Question 1

What is a PDUFA date?

Accepted Answer

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.

Question 2

How does ODIN predict FDA approvals?

Accepted Answer

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).

Question 3

What is the PDUFA runup strategy?

Accepted Answer

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.

Question 4

What are ODIN tiers?

Accepted Answer

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.

Question 5

What is a Complete Response Letter (CRL)?

Accepted Answer

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.

Question 6

When was ETON Pharmaceuticals topical baclofen PDUFA date?

Accepted Answer

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.

Question 7

What is the Vanda Pharmaceuticals PDUFA date in February 2026?

Accepted Answer

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.

Question 8

What are the upcoming PDUFA dates for February 2026?

Accepted Answer

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.

Question 9

What FDA approvals are expected in Q1 2026?

Accepted Answer

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.

Date	Ticker	Drug	Indication	Outcome
2026-01-12	FBIO	ZYCUBO (copper histidinate)	Menkes Disease	✓ APPROVED
2026-02-09	RGNX	RGX-121	MPS II	✗ CRL
2026-02-20	VNDA	Bysanti (milsaperidone)	Schizophrenia	✓ APPROVED

Date	Ticker	Drug	Indication	TA
2026-02-25	OTSKF	INQOVI + Venetoclax	Acute Myeloid Leukemia	Oncology
2026-02-24	REGN	Dupixent (dupilumab)	AFRS — APPROVED Feb 24	Immunology
2026-02-28	ASND	Navepegritide	Achondroplasia	Endocrinology
2026-03-06	BMY	Deucravacitinib (Sotyktu)	Psoriatic Arthritis	Immunology
2026-03-20	RYTM	Imcivree	Hypothalamic Obesity	Endocrinology
2026-03-24	GSK	Linerixibat	Cholestatic Pruritus (PBC)	Hepatology
2026-03-25	LLY	Orforglipron	Type 2 Diabetes	Endocrinology
2026-03-28	RCKT	Kresladi	Leukocyte Adhesion Deficiency-I (LAD-I)	Gene Therapy
2026-03-29	LNTH	Ga68-edotreotide	GEP-NETs Imaging	Oncology
2026-04-05	DNLI	Tividenofusp alfa	MPS-IIIA (Sanfilippo)	Rare Disease
2026-05-15	TVTX	Pivlicaftor Potentiator	Cystic Fibrosis	Pulmonology
2026-06-20	ACLX	Cytisinicline	Smoking Cessation	CNS
2026-07-01	KURA	Tipifarnib	HRAS-Mutant HNSCC	Oncology
2026-07-07	VERA	Atacicept	IgA Nephropathy	Nephrology

PDUFA Calendar 2026: Upcoming FDA Drug Approval Dates

Recent FDA Decisions (Resolved)

Upcoming PDUFA Dates

Frequently Asked Questions

How many PDUFA dates are scheduled for 2026?

What is the FDA's PDUFA date approval rate?

Can the FDA act before the PDUFA date?

Featured PDUFA Catalysts — ODIN Scored