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.

TRACK RECORD8/8 PERFECT

8 for 8: ODIN's Perfect February 2026

By David "Lionel" Moore · March 1, 2026 · 4 min read

February is done. Let's count the tape.

Eight PDUFA decisions hit in February 2026. ODIN called every single one correctly — 5 approvals, 3 Complete Response Letters. 100% directional accuracy for the month.

I'm not going to pretend this is normal. It's not. Even with a 0.9363 holdout AUC, a perfect month is the upper tail of what the model is capable of. But that's the point — ODIN is designed to be right when it's confident, and cautious when the signal is mixed. February happened to be a month where the signal was clear, and the model read it correctly across the board.

The Full Scorecard

Ticker	Drug	ODIN	Tier	Result	Move
ASND	TransCon hGH Weekly	95.5%	TIER_1	APPROVED	+19%
RGNX	RGX-121	45.0%	TIER_4	CRL	-21%
IRON	Bitopertin	39.4%	TIER_4	CRL	-52%
VNDA	Bysanti	89.7%	TIER_1	APPROVED	+44%
REGN	Dupixent AFRS	94.8%	TIER_1	APPROVED	+7.3%
ETON	ET-600	85.5%	TIER_2	APPROVED	+14.7%
ASND	YUVIWEL	88.9%	TIER_1	APPROVED	+6%
PHAR	Leniolisib sNDA	58.0%	TIER_3	CRL	-28%

The CRLs Matter More Than the Approvals

Anybody can predict approvals — the base rate is ~68%. The real alpha is in calling the CRLs. When ODIN scored IRON (Bitopertin) at 39.4% and RGNX (RGX-121) at 45.0%, those weren't popular opinions. IRON had the rare disease narrative. RGNX had the gene therapy excitement. Both had the kind of community conviction that makes you second-guess the data.

But the model doesn't have conviction bias. It has 51 features and 2,200+ outcomes. IRON tanked 52%. RGNX dropped 21%. PHAR fell 28%. If you were on the wrong side of those, you felt it. If you were watching ODIN, you were either flat or short.

What This Means Going Forward

One perfect month doesn't make a model. But it validates the approach: train on real outcomes, validate with walk-forward methodology (not overfitted backtests), and let the probabilities speak for themselves.

March has its own slate of catalysts lining up. LNTH, ALDX, MESO — each with its own risk profile. ODIN is already scoring them.

The model doesn't celebrate. It just reloads.

February 2026 — ODIN Summary

Total Decisions:8Correct Calls:8 (100%)Approvals Called:5/5CRLs Called:3/3Biggest Winner:VNDA +44%Biggest CRL Dodge:IRON -52%

March 2026 PDUFA Dates →Full ODIN Track Record February 2026 Detail

Disclaimer: PDUFA.BIO provides data and analysis for informational purposes only. ODIN scores are probabilistic estimates, not investment advice. Past performance does not guarantee future results. Always do your own due diligence.