FDA PDUFA Calendar 2026: Key Biotech Approval Dates
Last Updated: January 17, 2026 | BioMed Nexus Editorial Desk
Executive Takeaway
A PDUFA date is the target action date by which the FDA aims to complete its review of a New Drug Application (NDA) or Biologics License Application (BLA), typically resulting in an approval decision or a Complete Response Letter. For biotech investors, clinical operators, and pharmaceutical executives, these dates represent critical binary catalysts that can significantly move valuations and reshape competitive dynamics.
The FDA does not publish a single official master calendar of upcoming PDUFA dates. This calendar is compiled from sponsor press releases, SEC filings, and verified public disclosures, then updated continuously as dates shift or outcomes are announced.
2026 PDUFA Calendar
| Date | Program | Indication | Company | Type | Status |
|---|---|---|---|---|---|
| Jan 5 | Cablivi (caplacizumab) | aTTP | Sanofi | sBLA | Approved |
| Jan 10 | Tabelecleucel | EBV+ PTLD | Atara Biotherapeutics | BLA | CRL |
| Jan 13 | Sparsentan (Filspari) | FSGS | Travere Therapeutics | sNDA | Pending |
| Jan 14 | CUTX-101 | Menkes disease | Sentynl Therapeutics | NDA | Approved |
| Jan 31 | Anaphylm | Severe allergic reactions | Aquestive Therapeutics | NDA | Pending |
| Feb 8 | RGX-121 | MPS II (Hunter syndrome) | REGENXBIO | BLA | Pending |
| Feb 23 | Pegzilarginase | Arginase 1 deficiency | Immedica Pharma | BLA | Pending |
| Feb 25 | Inqovi + Venclexta | AML | Taiho Oncology | sNDA | Pending |
| Feb 28 | Navepegritide (TransCon CNP) | Achondroplasia | Ascendis Pharma | NDA | Pending |
| Feb 28 | Idebenone | LHON | Chiesi | NDA | Pending |
| Mar 6 | Sotyktu (deucravacitinib) | Psoriatic arthritis | Bristol Myers Squibb | sNDA | Pending |
| Mar 24 | Linerixibat | PBC (cholestatic pruritus) | GSK | NDA | Pending |
| Mar 28 | Kresladi | LAD-I | Rocket Pharmaceuticals | BLA | Pending |
| Apr 5 | Tividenofusp alfa | MPS II (Hunter syndrome) | Denali Therapeutics | BLA | Pending |
| Apr 6 | Orca-T | AML, ALL, MDS | Orca Bio | BLA | Pending |
| Apr 23 | Sarclisa (isatuximab) | Multiple myeloma | Sanofi | sBLA | Pending |
| May 10 | Vyvgart (efgartigimod) | Seronegative gMG | argenx | sBLA | Pending |
| May 18 | Enhertu + THP | HER2+ breast cancer (neoadjuvant) | Daiichi Sankyo/AstraZeneca | sBLA | Pending |
| Jun 10 | Oclaiz (CAM2029) | Acromegaly | Camurus | NDA | Pending |
| Jun 30 | Veligrotug | Thyroid eye disease | Viridian Therapeutics | BLA | Pending |
| Jul 7 | Atacicept | IgA nephropathy | Vera Therapeutics | BLA | Pending |
| Aug 30 | Besremi (ropeginterferon) | Essential thrombocythemia | PharmaEssentia | sBLA | Pending |
| Sep 18 | Zidesamtinib | ROS1+ NSCLC | Nuvalent | NDA | Pending |
| Oct 30 | INO-3107 | Recurrent respiratory papillomatosis | INOVIO | BLA | Pending |
Q1 2026 Highlights
January 2026
January opens with several high-profile decisions. Travere's sparsentan for FSGS would mark the first FDA-approved therapy for this rare kidney disease. Aquestive's Anaphylm could become the first needle-free epinephrine option for anaphylaxis. Atara received a Complete Response Letter for tabelecleucel on January 10, while Sanofi's caplacizumab was approved for aTTP on January 5. Sentynl achieved approval for CUTX-101 in Menkes disease.
February 2026
February concentrates several rare disease programs. REGENXBIO's gene therapy for MPS II faces its decision on February 8. Ascendis Pharma's navepegritide for achondroplasia (February 28) could provide a new treatment paradigm for short stature conditions. The month also includes decisions for pegzilarginase (arginase 1 deficiency) and idebenone (LHON).
March 2026
March brings Bristol Myers Squibb's deucravacitinib decision for psoriatic arthritis on March 6. If approved, this would be the first TYK2 inhibitor for PsA. GSK's linerixibat for cholestatic pruritus in PBC has a March 24 target. Rocket Pharmaceuticals' Kresladi for LAD-I has a March 28 decision date.
Biggest Decisions to Watch
Oncology & Hematology
Orca Bio's Orca-T (April 6) represents a potential shift in allogeneic transplant for AML, ALL, and MDS. Nuvalent's zidesamtinib (September 18) addresses ROS1+ NSCLC patients who have progressed on prior TKIs, including those with the G2032R resistance mutation. PharmaEssentia's Besremi expansion to essential thrombocythemia (August 30) would offer the first new approved therapy for ET in over two decades.
Rare & Genetic Diseases
Gene therapies dominate this category. REGENXBIO's RGX-121 (February 8) and Denali's tividenofusp alfa (April 5) both target Hunter syndrome with different mechanisms. Rocket's Kresladi (March 28) for LAD-I showed 100% survival in its pivotal study. Ascendis' navepegritide for achondroplasia could become the second approved therapy after vosoritide.
Nephrology & Immunology
Travere's sparsentan (January 13) would be the first therapy specifically indicated for FSGS. Vera Therapeutics' atacicept (July 7) showed a 46% reduction in proteinuria in IgA nephropathy patients in the ORIGIN Phase 3 trial. Bristol Myers Squibb's deucravacitinib for psoriatic arthritis would establish TYK2 inhibition as a new mechanism in PsA.
Endocrine & Metabolic
Viridian's veligrotug (June 30) for thyroid eye disease received both Breakthrough Therapy Designation and Priority Review based on THRIVE trial data showing diplopia response and resolution in chronic TED—the first Phase 3 trial to demonstrate such outcomes in this population.
How to Use This Calendar
Not all PDUFA dates carry equal risk. Binary decisions—first-in-class approvals, pivotal efficacy readouts embedded in the regulatory process—tend to drive larger price movements than label expansions or formulation changes. Advisory Committee (AdCom) meetings, when scheduled, typically signal FDA uncertainty and merit closer tracking; however, AdCom recommendations are not binding.
Late-cycle meeting requests from FDA can indicate labeling, manufacturing, or REMS discussions that may delay but not necessarily doom an application. Common reasons for PDUFA extensions include major amendments (typically adding 3 months), CMC deficiencies, or requests for additional clinical data.
Recent Calendar Updates
- Jan 14, 2026: Sentynl's CUTX-101 approved for Menkes disease
- Jan 13, 2026: PharmaEssentia confirms August 30, 2026 PDUFA date for Besremi in essential thrombocythemia
- Jan 10, 2026: Atara Biotherapeutics receives Complete Response Letter for tabelecleucel
- Jan 7, 2026: Vera Therapeutics receives Priority Review for atacicept; PDUFA date set for July 7, 2026
- Jan 6, 2026: Viridian announces commercial preparations underway following veligrotug BLA acceptance
FDA PDUFA Calendar FAQs
What is a PDUFA date?
A PDUFA date is the target action date established under the Prescription Drug User Fee Act by which the FDA commits to completing its review of a drug application. For standard reviews, this is typically 10 months from submission acceptance; for priority reviews, 6 months. The date represents a goal, not a guarantee of decision timing.
Is a PDUFA date the same as FDA approval?
No. The PDUFA date is when the FDA aims to complete its review. The outcome may be approval, a Complete Response Letter (CRL) requesting additional information, or in some cases, a decision to extend the review period.
How often do PDUFA dates change?
PDUFA dates can be extended when sponsors submit major amendments to their applications, typically adding 3 months to the review timeline. Extensions may also occur for manufacturing, CMC, or labeling discussions. Companies are required to disclose material changes to expected regulatory timelines.
Why doesn't the FDA publish an official PDUFA calendar?
The FDA does not maintain a public master list of pending applications and their target dates. PDUFA dates are disclosed by sponsoring companies through press releases, SEC filings, and investor communications. Third-party calendars compile these disclosures.
What is the difference between an NDA and a BLA?
A New Drug Application (NDA) covers small molecule drugs and certain other products. A Biologics License Application (BLA) covers biological products including therapeutic proteins, vaccines, blood products, gene therapies, and cell therapies. The review processes are similar but fall under different regulatory authorities within FDA.
What happens on a PDUFA action date?
By the PDUFA date, the FDA issues either an approval (with or without conditions), a Complete Response Letter identifying deficiencies, or may request additional time if warranted. Decisions often come on or before the PDUFA date; delays beyond the target are uncommon but do occur.
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