PDUFA Calendar 2026–2027: Upcoming FDA Decision Dates and How PDUFA Dates Work

What Is a PDUFA Date?

A PDUFA date, formally the PDUFA target action date, is the date by which the US Food and Drug Administration aims to finish reviewing a new drug application (NDA), a biologics license application (BLA) or a supplement, and to act on it. The name comes from the Prescription Drug User Fee Act of 1992, under which drug companies pay fees that fund FDA reviews and the FDA commits in return to review applications within set timeframes.

The FDA does not publish PDUFA dates. Companies disclose them, usually when the FDA accepts an application for review, and investors, partners and competitors track them closely because the date tells everyone when a product could reach the market. On or before the date, the FDA either approves the application or sends a complete response letter explaining why it cannot approve it as submitted.

Upcoming PDUFA Dates, October 2026 to May 2027

The table lists FDA decisions scheduled from late October 2026 through May 2027 that companies have disclosed. Every date was checked against the sponsor’s own announcement or SEC filing on October 22, 2026. PDUFA dates can change, and the FDA can act early, so always confirm a date with the company before relying on it.

Rare diseases account for a large share of the calendar, from type 3 Gaucher disease and limb-girdle muscular dystrophy to autoimmune pulmonary alveolar proteinosis and erythropoietic protoporphyria, which reflects how many recent approvals have come from orphan programs. Our orphan drug designation guide explains the incentives behind that trend. Oncology is the other large group, from lung and colorectal cancer to multiple myeloma and desmoid tumors.

Decisions to Watch

• Ivonescimab, November 14. Summit Therapeutics licensed the PD-1/VEGF bispecific antibody from China’s Akeso in December 2022 for $500 million upfront and up to $5 billion in total, one of the largest licensing deals for a China-originated drug at the time. The BLA covers EGFR-mutant lung cancer after EGFR TKI therapy. Our PD-1/VEGF bispecific landscape covers the class.
• Anito-cel, December 23. Gilead agreed in February 2026 to acquire its partner Arcellx for $115 per share in cash, an implied equity value of $7.8 billion, plus a $5 per share contingent value right tied to sales of the CAR-T therapy, ten months before the PDUFA date.
• Venglustat, November 25. Sanofi’s oral glucosylceramide synthase inhibitor would, if approved, be the first US treatment aimed at the neurological effects of type 3 Gaucher disease, according to the company.
• Cemdisiran, November. Regeneron used a priority review voucher for the siRNA, which it says could become the first siRNA approved for generalized myasthenia gravis, dosed subcutaneously four times a year.
• Lorundrostat, December 22. Mineralys’s aldosterone synthase inhibitor targets hypertension, one of the largest primary-care markets on the calendar.
• Z-rostudirsen, January 21, 2027. Dyne is seeking accelerated approval in Duchenne muscular dystrophy on the basis of dystrophin production and expects a US launch in the first quarter of 2027 if the drug is approved on time.

How PDUFA Dates Are Set

The PDUFA date follows from the type of application and the type of review. After a company submits, the FDA has 60 days to decide whether the application is complete enough to file. For new molecular entities and original biologics, which are reviewed under the FDA’s more structured program for novel products, the review clock starts at the end of that 60-day filing period. Within the 60 days the FDA also decides whether the review will be standard or priority, and by day 74 it tells the company whether it has found any filing review issues.

The calendar shows both clocks at work. Exelixis’s zanzalintinib application, accepted with a standard review early in 2026, has a December 3, 2026 date, while Dyne’s z-rostudirsen BLA, accepted with priority review in July 2026, has a January 21, 2027 date. Supplements, which add an indication or update the label of an approved drug, run on the clock from receipt, which is why sNDAs such as Agios’s mitapivat application reach a decision sooner after submission.

Priority Review and Faster Paths

The FDA grants priority review to applications for drugs that, if approved, would significantly improve the safety or effectiveness of treatment for a serious condition. Several other tools can shorten the path to a decision or to approval:

• Priority review vouchers. A company holding a voucher can redeem it to obtain priority review for an application that would not otherwise qualify. Regeneron did this for cemdisiran.
• National priority vouchers. In June 2025 the FDA launched the Commissioner’s National Priority Voucher pilot, which aims for a decision within one to two months of a complete application for products that align with national health priorities.
• Real-Time Oncology Review. Lets the FDA review oncology data before the full application is submitted; Cogent’s bezuclastinib application in gastrointestinal stromal tumor was filed this way.
• Accelerated approval. Allows approval on a surrogate endpoint reasonably likely to predict clinical benefit, with confirmatory trials afterwards. Dyne, Inovio and Agios are all seeking accelerated approval.

Breakthrough therapy and fast track designations come earlier in development and make a drug eligible for more FDA interaction and, in the case of fast track, rolling submission. Our guides to breakthrough therapy designation and fast track designation explain how they work, and our drug development stages guide shows where the PDUFA date falls in the overall timeline.

Why PDUFA Dates Move

The most common reason is a major amendment. If a company submits significant new information during the review, often in answer to FDA questions, the FDA can extend the goal date by three months. Three drugs on this calendar moved this way in 2026:

• Savara’s molgramostim. In April 2026 the FDA treated Savara’s responses to information requests as a major amendment, moving the date from August 22 to November 22, 2026. The review remains a priority review.
• Praxis’s relutrigine. Additional sensitivity analyses of existing data were deemed a major amendment, moving the date from September 27 to December 27, 2026. Praxis said the FDA had not requested new studies.
• Capricor’s deramiocel. After an FDA advisory committee voted 3 to 9 in July 2026 that the evidence did not support effectiveness in Duchenne cardiomyopathy, Capricor submitted a refined proposed indication focused on upper limb function. The FDA classified it as a major amendment, moving the date from August 22 to November 22, 2026.

The FDA can also act before the goal date: on July 22, 2026 it approved Nuvalent’s zidesamtinib (Jideytro) for ROS1-positive lung cancer two months ahead of its goal date, after a Real-Time Oncology Review. A decision can also slip if a pre-approval inspection is delayed. Weekends matter too: seven of the dates on this calendar, including November 1 and November 14, fall on a Saturday or Sunday, and in such cases a decision often comes on the previous business day.

What Happens on the Date

There are two possible actions. The FDA approves the application, in full or under accelerated approval, or it issues a complete response letter (CRL) that sets out the deficiencies, which can range from clinical questions to labeling or manufacturing issues. A company that receives a CRL can resubmit, and the FDA classifies the resubmission as Class 1 or Class 2 with a two- or six-month goal.

CRLs are now far more visible than they used to be. In September 2025 the FDA published 89 previously unpublished letters and said it would publish future CRLs promptly after issuing them, a practice that some lawyers argue conflicts with the FDA’s own disclosure rules. For companies and their partners, the content of a CRL is now likely to become public, which changes how setbacks are communicated.

Before the date, the FDA may also hold an advisory committee meeting, whose vote is advisory but closely watched, as Capricor’s experience showed. For several applications on this calendar, including ulixacaltamide, encaleret and AXS-12, the FDA has told the company it does not currently plan one.

PDUFA, User Fees and PDUFA VIII

PDUFA is reauthorized every five years. Under PDUFA VII, which covers fiscal years 2023 to 2027, the fee for an application with clinical data is $4,600,753 for fiscal 2027, down 1.7% from $4,682,003, and the annual program fee is $416,857.

PDUFA VII expires in September 2027. In August 2026 the FDA released a proposed PDUFA VIII commitment letter for fiscal years 2028 to 2032, held a public meeting on September 16 and took comments until October 16, 2026. Proposals relevant to sponsors include:

• A 50% reduction in the application fee for applications that include data from at least one US-anchored phase 1 trial started after October 1, 2027, which requires legislation.
• A one-time three-month extension of the goal date linked to a meeting after a pre-approval or pre-license inspection.
• A manufacturing facility program with at least 60 days’ notice before such inspections.

What PDUFA Dates Mean for Dealmaking

For business development teams, a PDUFA date is a pricing event. It is the point at which regulatory risk turns into commercial risk, and deal timing tends to cluster around it.

• Buying before the date. Gilead agreed to acquire Arcellx ten months before anito-cel’s PDUFA date, taking on the remaining regulatory risk itself and using a contingent value right to share part of the commercial risk with Arcellx shareholders.
• Buying during the review. GSK completed its acquisition of Nuvalent in July 2026, at an equity value of about $10.6 billion, while both of Nuvalent’s lung cancer drugs were under FDA review. One of them, zidesamtinib, was approved a week later.
• Buying at acceptance. LEO Pharma closed its acquisition of worldwide rights to dersimelagon from Japan’s Tanabe Pharma once the FDA had accepted the NDA with priority review. The deal is worth up to $435 million in upfront and near-term milestone payments, plus downstream milestones and tiered royalties up to the mid-teens.
• Milestones and contingent value rights. Approval milestones in licensing deals are usually triggered by FDA approval, so the PDUFA date tells both sides when a payment may fall due. Contingent value rights, like Gilead’s $5 per share tied to anito-cel sales, let buyers defer part of the price until the risk is resolved.

Our cross-border term sheet guide covers how approval payments are structured, our rNPV valuation guide shows how a pending decision is priced, and our licensing deal tracker follows the year’s transactions.

The Cross-Border Angle

Several decisions on the calendar involve drugs that originated outside the US. Ivonescimab came from Akeso in China, saroglitazar from Zydus in India, which has said it plans a US launch by March 2027 if the drug is approved, and dersimelagon from Tanabe in Japan. Their outcomes will be read as signals for other cross-border assets in the same classes.

Manufacturing can matter as much as the clinical data. The FDA has rejected Hengrui and Elevar’s camrelizumab and rivoceranib combination for liver cancer three times, most recently on July 10, 2026, with inspection findings, not the efficacy data, at the center of each decision. For any company licensing a China-originated product, the readiness of the manufacturing sites listed in the application, and whether they will pass a pre-approval inspection, belongs in diligence from the start.

Policy is pushing in the same direction. The proposed PDUFA VIII fee discount rewards applications that include a US-anchored phase 1 trial, and the Section 232 pharmaceutical tariffs make the place of manufacture a commercial question. Our guides to in-licensing biotech assets from China and using Chinese clinical data in global development cover the regulatory work involved.

How to Track PDUFA Dates

1. Watch for acceptance announcements. Companies usually disclose the PDUFA date when the FDA accepts an application, which for a new molecular entity is about two months after submission.
2. Read the quarterly results. Earnings releases and the 8-K filings that carry them repeat the date and report any extension.
3. Check the application type. A supplement for a new indication carries different risk from a first approval, and accelerated approval comes with confirmatory trial obligations.
4. Note who is reviewing what. Whether an advisory committee is planned, and whether the FDA has flagged review issues, are usually disclosed with the acceptance.

The Bottom Line

PDUFA dates are the FDA’s commitments to act, not guarantees of approval, and they can move by three months when new information arrives. Between late October 2026 and May 2027, at least 25 decisions are scheduled, led by ivonescimab, anito-cel and venglustat, and several of them involve drugs that crossed borders through licensing or acquisitions. For dealmakers, the calendar is also a timetable for milestone payments, acquisitions and partnering.

If you are planning a licensing deal around a regulatory milestone in the US or China, talk to our team.