Fechas PDUFA: cuándo decide la FDA
La fecha PDUFA es el plazo que la FDA se compromete a cumplir para contestar a la solicitud de aprobación de un fármaco. La FDA no publica estas fechas: las da cada empresa en sus documentos ante la SEC. Aquí van tal cual las cuenta, de la más próxima a la más lejana, con su frase y su documento.
29 fechas por delante.
14 nov 2026 · BTAI BioXcel Therapeutics
Lo que dice la empresa…accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026.
En un 8-K del 15 may 2026. El documento en la SEC.
14 nov 2026 · CYTK Cytokinetics
Lo que dice la empresa…Mecarbil Ulacamten Meet with regulatory authorities to discuss results from ACACIA-HCM & plans for submitting sNDA Launch MYQORZO in Germany in Q2 2026 Complete enrollment in sNDA for MAPLE-HCM PDUFA date Continue enrollment in Cohort 1 of November 14, 2026 COMET-HF AMBER-HFpEF through 2026 in 2H 2026 Complete enrollment in the adolescent cohort of CEDAR-HCM in Q4 2026…
En un 8-K del 5 may 2026. El documento en la SEC.
14 nov 2026 · SMMT Summit Therapeutics
Lo que dice la empresa…was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.
En un 8-K del 29 sep 2026. El documento en la SEC.
22 nov 2026 · CAPR Capricor Therapeutics
Lo que dice la empresaEX-99.1 2 capr-20260824xex99d1.htm EX-99.1 Exhibit 99.1 Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA – New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication – SAN…
En un 8-K del 24 ago 2026. El documento en la SEC.
30 nov 2026 · VRTX Vertex Pharmaceuticals INC / MA
Lo que dice la empresa…membranous nephropathy (pMN), and generalized myasthenia gravis (gMG). •The U.S. FDA accepted the BLA submission for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.
En un 8-K del 3 ago 2026. El documento en la SEC.
12 dic 2026 · VNDA Vanda Pharmaceuticals
Lo que dice la empresa…NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026 •BYSANTITM commercial launch expected in Q4 2026 •QuimilzaTM BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026 WASHINGTON – October 28, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and…
En un 8-K del 28 oct 2026. El documento en la SEC.
17 dic 2026 · CORT Corcept Therapeutics
Lo que dice la empresaHypercortisolism (Cushing’s Syndrome) •Relacorilant for patients with Cushing’s syndrome – New Drug Applicationfor relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026 •GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in…
En un 8-K del 29 jul 2026. El documento en la SEC.
22 dic 2026 · MLYS Mineralys Therapeutics
Lo que dice la empresaEX-99.1 3 mlys2026q28kex991.htm EX-99.1 Exhibit 99.1 Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update – PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval – – Appoints accomplished cardiovascular…
En un 8-K del 11 ago 2026. El documento en la SEC.
23 dic 2026 · GILD Gilead Sciences
Lo que dice la empresa…has the potential to strengthen Gilead’s portfolio in oncology and inflammation. •Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.
En un 8-K del 7 may 2026. El documento en la SEC.
27 dic 2026 · VTRS Viatris
Lo que dice la empresaThe FDA has assigned a PDUFA goal date of December 27, 2026. •The Company signed a distribution agreement with Accord Healthcare to commercialize three biosimilar products…
En un 8-K del 6 ago 2026. El documento en la SEC.
30 dic 2026 · COGT Cogent Biosciences
Lo que dice la empresa…for GIST earlier in 2026. • Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026 • Presented six posters with bezuclastinib in patients with NonAdvSM at the 2026 AAAAI annual meeting • Initiated…
En un 8-K del 5 may 2026. El documento en la SEC.
21 ene 2027 · DYN Dyne Therapeutics
Lo que dice la empresa…Second Quarter 2026 Financial Results and Recent Business Highlights - Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted for review by FDA; Priority Review granted; PDUFA target action date set for January 21, 2027 - - Completed enrollment of 71 participants in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z…
En un 8-K del 29 jul 2026. El documento en la SEC.
29 ene 2027 · PRAX Praxis Precision Medicines
Lo que dice la empresa…Financial Results Mid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of January 29, 2027 Mid-cycle meeting completed for relutrigine; FDA identified no major safety or efficacy concerns to date and does…
En un 8-K del 6 ago 2026. El documento en la SEC.
23 feb 2027 · ARQT Arcutis Biotherapeutics
Lo que dice la empresa…accepted an sNDA for ZORYVE cream 0.05% to expand the indication for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months with a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. 3027 Townsgate Road, Suite 300 Westlake Village, CA 91361 | arcutis.com •The Company completed enrollment of…
En un 8-K del 5 ago 2026. El documento en la SEC.
27 feb 2027 · CGEM Cullinan Therapeutics
Lo que dice la empresaAn NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
En un 8-K del 2 oct 2026. El documento en la SEC.
28 feb 2027 · APMD Apnimed
Lo que dice la empresa…Quarter 2026 Financial Results and Provides Corporate Update • U.S. Food and Drug Administration (“FDA”)Accepted the NDA for AD109, with a proposed proprietary name Oxnimbi™, and assigned a PDUFA target action date of February 28,2027 • If approved, Oxnimbi has the potential to become the first oral pharmacologic therapy designed to address the…
En un 8-K del 8 sep 2026. El documento en la SEC.
28 feb 2027 · BMRN Biomarin Pharmaceutical
Lo que dice la empresa…data update expected in 2027. •In July, BioMarin announced that the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027. •In the second quarter, the European Commission approved PALYNZIQ® for adolescents 12 years and older with phenylketonuria…
En un 8-K del 6 ago 2026. El documento en la SEC.
28 feb 2027 · LGND Ligand Pharmaceuticals
Lo que dice la empresaThe FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
En un 8-K del 29 oct 2026. El documento en la SEC.
28 feb 2027 · PVLA Palvella Therapeutics
Lo que dice la empresaThe FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
En un 8-K del 28 oct 2026. El documento en la SEC.
3 mar 2027 · EXEL Exelixis
Lo que dice la empresa…Zanzalintinib GI Highlights Ongoing Regulatory Review of Zanzalintinib in Combination with Atezolizumab (Tecentriq®) for Previously Treated Metastatic CRC with Prescription Drug User Fee Act (PDUFA) Target Action Date of March 3, 2027.
En un 8-K del 29 oct 2026. El documento en la SEC.
10 mar 2027 · NTLA Intellia Therapeutics
Lo que dice la empresa…Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE) • FDA sets Prescription Drug User Fee Act (PDUFA)date of March 10, 2027 • Positions lonvo-z to be the world’s first in vivo CRISPR-based therapy and the only one-time HAE treatment,…
En un 8-K del 8 sep 2026. El documento en la SEC.
29 mar 2027 · AQST Aquestive Therapeutics
Lo que dice la empresaThe NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.
En un 8-K del 14 oct 2026. El documento en la SEC.
29 mar 2027 · ETON Eton Pharmaceuticals
Lo que dice la empresaThe NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.
En un 8-K del 14 oct 2026. El documento en la SEC.
1 abr 2027 · HRMY Harmony Biosciences Holdings
Lo que dice la empresa…Sleep-Deprived Healthy Volunteers in Q3; Data Expected Early 2027 Initiating Phase 2 Trials for BP-205 in Mid-2027 to Evaluate Multiple CNS Indications Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027 Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028 Conference Call and Webcast…
En un 8-K del 4 ago 2026. El documento en la SEC.
14 abr 2027 · INBX Inhibrx Biosciences
Lo que dice la empresa…FDA) accepted for filing the Company’s biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. ◦The Company plans to meet with the FDA in the fourth quarter of 2026 to discuss plans to initiate a first-line…
En un 8-K del 13 ago 2026. El documento en la SEC.
28 abr 2027 · IMNM Immunome
Lo que dice la empresaEX-99.1 2 imnm-ex99_1.htm EX-99.1 Exhibit 99.1 Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update August 11, 2026 • Varegacestat PDUFA target action date set for April 28, 2027, following U.S. FDA acceptance of New Drug Application (NDA) for adults with desmoid tumors • Detailed Phase 3…
En un 8-K del 11 ago 2026. El documento en la SEC.
1 may 2027 · AXSM Axsome Therapeutics
Lo que dice la empresa…million AUVELITY launched for treatment of agitation associated with dementia due to Alzheimer’s disease in June 2026 NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027 FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescents with ADHD initiated Company to…
En un 8-K del 10 ago 2026. El documento en la SEC.
8 may 2027 · BBIO BridgeBio Pharma
Lo que dice la empresa…launch upon FDA approval Oral infigratinib for achondroplasia PDUFA date set for February 4, 2027, with Priority Review; MAA submitted to EMA U.S. launch upon FDA approval Encaleret for ADH1 PDUFA date set for May 8, 2027, with Priority Review; MAA submitted to EMA U.S. launch upon FDA approval Encaleret for chronic hypoparathyroidism…
En un 8-K del 29 oct 2026. El documento en la SEC.
27 may 2027 · ZBIO Zenas BioPharma
Lo que dice la empresa…EXHIBIT 99.1 Exhibit 99.1 Zenas BioPharmaReports Second Quarter 2026 Financial Results and Provides Corporate Update - Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27,2027 - -New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled…
En un 8-K del 13 ago 2026. El documento en la SEC.
La fecha es la que da la empresa, no la FDA, y puede moverse: si la FDA recibe datos nuevos puede alargar el plazo tres meses, y no siempre se anuncia. Si la empresa recibe después una decisión (aprobación o carta de rechazo), la fecha deja de salir aquí. No son recomendaciones de inversión.