Portada›Lunes 12 de enero de 2026
Biomédicas del NASDAQ ante la SEC, lunes 12 de enero de 2026
Los 97 documentos que 90 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.
← viernes 9 de enero de 2026 · martes 13 de enero de 2026 →
El día, bloque a bloque
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
- CINGCingulate Inc.424B5Nueva emisión de acciones con precioEDGAR
- CINGCingulate Inc.S-3Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…auditing. The audit report covering the December 31, 2024 consolidated financial statements contains an explanatory paragraph that states that our losses and negative cash flows from operations raise substantial doubt about the entity’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. 26 ADDITIONAL INFORMATION We have filed with the SEC a registration statement…
- ELABPMGC Holdings Inc.424B5Nueva emisión de acciones con precioEDGAR
A 31 de diciembre de 2024, la dirección determinó que existen dudas sustanciales sobre la capacidad de la empresa para continuar como empresa en funcionamiento (going concern).
Original en inglés · traducción automática
As of December 31, 2024, management has determined there is substantial doubt about the Company’s ability to continue as a going concern. The Company may need to obtain funds to support its working capital, the methods of which include, without limitation, the following: ● this offering; ● other available sources of financing (including debt) from banks and other financial institutions; and ● financial support from the Company’s related parties.
Traducción automática (claude-sonnet-5-5). 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.
El 6 de enero de 2026 la empresa realizó una agrupación de acciones (reverse split) de 1:4 de sus acciones ordinarias.
Original en inglés · traducción automática
On January 6, 2026, we effected a 1:4 reverse stock split of our Common Stock. Unless otherwise indicated, all share and per share information in this prospectus supplement reflects this reverse stock split.
Traducción automática (claude-sonnet-5-5). 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.
- FHTXFoghorn Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
La empresa ofrece 2.030.314 acciones ordinarias y warrants prefinanciados para comprar 5.421.250 acciones ordinarias, junto con dos series de warrants para comprar en total 7.451.564 acciones.
Original en inglés · traducción automática
we are offering 2,030,314 shares of our common stock and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 5,421,250 shares of our common stock, which we refer to as Pre-Funded Warrants, together with two series of warrants to purchase an aggregate of 7,451,564 shares of our common stock, which we refer to as Series 1 Warrants and Series 2 Warrants, and collectively, Series Warrants.
Traducción automática (claude-sonnet-5-5). 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.
- MTVAMetaVia Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…cash flows from operating activities since our inception, and we have a net loss of $11.0 million and an accumulated deficit of $146.9 million as of September 30, 2025. We have concluded that there is substantial doubt about the Company’s ability to continue as a going concern within twelve months from the date the consolidated financial statements were issued. Our independent registered public accounting firm has issued an opinion on our consolidated financial statements included…
En el documentoContrasplit de accionestexto original ▸
…the Company at a price of $ per Series D Common Warrant if certain conditions are met, and have a term of two years from the date of issuance and an exercise price equal to $ . On December 4, 2025, we effected a 1-for-11 reverse stock split of our common stock (the “Reverse Stock Split”). All information presented in this prospectus has been adjusted to account for the Reverse Stock Split, and unless otherwise indicated, all such amounts…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…condensed consolidated financial statements and related notes for the three and nine months ended September 30, 2025 included elsewhere in this prospectus. At-The-Market Offering On November 6, 2025, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with Ladenburg Thalmann & Co. Inc., as sales agent and/or principal (“Ladenburg”), pursuant to which we may offer and sell, from time to time through or to Ladenburg…
- SXTCChina SXT Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
La empresa ofrece 12.000.000 de acciones ordinarias Clase A y warrants prefinanciados (Pre-Funded Warrants) para comprar hasta 54.666.666 acciones ordinarias Clase A.
Original en inglés · traducción automática
12,000,000 Class A Ordinary Shares Pre-Funded Warrants to purchase up to 54,666,666 Class A Ordinary Shares
Traducción automática (claude-sonnet-5-5). 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.
- AUTLAutolus Therapeutics plc424B3Prospecto suplementario o de reventaEDGAR
Participaciones y control
Informes y hechos relevantes
- ALKSAlkermes plc.8-KResultadosEDGAR
La compañía anunció la adquisición prevista de Avadel Pharmaceuticals plc y tiene previsto cerrarla en el primer trimestre.
Original en inglés · traducción automática
Announced planned acquisition of Avadel Pharmaceuticals plc Granted FDA Breakthrough Therapy designation for alixorexton in NT1 2026 plans: Initiate alixorexton registrational phase 3 narcolepsy program in Q1 Close planned acquisition of Avadel and enter commercial sleep medicine market in Q1 Data expected from REVITALYZ LUMRYZ™ (sodium oxybate) idiopathic hypersomnia phase 3 study in Q2* Complete alixorexton idiopathic hypersomnia phase 2 study in H2 Advance alixorexton pre-launch planning activities *Assumes closing of the planned acquisition;
Traducción automática (claude-sonnet-5-5). 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.
En el documentoEl ensayo alcanzó su objetivo principal
…of each study; TEAE = treatment-emergent adverse event; ECG = electrocardiogram NT1 = narcolepsy type 1; NT2 = narcolepsy type 2 Vibrance-1 Primary Endpoint: Mean Sleep Latency on the MWT Alixorexton Achieved Normative Wakefulness at All Doses Primary Endpoint Analysis at Week 6 Alixorexton once daily Change from baseline at Week 6 (minutes)a PBO (N=23) 4 mg(N=23) 6 mg(N=22) 8 mg(N=24) LSM -0.6 21.6 23.5 25.5 (95% CI of LSM) (-4.5, 3.3) (17.7, 25.6) (19.4,…
En el documentoDesignación de medicamento huérfano
…Transaction expected to close in Q1 2026 LUMRYZ™ (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age or older with narcolepsy Patent protection into 2042; granted Orphan Drug Exclusivity in narcolepsy and Orphan Drug Designation in IH by FDA Enrollment of LUMRYZ phase 3 study in idiopathic hypersomnia (IH) recently completed, topline data expected Q2 2026 $1,218 $1,315 Experienced Commercial Enterprise with Diverse and Growing…
- BCABBioAtla, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- BTAIBioXcel Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified 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…
- DYNDyne Therapeutics, Inc.8-KResultadosEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…non-ambulant males with Duchenne muscular dystrophy (DMD) who are ages 4 to 16 and have mutations amenable to exon 51 skipping. 1. Safety data as of August 19, 2025. Registrational Expansion Cohort met primary endpoint of statistically significant and robust increase in dystrophin at 6 months (p<0.0001) Favorable safety profile1 Phase 3 study planned to support full approval of z-rostudirsen globally Z-Rostudirsen…
- IBIOiBio, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- IRONDisc Medicine, Inc.8-KResultadosEDGAR
En el documentoAprobación acelerada de la FDAtexto original ▸
…and meaningful progress toward becoming a fully integrated clinical and commercial organization,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “Most notably, bitopertin received CNPV designation and we submitted our NDA under the accelerated approval pathway, positioning the NDA for rapid review by the FDA. We also reported positive initial Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis, demonstrating robust and broad…
En el documentoRevisión prioritaria de la FDAtexto original ▸
…position Disc for sustained growth as we work to deliver meaningful new therapies to patients with serious hematologic diseases.” Summary of Key Achievements During 2025 • Bitopertin NDA submitted and accepted under the accelerated approval pathway with priority review • Bitopertin awarded the Commissioner’s National Priority Voucher (CNPV), a pilot program designed to accelerate the NDA review period to 1-2 months • Transition to commercial-ready organization through…
- JAGXJaguar Health, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- JAGXJaguar Health, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- JAGXJaguar Health, Inc.8-K/AVenta de acciones no registrada (colocación privada)EDGAR
- KPTIKaryopharm Therapeutics Inc.8-KResultadosEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; substantial doubt exists regarding Karyopharm's ability to continue as a going concern; development or regulatory approval of drug candidates by Karyopharm's 7 competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's…
- MBXMBX Biosciences, Inc.8-KResultadosEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…into 2029, we are well positioned to execute our strategy and continue to invest in long-term pipeline growth.” Once-weekly Canvuparatide for Hypoparathyroidism (HP) • The Phase 2 Avail™ trial (Avail) achieved its primary endpoint, demonstrating strong clinical proof-of-concept for canvuparatide with high responder rates and once-weekly dosing that was generally well-tolerated. Exhibit 99.1 • MBX plans to share the full 12-week…
- NXTSNexentis Technologies Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
- TELOTelomir Pharmaceuticals, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
- ZURAZura Bio Ltd8-KOtros hechos relevantesEDGAR
…significativo; QOL, calidad de vida; SHAQ-DI, Índice de discapacidad del Cuestionario de Evaluación de la Salud en la Esclerodermia; SSc, esclerosis sistémica; VAS, escala analógica visual. 26 ANTAGONISTA DEL RECEPTOR DE IL-17 – FASE 3 Brodalumab Alcanzó el criterio de… Sigue en la ficha
Original en inglés · traducción automática
significant; QOL, quality of life; SHAQ-DI, Scleroderma Health Assessment Questionnaire–Disability Index; SSc, systemic sclerosis; VAS, visual analog scale. 26 IL-17 RECEPTOR ANTAGONIST – PHASE 3 Brodalumab Met the primary endpoint of reduced mRSS at Week 24 for skin involvement, and demonstrated improvement in FVC as a secondary endpoint reflecting lung function Also showed therapeutic effects on lung/respiratory functions, digital
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- AARDAardvark Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
- ADMAADMA BIOLOGICS, INC.8-KResultadosEDGAR
- ADPTAdaptive Biotechnologies Corp8-KResultadosEDGAR
- AKBAAkebia Therapeutics, Inc.8-KResultadosEDGAR
- AKTSAktis Oncology, Inc.8-KCambio de estatutosEDGAR
- ALNYALNYLAM PHARMACEUTICALS, INC.8-KResultadosEDGAR
- AMPHAmphastar Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
- ANIPANI PHARMACEUTICALS INC8-KResultadosEDGAR
- ANIXAnixa Biosciences Inc10-KInforme anualEDGAR
- ANNXAnnexon, Inc.8-KOtros hechos relevantesEDGAR
- ARWRARROWHEAD PHARMACEUTICALS, INC.8-KNuevo acuerdo materialEDGAR
- ATRAAtara Biotherapeutics, Inc.8-KResultadosEDGAR
Atara Biotherapeutics anunció que la FDA ha emitido una carta de respuesta completa (CRL).
Original en inglés · traducción automática
Food and Drug Administration has issued a Complete Response Letter (CRL) THOUSAND OAKS, Calif. —(BUSINESS WIRE)— Atara Biotherapeutics, Inc.
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- AUTLAutolus Therapeutics plc8-KOtros hechos relevantesEDGAR
- AVTXAvalo Therapeutics, Inc.8-KResultadosEDGAR
- AXSMAxsome Therapeutics, Inc.8-KResultadosEDGAR
- BBIOBridgeBio Pharma, Inc.8-KResultadosEDGAR
- BCAXBicara Therapeutics Inc.8-KOtros hechos relevantesEDGAR
- BCRXBIOCRYST PHARMACEUTICALS INC8-KResultadosEDGAR
BioCryst anunció ingresos netos preliminares y sin auditar de ORLADEYO del cuarto trimestre y del conjunto de 2025.
Original en inglés · traducción automática
today announced preliminary, unaudited ORLADEYO (berotralstat) net revenue for the fourth quarter and full year 2025. The company also provided guidance for ORLADEYO net revenue, total revenue, and operating expenses for full year 2026. “2025 was a transformative year for BioCryst.
Traducción automática (claude-sonnet-5-5). 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.
- BCYCBICYCLE THERAPEUTICS PLC8-KOtros hechos relevantesEDGAR
- BEAMBeam Therapeutics Inc.8-KResultadosEDGAR
- BIOABioAge Labs, Inc.8-KOtros hechos relevantesEDGAR
- BMRNBIOMARIN PHARMACEUTICAL INC8-KResultadosEDGAR
- CABACabaletta Bio, Inc.8-KOtros hechos relevantesEDGAR
En el documentoDesignación de terapia avanzada (RMAT)texto original ▸
…data evaluating rese-cel without preconditioning in lupus patients. • Additional RMAT designation granted and registrational cohort alignments and initiations anticipated in 2026: The FDA has recently granted a Regenerative Medicine Advanced Therapy (RMAT) designation to rese-cel for the treatment of systemic sclerosis. Cabaletta is continuing to engage with the FDA to align on registrational cohort designs for RESET-SSc™ and anticipates providing…
- CLNNClene Inc.8-KOtros hechos relevantesEDGAR
- CRSPCRISPR Therapeutics AG8-KOtros hechos relevantesEDGAR
- DFTXDefinium Therapeutics, Inc.8-KResultadosEDGAR
En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸
…MDD)—which together affect over 50 million people2 in the U.S. 1 Definium’s late-stage pipeline includes four Phase 3 trials—two each for GAD and MDD—anchored by its lead candidate, DT120 ODT, which has received FDA Breakthrough Therapy Designation for GAD. In parallel, the Company is advancing its commercial strategy and operational readiness to support a best-in-class care model and prepare for the potential launch of DT120 ODT, if approved and…
- DNTHDianthus Therapeutics, Inc. /DE/8-KResultadosEDGAR
- ELABPMGC Holdings Inc.8-KNuevo acuerdo materialEDGAR
- ELUTELUTIA INC.8-KResultadosEDGAR
Elutia vendió EluPro a Boston Scientific en octubre de 2025 por 88 millones de dólares.
Original en inglés · traducción automática
EluPro was divested to Boston Scientific in October of 2025 for $88 million.
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- ERASErasca, Inc.8-KOtros hechos relevantesEDGAR
- EXELEXELIXIS, INC.8-KResultadosEDGAR
- FHTXFoghorn Therapeutics Inc.8-KResultadosEDGAR
- FULCFulcrum Therapeutics, Inc.8-KResultadosEDGAR
- GALTGALECTIN THERAPEUTICS INC8-KCambio en el consejo o la direcciónEDGAR
- GOVXGeoVax Labs, Inc.8-KCambio de estatutosEDGAR
- GRCEGrace Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
- HRMYHarmony Biosciences Holdings, Inc.8-KResultadosEDGAR
Harmony Biosciences Holdings anunció ingresos netos por producto preliminares y sin auditar de unos 243 millones de dólares en el cuarto trimestre de 2025 y de unos 868 millones en el conjunto del año.
Original en inglés · traducción automática
today announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth.
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ZYN002 ha recibido de la FDA la designación Fast Track para tratar síntomas de comportamiento en pacientes con síndrome X frágil (FXS).
Original en inglés · traducción automática
ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS. About Fragile X Syndrome Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder.
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En el documentoDesignación de medicamento huérfano
…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism…
En el documentoDesignación de terapia innovadora (breakthrough)
…for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated…
- IDYAIDEAYA Biosciences, Inc.8-KOtros hechos relevantesEDGAR
- IONSIONIS PHARMACEUTICALS INC8-KResultadosEDGAR
Ionis planea presentar una NDA en el primer trimestre de 2026 y lanzar el producto más tarde ese mismo año, tras recibir la designación de Terapia Innovadora.
Original en inglés · traducción automática
Planned NDA submission in Q1 2026 and launch later this year; received Breakthrough Therapy Designation
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- JAZZJazz Pharmaceuticals plc8-KResultadosEDGAR
- KNSAKiniksa Pharmaceuticals International, plc8-KResultadosEDGAR
La FDA concedió a ARCALYST la exclusividad de medicamento huérfano al aprobarlo para la pericarditis recurrente en 2021.
Original en inglés · traducción automática
The FDA granted Orphan Drug Exclusivity to ARCALYST upon its approval for recurrent pericarditis in 2021. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ● ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections.
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- KRYSKrystal Biotech, Inc.8-KResultadosEDGAR
Conferencia Morgan Healthcare. Ingresos netos preliminares de VYJUVEK en el cuarto trimestre de 2025 de entre 106 millones y 107 millones de dólares. Sólida cartera clínica con oportunidades de miles de millones de dólares y un balance fuerte para un crecimiento sostenido.… Sigue en la ficha
Original en inglés · traducción automática
Morgan Healthcare Conference Preliminary 4Q 2025 VYJUVEK net revenue of $106 million to $107 million Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth PITTSBURGH, January 11, 2026 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced selected preliminary unaudited 2025 financial results, including fourth quarter and full year 2025 VYJUVEK® net product revenue, and outlined the Company’s strategic vision to drive the next stage of growth of its rare disease business. These topics will be discussed during the Company’s presentation at the 44th Annual J.P.
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- KURAKura Oncology, Inc.8-KResultadosEDGAR
Kura Oncology informa de 2,1 millones de dólares de ingresos netos de KOMZIFTI desde la primera venta comercial, el 21 de noviembre de 2025, hasta el 31 de diciembre de 2025.
Original en inglés · traducción automática
$2.1 million KOMZIFTI net product revenue for the period from first commercial sale on November 21, 2025, through December 31, 2025 – – Company poised for breakthrough progress in 2026 with deep pipeline of potentially transformative therapies – SAN DIEGO, Jan. 11, 2026 — Kura Oncology, Inc.
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- KYTXKyverna Therapeutics, Inc.8-KResultadosEDGAR
- LPCNLipocine Inc.8-KOtros hechos relevantesEDGAR
- LPCNLipocine Inc.8-KOtros hechos relevantesEDGAR
- LRMRLarimar Therapeutics, Inc.8-KResultadosEDGAR
- LXEOLexeo Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
- MGXMetagenomi Therapeutics, Inc.8-KCambio de estatutosEDGAR
La compañía ha completado el cambio de nombre a Metagenomi Therapeutics, Inc.
Original en inglés · traducción automática
that it has completed its corporate name change to Metagenomi Therapeutics, Inc. to reflect the Company’s strategic evolution focused on driving forward the Company’s lead program in hemophilia A and other compelling programs and technologies that have the highest probability of near-term success.
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- MIRMMirum Pharmaceuticals, Inc.8-KResultadosEDGAR
En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸
…cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com. LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for the treatment of ALGS and PFIC. LIVMARLI is currently being evaluated in the Phase 3 EXPAND study in additional settings of cholestatic pruritus. To…
- MREOMereo BioPharma Group plc8-KOtros hechos relevantesEDGAR
Mereo presentó una actualización de sus programas y revisó su previsión de duración de la caja.
Original en inglés · traducción automática
today provided an update on its programs, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat, which is being studied for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), and revised its cash runway guidance.
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Navicixizumab tiene un acuerdo de licencia global con Feng Biosciences, Inc. que incluye pagos por hitos y royalties.
Original en inglés · traducción automática
Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties.
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En el documentoDesignación de vía rápida (Fast Track)
…imperfecta from the European Commission (“EC”) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which…
- MRNAModerna, Inc.8-KResultadosEDGAR
- MXCTMAXCYTE, INC.8-KResultadosEDGAR
MXCT), compañía líder centrada en la ingeniería celular que ofrece tecnologías de plataforma para avanzar en el descubrimiento, el desarrollo y la comercialización de terapias celulares de próxima generación, ofreció hoy un avance preliminar de los resultados financieros del… Sigue en la ficha
Original en inglés · traducción automática
MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, today provided a preliminary update on financial results for the fourth quarter and full year ended December 31, 2025. Preliminary Unaudited Fourth Quarter and Full Year 2025 Results ● Core revenue in the fourth quarter is expected to be between $6.6 million and $6.7 million. ● Core revenue for the full year is expected to be between $29.5 million and $29.6 million. ● Strategic Platform License (SPL) program-related revenue in the fourth quarter is expected to be between $0.4 million and $0.6 million. ● SPL program-related revenue for the full year is expected to be between $3.3 million and $3.5 million. Total cash, cash equivalents, and investments as of December 31, 2025, is expected to be approximately $155.6 million. “2025 was a challenging, but productive year at MaxCyte.
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En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit…
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PTC Therapeutics informó hoy de su progreso y de sus perspectivas para 2026.
Original en inglés · traducción automática
today provided an update on the Company’s progress and its outlook for 2026. Matthew B.
Traducción automática (claude-sonnet-5-5). 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.
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En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸
…Worse Much Worse Very Much Worse n=12; QD dose * = p-value <0.0001 100% of participants were either “Much Improved” or “Very Much Improved” on CGI-C after 12 weeks of treatment Palvella was subsequently granted FDA Breakthrough Therapy Designation based on this data Week 12 Phase 2 Results: Visible Improvement Baseline Patient CGI-C: Very Much Improved (+3). QTORIN™ 3.9% rapamycin anhydrous gel is for investigational use only and has not been approved…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…launched or in late-stage development Positive Phase 2 cVM data (December 2025) Phase 3 mLM SELVA trial exceeded enrollment Announced third QTORIN™ rapamycin program Announced QTORIN™ pitavastatin program Granted FDA Fast Track Designation for angiokeratomas Q1 2026: Phase 3 mLM SELVA topline data (March 2026) Potential Breakthrough Therapy Designation for cVMs (1H 2026) NDA submitted to FDA for QTORIN™ rapamycin in mLMs (2H 2026) Phase…
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En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…DTX401 (pariglasgene brecaparvovec) AAV gene therapy for glycogen storage disease type Ia (GSDIa): Biologics License Application (BLA) rolling submission completed in December 2025, with an anticipated PDUFA date in the third quarter of 2026. • UX111 (rebisufligene etisparvovec) AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA): Resubmission of the BLA is on track for early in 2026 and will be followed by an up to 6-month review…
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En el documentoCambio en la dirección de la empresatexto original ▸
…financial officer services. Ms. Liang has worked extensively with public and private companies across multiple sectors, providing financial leadership and strategic guidance. Most recently, Ms. Liang was appointed Chief Financial Officer of iSpecimen Inc. on December 13, 2024. In addition to her recent appointment as Chief Financial Officer of iSpecimen Inc., Ms. Liang currently serves as Chief Financial Officer of BlockchainK2 Corp.…
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Syndax cerró 2025 con unos 394 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, sin auditar.
Original en inglés · traducción automática
Ended 2025 with approximately $394 million in cash, cash equivalents and marketable securities (unaudited); fully funded through profitability – – Syndax to present at the 44th Annual J.P.
Traducción automática (claude-sonnet-5-5). 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.
En el documentoDesignación de medicamento huérfano
…revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML. Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation…
En el documentoDesignación de vía rápida (Fast Track)
…granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult…
- SRPTSarepta Therapeutics, Inc.8-KResultadosEDGAR
Sarepta presenta cifras preliminares de ingresos netos por producto del cuarto trimestre y del conjunto de 2025, junto con su caja a 31 de diciembre de 2025.
Original en inglés · traducción automática
today reports preliminary* fourth quarter and full-year 2025 net product revenues and cash, cash equivalents, restricted cash and investments on hand as of December 31, 2025, as part of its presentation today at the 44thAnnual J.P.
Traducción automática (claude-sonnet-5-5). 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.
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En el documentoCambio en la dirección de la empresatexto original ▸
…constructive and collaborative in-person Type A meeting with the FDA in November 2025, following the receipt of a Complete Response Letter (CRL) from FDA on September 22, 2025. • Transformed leadership team. Appointed 8-year Board Chairman, David Hallal, as Chief Executive Officer; Akshay Vaishnaw, M.D., Ph.D. as President of R&D; R. Keith Woods as Chief Operating Officer; Vikas Sinha as Chief Financial Officer; and Rebecca McLeod as Chief Brand Officer and U.S. General Manager…
En el documentoRevisión prioritaria de la FDAtexto original ▸
…Highlights and Accomplishments • Progressed U.S. and European regulatory activities for apitegromab for the treatment of children and adults with SMA. Scholar Rock submitted a BLA to the FDA in January 2025, received Priority Review designation in March 2025, and achieved acceptance of the EMA MAA in March 2025, representing significant regulatory milestones toward commercialization. The Company completed a constructive and collaborative…
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En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸
…improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen to develop and commercialize zorevunersen…
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En el documentoCambio en la dirección de la empresatexto original ▸
…announcing Mr. Cherry’s appointment to the Board is attached hereto as Exhibit 99.2 and is incorporated herein by reference. Termination of Chief Financial Officer On January 7, 2026, Ms. Leone Patterson was terminated from her positions as Executive Vice President, Chief Business Officer and Chief Financial Officer, including as the Company’s principal financial officer and principal accounting officer, effective as of January 9, 2026. Ms. Patterson will remain an employee of the Company until January 31, 2026.…
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