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 Track Record

Verified prediction accuracy with cryptographic proof. 52outcomes since Aug 2025. SHA-256 hash immutable ledger.

96.2% overall accuracy • 12 correctly called CRLs • 16/16 in 2026 • Full outcome audit trail since August 1, 2025

Latest Verified Wins (Feb 2026)

[2026-02-12T23:44:55Z] ASND YUVIWEL (navepegritide) | TIER_1 (88.9%) | APPROVED Feb 27 | Accelerated | RPD PRV | 15 days lead | 0d39685f6f665df18274d71df5875707b58ae5f939a382414f7fc5d49c8dd4b5
[2026-02-05T00:00:00Z] ETON Topical Baclofen | TIER_2 | APPROVED Feb 25 (T-20) | Runup +14.7% (T-25 to T-7) | b0c49ab6732729a9655e1ec8f5d14bf597dc3330
[2026-02-12T19:53:39Z] REGN Dupixent AFRS | TIER_1 | APPROVED Feb 24 | Clean/No REMS | f8db0ba77afc540fab209cb03f94f8722909b8d00e534b9370903466759dfba9
[2026-02-16T16:32:59Z] VNDA Bysanti (milsaperidone) | TIER_1 | APPROVED Feb 20 | Clean/No REMS | SHA-256 verified
[2026-01-06T00:00:00Z] FBIO ZYCUBO (CUTX-101) | TIER_1 | APPROVED Jan 13 | RPD PRV | 5a70f05643eafa25d314ce3c7fabb17781a25ccfb6aabbd91516cfa21e5b7839

What Is ODIN?

ODIN is a proprietary machine learning system that predicts the outcome of FDA biotech decisions (approvals, rejections, CRL/Complete Response Letters) before they are announced. ODIN assigns each upcoming PDUFA event a confidence tier (TIER_1 through TIER_4).

Unlike sentiment analysis or social media followers, ODIN is trained on:

Historical FDA approval rates by indication, company, trial design
Clinical trial data: enrollment, primary endpoints, competitor landscape
Stock price momentum and technical structure (runup window, IV dynamics)
Options market pricing (implied probability of approval)
CEWS (Catalyst Early Warning System): insider trading, C-suite selling patterns

The system's output is a tier (TIER_1 highest confidence, TIER_4 lowest) that has been validated across 53 verified outcomes since August 2025 with a 96.2% accuracy rate.

Overall Track Record Summary (Since August 1, 2025)

Verified Outcomes

96.2%

Overall Accuracy (51/53)

CRLs Correctly Called

16/16

Perfect in 2026

Results by Tier Classification (Since Aug 1, 2025)

ODIN Tier	Correct Predictions	Accuracy %	Description
TIER_1 (High Confidence)	26 / 27	96.3%	Strong approvals. 1 miss: SNY Tolebrutinib (Hy's Law)
TIER_2 (Good Confidence)	9 / 10	90.0%	Includes CAPR +534%, MIST +130%. 1 miss: FBIO original CRL
TIER_3 (Mixed/Trap Zone)	4 / 4	100%	3 CRLs correctly avoided + 1 approval (VNDA Tradipitant)
TIER_4 (CRL-Likely)	11 / 11	100%	Perfect CRL/delay detection. Every TIER_4 call correct.
CEWS Override	1 / 1	100%	AQST insider selling override saved -40% loss

Data: Aug 2025 - Feb 2026. Accuracy = correct prediction of approve/reject/CRL/delay. Only 2 misses total across 52outcomes.

Correctly Called CRLs & Delays (13/13 = 100%)

ODIN doesn't just predict approvals — it identifies CRLs and delays BEFORE they happen. Every CRL or delay correctly flagged is money saved. Here are 13 correctly called negative outcomes, each with losses avoided:

Ticker	Drug	Date	ODIN Tier	Outcome	Loss Avoided
IRON	Bitopertin (EPP)	Feb 13, 2026	TIER_4 (39.4%)	CRL	-52%
RGNX	RGX-121 (Hunter Syndrome)	Feb 7, 2026	TIER_4 (45%)	CRL	-21%
PHAR	Leniolisib (Joenja pediatric)	Feb 1, 2026	TIER_3 (58%)	CRL	-28%
TVTX	Filspari (Sparsentan) FSGS	Jan 13, 2026	TIER_4 (42%)	DELAYED	-33%
AQST	Anaphylm (epinephrine film)	Jan 9, 2026	CEWS OVERRIDE	CRL	-40%
ATRA	Tabelecleucel (EBV+ PTLD)	Jan 9, 2026	TIER_4 (28%)	CRL	-22%
OTLK	ONS-5010 Lytenava (3rd CRL)	Dec 31, 2025	TIER_4 (5%)	CRL	-68%
CORT	Relacorilant (Cushing's)	Dec 31, 2025	TIER_3 TRAP (58%)	CRL	-41%
BHVN	Troriluzole (SCA)	Nov 4, 2025	TIER_4 (38%)	CRL	-32%
RGNX	RGX-121 (Nov delay)	Nov 9, 2025	TIER_4 (45%)	DELAYED	-18%
SRRK	Nomlabofusp (Friedreich's Ataxia)	Sep 28, 2025	TIER_4 (42%)	CRL	-38%
PTCT	Vatiquinone (Friedreich Ataxia)	Aug 19, 2025	TIER_3 (31%)	CRL	-61%

Total losses avoided: -525% combined. ODIN's CRL detection is as valuable as its approval predictions.

2026 Predictions: 16/16 Perfect Record

Every ODIN prediction in 2026 has been correct — 10 approvals (incl. ASND YUVIWEL), 6 CRLs, 1 delay, 1 runup trade. Zero misses.

Ticker	Drug / Program	Date	ODIN Tier	Outcome	Stock Move
REGN	Dupixent (AFRS)	Feb 24	TIER_1	APPROVED	+7.3%
VNDA	Bysanti (milsaperidone)	Feb 20	TIER_1	APPROVED	+44%
ETON	ET-600 (Desmopressin)	Feb 25	TIER_2	APPROVED	+14.7%
RCKT	RP-A501 (Danon Disease)	Feb 20	TIER_4	RUNUP WIN	+20%
IRON	Bitopertin (EPP)	Feb 13	TIER_4	CRL	-52% avoided
ASND	YUVIWEL (navepegritide)	Feb 27	TIER_1	APPROVED	+6%
ASND	TransCon hGH Weekly	Feb 7	TIER_1	APPROVED	+19%
RGNX	RGX-121 (Hunter Syndrome)	Feb 7	TIER_4	CRL	-21% avoided
PHAR	Leniolisib (APDS pediatric)	Feb 1	TIER_3	CRL	-28% avoided
JNJ	Darzalex Faspro D-VRd	Jan 27	TIER_1	APPROVED	+2%
AZN	Tezspire (asthma expansion)	Jan 25	TIER_1	APPROVED	+8%
NVO	Oral Semaglutide (Wegovy)	Jan 20	TIER_1	POSITIVE	+13%
FBIO	ZYCUBO (Menkes resub)	Jan 13	TIER_1	APPROVED	+22%
TVTX	Filspari (FSGS)	Jan 13	TIER_4	DELAYED	-33% avoided
SNY	Cerezyme (GD3 expansion)	Jan 12	TIER_1	APPROVED	+1%
AQST	Anaphylm (CEWS override)	Jan 9	CEWS	CRL	-40% avoided
ATRA	Tabelecleucel (EBV+ PTLD)	Jan 9	TIER_4	CRL	-22% avoided
SNY	Cablivi (pediatric aTTP)	Jan 5	TIER_1	APPROVED	+2%

SHA-256 Hash Verification

To prevent hindsight bias and false claims, every ODIN prediction is locked with a SHA-256 cryptographic hash BEFORE the FDA announcement. This immutable ledger proves:

We made the prediction on date X (no retroactive changes)
The prediction was TIER_1 / TIER_2 / etc (no doctoring after the fact)
The actual outcome (approve/reject/CRL) is documented with timestamp

Latest Hash Ledger Entry (ASND YUVIWEL — Feb 27, 2026):

Prediction: 2026-02-12T23:44:55Z | Git: 300f86b | 15 days before approval

Ticker: ASND | Drug: Navepegritide (YUVIWEL) | ODIN Tier: TIER_1 (88.9%)

SHA-256: 0d39685f6f665df18274d71df5875707b58ae5f939a382414f7fc5d49c8dd4b5

Core Hash: 57e1c8a67ea721e6c5a6e7cda7f1dbdcf71a26affbd88d45f0b41f183d53eb6a

Outcome: APPROVED (Accelerated, 1 day early) | Move: +6% | Prior Chain: 2f75e484...

PREDICTION VERIFIED ✓ — 16/16 in 2026

Every verified outcome on this page is linked to its pre-decision hash. You can independently verify by checking the GitHub commit timestamp at github.com/rockyshoals-lgtm/pdufa-bio/commit/300f86b.

Notable Verified Wins (Since Aug 2025)

Ticker	Drug / Program	ODIN Score	Outcome	Stock Move
CAPR	Deramiocel (HOPE-3) — DMD Cardiomyopathy	TIER_2 (72.5%)	POSITIVE (BEAT)	+534%
MIST	Etripamil (CARDAMYST) — PSVT	TIER_1 (82.5%)	APPROVED	+130%
TOVX	VCN-01 — Pancreatic Cancer	TIER_2 (67.5%)	POSITIVE	+91%
OMER	Narsoplimab (YARTEMLEA) — TMA	TIER_2 (62%)	APPROVED	+76%
SNDX	Revumenib (REVUFORJ) — AML	TIER_1 (87.5%)	APPROVED	+51%
VNDA	Bysanti (milsaperidone) — Schizophrenia	TIER_1 (89.7%)	APPROVED	+44%
VNDA	Tradipitant (NEREUS) — Motion Sickness	TIER_3 (55%)	APPROVED	+42%

Stock moves are T+5 closing prices post-announcement. These are verified outcomes from the hash ledger since August 2025.

Frequently Asked Questions

How does ODIN predict FDA outcomes?

ODIN is trained on 2,200+ historical FDA events combined with 21 scoring signals. It analyzes: historical approval rates by indication/company, clinical trial design and endpoints, regulatory designations (BTD, Orphan, Priority Review), manufacturing risk profiles (CMO database), and real-time stock/options market pricing. The CEWS (Catalyst Early Warning System) adds insider trading detection with 86-day average lead time on CRLs.

How does ODIN predict CRLs so accurately?

ODIN's CRL detection combines manufacturing risk scoring (Svartalfheim CMO Oracle), therapeutic area risk adjustments (ophthalmology, pain, nephrology are high-risk), clinical trial design analysis (single-arm studies, external controls), and CEWS insider selling cluster detection. TIER_4 calls have a 100% CRL/delay detection rate across 11 events since August 2025.

What does SHA-256 hash verification prove?

The hash proves we made a specific prediction on a specific date BEFORE the FDA announced. It prevents the classic hindsight bias where someone claims they "knew" an approval would happen after it already did. Our track record is immutable: if the prediction hash doesn't match the announcement outcome, it's verifiable proof of error.

Why start tracking from August 1, 2025?

August 1, 2025 represents when ODIN v2.1 (current model) was deployed with improved signal weights and validation methodology. The 96.2% overall accuracy and 100% TIER_4 CRL detection rate reflect this refined system's predictive power across 53 verified outcomes.