone Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…In clinical studies, participants using etripamil were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered etripamil (N=99) converting from PSVT to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR=2.62; p<0.001). At one hour, the benefit was demonstrated…
- MLYSMineralys Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…positive data from the Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension, reduced kidney function and albuminuria. The crossover trial met its primary endpoint on systolic blood pressure reduction and demonstrated meaningful reduction in proteinuria. •Pivotal Launch-HTN Phase 3 Trial – The global trial met its primary endpoint in evaluating the efficacy and…
- TILInstil Bio, Inc.8-KFin de acuerdo materialEDGAR
- ACRSAclaris Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
- ADILADIAL PHARMACEUTICALS, INC.8-KCambio en el consejo o la direcciónEDGAR
- ALMSALUMIS INC.8-KOtros hechos relevantesEDGAR
- APGEApogee Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
- ARWRARROWHEAD PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
- ATOSATOSSA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
- CMPXCompass Therapeutics, Inc.8-KResultadosEDGAR
- ELABPMGC Holdings Inc.8-KCambio de estatutosEDGAR
- GERNGERON CORP8-KNuevo acuerdo materialEDGAR
- GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
- KRSAKorsana Biosciences, Inc.8-KNuevo acuerdo materialEDGAR
En el documentoAcuerdo de licencia o colaboracióntexto original ▸
…Entry into a Material Definitive Agreement. On January 3, 2026, Cyclerion Therapeutics, Inc. (the “Company”) and the Medsteer, SAS (“Medsteer”) entered into a Collaboration and Option Agreement (the “Collaboration Agreement”) pursuant to which Medsteer granted to the Company (i) a non-exclusive, worldwide, royalty-free, sublicensable license of certain of Medsteer’s technology, software and intellectual property to develop an anesthetic delivery system with Medsteer and (ii) an exclusive option (the “Option”)…
- PRAXPraxis Precision Medicines, Inc.8-KResultadosEDGAR
- RGENREPLIGEN CORP8-KCambio en el consejo o la direcciónEDGAR
Juntas de accionistas
- ADILADIAL PHARMACEUTICALS, INC.DEF 14AConvocatoria de junta de accionistasEDGAR
- TWSTTwist Bioscience CorpDEF 14AConvocatoria de junta de accionistasEDGAR
← lunes 5 de enero de 2026 · miércoles 7 de enero de 2026 →
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