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Historical PDUFA Outcomes & Stock Reactions
What actually happened at past FDA decision dates — the pre-event run-up, the decision-day move, and where the stock sat a week later. Verified approvals via openFDA.
64
Events Archived
3.4%
Avg 30d Run-up
48%
Closed Up Next Day
+41.5%
Biggest Pop
-70.7%
Biggest Drop
Model validation in progress. The Model PoA column shows the score our system
would have assigned before each decision. As openFDA confirms approvals, a verified hit-rate appears here.
Run-up 30d is the stock's move in the ~30 calendar days before the decision — the speculation phase. Decision 1d is the move from the close before the PDUFA date to the first close after it. After 5d shows where it settled a trading week later: approval pops often fade, and CRL drops sometimes bounce.
Outcome shows Approved only when the approval is verified against the openFDA database. Decisions we can't verify automatically stay Unverified — we don't guess from price action.
| Date | Ticker | Drug | Indication | Type | Model PoA | Run-up 30d | Decision 1d | After 5d | Outcome |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-29 | OTLK Outlook Therapeutics, Inc. |
— | Wet AMD <P STYLE="font: 10pt Times New Roma | BLA | 89% | -47.1% | +10.6% | — | Unverified |
| 2026-07-17 | CELC Celcuity Inc. |
— | a significant number of patients with HR+/HER | NDA | 84% | +0.1% | +0.1% | — | Unverified |
| 2026-07-11 | CORT CORCEPT THERAPEUTICS INC |
— | Platinum-Resistant Ovarian Cancer <P STYLE="m | NDA | 81% | +18.6% | — | — | Unverified |
| 2026-07-07 | VERA Vera Therapeutics, Inc. |
— | IgAN in adults | BLA | 89% | +28.3% | +7.1% | — | Unverified |
| 2026-06-30 | VRDN Viridian Therapeutics, Inc.\ |
— | patients with TED | BLA | 89% | +7.7% | -2.2% | — | Unverified |
| 2026-06-29 | UNCY Unicycive Therapeutics, Inc. |
— | hyperphosphatemia in patients | NDA | 87% | +0.9% | +8% | — | Unverified |
| 2026-06-20 | ACHV ACHIEVE LIFE SCIENCES, INC. |
— | nicotine dependence | NDA | 87% | +9% | — | — | Unverified |
| 2026-06-05 | ARVN ARVINAS, INC. |
— | estrogen receptor– | NDA | 80% | -27.1% | -4.1% | — | Unverified |
| 2026-05-29 | MNKD MANNKIND CORP |
— | NDA | 87% | +30.5% | +3.6% | -3.3% | Unverified | |
| 2026-05-24 | BIIB BIOGEN INC. |
— | NDA | 87% | +3.1% | -0.4% | -0.8% | Unverified | |
| 2026-04-30 | AXSM Axsome Therapeutics, Inc. |
— | Alzheimer’ | sNDA | 84% | +14.6% | +12.9% | +21% | Unverified |
| 2026-04-23 | GRCE Grace Therapeutics, Inc. |
— | aneurysmal Subarachnoid Hemorrhage (aSAH) < | NDA | 87% | -2.7% | -45.5% | -51.3% | Unverified |
| 2026-04-13 | TVTX Travere Therapeutics, Inc. |
— | NDA | 87% | +1.7% | +6% | +40.8% | Unverified | |
| 2026-04-10 | REPL Replimune Group, Inc. |
— | Advanced Melanoma <P STYLE="font: 10pt Times | BLA | 89% | -28.2% | -19.5% | -62.9% | Unverified |
| 2026-04-05 | DNLI Denali Therapeutics Inc. |
— | Hunter syndrome<div style="padding-left:36pt | BLA | 89% | +1.4% | -6.2% | -6.9% | Unverified |
| 2026-04-03 | BIIB BIOGEN INC. |
— | NDA | 87% | -6.6% | -2.8% | -2.5% | Unverified | |
| 2026-03-20 | RYTM RHYTHM PHARMACEUTICALS, INC. |
— | acquired hypothalamic obesity | sNDA | 92% | -10.9% | -3.2% | -9.3% | Unverified |
| 2026-03-17 | ALDX Aldeyra Therapeutics, Inc. |
— | Signs and Symptoms of Dry Eye Disease | NDA | 87% | -19.4% | -70.7% | -47.3% | Unverified |
| 2026-03-16 | ALDX Aldeyra Therapeutics, Inc. |
— | Dry Eye Disease<p style="font-size:10pt | NDA | 87% | -22.5% | +2.6% | -56.1% | Unverified |
| 2026-03-06 | LNTH Lantheus Holdings, Inc. |
New Formulation | NDA | 87% | +15.6% | -4.9% | +5.4% | Unverified | |
| 2026-02-25 | ETON Eton Pharmaceuticals, Inc. |
— | NDA | 87% | +22% | -3.5% | -4.5% | Unverified | |
| 2026-02-21 | VNDA Vanda Pharmaceuticals Inc. |
— | jet lag disorder by January 7 | NDA | 87% | -27.4% | +41.5% | +54.7% | Unverified |
| 2026-02-08 | RGNX REGENXBIO Inc. |
— | MPS II | BLA | 89% | -32.2% | -0.2% | -22.7% | Unverified |
| 2026-01-31 | AQST Aquestive Therapeutics, Inc. |
Anaphylm | Severe Allergic Reactions • | NDA | 93% | -53.8% | +39% | +39.3% | Unverified |
| 2026-01-13 | TVTX Travere Therapeutics, Inc. |
— | people living with classical HCU | sNDA | 92% | -0.8% | -14.6% | -18.1% | Unverified |
| 2026-01-10 | ATRA Atara Biotherapeutics, Inc. |
— | treatment of adult and pediatric patients two | BLA | 89% | -12.9% | -57% | -66.8% | Unverified |
| 2026-01-05 | DNLI Denali Therapeutics Inc. |
— | Hunter syndrome (mucopolysaccharidoses type I | BLA | 89% | -8.8% | -1.5% | +5% | Unverified |
| 2025-12-31 | OTLK Outlook Therapeutics, Inc. |
— | retina diseases | NDA | 87% | +4.2% | -15.3% | -68.4% | Unverified |
| 2025-12-30 | VNDA Vanda Pharmaceuticals Inc. |
— | motion sickness by November 26 | NDA | 87% | +35.9% | -2.4% | +12.9% | Unverified |
| 2025-12-30 | CORT CORCEPT THERAPEUTICS INC |
— | NDA | 87% | +0% | -12.1% | -55.2% | Unverified | |
| 2025-12-26 | CYTK CYTOKINETICS INC |
— | NDA | 80% | -4.5% | -1.7% | -3.8% | Unverified | |
| 2025-12-20 | RYTM RHYTHM PHARMACEUTICALS, INC. |
— | patients with BBS | sNDA | 92% | +8.7% | +0.7% | +0.4% | Unverified |
| 2025-12-16 | ALDX Aldeyra Therapeutics, Inc. |
— | Dry Eye Disease <P STYLE="font: 10pt Times Ne | NDA | 87% | -20.5% | +33.1% | +38.9% | Unverified |
| 2025-12-13 | MIST Milestone Pharmaceuticals In |
— | the treatment of patients with paroxysmal sup | NDA | 87% | +24.9% | -2.7% | -10.8% | Unverified |
| 2025-12-07 | AGIO AGIOS PHARMACEUTICALS, INC. |
— | adult patients with non– | sNDA | 92% | -31.6% | -1.6% | -1.7% | Unverified |
| 2025-12-04 | DNLI Denali Therapeutics Inc. |
— | mucopolysaccharidosis type II (MPS II) | BLA | 89% | +23.7% | +5.8% | -7.5% | Unverified |
| 2025-11-30 | KURA Kura Oncology, Inc. |
— | cancer | NDA | 81% | +18.3% | -5.8% | -1.6% | Unverified |
| 2025-11-18 | ARWR ARROWHEAD PHARMACEUTICALS, I |
— | type 1 myotonic dystrophy (DM1) | NDA | 80% | +9.1% | +0.8% | +10.2% | Unverified |
| 2025-11-06 | AQST Aquestive Therapeutics, Inc. |
— | severe allergic reactions | NDA | 93% | +0.5% | +2.2% | -7% | Unverified |
| 2025-11-05 | JAZZ Jazz Pharmaceuticals plc |
— | recurrent H3 K27M-mutant DMG – | NDA | 87% | +0.2% | -0.4% | -0.5% | Unverified |
| 2025-10-25 | SNDX Syndax Pharmaceuticals Inc |
— | R/R mNPM1 AML | sNDA | 92% | -10% | -3.1% | +1.3% | Unverified |
| 2025-10-13 | ARQT Arcutis Biotherapeutics, Inc |
— | individuals with plaque psoriasis of the scal | sNDA | 95% | +13.3% | +3.3% | +4.1% | Unverified |
| 2025-10-08 | AQST Aquestive Therapeutics, Inc. |
Anaphylm | severe allergic reactions | NDA | 93% | +19.2% | +3.9% | +15.2% | Unverified |
| 2025-10-07 | JAZZ Jazz Pharmaceuticals plc |
— | ES-SCLC based on positive data from IMforte t | NDA | 87% | +6.2% | -0.2% | -1.8% | Unverified |
| 2025-09-30 | LENZ LENZ Therapeutics, Inc. |
— | presbyopia | NDA | 87% | +17.5% | +3.8% | +2.7% | Unverified |
| 2025-09-25 | CRNX Crinetics Pharmaceuticals, I |
— | Children with Congenital Adrenal Hyperplasia | NDA | 87% | +16.9% | +2% | +18.3% | Unverified |
| 2025-09-22 | SRRK Scholar Rock Holding Corp |
— | BLA | 89% | -10.4% | +5.6% | +25.7% | Unverified | |
| 2025-09-12 | BCRX BIOCRYST PHARMACEUTICALS INC |
— | HAE under the age of 12 | NDA | 87% | -3.4% | -2% | -1.4% | Unverified |
| 2025-09-07 | AGIO AGIOS PHARMACEUTICALS, INC. |
— | adult patients with non-transfusion-dependent | sNDA | 92% | -4.5% | +1.1% | +2.1% | Unverified |
| 2025-08-31 | CAPR CAPRICOR THERAPEUTICS, INC. |
— | Duchenne muscular dystrophy (DMD) remains und | BLA | 89% | -23.2% | +0.8% | +1.1% | Unverified |
| 2025-08-27 | PGEN PRECIGEN, INC. |
— | RRP <P STYLE="margin-top: 0pt | BLA | 89% | +169.6% | +7.8% | +11.5% | Unverified |
| 2025-08-25 | AXGN Axogen, Inc. |
— | BLA | 89% | +23.1% | -9% | -0.7% | Unverified | |
| 2025-08-22 | GRCE Grace Therapeutics, Inc. |
— | NDA | 87% | -1.5% | -1.5% | -9.4% | Unverified | |
| 2025-08-21 | IONS IONIS PHARMACEUTICALS INC |
— | NDA | 87% | +2.1% | +1% | -0.1% | Unverified | |
| 2025-08-18 | RARE Ultragenyx Pharmaceutical In |
— | Sanfilippo syndrome | BLA | 89% | +8.3% | +0% | +0.3% | Unverified |
| 2025-08-15 | TNXP Tonix Pharmaceuticals Holdin |
— | NDA | 87% | +32.2% | -13.8% | -39.8% | Unverified | |
| 2025-08-08 | LENZ LENZ Therapeutics, Inc. |
— | presbyopia on track for PDUFA target action d | NDA | 87% | -7.8% | +8% | +27.4% | Unverified |
| 2025-07-29 | PTCT PTC THERAPEUTICS, INC. |
— | NDA | 87% | -10.5% | +11.2% | +17.8% | Unverified | |
| 2025-06-28 | UNCY Unicycive Therapeutics, Inc. |
— | hyperphosphatemia is aimed at lowering serum | NDA | 87% | +11.3% | -29.9% | -31% | Unverified |
| 2025-06-13 | URGN UroGen Pharma Ltd. |
— | this patient population in decades | NDA | 87% | +9.3% | +8.6% | +32.2% | Unverified |
| 2025-05-24 | LQDA Liquidia Corp |
— | PH-ILD)to the proposed label for YUTREPIA | NDA | 87% | +9.4% | +1.6% | +9.9% | Unverified |
| 2025-05-14 | BHVN Biohaven Ltd. |
Rare Disease | spinocerebellar ataxia (SCA) by three months | NDA | 84% | +10.7% | +0.8% | -16.7% | Unverified |
| 2025-05-13 | INO INOVIO PHARMACEUTICALS, INC. |
— | recurrent respiratory papillomatosis (RRP) in | BLA | 89% | +22.8% | -1% | +6.7% | Unverified |
| 2025-05-06 | OMER OMEROS CORP |
Narsoplimab | hematopoietic stem cell transplant-associated | BLA | 82% | -7.5% | -6.9% | -44.2% | Unverified |
Price data: Yahoo Finance daily closes • Approval verification: openFDA • Past performance does not guarantee future results.