Important: PDUFA.BIO is not the FDA. ODIN scores are ML model outputs, not financial advice. All investing carries risk. Read full disclaimer โ
Real-time catalyst intelligence feed
$BMY PDUFA in 3 days. Extreme IV crush territory. 90.7% ODIN score.
$STXS โ Professional standard: close positions before T-7. 6 days remain.
$BNTX โ Professional standard: close positions before T-7. 7 days remain.
$HTFL enters optimal buy zone. 15 days to Earnings.
$TNON enters optimal buy zone. 16 days to Earnings.
$RYTM enters optimal buy zone. 17 days to PDUFA.
$ABVX enters optimal buy zone. 20 days to Earnings.
$GSK enters optimal buy zone. 21 days to PDUFA.
$IPHA enters optimal buy zone. 23 days to Earnings.
$MLTX enters optimal buy zone. 24 days to READOUT.
$RCKT enters optimal buy zone. 25 days to PDUFA.
ODIN recommends no position. 1.1% probability โ risk/reward unfavorable.
ODIN scores 90.7% (Tier 1). Deucravacitinib (Sotyktu) for Psoriatic Arthritis. 3d to decision.
ODIN scores 93.6% (Tier 1). Linerixibat for Cholestatic Pruritus (PBC). 21d to decision.
ODIN scores 86.0% (Tier 1). Gallium-68 edotreotide for NET PET Imaging. 26d to decision.
ODIN scores 92.8% (Tier 1). Opdivo (nivolumab) for Stage III/IV Classical Hodgkin Lymphoma (1L). 36d to decision.
ODIN scores 93.1% (Tier 1). Orforglipron for Type 2 Diabetes / Obesity. 38d to decision.
Abstract release ~Mar 15, 2026. Oncology conference (Major). 12 days.
Abstract release ~Mar 20, 2026. CNS conference (Major). 17 days.
Q4 2025 Earnings Earnings in 1 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 1 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 1 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 1 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 2 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 2 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 2 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 2 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 2 days. Predict the outcome to earn BioCred.
Deucravacitinib (Sotyktu) PDUFA in 3 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 6 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 7 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 8 days. Predict the outcome to earn BioCred.
ARD-101 - (HERO) READOUT in 8 days. Predict the outcome to earn BioCred.
Selinexor (XPORT-MF-034) - (SENTRY) READOUT in 8 days. Predict the outcome to earn BioCred.
XPOVIO (selinexor), Pomalidomide and Dexamethasone - (EMN29/XPORT-MM-031) READOUT in 8 days. Predict the outcome to earn BioCred.
KB803 - (IOLITE) READOUT in 8 days. Predict the outcome to earn BioCred.
Orforglipron - (ACHIEVE-4) READOUT in 8 days. Predict the outcome to earn BioCred.
AVTX-009 (anti-IL-1ฮฒ mAb) - (LOTUS) READOUT in 8 days. Predict the outcome to earn BioCred.
NS002 READOUT in 8 days. Predict the outcome to earn BioCred.
[18F]ACI-15916 PET in ฮฑ-synucleinopathies READOUT in 8 days. Predict the outcome to earn BioCred.
Bicycle Toxin Conjugates zelenectide pevedotin (BT8009) - (Duravelo-2) READOUT in 8 days. Predict the outcome to earn BioCred.
RLYB116 READOUT in 8 days. Predict the outcome to earn BioCred.
SEP-631 READOUT in 8 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 10 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 10 days. Predict the outcome to earn BioCred.
Reproxalap PDUFA in 13 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 13 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 14 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 14 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 15 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 16 days. Predict the outcome to earn BioCred.
Imcivree (setmelanotide) PDUFA in 17 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 20 days. Predict the outcome to earn BioCred.
Linerixibat PDUFA in 21 days. Predict the outcome to earn BioCred.
Q4 2025 Earnings Earnings in 23 days. Predict the outcome to earn BioCred.
Nanobody (sonelokimab) - (VELA-TEEN) READOUT in 24 days. Predict the outcome to earn BioCred.
Kresladi (marnetegragene autotemcel) PDUFA in 25 days. Predict the outcome to earn BioCred.
Gallium-68 edotreotide PDUFA in 26 days. Predict the outcome to earn BioCred.
EPX-100 - (ARGUS) READOUT in 29 days. Predict the outcome to earn BioCred.
VRDN-003 - (REVEAL-2) READOUT in 29 days. Predict the outcome to earn BioCred.
FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015โ2026).
PDUFA.BIO is the data-driven FDA PDUFA calendar and biotech catalyst calendar built for quantitative investors. Track upcoming PDUFA dates for 2026, FDA drug approval action dates, and biotech earnings dates in a unified, filterable calendar. Learn what a PDUFA date is and how the ODIN AI scoring engine generates FDA approval probability scores. Use the biotech catalyst screener to filter by ticker, therapeutic area, and ODIN tier. Explore the PDUFA runup strategy and verify ODIN's accuracy on the verified track record page. Browse our biotech glossary and catalyst research hub.
DISCLAIMER: PDUFA.BIO is not affiliated with, endorsed by, or connected to the U.S. Food & Drug Administration (FDA) or any government agency. The name "PDUFA" refers to the Prescription Drug User Fee Act and is used descriptively. This site does not provide financial, investment, legal, or medical advice. PDUFA.BIO is not a registered investment advisor, broker-dealer, or financial planner. Probability scores are generated by machine-learning models based on historical data and publicly available information. These scores are statistical estimates, not predictions or guarantees of FDA action or securities performance. Past approval rates do not guarantee future results.
RISK WARNING: Investing in biotechnology and pharmaceutical securities involves substantial risk, including the risk of total loss of capital. Binary catalyst events (such as PDUFA dates) can result in extreme price volatility. You should not invest money you cannot afford to lose. Always consult with a qualified financial advisor before making investment decisions. PDUFA.BIO, its operators, contributors, and affiliates accept no responsibility or liability for any losses arising from use of this site.