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.

ODIN WINASND

ODIN Called ASND YUVIWEL Before the Street Blinked

By David "Lionel" Moore · March 1, 2026 · 3 min read

On February 27th, the FDA approved Ascendis Pharma's YUVIWEL (navepegritide) for pediatric achondroplasia. If you were watching ODIN, you weren't surprised.

Weeks before the decision, our 51-feature L2 Ridge regression scored ASND YUVIWEL at 88.9% approval probability — TIER_1. That's not a gut call. That's 2,200+ historical PDUFA outcomes, walk-forward validated at 0.9363 AUC, saying the data package was clean and the regulatory path was clear.

Why ODIN Was Confident

ASND had almost every box checked: Breakthrough Therapy Designation. Orphan Drug status. Phase 3 data showing statistically significant improvement in annualized height velocity. No AdCom — which historically signals the FDA doesn't need external convincing. Ascendis already had TransCon hGH approved earlier this month (Feb 7, ODIN score 95.5%) — proving their manufacturing and regulatory infrastructure was solid. When a sponsor walks in with back-to-back clean submissions, the model notices.

The Market Underpriced It

ASND moved +6% on the approval. Decent — but modest relative to the TIER_1 confidence level. The stock had already priced in much of the approval during the T-25 runup window, which ODIN's runup model flagged as an R2-tier expected move. Translation: the smart money was already positioning. If you waited for the headline, you caught the tail end.

This is the whole point. ODIN doesn't tell you what happened. It tells you what's likely to happen — and gives you the probability with receipts.

ASND YUVIWEL — ODIN Scorecard

ODIN Score:88.9%Tier:TIER_1 (Favorable)PDUFA Date:Feb 27, 2026Outcome:✅ APPROVEDStock Move:+6%Key Factors:BTD, Orphan, No AdCom, Strong P3

ASND marks ODIN's 5th consecutive correct call in February 2026 on the approval side. Combined with 3 correctly predicted CRLs (IRON, RGNX, PHAR), that's 8 for 8 this month.

Not bad for a machine that doesn't read Twitter.

See Full February 2026 Roundup →How ODIN Works

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.