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PDUFA Calendar 2026

Free PDUFA calendar with every upcoming PDUFA date, FDA drug approval date, and biotech catalyst for 2026. Updated daily with FDA advisory meetings, clinical trial readouts, and probability of approval scores. Built for investors tracking FDA approval decisions and biotech stocks.
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ionis-pharmaceuticals
Ionis Pharmaceuticals, Inc.

IONS

Drug Name
zilganersen
BreakthroughPriorityFast Track+1
PoA
85%
PDUFA Date2026-09-22
StagePDUFACatalystPDUFA Date
30-Day Trend
-22.3%
PoA Summary

Zilganersen (ION373), developed by Ionis Pharmaceuticals (IONS), is an innovative investigational antisense oligonucleotide (ASO) administered intrathecally, specifically targeting Alexander disease (AxD), an ultra-rare, progressive, and fatal neurological disorder caused by dominant mutations in the GFAP gene. This therapy aims to... Show more

Treatment

Alexander disease (AxD)

Description

Drug: zilganersen. Indication: Alexander disease (AxD). Timeline: September 22, 2026. Ionis announced the FDA accepted the NDA for zilganersen, an investigational RNA-targeted medicine for Alexander disease (AxD), for Priority Review. The FDA set a PDUFA target action date of September... Show more

telix-pharmaceuticals-limited
Telix Pharmaceuticals Limited

TLX

Drug Name
TLX101-Px (Pixclara®, Floretyrosine F18 / 18F-FET)
Fast TrackOrphan
PoA
78.5%
PDUFA Date2026-09-11
StagePDUFACatalystPDUFA Date
30-Day Trend
-0.9%
PoA Summary

TLX101-Px (Pixclara®) is a diagnostic positron emission tomography (PET) imaging agent developed by Telix Pharmaceuticals Limited (NASDAQ: TLX) for the characterization of recurrent or progressive glioma. This innovative agent aims to differentiate true tumor progression from treatment-related changes in both... Show more

Treatment

Imaging of glioma, characterization of recurrent or progressive glioma from treatment-related changes in adult and pediatric patients

Description

Drug: TLX101-Px (Pixclara®, Floretyrosine F18 / 18F-FET). Indication: Imaging of glioma, characterization of recurrent or progressive glioma from treatment-related changes in adult and pediatric patients. Timeline: September 11, 2026. The FDA accepted Telix's resubmitted NDA for TLX101-Px (Pixclara®, Floretyrosine F18/18F-FET),... Show more

biofrontera
Biofrontera Inc.

BFRI

Drug Name
Ameluz®PDT
PoA
88.5%
PDUFA Date2026-09-28
StagePDUFACatalystPDUFA Date
30-Day Trend
-16.3%
PoA Summary

Ameluz®PDT, developed by Biofrontera Inc. (ticker: BFRI), is a promising best-in-class photodynamic therapy (PDT) designed for the treatment of superficial basal cell carcinoma (sBCC). This innovative therapy combines 10% aminolevulinic acid (ALA) gel with red-light illumination using the BF-RhodoLED® device.... Show more

Treatment

superficial basal cell carcinoma (sBCC)

Description

Drug: Ameluz®PDT. Indication: superficial basal cell carcinoma (sBCC). Timeline: September 28, 2026. FDA completed filing review and accepted Biofrontera's supplemental New Drug Application (sNDA) for Ameluz®PDT for the treatment of superficial basal cell carcinoma (sBCC); the sNDA has a PDUFA... Show more

mirum-pharmaceuticals
Mirum Pharmaceuticals, Inc.

MIRM

Drug Name
Zilurgisertib
PriorityRare Pediatric
PoA
78.5%
PDUFA Date2026-09-26
StagePDUFACatalystPDUFA Date
30-Day Trend
-11.9%
PoA Summary

Zilurgisertib (INCB000928), an oral small-molecule activin receptor-like kinase 2 (ALK2) inhibitor developed by Mirum Pharmaceuticals in collaboration with Incyte, is positioned as a first-in-class, disease-modifying therapy for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder affecting approximately 300 patients in... Show more

Treatment

fibrodysplasia ossificans progressiva (FOP)

Description

Drug: Zilurgisertib. Indication: fibrodysplasia ossificans progressiva (FOP). Timeline: September 26, 2026. U.S. FDA granted Priority Review with a PDUFA date of September 26, 2026 for the NDA for Zilurgisertib for fibrodysplasia ossificans progressiva (FOP) in patients 12 years and older.

ZP
Zealand Pharma A/S American Depositary Shares

ZEAL

Drug Name
rusfertide (PTG-300)
PoA
84%
PDUFA Date2026-09-30
StagePDUFACatalystPDUFA Date
PoA Summary

Rusfertide (PTG-300) is a first-in-class hepcidin mimetic peptide currently under development by Takeda and Protagonist Therapeutics for the treatment of adults with polycythemia vera (PV). This innovative therapy aims to mimic the action of hepcidin, thereby reducing iron availability for... Show more

Treatment

polycythemia vera

Description

Drug: rusfertide (PTG-300). Indication: polycythemia vera. Timeline: the third quarter of 2026. The U.S. FDA set a PDUFA goal date for the NDA for rusfertide (PTG-300) for the treatment of adults with polycythemia vera in the third quarter of 2026;... Show more

• FAQs

Frequently asked questions about PDUFA dates

A PDUFA date is the deadline by which the FDA aims to complete its review of a new drug or biologic application and issue a decision. The name comes from the Prescription Drug User Fee Act, the law that lets the FDA collect fees from drug makers in exchange for committing to these review timelines. On or before the PDUFA date the FDA will approve the drug, issue a Complete Response Letter, or otherwise act on the application. Because these dates are binary events, they are among the most watched catalysts for biotech stocks, and upcoming ones are listed on the calendar above.

The PDUFA calendar above can be sorted by date to show decisions expected this week or over the next five trading days, including small-cap biotech catalysts. Each entry lists the company, drug, indication, and expected decision date so you can scan what is coming at a glance. Because the FDA can act a few days before a listed PDUFA date, watch the days leading up to each event, not only the date itself.

No. The FDA does not publish a public, forward-looking calendar of pending PDUFA dates, because confidentiality rules (21 CFR 314.430) generally bar it from confirming that an application even exists until the sponsor makes it public. The PDUFA dates you see come from the drug companies themselves, who disclose expected action dates in press releases and SEC filings, and from aggregators that compile and verify them. The PDUFA calendar on this page is one such aggregated, regularly updated source.

The FDA issues its decision on or before the PDUFA date, so an approval or rejection can come a few days early rather than exactly on the listed date. There is no fixed announcement time: decisions are often disclosed after the market closes or in the pre-market hours, frequently through a company press release rather than an FDA notice. Because the timing is unpredictable, traders track both the date itself and the days immediately before it.

A Complete Response Letter is the FDA's way of telling a drug company that its application cannot be approved in its current form. The letter spells out the deficiencies the company must address, which can range from manufacturing and labeling issues to questions about safety or effectiveness. A CRL is not a permanent rejection: the sponsor can fix the problems and resubmit, which starts a new review cycle and a new PDUFA date. CRLs often trigger sharp stock declines because they delay or jeopardize a product launch.

An AdCom date is when an outside expert panel meets to review a drug's data and cast a non-binding vote, usually several months before the final decision. The PDUFA date is the FDA's own deadline to act on the application, when the actual approval or Complete Response Letter is issued. A drug may have both an AdCom date and a PDUFA date, and both appear as separate catalysts on the calendar above.

A New Drug Application (NDA) is the submission used to seek approval for small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies. Both are reviewed under the same PDUFA timelines and both result in either approval or a Complete Response Letter. The distinction matters because biologics follow a separate regulatory pathway and have different exclusivity rules.