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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.
August 2026calender-logo
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OTLK
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REPL
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MRNA
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LNTH
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MRK

+2 More

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SVRA

+1 More

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RARE
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BIIB
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JAZZ

+1 More

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GILD

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ultragenyx-pharmaceutical
Ultragenyx Pharmaceutical Inc.

RARE

Drug Name
DTX401 (AAV gene therapy)
Priority
PoA
76%
PDUFA Date2026-08-23
StagePDUFACatalystPDUFA Date
30-Day Trend
-21.4%
PoA Summary

DTX401 (pariglasgene brecaparvovec), developed by Ultragenyx Pharmaceutical, shows a robust estimated probability of approval at 76%. This gene therapy targets glycogen storage disease type Ia, a rare metabolic disorder impacting around 6,000 patients in accessible markets, with a prevalence rate... Show more

Treatment

Glycogen Storage Disease Type Ia (GSDIa)

Description

The FDA has set a PDUFA action date for DTX401, which, if approved, will be the first treatment addressing the underlying cause of GSDIa, potentially improving patient quality of life.

savara
Savara, Inc.

SVRA

Drug Name
MOLBREEVI (molgramostim inhalation solution)
BreakthroughFast TrackOrphan
PoA
81.5%
PDUFA Date2026-08-22
StagePDUFACatalystPDUFA Date
30-Day Trend
-13.2%
PoA Summary

MOLBREEVI (molgramostim) is an inhaled recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) developed by Savara Inc. (SVRA) for the treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare and debilitating lung disease characterized by pathological surfactant accumulation. The drug is... Show more

Treatment

autoimmune pulmonary alveolar proteinosis (autoimmune PAP)

Description

Drug: MOLBREEVI (molgramostim inhalation solution). Indication: autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Timeline: August 22, 2026. FDA issued a Day 74 letter indicating no advisory committee is planned; the MOLBREEVI Biologics License Application (BLA) review is ongoing with a PDUFA... Show more

capricor-therapeutics
Capricor Therapeutics, Inc.

CAPR

Drug Name
Deramiocel (CAP-1002)
PriorityRMATOrphan+1
PoA
77%
PDUFA Date2026-08-22
StagePDUFACatalystPDUFA Date
30-Day Trend
-70.4%
PoA Summary

Deramiocel (CAP-1002), developed by Capricor Therapeutics, is an investigational allogeneic cardiosphere-derived cell therapy aimed at treating Duchenne muscular dystrophy (DMD). This therapy is positioned as a first-in-class treatment, targeting both skeletal muscle weakness and cardiac complications associated with DMD, addressing... Show more

Treatment

Duchenne muscular dystrophy (DMD)

Description

The PDUFA target action date for the Biologics License Application for Deramiocel is set for August 22, 2026, as the company works with the FDA toward potential approval.

merck-and-co
Merck & Company, Inc.

MRK

Drug Name
KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv)
Priority
PoA
25.5%
PDUFA Date2026-08-17
StagePDUFACatalystPDUFA Date
30-Day Trend
+7.1%
PoA Summary

Merck's KEYTRUDA (pembrolizumab), an anti-PD-1 monoclonal antibody, in combination with Astellas/Seagen's Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody-drug conjugate, represents a significant advancement in the treatment of advanced bladder cancer. This first-in-U.S. anti-PD-1 and ADC regimen has already transformed the treatment... Show more

Treatment

muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy

Description

Drug: KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv). Indication: muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. Timeline: 2026-08-17. FDA granted priority review for a supplemental BLA for KEYTRUDA combined with Padcev for cisplatin-eligible MIBC. The filing... Show more

merck-and-co
Merck & Company, Inc.

MRK

Drug Name
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv)
Priority
PoA
85.5%
PDUFA Date2026-08-17
StagePDUFACatalystPDUFA Date
30-Day Trend
+7.1%
PoA Summary

KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), Merck's (MRK) subcutaneous formulation of the PD-1 inhibitor, is currently under FDA priority review for its use in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC) developed by Astellas and Seagen. This combination... Show more

Treatment

muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy

Description

Drug: KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv). Indication: muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. Timeline: 2026-08-17. FDA granted priority review for a supplemental BLA for KEYTRUDA QLEX combined with Padcev... Show more

jazz-pharmaceuticals
Jazz Pharmaceuticals plc

JAZZ

Drug Name
Ziihera (zanidatamab-hrii)
BreakthroughPriorityFast Track+1
PoA
82.5%
PDUFA Date2026-08-25
StagePDUFACatalystPDUFA Date
30-Day Trend
+0.3%
PoA Summary

Ziihera (zanidatamab-hrii), developed by Jazz Pharmaceuticals (JAZZ), is a bispecific HER2-directed antibody designed for dual epitope binding on HER2-positive tumor cells. This innovative mechanism promotes enhanced tumor growth inhibition, antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC) both in vitro... Show more

Treatment

HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA)

Description

Drug: Ziihera (zanidatamab-hrii). Indication: HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). Timeline: August 25, 2026. FDA accepted Jazz's sBLA for Ziihera (zanidatamab-hrii) with Priority Review for combinations in first-line treatment of adult patients... Show more

biogen
Biogen Inc.

BIIB

Drug Name
lecanemab-irmb (LEQEMBI IQLIK) subcutaneous injection
PriorityFast TrackAccelerated
PoA
78.5%
PDUFA Date2026-08-24
StagePDUFACatalystPDUFA Date
30-Day Trend
+0.7%
PoA Summary

LEQEMBI® IQLIK™ (lecanemab-irmb), developed by Eisai and Biogen (ticker: BIIB), signifies a significant advancement in the treatment of early Alzheimer's disease (AD). This best-in-class, amyloid beta-directed antibody aims to provide the same disease-modifying efficacy as the approved intravenous (IV) formulation... Show more

Treatment

early Alzheimer’s disease (starting dose)

Description

Drug: lecanemab-irmb (LEQEMBI IQLIK) subcutaneous injection. Indication: early Alzheimer’s disease (starting dose). Timeline: August 24, 2026. The FDA has extended review of the supplemental BLA for once-weekly lecanemab-irmb (LEQEMBI IQLIK) as a starting dose for early Alzheimer’s disease, designating the... Show more

replimune
Replimune Group, Inc.

REPL

Drug Name
RP1 (vusolimogene oderparepvec) in combination with nivolumab
BreakthroughPriorityAccelerated
PoA
18.5%
PDUFA Date2026-08-02
StagePDUFACatalystPDUFA Date
30-Day Trend
+30.5%
PoA Summary

Replimune Group (NASDAQ: REPL) is advancing its investigational therapy, RP1 (vusolimogene oderparepvec), a genetically modified herpes simplex virus type 1-based oncolytic immunotherapy, in combination with nivolumab for the treatment of advanced melanoma. This first-in-class agent is designed to locally destroy... Show more

Treatment

advanced melanoma

Description

Drug: RP1 (vusolimogene oderparepvec) in combination with nivolumab. Indication: advanced melanoma. Timeline: 2026-08-02. The FDA has accepted for review the resubmission of the BLA for RP1 combined with nivolumab for advanced melanoma and set a goal date for FDA action... Show more

moderna
Moderna, Inc.

MRNA

Drug Name
mRNA-1010
PoA
85%
PDUFA Date2026-08-05
StagePDUFACatalystPDUFA Date
30-Day Trend
-22.6%
PoA Summary

mRNA-1010, developed by Moderna (MRNA), is currently in the NDA/BLA review stage, with a high estimated Probability of Approval (PoA) of 85.0%. This strong PoA is supported by robust immunogenicity data, acceptable safety profiles in over 14,000 adults, and alignment... Show more

Treatment

seasonal flu vaccine

Description

Drug: mRNA-1010. Indication: seasonal flu vaccine. Timeline: August 5, 2026. The U.S. FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026.

lantheus
Lantheus Holdings, Inc.

LNTH

Drug Name
MK-6240
PoA
87.5%
PDUFA Date2026-08-13
StagePDUFACatalystPDUFA Date
30-Day Trend
-1.8%
PoA Summary

MK-6240, developed by Lantheus Holdings (LNTH), is a first-in-class F18-labeled tau PET radiodiagnostic designed to detect neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. Acquired by Lantheus in 2023 from Enigma Biomedical, MK-6240 targets... Show more

Treatment

Detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease

Description

Drug: MK-6240. Indication: Detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. Timeline: August 13, 2026. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August... Show more

bristol-myers-squibb
Bristol-Myers Squibb Company

BMY

Drug Name
iberdomide
PoA
78.5%
PDUFA Date2026-08-17
StagePDUFACatalystPDUFA Date
30-Day Trend
+12.6%
PoA Summary

Iberdomide (BMS-986382), developed by Bristol Myers Squibb (BMY), is a cereblon E3 ligase modulator (CELMoD™) that operates by directly inducing tumor cell death and enhancing immune response through CRBN binding. This investigational drug is currently under evaluation for relapsed or... Show more

Treatment

relapsed or refractory multiple myeloma (RRMM)

Description

Drug: iberdomide. Indication: relapsed or refractory multiple myeloma (RRMM). Timeline: August 17, 2026. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026 for iberdomide combined with daratumumab and dexamethasone (IberDd) in patients with... Show more

zymeworks
Zymeworks Inc.

ZYME

Drug Name
Ziihera (zanidatamab-hrii)
BreakthroughPriorityAccelerated
PoA
82.5%
PDUFA Date2026-08-25
StagePDUFACatalystPDUFA Date
30-Day Trend
-0.8%
PoA Summary

Ziihera (zanidatamab-hrii), developed by Zymeworks and now commercialized by Jazz Pharmaceuticals, is a bispecific HER2-targeted antibody designed to bind two distinct HER2 domains. This mechanism enables dual signaling blockade and enhances immune-mediated tumor cell destruction. Ziihera is currently under evaluation... Show more

Treatment

first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA)

Description

Drug: Ziihera (zanidatamab-hrii). Indication: first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). Timeline: August 25, 2026. U.S. FDA accepted Jazz's sBLA for Ziihera (zanidatamab-hrii) for first-line HER2+ unresectable locally advanced or metastatic GEA and set a PDUFA target... Show more

gilead
Gilead Sciences, Inc.

GILD

Drug Name
bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN)
PoA
88.5%
PDUFA Date2026-08-27
StagePDUFACatalystPDUFA Date
30-Day Trend
+6.8%
PoA Summary

Gilead Sciences (GILD) is advancing bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), an innovative single-tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. This combination pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) known for... Show more

Treatment

treatment of HIV in adults who are virologically suppressed

Description

Drug: bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). Indication: treatment of HIV in adults who are virologically suppressed. Timeline: 2026-08-27. FDA accepted the New Drug Application for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) for the treatment of HIV in adults who... Show more

gilead
Gilead Sciences, Inc.

GILD

Drug Name
BIC LEN
PoA
88.5%
PDUFA Date2026-08-27
StagePDUFACatalystPDUFA Date
30-Day Trend
+6.8%
PoA Summary

Gilead Sciences (GILD) is advancing its investigational once-daily single-tablet regimen, bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), aimed at treating virologically suppressed adults with HIV. This innovative combination pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) known for its high... Show more

Treatment

virologically suppressed people with HIV

Description

Drug: BIC LEN. Indication: virologically suppressed people with HIV. Timeline: August 27, 2026. FDA accepted New Drug Application for bictegravir and lenacapavir (BIC LEN) for virologically suppressed people with HIV under priority review, with a PDUFA target action date of... Show more

outlook-therapeutics
Outlook Therapeutics, Inc.

OTLK

Drug Name
ONS-5010/LYTENAVA™ (bevacizumab-vikg)
PoA
25%
PDUFA Date2026-08-01
StageBLACatalystPDUFA Date
30-Day Trend
-46.7%
PoA Summary

ONS-5010/LYTENAVA™ (bevacizumab-vikg) is an ophthalmic formulation of bevacizumab being developed by Outlook Therapeutics (OTLK) for the treatment of neovascular age-related macular degeneration (nAMD), also known as wet AMD. As of the latest public information, the U.S. program is currently in... Show more

Treatment

neovascular age-related macular degeneration (nAMD)

Description

Drug: ONS-5010/LYTENAVA™ (bevacizumab-vikg). Indication: neovascular age-related macular degeneration (nAMD). Timeline: 2026-08-01. Outlook Therapeutics has resubmitted its Biologics License Application (BLA) for ONS-5010/LYTENAVA™ to the FDA. A PDUFA date and decision are expected within 60 days of the FDA's receipt of... 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.