# September 2026 PDUFA Calendar: FDA Decision Dates & Biotech Catalysts Canonical URL: https://biopharmsignal.com/pdufa-calendar/2026/september BioPharmSignal tracks active PDUFA and FDA decision milestones for September 2026. ## PDUFA Events In September 2026 - 2026-09-11 — TLX — Telix Pharmaceuticals Ltd Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 11, 2026 PDUFA goal date to the resubmitted Pixclara NDA. Source: https://telixpharma.com/news-views/fda-accepts-nda-for-tlx101-px-pixclara/ Event detail: https://biopharmsignal.com/pdufa-calendar/TLX/pixclara-floretyrosine-f18-glioma-imaging-review-2.md Company page: https://biopharmsignal.com/company/TLX - 2026-09-18 — NUVL — Nuvalent Stage: PDUFA Summary: FDA approved JIDEYTRO. FDA approved JIDEYTRO for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 TKI. The action... Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer Event detail: https://biopharmsignal.com/pdufa-calendar/NUVL/zidesamtinib-ros1-positive-nsclc.md Company page: https://biopharmsignal.com/company/NUVL - 2026-09-19 — RARE — Ultragenyx Pharmaceutical Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 19, 2026 PDUFA action date to the resubmitted BLA seeking accelerated approval for UX111. Source: https://ir.ultragenyx.com/node/18781 Event detail: https://biopharmsignal.com/pdufa-calendar/RARE/ux111-sanfilippo-syndrome-type-a-review-2.md Company page: https://biopharmsignal.com/company/RARE - 2026-09-21 — MRK — Merck Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 21, 2026 PDUFA date to the HYPERION-based WINREVAIR label-update application. Source: https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/ Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/winrevair-recently-diagnosed-pah-hyperion.md Company page: https://biopharmsignal.com/company/MRK - 2026-09-22 — IONS — Ionis Pharmaceuticals, Inc. Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 22, 2026 PDUFA target action date to the zilganersen NDA. Source: https://ir.ionis.com/news-releases/news-release-details/ionis-announces-zilganersen-new-drug-application-alexander Event detail: https://biopharmsignal.com/pdufa-calendar/IONS/zilganersen-alexander-disease.md Company page: https://biopharmsignal.com/company/IONS - 2026-09-26 — MIRM — Mirum Pharmaceuticals Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 26, 2026 PDUFA target action date to the zilurgisertib NDA. Source: https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/zilurgisertib-fibrodysplasia-ossificans-progressiva.md Company page: https://biopharmsignal.com/company/MIRM - 2026-09-28 — BFRI — Biofrontera Inc Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 28, 2026 PDUFA target action date to the AMELUZ photodynamic-therapy sNDA for superficial basal cell carcinoma. Source: https://www.globenewswire.com/news-release/2026/02/11/3236372/0/en/biofrontera-announces-fda-filing-acceptance-of-supplemental-new-drug-application-for-ameluz-pdt-in-superficial-basal-cell-carcinoma.html Event detail: https://biopharmsignal.com/pdufa-calendar/BFRI/ameluz-superficial-basal-cell-carcinoma.md Company page: https://biopharmsignal.com/company/BFRI - 2026-09-28 — EGTX — Egetis Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 28, 2026 PDUFA target action date to the Emcitate NDA. Source: https://www.egetis.com/mfn_news/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-tiratricol-for-mct8-deficiency/ Event detail: https://biopharmsignal.com/pdufa-calendar/EGTX/emcitate-tiratricol-mct8-deficiency.md Company page: https://biopharmsignal.com/company/EGTX - 2026-09-30 — BMY — BMYBristol-Myers Squibb Company Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 30, 2026 PDUFA date to the CAMZYOS sNDA for adolescents with symptomatic obstructive hypertrophic cardiomyopa... Source: https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-for-Camzyos-mavacamten-to-Treat-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/camzyos-adolescent-obstructive-hypertrophic-cardiomyopathy.md Company page: https://biopharmsignal.com/company/BMY - 2026-09-30 — SRRK — Scholar Rock Stage: PDUFA Summary: FDA decision expected. FDA assigned a September 30, 2026 PDUFA action date to the accepted apitegromab BLA resubmission. Source: https://investors.scholarrock.com/news-releases/news-release-details/scholar-rock-reports-first-quarter-2026-financial-results-and/ Event detail: https://biopharmsignal.com/pdufa-calendar/SRRK/apitegromab-spinal-muscular-atrophy-review-2.md Company page: https://biopharmsignal.com/company/SRRK ## How To Use This Page Use the event date, ticker, company, and stage to understand which regulatory decisions may matter during the month. Open the company page for recent news and stock context. ## FAQ ### What is listed on the September 2026 PDUFA calendar? This page lists active BioPharmSignal PDUFA and FDA decision milestones dated in September 2026, including ticker, company, application stage, and available source context. ### Can PDUFA dates change? Yes. FDA target action dates can move when applications, reviews, labels, or company guidance change. Use the page as a dated research aid and check source links when available. ### How is this different from LiveFeed? The PDUFA calendar is organized by expected FDA decision date. LiveFeed is organized by newly published biotech news and company updates.