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 WINETONSMALL CAP

ETON ET-600: The Quiet ODIN Win Nobody Talked About

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

Nobody on FinTwit was breathless about ETON Pharmaceuticals heading into February 25th. No "🚀🚀🚀" threads. No Seeking Alpha deep dives. Just a sub-$500M orphan drug company with a desmopressin reformulation and a PDUFA date.

ODIN didn't care about the hype gap. It scored ETON ET-600 at 85.5% approval probability — TIER_2. Not the highest-conviction score on the board, but comfortably in the "favorable" range with a clear regulatory path.

Small Cap, Big Edge

Here's what the model saw that the crowd missed: ET-600 is an oral desmopressin solution for central diabetes insipidus (now called Arginine Vasopressin Deficiency). It's not a novel mechanism. It's a 505(b)(2) — a reformulation play with Orphan Drug designation. The FDA had already approved the underlying compound decades ago. The clinical question was narrow: does this formulation work as well as existing options with better dosing convenience? The answer was yes. ODIN knew the regulatory bar was low and the safety profile was established.

+14.7% for Those Paying Attention

ETON ran +14.7% from T-25 to the approval date. For a small-cap orphan drug name, that's the kind of move that turns a position into a month. The runway was there in the data — ODIN's runup model had flagged the expected pre-PDUFA drift — but you had to actually be looking at the calendar to catch it.

This is the play that institutional quants grind on every quarter. Not the VNDA +44% moonshot that makes Reddit scream. The boring, repeatable, data-backed positioning on a name the market forgot to price.

ETON ET-600 — ODIN Scorecard

ODIN Score:85.5%Tier:TIER_2 (Favorable)PDUFA Date:Feb 25, 2026Outcome:✅ APPROVEDStock Move:+14.7%Pathway:505(b)(2), Orphan Drug

ETON was exactly the kind of event ODIN was built for. Not glamorous. Not trending. Just a favorable risk/reward setup with quantifiable edges — the kind of thing you only find if you're running the numbers instead of refreshing your feed.

Full ETON PDUFA Analysis →February 2026 Roundup

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.