What is a PDUFA date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target action date for making a regulatory decision on a drug application (NDA or BLA). These dates are critical binary events for biotech investors as they can cause significant stock price movements of 20-70% in either direction.

How does ODIN predict FDA approvals?

ODIN v14 is a 51-feature L2 Ridge regression trained on 2,210 historical FDA PDUFA events (705 CRLs, 32.0% base rate) from 2015-2026. It analyzes signals across regulatory designations, manufacturing risk, therapeutic area history, sponsor experience, clinical trial design, and FDA era effects to produce a calibrated approval probability. It achieves 0.9363 AUC on walk-forward testing with consistent yearly performance (0.89-0.94).

What is the PDUFA runup strategy?

The PDUFA runup strategy is a validated trading approach based on analysis of 934 PDUFA events showing that biotech stocks systematically appreciate in the 25 trading days before an FDA decision date. The strategy enters at T-25 and exits at T-5 or T-7 depending on ODIN tier, capturing the anticipatory move without holding through the binary event.

ODIN assigns each FDA catalyst to one of four conviction tiers: TIER_1 (85%+ approval probability, full position), TIER_2 (65-85%, half position), TIER_3 (40-65%, small speculative or avoid), and TIER_4 (below 40%, no trade). The tiers drive position sizing and risk management for the PDUFA runup trading strategy.

What is a Complete Response Letter (CRL)?

A Complete Response Letter (CRL) is an FDA notification that the agency cannot approve a drug application in its current form. CRLs cite deficiencies in manufacturing (CMC), clinical efficacy, or safety data. Historically, 32.3% of PDUFA decisions result in CRLs. ODIN's strongest signal is prior CRL history, which carries a -3.21 logit penalty.

When was ETON Pharmaceuticals topical baclofen PDUFA date?

ETON Pharmaceuticals topical baclofen had a PDUFA target action date of February 25, 2026. The FDA approved the drug on schedule on February 25, 2026. ODIN scored it at 85.5% TIER_1, and the stock rose +14.7% during the runup from T-25 to T-7. Track live PDUFA status and ODIN AI approval probability (AUC 0.9363) at pdufa.bio/eton-pdufa.

What is the Vanda Pharmaceuticals PDUFA date in February 2026?

Vanda Pharmaceuticals (VNDA) had a PDUFA target action date of February 21, 2026 for Bysanti (milsaperidone) for schizophrenia. The FDA approved the drug one day early on February 20, 2026. ODIN scored it at 89.7% TIER_1, and the stock rose +44% after hours. Track live PDUFA status and ODIN AI approval probability (AUC 0.9363) at pdufa.bio/calendar.

What are the upcoming PDUFA dates for February 2026?

Key February 2026 PDUFA dates include ETON Topical Baclofen (Feb 25, APPROVED), VNDA Bysanti (Feb 21, APPROVED), OTSKF INQOVI+Venetoclax for AML (Feb 25), REGN Dupixent for allergic fungal rhinosinusitis (Feb 28, APPROVED), and ASND Navepegritide for anemia of CKD (Feb 28). The full Q1 2026 calendar with ODIN AI biotech catalyst scores is available at pdufa.bio/pdufa-calendar-2026.

What FDA approvals are expected in Q1 2026?

Q1 2026 features approximately 10-12 FDA PDUFA decisions, including high-profile oncology, immunology, and endocrinology catalysts. Key names include BMY deucravacitinib for UC (March 6), LLY orforglipron for diabetes (April 10), RCKT Kresladi gene therapy (March 28), and LNTH Ga68-edotreotide for NET imaging (March 29). Track all dates with ODIN probability scores at pdufa.bio.

Biotech Catalyst Glossary

A comprehensive guide to FDA approval terminology, regulatory pathways, and event-driven investing concepts. Understand PDUFA dates, advisory committees, breakthrough designations, and ODIN scores.

Designed for biotech investors, event-driven traders, and anyone researching pharmaceutical catalysts. Each term includes a clear definition tailored for non-regulatory professionals.

PDUFA

Prescription Drug User Fee Act. The FDA's commitment to review drug applications (NDAs, BLAs) within standard (10 months) or priority (6 months) timelines. PDUFA dates are key biotech catalysts.

NDA

New Drug Application. The formal submission to FDA seeking approval to market a new drug in the United States. Required for all new small-molecule therapeutics and some biologics.

BLA

Biologics License Application. The FDA submission for biological products (monoclonal antibodies, cell therapies, gene therapies, vaccines). Follows similar review timelines as NDAs.

sNDA

Supplemental New Drug Application. An application to amend an already-approved NDA (e.g., new indication, formulation, or dosage). Often faster to approve than original NDAs.

CRL

Complete Response Letter. FDA rejection of a drug application citing deficiencies. Companies must address all CRL issues and resubmit. Multiple CRLs reduce approval probability significantly.

AdCom

Advisory Committee Meeting. The FDA convenes independent experts to review trial data and vote on a drug's benefit-risk profile. AdCom votes strongly influence FDA approval decisions.

Priority Review

FDA expedited review pathway (6-month timeline instead of standard 10 months). Granted for drugs that provide substantial improvement over existing therapies.

Breakthrough Therapy

FDA designation for drugs showing significant efficacy advantage over available therapies. Enables expedited review, more frequent meetings with FDA, and potential accelerated approval.

Fast Track

FDA expedited development pathway for drugs addressing serious or unmet medical needs. Enables priority review and rolling submission of application data.

Accelerated Approval

FDA approval based on surrogate or intermediate endpoints rather than clinical benefit. Requires confirmatory Phase 4 trials. Enables faster market entry but carries uncertainty risk.

REMS

Risk Evaluation and Mitigation Strategy. FDA-mandated program for drugs with serious safety risks. REMS requirements complicate marketing and reduce patient access, impacting peak sales potential.

CMC

Chemistry, Manufacturing, and Controls. The regulatory section of a drug application covering drug substance synthesis, drug product formulation, stability, and quality assurance. CMC deficiencies often delay approval.

sBLA

Supplemental Biologics License Application. Amendment to an approved BLA (e.g., new indication, manufacturing change). sBLA approvals can provide near-term catalysts for biotech companies.

Orphan Drug

Designation for drugs treating rare diseases (<200,000 patients in US). Provides 7-year market exclusivity post-approval, tax credits, and expedited review. Reduces market size but increases profit margins.

ODIN Score

Proprietary machine learning score (0–100%) predicting FDA approval probability for a PDUFA event. Trained on 2,210 historical FDA decisions. PDUFA.bio's flagship predictive metric.

Runup Strategy

Trading strategy buying biotech stock weeks or months before a PDUFA decision, expecting stock appreciation if approved. TIER_1 and TIER_2 ODIN events are prime runup candidates.

Regulatory Pathways at a Glance

Pathway	Timeline	Eligibility	Impact
Standard Review	10 months (NDA/BLA)	All drugs	Neutral
Priority Review	6 months	Substantial advantage over existing	Bullish
Breakthrough Therapy	Expedited	Significant advantage	Very Bullish
Fast Track	Expedited	Serious unmet need	Bullish
Accelerated Approval	Expedited	Surrogate endpoint evidence	Very Bullish / Risky

Drug Application Types

NDA

Original approval for new small-molecule drugs. Full data package (chemistry, manufacturing, nonclinical, clinical). Standard or priority review timelines apply.

BLA

Approval for biologics: monoclonal antibodies, cell therapies, gene therapies, recombinant proteins, vaccines. Follow similar pathways as NDAs but with specialized chemistry/manufacturing requirements.

sNDA

Amendment to approved NDA for new indication, dosage, formulation, or manufacturing change. Often faster approval (3–6 months) because active ingredient already approved.

sBLA

Amendment to approved BLA for manufacturing, indication, or dosage changes. Important catalyst for approved biotech companies seeking label expansions.

Key Investing Concepts

CRL Risk

A Complete Response Letter from FDA means rejection. The drug cannot launch; company must address deficiencies and resubmit. CRL probability is 15–30% even for strong candidates. TIER_4 ODIN events have >50% CRL risk.

REMS Burden

Risk Evaluation and Mitigation Strategy requirements (e.g., patient enrollment registries, prescriber training) reduce peak sales potential by 20–50%. Common for cancer drugs, opioids, and other high-risk products.

Label Expansion

sNDA/sBLA approvals for new indications or patient populations. Often quicker than original approval and can double-triple peak sales. Secondary catalysts for approved drugs.

Orphan Advantage

Rare disease designation (Orphan Drug status) grants 7-year market exclusivity post-approval. Smaller peak sales but higher margins. Common in oncology, neurology, immunology.