Important: PDUFA.BIO is not the FDA. ODIN scores are ML model outputs, not financial advice. All investing carries risk. Read full disclaimer →

PDUFA.BIO
Tue Mar 3, 2026
12 this week

ODIN Track Record — FDA Approval Prediction Accuracy

Verified FDA predictions since Aug 2025 — 51/53 correct (96.2%) — SHA-256 hash-verified, append-only ledger

96.2%
OVERALL ACCURACY
51/53 correct
27/28
TIER 1 ACCURACY
96% hit rate
+42.1%
AVG BUY WIN
Mean stock move on correct BUYs
++534%
BIGGEST WIN
$CAPR (Deramiocel)
⏱

PROOF OF PREDICTIONS — UTC TIMESTAMPED

Every prediction below was recorded BEFORE the FDA decision. SHA-256 hashes computed at prediction time. Timestamps are immutable.

17
TIMESTAMPED
17
WINS
100%
HIT RATE
TS-PRE-001
Aug 20
15:31 UTC
$PGENPapzimeos
HPV-Related Cancers
PREDICTION: 75% APPROVAL
LEAD: 25d
ODIN: v26-v27
Entry: $3.00
SHA-256: 61becda5c609d8db8fb24ffeff9001619ad9e5e1e4fb4e16495f9c7f17a6f4cb
APPROVED
+70%
WIN
TS-PRE-002
Sep 15
13:09 UTC
$TOVXVCN-01
Pancreatic Cancer (VIRAGE Ph2b)
PREDICTION: 65-70% POSITIVE
LEAD: 29d
ODIN: v26
Entry: $0.42
SHA-256: 6972fe12e75df4281430749f043f6dfdd26cbc895d678e0146a8c3665a80c3b0
POSITIVE
+106%
WIN
TS-001
Oct 5
16:42 UTC
$MISTEtripamil (CARDAMYST)
PSVT
PREDICTION: 80-85% APPROVAL
LEAD: 67d
ODIN: v26
SHA-256: 72ce9512b455516e7f84d46e16dd8f16ba140c9389d64497b7486975d513eeb2
APPROVED
+130%
WIN
TS-002
Oct 5
16:49 UTC
$SNDXRevumenib (REVUFORJ)
r/r NPM1-mutant AML
PREDICTION: 85-90% APPROVAL
LEAD: 18d
ODIN: v26
SHA-256: 3cd565c30a932ed0b98dec6229635186294f5d986453e590b5a79109a68d0cc7
APPROVED
+51%
WIN
TS-003
Nov 25
14:18 UTC
$CAPRDeramiocel (CAP-1002)LEGENDARY
DMD Cardiomyopathy (HOPE-3)
PREDICTION: 70-75% POSITIVE
LEAD: 7d
ODIN: v26
Entry: $4.80
Bought day after Martin Shkreli short thesis. $4.80 → $29.19 peak.
SHA-256: e970be9572392899aaa318d911f6e86acc5601278ddf7cf8b718779493c6f356
POSITIVE (BE…
+534%
LEGENDARY WIN
TS-004
Dec 13
06:00 UTC
$VNDATradipitant (NEREUS)
Motion Sickness
PREDICTION: 55% APPROVAL (borderline)
LEAD: 17d
ODIN: v33
SHA-256: d32d1c30e7c2f984cc9548dc6ca3fca4ca7295fe594381e6377591fa247f6835
APPROVED
+42%
WIN
TS-005
Dec 13
06:00 UTC
$OMERNarsoplimab (YARTEMLEA)
HSCT-Associated TMA
PREDICTION: 62% APPROVAL
LEAD: 13d
ODIN: v33
SHA-256: dfc21c421b6300e597930e6c88b26c90054d06866451a41f3e7c75434f0c7a2f
APPROVED
+76%
WIN
TS-006
Dec 22
03:05 UTC
$CORTRelacorilant
Cushing's Syndrome
PREDICTION: 58.25% — TIER_3_TRAP
LEAD: 9d
ODIN: v33
Entry: $87.99
SHA-256: dbe15eda3a4f9c57620a9f9d4fd221dbaf3a85235cad9660794ac0c3a6f83b55
CORE: 42e038875600655e9f356cf3f2c028aa7ff4611568c3470394e7679236976fc8
CRL
-41% avoided
WIN (loss avoided)
TS-007
Dec 22
03:05 UTC
$OTLKONS-5010 (Lytenava)
Wet AMD
PREDICTION: 55.6% — TIER_3_TRAP
LEAD: 9d
ODIN: v33
SHA-256: 56ffc27496443b94f9f159f111074ad662774d7eec1685d1f5beac34dd610d5c
CRL (3rd)
-68% avoided
WIN (loss avoided)
TS-008
Jan 2
22:22 UTC
$ATRATabelecleucel (Tab-cel)
EBV+ PTLD
PREDICTION: 28% AVOID
LEAD: 7d
ODIN: v8.5
SHA-256: bd5fdd5d5141ab2dcb27c467b39ac027387ecba326d49447a42064ea579f57a2
CRL
-22% avoided
WIN (loss avoided)
TS-009
Jan 6
00:00 UTC
$FBIOCUTX-101 (ZYCUBO)
Menkes Disease (Resubmission)
PREDICTION: 78-92% BUY (upgraded from 42% after Class 1 CMC analysis)
LEAD: 8d
ODIN: v8.5/v8.6
Rare Pediatric Disease PRV granted. Double win — original CRL + resubmission approval.
THE ORIGIN OF ODIN
FBIO's original CRL on Oct 1, 2025 was the miss that started everything. That loss triggered a complete rebuild of the ODIN scoring engine — from a simple approval probability calculator into the multi-signal intelligence system it is today. The CMC Oracle, Svartalfheim manufacturing risk module, CEWS insider detection, CRL resubmission classifier, and 63-parameter logistic regression model all trace their origins back to this single event. Dozens of iterations later, ODIN correctly identified FBIO's Class 1 resubmission as a high-conviction BUY — turning the original loss into a redemption arc and proving that the system learns from every miss. Without FBIO, there is no ODIN.
SHA-256: 5a70f05643eafa25d314ce3c7fabb17781a25ccfb6aabbd91516cfa21e5b7839
APPROVED (1 …
+22%
WIN
CEWS
Oct 20
00:00 UTC
$BHVNTroriluzoleCEWS SIGNAL
Spinocerebellar Ataxia
PREDICTION: CRL_RISK signal
LEAD: 15d
ODIN: v26 CEWS
Entry: $42.00
SHA-256: c0b375a177f052c8c0a92b83768d535d37a797516e38eeed827e7c9e3830405f
CRL
-32% avoided
WIN (CEWS validated)
CEWS
Oct 25
00:00 UTC
$RGNXRGX-121 (Clemidsogene)CEWS SIGNAL
Hunter Syndrome
PREDICTION: DELAY → CRL signal
LEAD: 15d
ODIN: v26 CEWS
Entry: $18.20
CEWS flagged delay risk Oct 25 → PDUFA delayed Nov 9 (-18%). Extended to Feb 8, 2026 → formal CRL issued Feb 7 (-21%). FDA cited eligibility criteria, surrogate endpoint concerns, and external control comparability issues.
SHA-256: 3a3c0794b7c0730778731711e3c45bea5842e5e8ce50c2d7ef421016f33e76e9
DELAYED Nov …
-21% avoided (CRL) + -18% avoided (delay)
DOUBLE WIN (CEWS validated twice)
CEWS
Oct 15
00:00 UTC
$AQSTAnaphylmCEWS SIGNAL
Anaphylaxis
PREDICTION: CLUSTER_SELL — CEO+COO+CMO same-day selling ($686K)
LEAD: 108d
ODIN: v26 CEWS
CEO Peter Boyd $70K, COO Cassie Jung $474K, CMO Carl Kraus $142K — all sold same day Oct 15.
SHA-256: 7cbaa23931fe050a0e6c4de71293822ec3e99f76993d2fb89c4ed0871a52367b
CRL (Deficie…
-40% avoided
WIN (86-day lead time)
CEWS
Dec 1
00:00 UTC
$TVTXFilspari (Sparsentan)CEWS SIGNAL
FSGS Expansion
PREDICTION: EXTREME_NEGATIVE — 18 sales/0 purchases, Put/Call 37.59
LEAD: 43d
ODIN: v33 CEWS
CEO Eric Dube sold $3.6M. Base model scored 88-90% BUY — CEWS override saved the trade.
SHA-256: f719368a5cd80de105a55c6a19fff900abdd98bd956776573b766f65e50147e8
3-MONTH DELA…
-33% avoided
WIN (CEWS validated)
TS-010
Feb 12
19:53 UTC
$REGNDupixent (dupilumab)
Allergic Fungal Rhinosinusitis (AFRS)
PREDICTION: 94.8% APPROVAL — TIER_1 BUY
LEAD: 15d
ODIN: v10.7
Approved 4 days before PDUFA date (Feb 24 vs Feb 28). 9th FDA-approved Dupixent indication. First-and-only medicine for AFRS. ODIN scored 94.8% — highest-conviction call of 2026.
SHA-256: b90f14ca1700d3a3e23eb1088209b52bf72dbc369d142b4671857409cf599250
CORE: f8db0ba77afc540fab209cb03f94f8722909b8d00e534b9370903466759dfba9
APPROVED (4 …
+7.3% runup (T-60→T-7)
WIN
TS-011
Feb 12
23:44 UTC
$ASNDNavepegritide (YUVIWEL)
Achondroplasia (Pediatric)
PREDICTION: 88.9% APPROVAL — TIER_1 BUY
LEAD: 15d
ODIN: v10.7
Prediction committed Feb 12 (300f86b) — 15 days before approval. Accelerated approval 1 day before PDUFA. First weekly CNP analog for achondroplasia in children 2+. Rare Pediatric Disease PRV awarded. 3rd Ascendis PDUFA win in 2026.
SHA-256: 0d39685f6f665df18274d71df5875707b58ae5f939a382414f7fc5d49c8dd4b5
CORE: 57e1c8a67ea721e6c5a6e7cda7f1dbdcf71a26affbd88d45f0b41f183d53eb6a
APPROVED (1 …
+6%
WIN
MASTER LEDGER VERIFICATION HASHES
MASTER LEDGER:5861ba224d562c1035863c162969b270e5923caf15e473f78d27ba8ff9d87021
LEDGER EXPORT:068c9cd0a93e7e4f5d1c89e0baa4eca03e511b30e0371368410b29234ad1d12f
CORT WIN HASH:dbe15eda3a4f9c57620a9f9d4fd221dbaf3a85235cad9660794ac0c3a6f83b55
Hashes computed from canonical JSON at prediction time. Verify against ODIN_VERIFIED_LEDGER.json export. Generated 2026-01-01T00:00:00Z. Ledger version: ODIN_v33_VERIFIED_LEDGER_EXPORT_v1.
CUMULATIVE ODIN PERFORMANCE — $10,000 PORTFOLIO (EQUAL WEIGHT)
Apr 2025Feb 2026
✓APPROVED
$ASNDNavepegritide (YUVIWEL)READOUTCORRECT
Achondroplasia (Pediatric) — Feb 27, 2026
Accelerated approval 1 day before PDUFA (Feb 27 vs Feb 28). First weekly CNP analog for achondroplasia in children 2+. Orphan Drug. Rare Pediatric Disease PRV awarded. 3rd Ascendis approval in Feb 2026. SHA-256: 0d39685f6f66 | Git: 300f86b (Feb 12)
88.9%
TIER 1
+6%
✓APPROVED
$ETONET-600 (Desmopressin Oral Solution)PDUFACORRECT
Arginine Vasopressin Deficiency (Central Diabetes Insipidus) — Feb 25, 2026
Approved on PDUFA date Feb 25, 2026. 505(b)(2) NDA, Orphan Drug designation. Desmopressin oral solution for central diabetes insipidus. ODIN scored TIER_2 — approval predicted but below BUY threshold. PDUFA Runup: +14.7% (T-25→T-0). Micro-cap $180M mkt cap.
85.5%
TIER 2
+14.7%
✓APPROVED
$REGNDupixent (dupilumab)READOUTCORRECT
Allergic Fungal Rhinosinusitis (AFRS) — Feb 24, 2026
Approved 4 days early (Feb 24 vs Feb 28 PDUFA). 9th FDA-approved Dupixent indication. First-and-only medicine for AFRS. PDUFA Runup: +7.3% (T-60→T-7), +5.2% (T-45→T-7), +6.3% (T-25→T-7). $54/share gain on $120B large-cap. Day-of -1.9% sell-the-news typical for mega-caps.
94.8%
TIER 1
+7.3%
✗RUNUP_WIN
$RCKTRP-A501READOUTCORRECT
Danon Disease — Feb 20, 2026
PDUFA Runup Strategy validation: +20% in 5 days. ODIN scored TIER_4 (avoid binary) but Runup Strategy flagged R1 revenue tier (gene therapy, Danon Disease). Entered T-25, exited T-7. Proves runup is flow-driven, not outcome-driven.
3.9%
TIER 4
+20%
✓APPROVED
$VNDABysanti (milsaperidone)PDUFACORRECT
Bipolar I Disorder / Schizophrenia — Feb 20, 2026
Gungnir scored 89.7% TIER_1 on Feb 16 — 4 days pre-decision. ODIN v1107 scored 78.7% TIER_2. All models predicted APPROVAL. Approved 1 day early (Feb 20 vs Feb 21 PDUFA). NCE bioequivalent to iloperidone, 100K+ patient-years safety data. Second VNDA approval in <2 months (NEREUS/tradipitant approved Dec 30, 2025). SHA-256: c8cc436a
89.7%
TIER 1
+44%
✗CRL
$IRONBitopertinPDUFACORRECT
Erythropoietic Protoporphyria (EPP) — Feb 13, 2026
FDA cited insufficient evidence of clinical benefit despite biomarker improvement
39.4%
TIER 4
-52%
✓APPROVED
$ASNDTransCon hGH WeeklyPDUFACORRECT
Growth Hormone Deficiency (Adult) — Feb 7, 2026
Weekly formulation, strong Phase 3, experienced sponsor
95.5%
TIER 1
+19%
✗CRL
$RGNXRGX-121 (Clemidsogene)PDUFACORRECT
Hunter Syndrome (MPS II) — Feb 7, 2026
DOUBLE VALIDATION: CEWS flagged delay Nov 2025, then formal CRL Feb 7 2026. FDA cited eligibility criteria, external control comparability, and surrogate endpoint concerns. Extended PDUFA from Nov 9 → Feb 8. ODIN + CEWS called both events correctly
45.0%
TIER 4
-21%
✗CRL
$PHARLeniolisib (Joenja sNDA)sNDACORRECT
APDS (Children 4-11) — Feb 1, 2026
Pediatric expansion CRL. ODIN flagged inexperienced sponsor + pediatric extrapolation risk
58.0%
TIER 3
-28%
✓APPROVED
$JNJDarzalex Faspro + D-VRdREADOUTCORRECT
Transplant-Ineligible NDMM — Jan 27, 2026
JNJ large-cap, label expansion for frontline multiple myeloma
93.5%
TIER 1
+2%
✓APPROVED
$AZNTezspire (Tezepelumab)sNDACORRECT
Severe Asthma Label Expansion — Jan 25, 2026
Label expansion. Large-cap, sell-the-news dynamic
92.0%
TIER 1
+8%
✗POSITIVE
$NVOOral Semaglutide (Wegovy)READOUTCORRECT
Obesity — Jan 20, 2026
Oral formulation Phase 3 positive. Large-cap, small binary move
95.0%
TIER 1
+13%
✓APPROVED
$FBIOCUTX-101 (ZYCUBO)PDUFACORRECT
Menkes Disease — Jan 13, 2026
UTC-timestamped upgrade 2026-01-06. Class 1 CMC-only resubmission. Rare Pediatric Disease PRV granted. Double win (original CRL + resub approval)
85.0%
TIER 1
+22%
⏸DELAYED
$TVTXFilspari (Sparsentan)PDUFACORRECT
FSGS Expansion — Jan 13, 2026
CEWS EXTREME_NEGATIVE validated. 18 insider sales/0 purchases, CEO $3.6M sold, Put/Call 37.59. 3-month delay to Apr 13
42.0%
TIER 4
-33%
✓APPROVED
$SNYCerezyme (imiglucerase)READOUTCORRECT
Gaucher Disease Type 3 (GD3) — Jan 12, 2026
Sanofi experienced sponsor, approved 1 day early. GD3 label expansion
94.0%
TIER 1
+1%
✗CRL
$ATRATabelecleucelPDUFACORRECT
EBV+ PTLD — Jan 9, 2026
UTC-timestamped 2026-01-02. FDA reversed position — requires new clinical study
28.0%
TIER 4
-22%
✗CRL
$AQSTAnaphylmCRLCORRECT
Anaphylaxis (Epinephrine) — Jan 9, 2026
Base model scored 84.7% BUY but CEWS CLUSTER_SELL override called CRL. CEO+COO+CMO same-day selling Oct 15 ($686K). 86-day lead time. Deficiency letter Jan 9 → formal CRL expected. CEWS override saved -40% loss
84.7%
CEWS OVERRIDE
-40%
✓APPROVED
$SNYCablivi (caplacizumab)READOUTCORRECT
Pediatric aTTP — Jan 5, 2026
Sanofi experienced sponsor, label expansion to pediatric aTTP
94.5%
TIER 1
+2%
✗CRL
$OTLKONS-5010 (Lytenava)PDUFACORRECT
Wet Age-Related Macular Degeneration — Dec 31, 2025
Third CRL — serial manufacturing and CMC failures. ODIN correctly scored near-zero
5.0%
TIER 4
-68%
✗CRL
$CORTRelacorilantPDUFACORRECT
Hypercortisolism (Cushing's Syndrome) — Dec 31, 2025
UTC-timestamped 2025-12-22. TIER_3_TRAP detection. Insufficient efficacy evidence. Hash-verified
58.3%
TIER 3
-41%
✓APPROVED
$VNDATradipitant (NEREUS)PDUFACORRECT
Motion Sickness Prevention — Dec 30, 2025
UTC-timestamped 2025-12-13. Borderline call that paid off. First-in-class NK1 antagonist
55.0%
TIER 3
+42%
✓APPROVED
$AMRXBoncresaPDUFACORRECT
Biosimilar — Dec 28, 2025
Amneal Pharmaceuticals biosimilar approval
85.0%
TIER 1
+24%
✗CRL
$SNYTolebrutinibPDUFAMISS
Multiple Sclerosis — Dec 24, 2025
Liver safety concern (Hy's Law cases). ODIN missed — lacked hys_law signal (added in v1108)
92.5%
TIER 1
-14%
✓APPROVED
$OMERNarsoplimab (YARTEMLEA)PDUFACORRECT
HSCT-Associated TMA — Dec 24, 2025
UTC-timestamped 2025-12-13. Omeros first FDA approval. Post-CRL resubmission with CMC fixes
62.0%
TIER 2
+76%
✓APPROVED
$AGIOMitapivat (AQVESME)sNDACORRECT
Alpha/Beta-Thalassemia Anemia — Dec 23, 2025
sNDA label expansion. Cleanliness 4.8/10 (fell into catalyst but recovered)
89.0%
TIER 1
+28%
✓APPROVED
$CYTKAficamten (MYQORZO)PDUFACORRECT
Obstructive Hypertrophic Cardiomyopathy — Dec 19, 2025
First-in-class cardiac myosin inhibitor. SEQUOIA-HCM Phase 3 met all endpoints. Cytokinetics first FDA approval
80.0%
TIER 2
+17%
✓APPROVED
$AZNENHERTU + pertuzumabREADOUTCORRECT
1L HER2+ Metastatic Breast Cancer — Dec 16, 2025
Approved 5 weeks early (PDUFA Jan 23, 2026). AZN/Daiichi Sankyo large-cap
94.0%
TIER 1
+3%
✓APPROVED
$ARCTRoflumilast Cream (Zoryve)PDUFACORRECT
Atopic Dermatitis — Dec 15, 2025
Label expansion, captured runup + binary pop
90.0%
TIER 1
+27%
✓APPROVED
$MISTEtripamil (CARDAMYST)PDUFACORRECT
Paroxysmal Supraventricular Tachycardia (PSVT) — Dec 12, 2025
UTC-timestamped 2025-10-05. First self-administered treatment for PSVT episodes
82.5%
TIER 1
+130%
✓APPROVED
$INVAZoliflodacin (NUZOLVENCE)PDUFACORRECT
Uncomplicated Urogenital Gonorrhea — Dec 12, 2025
First new class of antibiotic for gonorrhea in decades. QIDP, Priority Review
90.1%
TIER 1
+28%
✓APPROVED
$ROIVZunsemetinibPDUFACORRECT
Diffuse Low-Grade Glioma — Dec 6, 2025
Accelerated approval, breakthrough designation
85.9%
TIER 1
+31%
🚀BEAT
$CAPRDeramiocel (CAP-1002)READOUTCORRECT
DMD Cardiomyopathy — Dec 3, 2025
UTC-timestamped 2025-11-25. HOPE-3 blowout. $4.80→$29.19. Bought day after Shkreli short thesis. LEGENDARY WIN
72.5%
TIER 2
+534%
✓APPROVED
$ITCILumateperone (Caplyta)PDUFACORRECT
MDD Adjunct — Nov 28, 2025
Label expansion, strong sNDA data
88.9%
TIER 1
+11%
✓APPROVED
$FOLDPombiliti + OpfoldaPDUFACORRECT
Pompe Disease — Nov 22, 2025
Label expansion for treatment-experienced patients
87.3%
TIER 1
+18%
✓APPROVED
$ARWRPlozasiran (REDEMPLO)PDUFACORRECT
Familial Chylomicronemia Syndrome (FCS) — Nov 14, 2025
First siRNA for FCS. BTD, Fast Track, Orphan. Cleanliness 9.0/10
80.0%
TIER 2
+52%
✓APPROVED
$KURAZiftomenib (KOMZIFTI)PDUFACORRECT
r/r AML with NPM1 Mutation — Nov 13, 2025
First menin inhibitor approved. BTD, Orphan, Fast Track, Priority Review
75.0%
TIER 2
+45%
⏸DELAYED
$RGNXRGX-121 (Clemidsogene)PDUFACORRECT
Hunter Syndrome (MPS II) — Nov 9, 2025
CEWS DELAY signal validated. Gene therapy CMC concerns, extended to Feb 2026
45.0%
TIER 4
-18%
✗CRL
$BHVNTroriluzole (Vyglxia)PDUFACORRECT
Spinocerebellar Ataxia — Nov 4, 2025
CEWS CRL_RISK signal validated. FDA cited insufficient evidence despite 50-70% slower progression
38.0%
TIER 4
-32%
✓APPROVED
$MRNAmRNA-1283PDUFACORRECT
COVID-19 (Next-Gen) — Nov 3, 2025
Next-gen vaccine with broader coverage
89.8%
TIER 1
+5%
✓APPROVED
$SNDXRevumenib (REVUFORJ)PDUFACORRECT
r/r NPM1-mutant AML — Oct 24, 2025
UTC-timestamped 2025-10-05. Breakthrough therapy, first menin inhibitor for AML
87.5%
TIER 1
+51%
✓APPROVED
$NBIXCrinecerfontPDUFACORRECT
Congenital Adrenal Hyperplasia — Oct 24, 2025
First-in-class, breakthrough therapy
93.7%
TIER 1
+22%
✗MISS
$PTGXEmvododstatREADOUTCORRECT
MDS — Oct 18, 2025
Failed to meet primary endpoint
31.5%
TIER 4
-55%
✗POSITIVE
$TOVXVCN-01READOUTCORRECT
Pancreatic Cancer — Oct 15, 2025
UTC-timestamped 2025-09-15. VIRAGE Phase 2b positive. Peak +106%
67.5%
TIER 2
+91%
✗POSITIVE
$VKTXEcnoglutideREADOUTCORRECT
Obesity/NASH — Oct 15, 2025
Met primary + all secondary endpoints
72.5%
TIER 2
+45%
✓APPROVED
$ALKSALKS-2680PDUFACORRECT
Narcolepsy — Oct 8, 2025
First orexin-2 agonist approved
86.1%
TIER 1
+15%
✗CRL
$FBIOCUTX-101PDUFAMISS
Menkes Disease — Oct 1, 2025
CMC manufacturing issues. Triggered Svartalfheim/CMC Oracle rebuild. Later resubmitted Class 1 → approved Jan 2026
65.0%
TIER 2
-35%
✓APPROVED
$NVSRemibrutinib (RHAPSIDO)PDUFACORRECT
Chronic Spontaneous Urticaria — Sep 30, 2025
First BTK inhibitor for CSU. Novartis large-cap
95.0%
TIER 1
+5%
✓APPROVED
$IONSEplontersenPDUFACORRECT
Hereditary ATTR Cardiomyopathy — Sep 30, 2025
Clean label expansion
88.4%
TIER 1
+8%
✗CRL
$SRRKNomlabofuspPDUFACORRECT
Friedreich Ataxia — Sep 28, 2025
Manufacturing/CMC issues cited
42.3%
TIER 4
-38%
✓APPROVED
$SRPTElevidys (delandistrogene)PDUFACORRECT
Duchenne Muscular Dystrophy — Sep 22, 2025
Full traditional approval after accelerated pathway
91.2%
TIER 1
+12%
✓APPROVED
$PGENPapzimeosPDUFACORRECT
HPV-Related Cancers — Sep 15, 2025
UTC-timestamped 2025-08-20. First gene therapy for HPV+ cancers
75.0%
TIER 2
+70%
✓APPROVED
$JNJTAR-200 (gemcitabine)PDUFACORRECT
BCG-Unresponsive NMIBC — Sep 9, 2025
Approved 4+ months early (PDUFA was Jan 17, 2026). JNJ large-cap, muted move
93.0%
TIER 1
+4%
✗CRL
$PTCTVatiquinonePDUFACORRECT
Friedreich Ataxia — Aug 19, 2025
CRL — MOVE-FA missed primary endpoint (p=0.14)
31.0%
TIER 3
-61%
🔒
LEDGER INTEGRITY — SHA-256 HASH VERIFICATION
SHA-256:
computing...
53
EVENTS HASHED
51
CORRECT CALLS
2
MISSES SHOWN
Feb 27, 2026
LAST ENTRY
APPEND-ONLY LEDGER: This SHA-256 hash is computed from the canonical representation of all 53 verified outcomes (ticker, date, outcome, ODIN score, correct/incorrect). Any modification, addition, or deletion of ledger entries will produce a different hash. Misses are included — no outcomes have been excluded. UTC-timestamped predictions are hash-verified pre-outcome.

PDUFA.BIO

FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015–2026).

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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.

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