{"data":{"available":true,"headline":"Company-disclosed FDA PDUFA dates, scored against the actual FDA decision: median 1.0 day(s) apart, 90% within 30 days (n=212 resolved decisions, 32 rejection(s)).","date_accuracy":{"decisions_matched":212,"matched_approvals":180,"matched_crls":32,"median_delta_days":1.0,"within_7_days":0.7028,"within_30_days":0.8962},"coverage":{"predictions_total":242,"baseline_decisions_matched":205,"implausible_dropped":2,"unmatched":59,"matched_note":"baseline_decisions_matched counts FDA DECISIONS; predictions_total and unmatched count PREDICTION rows — so matched + unmatched need not equal predictions_total. Since the per-cycle scoring pass, one prediction folder can legitimately score several sequential FDA decisions on the same application (an earlier Complete Response Letter and the later approval each count as a matched decision), so the decisions matched can exceed the prediction rows that produced them.","addressable_caught":79,"decisions_addressable":137,"decisions_addressable_note":"The denominator of recall_addressable: FDA decisions in the action window that we COULD have caught — original NDA/BLA decisions (not supplements) whose sponsor we could resolve to a public company by CIK or exact name match. It deliberately excludes decisions by private companies and those whose sponsor we could not identify, because no SEC-filing-derived feed could ever have seen them. It comes from the report generation (see baseline_source: recomputed daily against openFDA when 'live'; the frozen 2023-2025 figure when 'committed_fallback'), and it rests on sponsor->public-name matching, which has a real error rate — so treat recall as a diagnostic band, not a precise measurement.","recall_addressable":0.5766,"decisions_total":512,"decisions_caught":90,"recall_floor":0.1758,"sponsor_method_counts":{"none":360,"name_exact":58,"name_fuzzy":15,"cik":79},"recall_floor_note":"recall_floor = decisions_caught / decisions_total: unconditional coverage over EVERY original NDA/BLA decision in the action window, including sponsors that never file with the SEC — the coverage a buyer gets with no conditions attached. recall_addressable conditions the same numerator class on decisions an SEC-filing-derived feed could have seen: decisions_addressable keeps only sponsor_method_counts.cik + .name_exact and drops .none + .name_fuzzy. name_fuzzy is dropped because a fuzzy sponsor->filer match is a guess with a real error rate: counting guessed matches as addressable would move the denominator with the matcher's aggressiveness rather than with SEC observability. Note the direction: excluding them SHRINKS the addressable denominator and so flatters the conditional figure - recall_floor carries no such conditioning. Both come from the report generation (see baseline_source): recomputed daily against a fresh openFDA pull when 'live' — and openFDA revises weekly, so these denominators can move without any event of ours — or the frozen 2023-2025 figures when 'committed_fallback'. Approvals scope only (rejection coverage stays separate, see rejections).","crl_decisions":37,"rejections":{"addressable":47,"caught":28,"recall":0.5957,"note":"Coverage of FDA REJECTIONS (Complete Response Letters), reported separately from approvals recall because the two denominators are not comparable: the approvals dataset is effectively complete for CDER-reviewed drugs (the CBER/Purple Book gap is documented separately, see no_fda_action_found), while openFDA's CRL corpus is an expanding transparency programme. Scope matches the approvals denominator (NDA/BLA, public sponsor). Date accuracy on the rejections we DID catch is in date_accuracy.matched_crls. NOTE the two are different populations and are SUPPOSED to differ: `caught`/`addressable` are the report generation's own operands (see baseline_source — recomputed daily against openFDA's CRL corpus when 'live', the frozen 2023-2025 band when 'committed_fallback'), while date_accuracy.matched_crls counts every dated rejection on the record TODAY, generation plus live. Expect matched_crls >= caught."}},"windows":{"filing":["2023-01-01","2026-09-23"],"action":["2022-12-19","2026-09-23"]},"additional_rejections":{"count":5,"note":"Rejections (CRLs) captured from a company's own SEC filing — grounded, EDGAR-verifiable — but with no FDA application number to independently date. Counted here for coverage; deliberately EXCLUDED from the headline n and the date-accuracy median above (the disclosure date is not the FDA decision date). Each upgrades into the headline set automatically if the reconcile later recovers a verifiable app# + decision date — and is dropped from this list when it does, so no rejection is counted in both places. coverage.crl_decisions = date_accuracy.matched_crls + this count + any date-less rejection that carries an application number but no FDA decision date to score against.","items":[{"drug_name":"GTx-104","company":"Grace Therapeutics, Inc.","ticker":"GRCE","disclosed":"2026-04-23","source_quote":"Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104 FDA Issued Complete Response Letter","filing_url":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/0001140361-26-016324-index.htm"},{"drug_name":"ONPATTRO (patisiran)","company":"Alnylam Pharmaceuticals, Inc.","ticker":"ALNY","disclosed":"2023-11-02","source_quote":"While we were disappointed by the recent Complete Response Letter for ONPATTRO for the treatment of the cardiomyopathy of ATTR amyloidosis, we remain confident in the HELIOS-B Phase 3 study of vutrisiran, which is on track to deliver topline results in early 2024.","filing_url":"https://www.sec.gov/Archives/edgar/data/1178670/000115752323001622/0001157523-23-001622-index.htm"},{"drug_name":"dehydrated alcohol injection","company":"Eton Pharmaceuticals, Inc.","ticker":"ETON","disclosed":"2023-06-28","source_quote":"Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.","filing_url":"https://www.sec.gov/Archives/edgar/data/1710340/000149315223022681/0001493152-23-022681-index.htm"},{"drug_name":"obeticholic acid (OCA)","company":"Intercept Pharmaceuticals, Inc.","ticker":null,"disclosed":"2023-06-23","source_quote":"Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).","filing_url":"https://www.sec.gov/Archives/edgar/data/1270073/000110465923073909/0001104659-23-073909-index.htm"},{"drug_name":"Omecamtiv Mecarbil","company":"Cytokinetics, Incorporated","ticker":"CYTK","disclosed":"2023-03-01","source_quote":"Cytokinetics announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil , stating that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations.","filing_url":"https://www.sec.gov/Archives/edgar/data/1061983/000095017023005503/0000950170-23-005503-index.htm"}]},"recall_misses":{"note":"The FDA decisions we did NOT catch — the rows the recall denominator is made of, minus the ones we hit. caught + missed = addressable, so the recall ratio above can be checked rather than taken on trust. Approvals and rejections are listed separately because their denominators are not comparable (see coverage.rejections.note). Every row is a decision that has already happened; look up any application_number at Drugs@FDA to confirm we missed it. These rows carry no drug name because we hold no record of a decision we never caught — the application number is the identifier, and it is sufficient.","approvals":{"addressable":137,"caught":79,"missed":58,"items":[{"application_number":"NDA214070","action_date":"2023-01-10","outcome":"approved","sponsor_name":"ASTRAZENECA","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"NDA216403","action_date":"2023-02-17","outcome":"approved","sponsor_name":"TRAVERE","sponsor_ticker":"TVTX","sponsor_match":"name_exact"},{"application_number":"NDA216718","action_date":"2023-02-28","outcome":"approved","sponsor_name":"BIOGEN US","sponsor_ticker":"BIIB","sponsor_match":"name_exact"},{"application_number":"NDA216386","action_date":"2023-03-09","outcome":"approved","sponsor_name":"PFIZER","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"NDA217513","action_date":"2023-03-16","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"NDA217514","action_date":"2023-03-16","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"BLA761334","action_date":"2023-03-22","outcome":"approved","sponsor_name":"INCYTE CORP","sponsor_ticker":"INCY","sponsor_match":"name_exact"},{"application_number":"NDA216579","action_date":"2023-04-28","outcome":"approved","sponsor_name":"ASTRAZENECA","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"NDA214755","action_date":"2023-05-01","outcome":"approved","sponsor_name":"ALKERMES INC","sponsor_ticker":"ALKS","sponsor_match":"name_exact"},{"application_number":"NDA217470","action_date":"2023-05-22","outcome":"approved","sponsor_name":"INDIVIOR","sponsor_ticker":"INDV","sponsor_match":"name_exact"},{"application_number":"NDA217188","action_date":"2023-05-25","outcome":"approved","sponsor_name":"PFIZER","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"NDA215830","action_date":"2023-06-23","outcome":"approved","sponsor_name":"PFIZER","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"BLA761328","action_date":"2023-07-17","outcome":"approved","sponsor_name":"ASTRAZENECA AB","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"BLA761345","action_date":"2023-08-14","outcome":"approved","sponsor_name":"PFIZER INC","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"BLA761339","action_date":"2023-08-18","outcome":"approved","sponsor_name":"REGENERON PHARMACEUTICALS","sponsor_ticker":"REGN","sponsor_match":"name_exact"},{"application_number":"BLA761355","action_date":"2023-08-18","outcome":"approved","sponsor_name":"REGENERON PHARMACEUTICALS","sponsor_ticker":"REGN","sponsor_match":"name_exact"},{"application_number":"NDA216956","action_date":"2023-10-12","outcome":"approved","sponsor_name":"PFIZER","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"NDA213931","action_date":"2023-10-17","outcome":"approved","sponsor_name":"ARDELYX INC","sponsor_ticker":"ARDX","sponsor_match":"name_exact"},{"application_number":"BLA761285","action_date":"2023-10-31","outcome":"approved","sponsor_name":"AMGEN INC","sponsor_ticker":"AMGN","sponsor_match":"name_exact"},{"application_number":"NDA218197","action_date":"2023-11-16","outcome":"approved","sponsor_name":"ASTRAZENECA","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"NDA218276","action_date":"2023-12-05","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"BLA761299","action_date":"2024-02-23","outcome":"approved","sponsor_name":"ALVOTECH USA INC","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"NDA217439","action_date":"2024-03-07","outcome":"approved","sponsor_name":"PFIZER","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"NDA218591","action_date":"2024-04-12","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"BLA761343","action_date":"2024-04-16","outcome":"approved","sponsor_name":"ALVOTECH USA INC","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"NDA215487","action_date":"2024-04-19","outcome":"approved","sponsor_name":"SCIENTURE","sponsor_ticker":"SCNX","sponsor_match":"name_exact"},{"application_number":"NDA218466","action_date":"2024-04-24","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"NDA218347","action_date":"2024-04-26","outcome":"approved","sponsor_name":"ABBVIE","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"BLA761333","action_date":"2024-05-28","outcome":"approved","sponsor_name":"AMGEN INC","sponsor_ticker":"AMGN","sponsor_match":"name_exact"},{"application_number":"BLA761248","action_date":"2024-07-02","outcome":"approved","sponsor_name":"ELI LILLY CO","sponsor_ticker":"LLY","sponsor_match":"name_exact"},{"application_number":"NDA218343","action_date":"2024-07-26","outcome":"approved","sponsor_name":"AMNEAL","sponsor_ticker":"AMRX","sponsor_match":"name_exact"},{"application_number":"NDA218549","action_date":"2024-07-26","outcome":"approved","sponsor_name":"ALPHA COGNITION","sponsor_ticker":"ACOG","sponsor_match":"name_exact"},{"application_number":"BLA761411","action_date":"2024-08-14","outcome":"approved","sponsor_name":"INCYTE CORP","sponsor_ticker":"INCY","sponsor_match":"name_exact"},{"application_number":"BLA761298","action_date":"2024-08-23","outcome":"approved","sponsor_name":"AMGEN INC","sponsor_ticker":"AMGN","sponsor_match":"name_exact"},{"application_number":"NDA217604","action_date":"2024-10-04","outcome":"approved","sponsor_name":"AMNEAL","sponsor_ticker":"AMRX","sponsor_match":"name_exact"},{"application_number":"BLA761369","action_date":"2024-10-11","outcome":"approved","sponsor_name":"PFIZER INC","sponsor_ticker":"PFE","sponsor_match":"name_exact"},{"application_number":"NDA216962","action_date":"2024-10-16","outcome":"approved","sponsor_name":"ABBVIE","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"NDA217906","action_date":"2025-02-07","outcome":"approved","sponsor_name":"ABBVIE","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"NDA218772","action_date":"2025-03-13","outcome":"approved","sponsor_name":"SCIENTURE","sponsor_ticker":"SCNX","sponsor_match":"name_exact"},{"application_number":"NDA219208","action_date":"2025-04-02","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"NDA219485","action_date":"2025-04-10","outcome":"approved","sponsor_name":"MIRUM","sponsor_ticker":"MIRM","sponsor_match":"name_exact"},{"application_number":"BLA761384","action_date":"2025-05-14","outcome":"approved","sponsor_name":"ABBVIE INC","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"NDA215400","action_date":"2025-05-14","outcome":"approved","sponsor_name":"AMNEAL","sponsor_ticker":"AMRX","sponsor_match":"name_exact"},{"application_number":"NDA218785","action_date":"2025-06-10","outcome":"approved","sponsor_name":"BEONE MEDICINES USA","sponsor_ticker":"ONC","sponsor_match":"name_exact"},{"application_number":"NDA210745","action_date":"2025-08-29","outcome":"approved","sponsor_name":"AMGEN INC","sponsor_ticker":"AMGN","sponsor_match":"name_exact"},{"application_number":"NDA219943","action_date":"2025-09-10","outcome":"approved","sponsor_name":"ASTRAZENECA","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"NDA218436","action_date":"2025-09-30","outcome":"approved","sponsor_name":"NOVARTIS","sponsor_ticker":"NVS","sponsor_match":"name_exact"},{"application_number":"NDA217338","action_date":"2025-12-22","outcome":"approved","sponsor_name":"RECKITT BENCKISER","sponsor_ticker":"RBGLY","sponsor_match":"name_exact"},{"application_number":"BLA761451","action_date":"2026-04-24","outcome":"approved","sponsor_name":"ASTRAZENECA AB","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"NDA217180","action_date":"2026-05-01","outcome":"approved","sponsor_name":"INCYTE CORP","sponsor_ticker":"INCY","sponsor_match":"name_exact"},{"application_number":"NDA220711","action_date":"2026-05-13","outcome":"approved","sponsor_name":"BEONE MEDICINES USA","sponsor_ticker":"ONC","sponsor_match":"name_exact"},{"application_number":"NDA219878","action_date":"2026-05-15","outcome":"approved","sponsor_name":"ASTRAZENECA AB","sponsor_ticker":"AZN","sponsor_match":"name_exact"},{"application_number":"BLA761468","action_date":"2026-05-22","outcome":"approved","sponsor_name":"GILEAD SCIENCES INC","sponsor_ticker":"GILD","sponsor_match":"name_exact"},{"application_number":"BLA761460","action_date":"2026-05-27","outcome":"approved","sponsor_name":"ABBVIE INC","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"NDA220442","action_date":"2026-05-29","outcome":"approved","sponsor_name":"SHIONOGI","sponsor_ticker":"SGIOF","sponsor_match":"name_exact"},{"application_number":"NDA220790","action_date":"2026-07-09","outcome":"approved","sponsor_name":"AMNEAL","sponsor_ticker":"AMRX","sponsor_match":"name_exact"},{"application_number":"BLA761508","action_date":"2026-08-19","outcome":"approved","sponsor_name":"REGENERON PHARMACEUTICALS, INC","sponsor_ticker":"REGN","sponsor_match":"name_exact"},{"application_number":"NDA220910","action_date":"2026-08-26","outcome":"approved","sponsor_name":"REVOLUTION MEDICINES","sponsor_ticker":"RVMD","sponsor_match":"name_exact"}]},"rejections":{"addressable":47,"caught":28,"missed":19,"items":[{"application_number":"NDA215151","action_date":"2023-02-07","outcome":"crl","sponsor_name":"Phathom Pharmaceuticals, Inc.","sponsor_ticker":"PHAT","sponsor_match":"name_exact"},{"application_number":"NDA216962","action_date":"2023-03-17","outcome":"crl","sponsor_name":"AbbVie Inc.","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"BLA761343","action_date":"2023-10-11","outcome":"crl","sponsor_name":"Alvotech USA Inc.","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"NDA212097","action_date":"2024-02-09","outcome":"crl","sponsor_name":"Xeris Pharmaceuticals, Inc.","sponsor_ticker":"XERS","sponsor_match":"name_exact"},{"application_number":"NDA217002","action_date":"2024-02-26","outcome":"crl","sponsor_name":"Minerva Neurosciences, Inc","sponsor_ticker":"NERV","sponsor_match":"name_exact"},{"application_number":"NDA216962","action_date":"2024-06-18","outcome":"crl","sponsor_name":"AbbVie Inc.","sponsor_ticker":"ABBV","sponsor_match":"name_exact"},{"application_number":"NDA218772","action_date":"2024-08-19","outcome":"crl","sponsor_name":"Scienture Inc.","sponsor_ticker":"SCNX","sponsor_match":"name_exact"},{"application_number":"BLA125845","action_date":"2025-07-07","outcome":"crl","sponsor_name":"Ultragenyx Pharmaceutical Inc.","sponsor_ticker":"RARE","sponsor_match":"name_exact"},{"application_number":"BLA761303","action_date":"2025-07-30","outcome":"crl","sponsor_name":"Regeneron Pharmaceuticals, Inc.","sponsor_ticker":"REGN","sponsor_match":"name_exact"},{"application_number":"NDA209531","action_date":"2025-09-22","outcome":"crl","sponsor_name":"Biogen, Inc.","sponsor_ticker":"BIIB","sponsor_match":"name_exact"},{"application_number":"BLA761462","action_date":"2025-10-31","outcome":"crl","sponsor_name":"Alvotech USA Inc.","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"NDA210862","action_date":"2025-11-04","outcome":"crl","sponsor_name":"Biohaven Therapeutics, Ltd.","sponsor_ticker":"BHVN","sponsor_match":"name_exact"},{"application_number":"BLA761435","action_date":"2025-11-24","outcome":"crl","sponsor_name":"Alvotech USA Inc.","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"BLA761461","action_date":"2025-11-26","outcome":"crl","sponsor_name":"Alvotech USA Inc.","sponsor_ticker":"ALVO","sponsor_match":"name_exact"},{"application_number":"NDA220707","action_date":"2026-02-13","outcome":"crl","sponsor_name":"Disc Medicine, Inc.","sponsor_ticker":"IRON","sponsor_match":"name_exact"},{"application_number":"BLA761403","action_date":"2026-02-26","outcome":"crl","sponsor_name":"Amphastar Pharmaceuticals, Inc.","sponsor_ticker":"AMPH","sponsor_match":"name_exact"},{"application_number":"BLA125827","action_date":"2026-04-10","outcome":"crl","sponsor_name":"Replimune, Inc.","sponsor_ticker":"REPL","sponsor_match":"name_exact"},{"application_number":"BLA761401","action_date":"2026-04-10","outcome":"crl","sponsor_name":"Telix Pharmaceuticals (US) Inc.","sponsor_ticker":"TLX","sponsor_match":"name_exact"},{"application_number":"BLA761459","action_date":"2026-04-22","outcome":"crl","sponsor_name":"AbbVie Inc.","sponsor_ticker":"ABBV","sponsor_match":"name_exact"}]}},"unresolved_predictions":{"count":59,"withheld_not_yet_matured":0,"note":"Predictions we published that never resolved to a verifiable FDA decision, with the reason each one failed to join. These are the counterpart to coverage.unmatched, which was previously a bare integer. A row here does NOT mean the date was wrong — most mean no FDA decision could be matched to it at all, which is a failure of our join or of openFDA's coverage, not necessarily of the date. Predictions whose date has not yet passed are excluded (that is forward-looking data, and it is what the paid feed sells).","reason_counts":{"no_fda_action_found":46,"approval_implausibly_far":6,"ambiguous_applications":6,"crl_suppressed_since_approved":1},"reason_notes":{"no_fda_action_found":"No FDA decision joined this prediction at all. Deliberately undifferentiated: it covers a decision openFDA does not carry (the CBER/Purple Book gap), one that has not happened yet, a withdrawn or never-filed application, and a drug or sponsor identity our matcher failed to resolve. From the reconciliation these look identical — nothing joined — so we do not guess between them.","approval_implausibly_far":"An FDA decision was found for this drug but fell more than 180 days from the predicted date, so it belongs to a different decision cycle and was refused rather than scored as this prediction's outcome.","ambiguous_applications":"More than one distinct FDA application matched the drug and sponsor near the predicted date, and they were not the same decision — so no match was made.","crl_suppressed_since_approved":"A rejection was found by company match, but openFDA now marks that application approved and we could not verify the letter belongs to this decision cycle, so we declined to assert a rejection."},"items":[{"drug_name":"efanesoctocog alfa (Altuviiio)","company":"Sanofi","ticker":"SNY","cik":"0001121404","pdufa_date":"2023-02-28","reason":"no_fda_action_found"},{"drug_name":"Efgartigimod SC","company":"Halozyme","ticker":"HALO","cik":"0001159036","pdufa_date":"2023-03-20","reason":"no_fda_action_found"},{"drug_name":"PADCEV (enfortumab vedotin-ejfv) with KEYTRUDA (pembrolizumab)","company":"Seagen Inc.","ticker":null,"cik":"0001060736","pdufa_date":"2023-04-21","reason":"no_fda_action_found"},{"drug_name":"SER-109","company":"Seres Therapeutics","ticker":"MCRB","cik":"0001609809","pdufa_date":"2023-04-26","reason":"no_fda_action_found"},{"drug_name":"RSV older adult vaccine candidate (RSVPreF3 OA)","company":"GSK plc","ticker":"GSK","cik":"0001131399","pdufa_date":"2023-05-03","reason":"no_fda_action_found"},{"drug_name":"PRX-102 (pegunigalsidase alfa)","company":"Protalix","ticker":"PLX","cik":"0001006281","pdufa_date":"2023-05-09","reason":"no_fda_action_found"},{"drug_name":"SRP-9001","company":"Sarepta","ticker":"SRPT","cik":"0000873303","pdufa_date":"2023-05-29","reason":"no_fda_action_found"},{"drug_name":"SUL-DUR","company":"Innoviva, Inc.","ticker":"INVA","cik":"0001080014","pdufa_date":"2023-05-29","reason":"no_fda_action_found"},{"drug_name":"ADX-2191 (methotrexate injection, USP)","company":"Aldeyra Therapeutics, Inc.","ticker":"ALDX","cik":"0001341235","pdufa_date":"2023-06-21","reason":"no_fda_action_found"},{"drug_name":"I/ONTAK (E7777)","company":"Citius Pharmaceuticals, Inc.","ticker":"CTXR","cik":"0001506251","pdufa_date":"2023-07-28","reason":"approval_implausibly_far"},{"drug_name":"avasopasem manganese","company":"Galera Therapeutics, Inc.","ticker":"GRTX","cik":"0001563577","pdufa_date":"2023-08-09","reason":"no_fda_action_found"},{"drug_name":"Avacincaptad Pegol (ACP)","company":"IVERIC bio, Inc.","ticker":null,"cik":"0001410939","pdufa_date":"2023-08-19","reason":"no_fda_action_found"},{"drug_name":"APHEXDA® (motixafortide)","company":"BioLineRx Ltd.","ticker":"BLRX","cik":"0001498403","pdufa_date":"2023-09-09","reason":"no_fda_action_found"},{"drug_name":"neffy (Intranasal (IN) Epinephrine)","company":"ARS Pharmaceuticals, Inc.","ticker":"SPRY","cik":"0001671858","pdufa_date":"2023-09-19","reason":"approval_implausibly_far"},{"drug_name":"Nyxol® (phentolamine mesylate)","company":"Ocuphire Pharma, Inc.","ticker":"IRD","cik":"0001228627","pdufa_date":"2023-09-28","reason":"no_fda_action_found"},{"drug_name":"IDP-126","company":"Bausch Health Companies Inc.","ticker":"BHC","cik":"0000885590","pdufa_date":"2023-10-20","reason":"no_fda_action_found"},{"drug_name":"NurOwn®","company":"BrainStorm Cell Therapeutics Inc.","ticker":"BCLI","cik":"0001137883","pdufa_date":"2023-12-08","reason":"no_fda_action_found"},{"drug_name":"lovo-cel","company":"bluebird bio","ticker":null,"cik":"0001293971","pdufa_date":"2023-12-20","reason":"no_fda_action_found"},{"drug_name":"gefapixant","company":"Merck & Co., Inc.","ticker":"MRK","cik":"0000310158","pdufa_date":"2023-12-27","reason":"no_fda_action_found"},{"drug_name":"berdazimer gel, 10.3% (SB206)","company":"Novan, 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Inc.","ticker":"AQST","cik":"0001398733","pdufa_date":"2024-04-28","reason":"ambiguous_applications"},{"drug_name":"Tivdak (tisotumab vedotin-tftv)","company":"Pfizer and Genmab A/S","ticker":"PFE","cik":"0000078003","pdufa_date":"2024-05-09","reason":"no_fda_action_found"},{"drug_name":"HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]","company":"Dynavax Technologies Corporation","ticker":null,"cik":"0001029142","pdufa_date":"2024-05-13","reason":"approval_implausibly_far"},{"drug_name":"Arexvy (respiratory syncytial virus vaccine, adjuvanted)","company":"GSK plc","ticker":"GSK","cik":"0001131399","pdufa_date":"2024-06-07","reason":"approval_implausibly_far"},{"drug_name":"V116","company":"Merck & Co., Inc.","ticker":"MRK","cik":"0000310158","pdufa_date":"2024-06-17","reason":"no_fda_action_found"},{"drug_name":"ensifentrine","company":"Verona Pharma plc","ticker":null,"cik":"0001657312","pdufa_date":"2024-06-26","reason":"no_fda_action_found"},{"drug_name":"patritumab 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vaccine candidate","company":"GSK plc","ticker":"GSK","cik":"0001131399","pdufa_date":"2025-02-14","reason":"no_fda_action_found"},{"drug_name":"cabozantinib (CABOMETYX)","company":"Exelixis, Inc.","ticker":"EXEL","cik":"0000939767","pdufa_date":"2025-04-03","reason":"ambiguous_applications"},{"drug_name":"EYLEA HD (aflibercept) Injection 8 mg","company":"Regeneron Pharmaceuticals, Inc.","ticker":"REGN","cik":"0000872589","pdufa_date":"2025-04-20","reason":"ambiguous_applications"},{"drug_name":"Opdivo (nivolumab) + Yervoy (ipilimumab)","company":"Bristol Myers Squibb","ticker":"BMY","cik":"0000014272","pdufa_date":"2025-04-21","reason":"ambiguous_applications"},{"drug_name":"ZORYVE foam (roflumilast)","company":"Arcutis Biotherapeutics, Inc.","ticker":"ARQT","cik":"0001787306","pdufa_date":"2025-05-22","reason":"ambiguous_applications"},{"drug_name":"AR-15512","company":"Alcon Inc.","ticker":"ALC","cik":"0001167379","pdufa_date":"2025-05-30","reason":"no_fda_action_found"},{"drug_name":"mRNA-1283 (next-generation COVID-19 vaccine)","company":"Moderna, Inc.","ticker":"MRNA","cik":"0001682852","pdufa_date":"2025-05-31","reason":"no_fda_action_found"},{"drug_name":"LEQEMBI","company":"Biogen Inc.","ticker":"BIIB","cik":"0000875045","pdufa_date":"2025-08-31","reason":"no_fda_action_found"},{"drug_name":"UPLIZNA","company":"Amgen","ticker":"AMGN","cik":"0000318154","pdufa_date":"2025-12-14","reason":"no_fda_action_found"},{"drug_name":"zoliflodacin","company":"Innoviva, Inc.","ticker":"INVA","cik":"0001080014","pdufa_date":"2025-12-15","reason":"no_fda_action_found"},{"drug_name":"CUTX-101 (copper histidinate)","company":"Fortress Biotech, Inc.","ticker":"FBIO","cik":"0001429260","pdufa_date":"2026-01-14","reason":"no_fda_action_found"},{"drug_name":"Dupixent (dupilumab)","company":"Sanofi","ticker":"SNY","cik":"0001121404","pdufa_date":"2026-02-28","reason":"no_fda_action_found"},{"drug_name":"piflufolastat F 18 (new formulation for PSMA PET imaging agent)","company":"Lantheus Holdings, Inc.","ticker":"LNTH","cik":"0001521036","pdufa_date":"2026-03-06","reason":"no_fda_action_found"},{"drug_name":"linerixibat","company":"GSK plc","ticker":"GSK","cik":"0001131399","pdufa_date":"2026-03-24","reason":"no_fda_action_found"},{"drug_name":"doravirine/islatravir","company":"Merck & Co., Inc.","ticker":"MRK","cik":"0000310158","pdufa_date":"2026-04-28","reason":"no_fda_action_found"},{"drug_name":"Tzield (teplizumab-mzwv)","company":"Sanofi","ticker":"SNY","cik":"0001121404","pdufa_date":"2026-04-29","reason":"no_fda_action_found"},{"drug_name":"LINZESS (linaclotide)","company":"Ironwood Pharmaceuticals, Inc.","ticker":"IRWD","cik":"0001446847","pdufa_date":"2026-05-24","reason":"no_fda_action_found"},{"drug_name":"vepdegestrant","company":"Arvinas, Inc.","ticker":"ARVN","cik":"0001655759","pdufa_date":"2026-06-05","reason":"no_fda_action_found"},{"drug_name":"tebipenem HBr","company":"GSK plc","ticker":"GSK","cik":"0001131399","pdufa_date":"2026-06-18","reason":"no_fda_action_found"},{"drug_name":"LNTH-2501 (Ga 68 edotreotide)","company":"Lantheus Holdings, Inc.","ticker":"LNTH","cik":"0001521036","pdufa_date":"2026-06-29","reason":"no_fda_action_found"},{"drug_name":"Furoscix ReadyFlow Autoinjector","company":"MannKind Corporation","ticker":"MNKD","cik":"0000899460","pdufa_date":"2026-07-26","reason":"no_fda_action_found"},{"drug_name":"mRNA-1010 (Seasonal flu vaccine)","company":"Moderna, Inc.","ticker":"MRNA","cik":"0001682852","pdufa_date":"2026-08-05","reason":"no_fda_action_found"},{"drug_name":"UX111","company":"Ultragenyx Pharmaceutical Inc.","ticker":"RARE","cik":"0001515673","pdufa_date":"2026-09-19","reason":"no_fda_action_found"}]},"method":"PDUFA dates as DISCLOSED BY THE COMPANY in its own SEC 8-K/6-K filing — extracted, grounded in a verbatim quote, then matched on drug+sponsor against openFDA's record of what the FDA actually did, bounded to |Δ|≤180d and keyed on the FDA decision. We do not forecast a date: we relay the issuer's date and then score it. So the error below measures two things together — whether we read the filing correctly, and whether the FDA then acted on the date it had published. Both are what an operator needs; neither is a claim to predict the FDA.","caveat":"Date accuracy is the defensible headline. Recall is a diagnostic band: the addressable denominator rests on sponsor→public-name matching, which has a real error rate, and some 'unmatched' predictions are openFDA coverage gaps (CBER biologics), not misses. The headline blends the report generation (see baseline_source/generated_at: 'live' = regenerated daily from our full corpus against a fresh openFDA ground-truth pull; 'committed_fallback' = the frozen 2023-2025 committed artifact) with live decisions resolved since — matched automatically on drug + sponsor with a near-date and single-application check, not individually human-reviewed — so date_accuracy.decisions_matched (blended) can exceed coverage.baseline_decisions_matched (the generation's own count). The matched set is not a frozen benchmark: it GROWS as the join improves, because identifying a decision we previously could not adds it to the matched count AND to the addressable denominator — so every figure here is conditional on the current matching rules rather than a fixed population, and a later revision can move it in either direction. openFDA also revises its own record weekly, so a daily-regenerated denominator can move without any event of ours. Rejections (CRLs) are captured from company filings + the openFDA CRL dataset; date_accuracy.matched_crls labels how many entered the median, and coverage.crl_decisions is the total captured — but capture is incomplete, so rejection counts undercount reality.","verify":"Every row in track_record is a resolved FDA decision (never an upcoming prediction). Confirm any date against the FDA's public records (openFDA / Drugs@FDA) using its application_number — the prediction itself came from a public SEC filing. That is what makes this independently auditable rather than a self-reported number.","track_record_note":"192 receipt rows document the 212 scored decisions; the 16 scored decisions with no receipt row under their own application number are enumerated in unlisted_scored_decisions below. One FDA decision resolved under TWIN application numbers (two strengths or presentations acted on together) can appear once per application across these lists — every such row is independently checkable, and the decision counts exactly once in every statistic. The split exists because the committed baseline's sponsor-attributed ledger is built from the FDA ORIGINALS denominator, so a supplement (new indication on an existing application), a CBER Purple Book recovery, or a scored cycle-pass recovery counts toward the median without a ledger receipt. Every row in either list is independently checkable by its application_number. had_prior_crl marks an APPROVAL that superseded an earlier Complete Response Letter on the same application (the rejection row stays on the board). It is never set on a rejection row itself: a second CRL on the same application appears as its own row instead. Sign convention, here and in unlisted_scored_decisions: error_days = predicted_date − actual_date, in days. Positive = the FDA acted that many days BEFORE the date we relayed (early); negative = it acted after (late); 0 = exact to the day. date_accuracy.median_delta_days is the median of the SIGNED errors; the within_7_days / within_30_days ratios use |error_days|.","track_record":[{"sponsor":"Telix Pharmaceuticals Limited","ticker":"TLX","drug_name":"Pixclara (TLX101-Px, Floretyrosine F 18 or 18F-FET)","application_number":"NDA218592","predicted_date":"2026-09-11","actual_date":"2026-09-11","error_days":0,"outcome":"approved","had_prior_crl":false,"source":"openfda_drugsfda","match_tier":"fuzzy","operator_approved":false,"filing_url":"https://www.sec.gov/Archives/edgar/data/2007191/000162828026058126/0001628280-26-058126-index.htm"},{"sponsor":"Ionis and 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