{"name":"FDA Decision Calendar (PDUFA Dates)","publisher":"Regards of Wallstreet","url":"https://www.regardsofwallstreet.com/tools/fda-calendar","license":"https://creativecommons.org/licenses/by/4.0/","cite_as":"FDA Decision Calendar, Regards of Wallstreet, https://www.regardsofwallstreet.com/tools/fda-calendar","definitions":{"date":"The PDUFA target action date: the date by which the FDA has committed to act. Decisions can arrive early, and weekend dates resolve by the preceding business day in practice.","date_status":"scheduled: the date stands as first set. extended: the FDA moved the date; original_date carries the superseded one. pending_extension: the company has said the date will move but no replacement is set, so date is null.","priority_review":"true where the FDA granted priority review (six-month target instead of ten).","sources":"The company press release or filing each date was verified against. Aggregators are never the basis for a date on this calendar."},"caveat":"A PDUFA date is a deadline for the FDA to act, not a promise of approval. The agency can approve, issue a complete response letter, or extend the review.","updated":"2026-08-19","upcoming":[{"id":"rare-dtx401-2026","ticker":"RARE","company":"Ultragenyx Pharmaceutical","drug":"DTX401 (pariglasgene brecaparvovec)","indication":"Glycogen storage disease type Ia, AAV gene therapy","application":"BLA","date":"2026-08-23","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"August 23 is a Sunday; the FDA acts by the date, so the practical window closes with the preceding business day. Would be the first treatment addressing the underlying cause of GSDIa.","sources":[{"url":"https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-and-priority-review","label":"Ultragenyx press release, BLA acceptance and priority review","date":"2026-02-23"}],"site_articles":["ultragenyx-rare-dtx401-fda-decision-august-23-preview"]},{"id":"jazz-ziihera-gea-2026","ticker":"JAZZ","company":"Jazz Pharmaceuticals","drug":"Ziihera (zanidatamab) combinations","indication":"First-line HER2-positive locally advanced or metastatic gastric / GEJ / gastroesophageal adenocarcinoma","application":"sBLA","date":"2026-08-25","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Label expansion on an already-approved drug, supported by the HERIZON-GEA-01 trial, so the binary is commercial rather than existential.","sources":[{"url":"https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0","label":"Jazz press release, sBLA acceptance and priority review","date":"2026-04-27"}],"site_articles":[]},{"id":"gild-bic-len-2026","ticker":"GILD","company":"Gilead Sciences","drug":"Bictegravir plus lenacapavir (BIC/LEN)","indication":"Once-daily single-tablet HIV treatment for virologically suppressed adults","application":"NDA","date":"2026-08-27","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Pairs bictegravir with the capsid inhibitor lenacapavir in one daily pill.","sources":[{"url":"https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir","label":"Gilead press release, priority review granted","date":"2026-04-27"}],"site_articles":[]},{"id":"nuvl-zidesamtinib-2026","ticker":"NUVL","company":"Nuvalent","drug":"Zidesamtinib","indication":"TKI pre-treated advanced ROS1-positive non-small cell lung cancer","application":"NDA","date":"2026-09-18","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":false,"adcomm":null,"notes":"First of two Nuvalent PDUFA dates in 2026; the ALK-selective sibling neladalkib follows on November 27.","sources":[{"url":"https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC","label":"Nuvalent press release, NDA acceptance","date":"2025-11-19"}],"site_articles":[]},{"id":"rare-ux111-2026","ticker":"RARE","company":"Ultragenyx Pharmaceutical","drug":"UX111 (rebisufligene etisparvovec)","indication":"Sanfilippo syndrome type A (MPS IIIA), AAV9 gene therapy, accelerated approval sought","application":"BLA (resubmission)","date":"2026-09-19","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Resubmission after a 2025 complete response letter on manufacturing items; September 19 is a Saturday, so the practical window closes with the preceding business day. Second Ultragenyx gene-therapy decision inside a month.","sources":[{"url":"https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-bla-resubmission-ux111","label":"Ultragenyx press release, BLA resubmission accepted","date":"2026-04-02"}],"site_articles":[]},{"id":"ions-zilganersen-2026","ticker":"IONS","company":"Ionis Pharmaceuticals","drug":"Zilganersen","indication":"Alexander disease, RNA-targeted antisense therapy","application":"NDA","date":"2026-09-22","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Would be the first disease-modifying therapy for Alexander disease; pivotal study met its primary endpoint on gait speed.","sources":[{"url":"https://ir.ionis.com/news-releases/news-release-details/ionis-announces-zilganersen-new-drug-application-alexander","label":"Ionis press release, NDA accepted with priority review","date":"2026-03-23"}],"site_articles":[]},{"id":"mrk-idxd-2026","ticker":"MRK","company":"Merck / Daiichi Sankyo","drug":"Ifinatamab deruxtecan (I-DXd)","indication":"Previously treated extensive-stage small cell lung cancer","application":"BLA","date":"2026-10-10","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Would be a first-in-class B7-H3 directed antibody-drug conjugate. October 10 is a Saturday, so the practical window closes with the preceding business day.","sources":[{"url":"https://www.merck.com/news/ifinatamab-deruxtecan-granted-priority-review-in-the-u-s-for-adult-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-who-experienced-disease-progression-on-or-after-platinum-bas/","label":"Merck press release, priority review granted","date":"2026-04-13"}],"site_articles":[]},{"id":"svra-molgramostim-2026","ticker":"SVRA","company":"Savara","drug":"MOLBREEVI (molgramostim inhalation solution)","indication":"Autoimmune pulmonary alveolar proteinosis","application":"BLA","date":"2026-11-22","date_text":null,"original_date":"2026-08-22","date_status":"extended","priority_review":true,"adcomm":null,"notes":"Extended three months from August 22 after the FDA classed Savara's responses to information requests as a major amendment. Several aggregator calendars still carry the old August date. November 22 is a Sunday.","sources":[{"url":"https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx","label":"Savara press release, review period extended","date":"2026-08-01"}],"site_articles":[]},{"id":"nuvl-neladalkib-2026","ticker":"NUVL","company":"Nuvalent","drug":"Neladalkib","indication":"TKI pre-treated advanced ALK-positive non-small cell lung cancer","application":"NDA","date":"2026-11-27","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":null,"notes":"Nuvalent's second 2026 decision, ten weeks after zidesamtinib.","sources":[{"url":"https://investors.nuvalent.com/2026-05-27-Nuvalent-Announces-Key-Program-and-Business-Updates,-Strengthening-Foundation-for-Global-Leadership-in-ROS1-and-ALK-positive-NSCLC","label":"Nuvalent program update naming the November 27 action date","date":"2026-05-27"}],"site_articles":[]},{"id":"bbio-bbp418-2026","ticker":"BBIO","company":"BridgeBio Pharma","drug":"BBP-418","indication":"Limb-girdle muscular dystrophy type 2I/R9","application":"NDA","date":"2026-11-27","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":true,"adcomm":"FDA told the company it is not currently planning an advisory committee meeting.","notes":"Would be the first approved therapy for any form of limb-girdle muscular dystrophy.","sources":[{"url":"https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx","label":"BridgeBio press release, NDA accepted with priority review","date":"2026-05-27"}],"site_articles":[]},{"id":"cogt-bezuclastinib-2026","ticker":"COGT","company":"Cogent Biosciences","drug":"Bezuclastinib","indication":"Non-advanced systemic mastocytosis","application":"NDA","date":"2026-12-30","date_text":null,"original_date":null,"date_status":"scheduled","priority_review":false,"adcomm":"FDA communicated no plan to hold an advisory committee and no review issues identified at acceptance.","notes":"Some aggregator calendars carry November 30; the company's own release says December 30. A second NDA, in advanced systemic mastocytosis, was guided for submission in the first half of 2026.","sources":[{"url":"https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-fda-acceptance-new-drug-application","label":"Cogent press release, NDA accepted","date":"2026-03-16"}],"site_articles":[]}],"undated":[{"id":"capr-deramiocel-2026","ticker":"CAPR","company":"Capricor Therapeutics","drug":"deramiocel","indication":"Duchenne muscular dystrophy (label being narrowed to upper limb dysfunction)","application":"BLA (Class 2 resubmission, amendment in progress)","date":null,"date_text":"Extension pending; was August 22, 2026","original_date":"2026-08-22","date_status":"pending_extension","priority_review":false,"adcomm":"Advisory committee voted 3-9 against on July 29, 2026, on the cardiomyopathy framing.","notes":"Capricor said on its August 13 call that it will amend the BLA to cover upper limb dysfunction only, and that the FDA indicated the August 22 action date will be extended once the amendment is received. No new date has been set; a major amendment normally adds three months, but the classification has not been stated.","sources":[{"url":"https://www.parentprojectmd.org/update-on-the-fdas-review-of-deramiocel-continuing-the-path-forward/","label":"Parent Project MD account of the FDA's extension signal","date":"2026-08-13"},{"url":"https://www.capricor.com/investors/news-events/press-releases","label":"Capricor Q2 2026 release","date":"2026-08-13"}],"site_articles":["capricor-capr-deramiocel-fda-decision-august-22-preview","why-capricor-capr-stock-rose-58-percent-fda-decision-delayed"]}],"past":[]}