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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. Outcomes verified against openFDA and dated FDA-decision headlines.
87
Events Archived
2.8%
Avg 30d Run-up
52%
Closed Up Next Day
+41.5%
Biggest Pop
-70.7%
Biggest Drop
Model track record, unvarnished: across 39 verified decisions,
26 were approved and 13 received a CRL
(realised approval rate 67%). Model v2 rates those decisions at
66% on average, so the model is roughly calibrated. It rates the eventual approvals at
69% on average and the eventual CRLs at
61%: a modest separation.
We publish this because a track record you can check is worth more than a flattering one.
Model v2 was calibrated on 2 Sep 2026 against the decisions in this table, so treat the figures above as in-sample. Out-of-sample record since then:
1 decision so far, accruing.
Outcomes are verified against openFDA or an explicit, dated FDA-decision announcement, never inferred from price action.
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Outcome shows Approved, CRL (Complete Response Letter), Delayed or Withdrawn only when the decision is verified against the openFDA database or a dated headline that explicitly reports the FDA action. Hover a badge to see the source. Decisions we can't verify stay Unverified: we don't guess from price action.
| Date | Ticker | Drug | Indication | Type | Model PoA | Run-up 30d | Decision 1d | After 5d | Outcome |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-29 | UNCY Unicycive Therapeutics, Inc. |
— | hyperphosphatemia in patients with chronic ki | NDA | 66% | -15.6% | -1.9% | — | Unverified |
| 2026-09-26 | MIRM Mirum Pharmaceuticals, Inc. |
Atebrioz (zilurgisertib) | NDA | 66% | -8.9% | — | — | Approved | |
| 2026-09-22 | IONS IONIS PHARMACEUTICALS INC |
— | NDA | 66% | -23.6% | -2.2% | — | Unverified | |
| 2026-09-11 | SRRK Scholar Rock Holding Corp |
ISEMBYLD | children and adults with spinal muscular atro | BLA | — | +6.9% | -0.5% | -12% | Approved |
| 2026-08-25 | ZYME Zymeworks Inc. |
Ziihera | adults with previously treated | NDA | 66% | +25.9% | -4.5% | — | Approved |
| 2026-08-25 | JAZZ Jazz Pharmaceuticals plc |
Ziihera | sBLA | 88% | +0.2% | +2.3% | — | Approved | |
| 2026-08-22 | CAPR CAPRICOR THERAPEUTICS, INC. |
Deramiocel | rare diseases | BLA | 50% | -68.3% | — | — | Delayed |
| 2026-08-05 | PTGX Protagonist Therapeutics, In |
MIMRYLO | NDA | 66% | +3.3% | +1.1% | +9.2% | Approved | |
| 2026-08-04 | RARE Ultragenyx Pharmaceutical In |
FAYUVI | NDA | 66% | -25.3% | +3.2% | +7.1% | Approved | |
| 2026-07-31 | MRNA Moderna, Inc. |
— | NDA | 66% | -17.3% | -5.4% | -7% | Unverified | |
| 2026-07-29 | OTLK Outlook Therapeutics, Inc. |
LYTENAVA | Wet AMD <P STYLE="font: 10pt Times New Roma | BLA | 60% | -47.1% | +10.6% | — | Approved |
| 2026-07-22 | NUVL Nuvalent, Inc. |
zidesamtinib (Jideytro) | ROS1-positive NSCLC previously treated with a | NDA | — | — | — | — | Approved |
| 2026-07-17 | CELC Celcuity Inc. |
REVTORPYK™ (gedatolisib) | a significant number of patients with HR+/HER | NDA | 66% | +0.1% | +0.1% | — | Approved |
| 2026-07-11 | CORT CORCEPT THERAPEUTICS INC |
Relacorilant | Platinum-Resistant Ovarian Cancer <P STYLE="m | NDA | 63% | +18.6% | — | — | Unverified |
| 2026-07-07 | VERA Vera Therapeutics, Inc. |
TRUTAKNA | IgAN in adults | BLA | 64% | +28.3% | +7.1% | — | Approved |
| 2026-06-30 | ANAB ANAPTYSBIO, INC |
— | NDA | 66% | +15.7% | +2.3% | +2.1% | Unverified | |
| 2026-06-30 | VRDN Viridian Therapeutics, Inc.\ |
Lumvoa™ (veligrotug-vvze) | patients with TED | BLA | 64% | +7.7% | -2.2% | — | Approved |
| 2026-06-30 | PTGX Protagonist Therapeutics, In |
— | moderate-to-severe plaque psoriasis | NDA | 69% | +21.1% | +0.8% | +15.8% | Unverified |
| 2026-06-29 | UNCY Unicycive Therapeutics, Inc. |
Oxylanthanum Carbonate (OLC) | hyperphosphatemia in patients | NDA | 66% | +0.9% | +8% | — | CRL |
| 2026-06-20 | ACHV ACHIEVE LIFE SCIENCES, INC. |
cytisinicline | nicotine dependence | NDA | 66% | +9% | — | — | CRL |
| 2026-06-18 | SPRO Spero Therapeutics, Inc. |
Utebzi | NDA | 66% | -18.2% | +8.1% | -4.3% | Approved | |
| 2026-06-05 | ARVN ARVINAS, INC. |
— | estrogen receptor– | NDA | 66% | -27.1% | -4.1% | — | Unverified |
| 2026-05-29 | MNKD MANNKIND CORP |
Afrezza | NDA | 66% | +30.5% | +3.6% | -3.3% | Approved | |
| 2026-05-24 | BIIB BIOGEN INC. |
— | NDA | 66% | +3.1% | -0.4% | -0.8% | Unverified | |
| 2026-05-01 | CELC Celcuity Inc. |
— | PIK3CA mutant HR+/HER2-advanced breast cancer | sNDA | 83% | +6.3% | +3.5% | +7.7% | Unverified |
| 2026-04-30 | AXSM Axsome Therapeutics, Inc. |
AUVELITY | Alzheimer’ | sNDA | 80% | +14.6% | +12.9% | +21% | Approved |
| 2026-04-23 | GRCE Grace Therapeutics, Inc. |
GTx-104 | aneurysmal Subarachnoid Hemorrhage (aSAH) < | NDA | 66% | -2.7% | -45.5% | -51.3% | CRL |
| 2026-04-13 | TVTX Travere Therapeutics, Inc. |
FILSPARI | NDA | 66% | +1.7% | +6% | +40.8% | Approved | |
| 2026-04-10 | REPL Replimune Group, Inc. |
vusolimogene oderparepvec | Advanced Melanoma <P STYLE="font: 10pt Times | BLA | 49% | -28.2% | -19.5% | -62.9% | CRL |
| 2026-04-05 | DNLI Denali Therapeutics Inc. |
Tividenofusp Alfa | Hunter syndrome<div style="padding-left:36pt | BLA | 64% | +1.4% | -6.2% | -6.9% | Approved |
| 2026-04-03 | BIIB BIOGEN INC. |
LEQEMBI® IQLIK™ (lecanemab-irmb) | NDA | 66% | -6.6% | -2.8% | -2.5% | Delayed | |
| 2026-03-20 | RYTM RHYTHM PHARMACEUTICALS, INC. |
IMCIVREE | acquired hypothalamic obesity | sNDA | 86% | -10.9% | -3.2% | -9.3% | Approved |
| 2026-03-17 | ALDX Aldeyra Therapeutics, Inc. |
reproxalap | Signs and Symptoms of Dry Eye Disease | NDA | 66% | -19.4% | -70.7% | -47.3% | CRL |
| 2026-03-16 | ALDX Aldeyra Therapeutics, Inc. |
Reproxalap | Dry Eye Disease<p style="font-size:10pt | NDA | 66% | -22.5% | +2.6% | -56.1% | CRL |
| 2026-03-10 | IRD Opus Genetics, Inc. |
— | presbyopia - - Funding from prominent healthc | NDA | 66% | +84.9% | +1.7% | +8.8% | Unverified |
| 2026-03-06 | LNTH Lantheus Holdings, Inc. |
PYLARIFY TruVu | NDA | 66% | +15.6% | -4.9% | +5.4% | Approved | |
| 2026-03-03 | SRRK Scholar Rock Holding Corp |
— | Children and Adults with Spinal Muscular Atro | BLA | 64% | -3.2% | +1.9% | +1.7% | Unverified |
| 2026-02-25 | ETON Eton Pharmaceuticals, Inc. |
DESMODA | NDA | 66% | +22% | -3.5% | -4.5% | Approved | |
| 2026-02-23 | SMMT Summit Therapeutics Inc. |
— | BLA | 64% | -5.4% | +0.9% | +4.1% | Unverified | |
| 2026-02-21 | VNDA Vanda Pharmaceuticals Inc. |
— | jet lag disorder by January 7 | NDA | 66% | -27.4% | +41.5% | +54.7% | Unverified |
| 2026-02-08 | RGNX REGENXBIO Inc. |
RGX-121 | MPS II | BLA | 52% | -32.2% | -0.2% | -22.7% | CRL |
| 2026-01-31 | AQST Aquestive Therapeutics, Inc. |
Anaphylm | Severe Allergic Reactions • | NDA | 66% | -53.8% | +39% | +39.3% | CRL |
| 2026-01-13 | TVTX Travere Therapeutics, Inc. |
— | people living with classical HCU | sNDA | 86% | -0.8% | -14.6% | -18.1% | Unverified |
| 2026-01-10 | ATRA Atara Biotherapeutics, Inc. |
EBVALLO | treatment of adult and pediatric patients two | BLA | 52% | -12.9% | -57% | -66.8% | CRL |
| 2026-01-09 | CLNN Clene Inc. |
— | neurodegenerative diseases | NDA | 60% | +1.9% | +7.2% | -14.4% | Unverified |
| 2026-01-05 | DNLI Denali Therapeutics Inc. |
— | Hunter syndrome (mucopolysaccharidoses type I | BLA | 64% | -8.8% | -1.5% | +5% | Unverified |
| 2025-12-31 | CORT CORCEPT THERAPEUTICS INC |
— | NDA | 66% | -11.6% | -50.4% | -47.3% | Unverified | |
| 2025-12-31 | OTLK Outlook Therapeutics, Inc. |
ONS-5010/LYTENAVA | retina diseases | NDA | 62% | +4.2% | -15.3% | -68.4% | CRL |
| 2025-12-31 | PRAX Praxis Precision Medicines, |
— | SCN2A and SCN8A-DEE and RPD designation for D | NDA | 66% | +51.2% | -0.8% | -1.5% | Unverified |
| 2025-12-30 | VNDA Vanda Pharmaceuticals Inc. |
NEREUS™ (tradipitant) | motion sickness by November 26 | NDA | 66% | +35.9% | -2.4% | +12.9% | Approved |
| 2025-12-30 | CORT CORCEPT THERAPEUTICS INC |
relacorilant | NDA | 66% | +0% | -12.1% | -55.2% | CRL | |
| 2025-12-26 | CYTK CYTOKINETICS INC |
MYQORZO | NDA | 66% | -4.5% | -1.7% | -3.8% | Approved | |
| 2025-12-20 | RYTM RHYTHM PHARMACEUTICALS, INC. |
— | patients with BBS | sNDA | 86% | +8.7% | +0.7% | +0.4% | Unverified |
| 2025-12-16 | ALDX Aldeyra Therapeutics, Inc. |
Reproxalap | Dry Eye Disease <P STYLE="font: 10pt Times Ne | NDA | 66% | -20.5% | +33.1% | +38.9% | Delayed |
| 2025-12-13 | MIST Milestone Pharmaceuticals In |
CARDAMYST™ (etripamil) | the treatment of patients with paroxysmal sup | NDA | 66% | +24.9% | -2.7% | -10.8% | Approved |
| 2025-12-07 | AGIO AGIOS PHARMACEUTICALS, INC. |
AQVESME | adult patients with non– | sNDA | 86% | -31.6% | -1.6% | -1.7% | Approved |
| 2025-12-04 | DNLI Denali Therapeutics Inc. |
— | mucopolysaccharidosis type II (MPS II) | BLA | 64% | +23.7% | +5.8% | -7.5% | Unverified |
| 2025-11-30 | KURA Kura Oncology, Inc. |
KOMZIFTI | cancer | NDA | 63% | +18.3% | -5.8% | -1.6% | Approved |
| 2025-11-18 | ARWR ARROWHEAD PHARMACEUTICALS, I |
— | type 1 myotonic dystrophy (DM1) | NDA | 66% | +9.1% | +0.8% | +10.2% | Unverified |
| 2025-11-07 | RYTM RHYTHM PHARMACEUTICALS, INC. |
— | sNDA | 86% | -1.7% | +1.8% | -2.6% | Unverified | |
| 2025-11-06 | AQST Aquestive Therapeutics, Inc. |
— | severe allergic reactions | NDA | 66% | +0.5% | +2.2% | -7% | Unverified |
| 2025-11-05 | INVA Innoviva, Inc. |
— | NDA | 66% | +4.2% | +0.4% | +20.7% | Unverified | |
| 2025-11-05 | JAZZ Jazz Pharmaceuticals plc |
— | recurrent H3 K27M-mutant DMG – | NDA | 66% | +0.2% | -0.4% | -0.5% | Unverified |
| 2025-10-25 | SNDX Syndax Pharmaceuticals Inc |
Revuforj | R/R mNPM1 AML | sNDA | 86% | -10% | -3.1% | +1.3% | Approved |
| 2025-10-13 | ARQT Arcutis Biotherapeutics, Inc |
— | individuals with plaque psoriasis of the scal | sNDA | 89% | +13.3% | +3.3% | +4.1% | Unverified |
| 2025-10-08 | AQST Aquestive Therapeutics, Inc. |
Anaphylm | severe allergic reactions | NDA | 66% | +19.2% | +3.9% | +15.2% | Unverified |
| 2025-10-07 | JAZZ Jazz Pharmaceuticals plc |
— | ES-SCLC based on positive data from IMforte t | NDA | 66% | +6.2% | -0.2% | -1.8% | Unverified |
| 2025-09-30 | LENZ LENZ Therapeutics, Inc. |
VIZZ | presbyopia | NDA | 66% | +17.5% | +3.8% | +2.7% | Approved |
| 2025-09-25 | CRNX Crinetics Pharmaceuticals, I |
— | Children with Congenital Adrenal Hyperplasia | NDA | 66% | +16.9% | +2% | +18.3% | Unverified |
| 2025-09-22 | SRRK Scholar Rock Holding Corp |
apitegromab | BLA | 64% | -10.4% | +5.6% | +25.7% | CRL | |
| 2025-09-12 | BCRX BIOCRYST PHARMACEUTICALS INC |
— | HAE under the age of 12 | NDA | 66% | -3.4% | -2% | -1.4% | Unverified |
| 2025-09-07 | AGIO AGIOS PHARMACEUTICALS, INC. |
PYRUKYND | adult patients with non-transfusion-dependent | sNDA | 86% | -4.5% | +1.1% | +2.1% | Unverified |
| 2025-08-31 | CAPR CAPRICOR THERAPEUTICS, INC. |
Deramiocel | Duchenne muscular dystrophy (DMD) remains und | BLA | 52% | -23.2% | +0.8% | +1.1% | CRL |
| 2025-08-27 | PGEN PRECIGEN, INC. |
PAPZIMEOS | RRP <P STYLE="margin-top: 0pt | BLA | 52% | +169.6% | +7.8% | +11.5% | Approved |
| 2025-08-25 | AXGN Axogen, Inc. |
— | BLA | 64% | +23.1% | -9% | -0.7% | Unverified | |
| 2025-08-22 | GRCE Grace Therapeutics, Inc. |
— | NDA | 66% | -1.5% | -1.5% | -9.4% | Unverified | |
| 2025-08-21 | IONS IONIS PHARMACEUTICALS INC |
— | NDA | 66% | +2.1% | +1% | -0.1% | Unverified | |
| 2025-08-18 | RARE Ultragenyx Pharmaceutical In |
— | Sanfilippo syndrome | BLA | 64% | +8.3% | +0% | +0.3% | Unverified |
| 2025-08-15 | TNXP Tonix Pharmaceuticals Holdin |
Tonmya™ | NDA | 66% | +32.2% | -13.8% | -39.8% | Approved | |
| 2025-08-08 | LENZ LENZ Therapeutics, Inc. |
— | presbyopia on track for PDUFA target action d | NDA | 66% | -7.8% | +8% | +27.4% | Unverified |
| 2025-07-29 | PTCT PTC THERAPEUTICS, INC. |
— | NDA | 66% | -10.5% | +11.2% | +17.8% | Unverified | |
| 2025-06-28 | UNCY Unicycive Therapeutics, Inc. |
— | hyperphosphatemia is aimed at lowering serum | NDA | 66% | +11.3% | -29.9% | -31% | Unverified |
| 2025-06-13 | URGN UroGen Pharma Ltd. |
— | this patient population in decades | NDA | 66% | +9.3% | +8.6% | +32.2% | Unverified |
| 2025-05-24 | LQDA Liquidia Corp |
— | PH-ILD)to the proposed label for YUTREPIA | NDA | 66% | +9.4% | +1.6% | +9.9% | Unverified |
| 2025-05-14 | BHVN Biohaven Ltd. |
Rare Disease | spinocerebellar ataxia (SCA) by three months | NDA | 64% | +10.7% | +0.8% | -16.7% | Unverified |
| 2025-05-13 | INO INOVIO PHARMACEUTICALS, INC. |
— | recurrent respiratory papillomatosis (RRP) in | BLA | 60% | +22.8% | -1% | +6.7% | Unverified |
| 2025-05-06 | OMER OMEROS CORP |
Narsoplimab | hematopoietic stem cell transplant-associated | BLA | 64% | -7.5% | -6.9% | -44.2% | Unverified |
Price data: Yahoo Finance daily closes • Outcome verification: openFDA + dated FDA-decision headlines • Past performance does not guarantee future results.