{"filings":[{"id":787961,"accession_number":"0001437749-26-019102","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2026-06-02T12:04:53+00:00","items":["8.01"],"status":"ready","headline":"UroGen settles patent litigation with Teva over Jelmyto; generic entry Sept 15, 2030","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Settlement resolves patent litigation regarding Teva's generic version of Jelmyto (mitomycin) for pyelocalyceal solution.","Teva granted non-exclusive license to sell generic Jelmyto starting September 15, 2030, if FDA approved.","All ongoing patent litigation between the parties in U.S. District Court for Delaware will be terminated.","Agreement is subject to review by U.S. Federal Trade Commission and U.S. Department of Justice."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94548,"accession_number":"0001437749-26-015018","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2026-05-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Q1 2026: ZUSDURI revenue $29.2M (+109% QoQ); net loss narrows to $0.47/share","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Total revenue $51.0M, up 152% YoY on ZUSDURI launch and JELMYTO growth.","ZUSDURI net revenue $29.2M, 109% sequential growth; 256 unique prescribers as of March 31.","JELMYTO revenue $21.7M (+7% YoY); FY 2026 guidance reaffirmed at $97–101M.","Net loss $23.6M ($0.47/share) vs $43.8M ($0.92/share) in Q1 2025; cash $140.3M.","UGN-103 NDA submission on track for H2 2026; six-month durability data expected mid-2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":50959000.0,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107009,"accession_number":"0001437749-26-006233","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2026-03-02T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen reports FY2025 net loss $153.5M; ZUSDURI launch net sales $15.8M; refinances debt at 8.25%","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["FY2025 revenue $109.8M (+21% YoY); JELMYTO net sales $94M (underlying demand +7%).","ZUSDURI net sales $15.8M in initial launch; 838 activated sites, 102 unique prescribers as of Dec 31, 2025.","Permanent J Code (J9282) effective Jan 1, 2026; launch acceleration expected.","Refinanced existing term loan: $200M funded at 8.25% fixed, new $50M tranche available until June 2027.","2026 guidance: JELMYTO net sales $97-101M; total operating expenses $240-250M."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107008,"accession_number":"0001193125-26-084282","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2026-03-02T23:59:59+00:00","items":["1.01","2.03"],"status":"ready","headline":"UroGen Pharma secures up to $250M loan at 8.25%; $200M funded to refinance existing debt","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Tranche A of $200M funded on Feb 26, used to refinance $125M existing term loan and fund working capital.","Loan bears fixed 8.25% interest quarterly; principal repayments start Q1 2030 in four equal quarterly installments.","Second tranche of $50M available upon election by June 30, 2027, subject to conditions.","No financial covenants; collateral includes substantially all assets including intellectual property.","Loan matures 5 years from closing; prepayment subject to exit fee of 1% and makewhole within first year."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":123353,"accession_number":"0001437749-25-033466","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-11-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["ZUSDURI achieved net product revenue of $1.8M in Q3; October 2025 preliminary demand revenue estimate of $4.5M, with 592 activated sites and 54 prescribers since July launch.","JELMYTO net revenue $25.7M (+13% YoY underlying demand growth); full-year JELMYTO guidance unchanged at $94-98M, op expenses $215-225M.","Net loss of $33.3M ($0.69/share) vs $23.7M ($0.51) in Q3 2024; cash $127.4M as of Sept 30, 2025.","UGN-103 Phase 3 UTOPIA shows 77.8% CRR; FDA agrees to NDA submission plan; NDA expected H2 2026 with potential approval 2027.","UGN-301 (zalifrelimab) development discontinued; UroGen terminates license with Agenus."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":71951000.0,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":140022,"accession_number":"0001437749-25-027874","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-08-27T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"UroGen shareholders approve 2.75M share increase under 2017 equity plan and new compensation policy","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Shareholders approved amendment to 2017 Equity Incentive Plan, authorizing 2,750,000 additional ordinary shares.","Shareholders approved Amended and Restated Non-Employee Director and Officer Compensation Policy.","All seven director nominees elected: Arie Belldegrun, Elizabeth Barrett, Cynthia Butitta, Stuart Holden, James Robinson, Leana Wen, Daniel Wildman.","Advisory vote on executive compensation approved (18.85M for); one-year frequency for future say-on-pay votes selected.","PricewaterhouseCoopers LLP ratified as independent auditor with 32.9M votes in favor."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":140021,"accession_number":"0001437749-25-025242","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-08-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen reports Q2 loss of $49.9M; launches ZUSDURI after June FDA approval","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["ZUSDURI (mitomycin) FDA-approved June 12 for recurrent LG-IR-NMIBC; now commercially available.","JELMYTO Q2 net revenue $24.2M (+11% vs Q2 2024); FY guidance $94-98M unchanged.","Net loss $49.9M ($1.05/share) vs $33.4M ($0.82) in Q2 2024; operating loss $41.4M.","Cash and marketable securities $161.6M at June 30, 2025.","Enrollment complete in Phase 3 UTOPIA trial for next-gen mitomycin UGN-103."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":44469000.0,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":140020,"accession_number":"0001193125-25-155503","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-07-03T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"UroGen awards special bonuses totaling $845K to CEO, CFO, GC for ZUSDURI FDA approval","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["CEO Elizabeth Barrett receives $645,000; CFO Chris Degnan and GC Jason Smith each get $100,000.","Bonuses approved June 30, 2025, for leadership leading to FDA approval of ZUSDURI for recurrent low-grade intermediate risk NMIBC.","ZUSDURI is a novel therapy for non-muscle invasive bladder cancer (NMIBC).","One-time special awards; no recurrence or changes to base compensation."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157636,"accession_number":"0001193125-25-140339","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-06-13T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"FDA approves UroGen Pharma's ZUSDURI (mitomycin) for recurrent LG-IR-NMIBC","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA approved ZUSDURI (mitomycin) for adults with recurrent low-grade intermediate-risk NMIBC on June 12, 2025.","Phase 3 ENVISION trial: 78% achieved complete response at 3 months; 79% of those maintained at 12 months.","Expected commercial availability in the U.S. on or around July 1, 2025.","Common adverse reactions include increased creatinine, dysuria, hematuria; serious reactions in 12% of patients.","Post-marketing commitment: ongoing ENVISION trial to further characterize clinical benefit; annual duration of response updates."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157635,"accession_number":"0001437749-25-015955","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-05-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Pharma Q1 2025: JELMYTO revenue $20.3M, net loss widens to $43.8M; UGN-102 PDUFA June 13","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["JELMYTO net sales $20.3M (+8% YoY); underlying demand grew 12%.","Net loss of $43.8M ($0.92 per share) vs $32.3M ($0.87) in Q1 2024.","Cash and marketable securities $200.4M; FY2025 JELMYTO revenue guidance unchanged at $94–$98M.","UGN-102 NDA under FDA review; PDUFA target action date June 13, 2025; ODAC meeting May 21.","UGN-501 acquisition from IconOVir expensed; UGN-103 Phase 3 UTOPIA trial enrollment to complete mid-2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":20254000.0,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176011,"accession_number":"0001437749-25-006757","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-03-10T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen reports Q4/FY2024: JELMYTO rev $90.4M; net loss $126.9M; guides FY2025 rev $94-98M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["UGN-102 NDA under FDA review; PDUFA June 13, 2025; 18-month DOR 80.6% in Phase 3 ENVISION trial.","JELMYTO net product revenue $90.4M in FY2024, up 9% YoY; underlying demand revenue grew 12% (FY) and 15% (Q4).","Net loss Q4 2024 $37.5M ($0.80/share) vs $26.0M ($0.72/share) in Q4 2023; FY net loss $126.9M ($2.96/share) vs $102.2M ($3.55/share).","FY2025 guidance: JELMYTO revenue $94-98M; operating expenses $215-225M (incl. $11-14M share-based comp).","Cash, equivalents and marketable securities $241.7M at Dec 31, 2024, up from $141.5M at Dec 31, 2023."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176010,"accession_number":"0001193125-25-030143","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-02-20T23:59:59+00:00","items":["1.01","3.02"],"status":"ready","headline":"UroGen acquires ICVB-1042 assets from IconOVir for shares, milestone, and royalties","summary_kind":"llm","event_type":"m_and_a","confidence":"high","bullets":["UroGen issued 374,843 ordinary shares (worth $4.0M) to IconOVir as upfront consideration.","UroGen agreed to pay $15.0M cash milestone on cumulative global net sales of ICVB-1042 products.","UroGen will pay low single-digit royalties on worldwide net sales of ICVB Products.","Entities affiliated with Chair Arie Belldegrun hold promissory notes entitling them to ~28.3% of purchase price."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176009,"accession_number":"0001193125-25-005649","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2025-01-14T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"UroGen Pharma furnishes January 2025 corporate presentation; no material new disclosures","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Presentation reiterates UGN-102 PDUFA target date of June 13, 2025 and planned ODAC meeting.","Highlights ongoing Phase 3 UTOPIA study for UGN-103 and planned Phase 3 for UGN-104.","No new financial data or material changes disclosed."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.25,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":192934,"accession_number":"0001193125-24-251712","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-11-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Q3 revenue $25.2M, net loss $23.7M; UGN-102 PDUFA June 2025; cuts FY revenue view","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["JELMYTO Q3 net product revenue $25.2M (+21% YoY from $20.9M).","Net loss $23.7M ($0.55/share) vs $21.9M ($0.68/share) in Q3 2023.","NDA for UGN-102 accepted; PDUFA target action date June 13, 2025.","Full-year 2024 JELMYTO revenue expected below prior guidance low end; still low double-digit YoY growth.","Cash, equivalents, marketable securities $254.2M as of Sept 30, 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":65833000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":192933,"accession_number":"0001193125-24-234808","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-10-09T23:59:59+00:00","items":["5.02","9.01"],"status":"ready","headline":"UroGen Pharma appoints Christopher Degnan as CFO; Don Kim resigns effectively Oct 8, 2024","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Don Kim resigned as CFO, principal financial and accounting officer effective Oct 8, 2024; will provide part-time consulting through Apr 28, 2025 for $36,260.","Kim receives 9 months base salary continuation, $217,590 lump sum (2024 target bonus), and COBRA reimbursement for 9 months.","Christopher Degnan appointed CFO effective Oct 8; prior CFO of Galera Therapeutics and Verrica Pharmaceuticals.","Degnan receives $500,000 annual base salary, 50% target bonus, and inducement equity: option for 74,142 shares at $13.11 and 13,450 RSUs vesting over 3 years.","Severance terms for Degnan include 6 months base salary, pro-rata bonus, and accelerated vesting of 8.33% of equity on qualifying termination."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209314,"accession_number":"0001193125-24-224801","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-09-24T23:59:59+00:00","items":["2.03"],"status":"ready","headline":"UroGen Pharma draws $25M Tranche C loan under credit facility","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Received $25M third tranche loan on Sept 23, 2024; proceeds for general corporate and working capital needs.","Interest rate: 3-month SOFR + 7.25% + 0.26161% p.a., floor 2.50%, payable quarterly.","Matures Mar 16, 2027, extended to Mar 16, 2028 if FDA approves UGN-102 by June 30, 2025.","Repayment in four equal quarterly installments starting June 30, 2026 (or June 30, 2027 if FDA condition met).","Loan is secured by substantially all of the credit parties' tangible and intangible assets."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209313,"accession_number":"0001193125-24-218868","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-09-13T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Director Fred E. Cohen resigns from UroGen Pharma board effective immediately","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Fred E. Cohen resigned as director on Sept 12, 2024.","Resignation is not due to any disagreement with the company.","No replacement director has been announced.","Dr. Cohen's departure is effective immediately."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.2,"calibrated_materiality_score":0.2,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209312,"accession_number":"0001193125-24-200993","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-08-15T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"UroGen Pharma submits NDA to FDA for UGN-102 for low-grade intermediate-risk NMIBC","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Completed NDA submission for UGN-102 to the U.S. FDA.","UGN-102 is intended for low-grade intermediate-risk non-muscle invasive bladder cancer treatment.","Regulatory submission marks a key milestone toward potential approval."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209311,"accession_number":"0001193125-24-199425","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-08-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen ahead of schedule completing UGN-102 NDA; Q2 revenue $21.8M, net loss $33.4M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["UGN-102 NDA completion imminent; potential FDA decision as early as Q1 2025 assuming priority review.","Q2 JELMYTO net revenue $21.8M (+3% YoY); full-year revenue expected at lower end of guidance range.","Q2 net loss $33.4M ($0.91/share) vs $24.1M ($1.03/share) in Q2 2023; operating loss $25.8M.","Cash & marketable securities $241.3M at June 30; June public offering raised $107.5M gross.","Full-year operating expenses expected at higher end of guidance; R&D $15.4M, SG&A $30.1M in Q2."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":40629000.0,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209310,"accession_number":"0001193125-24-197008","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-08-08T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"UroGen shareholders elect directors and approve compensation policy and equity plan amendment at 2024 annual meeting","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["All eight director nominees elected with over 24M votes for each; broker non-votes 6.75M.","2024 Compensation Policy approved: 22.4M for, 3.4M against, 513K abstentions, 6.75M broker non-votes.","Amendment to 2017 Equity Plan adding 800K shares approved: 22.7M for, 3.1M against, 548K abstentions.","Advisory vote on named executive officer compensation passed: 22.6M for, 3.1M against, 553K abstentions.","PricewaterhouseCoopers LLP ratified as auditor: 33.0M for, 8,345 against, 7,053 abstentions; no broker non-votes."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":227290,"accession_number":"0001193125-24-163498","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-06-18T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"UroGen Pharma prices $107.5M public offering of 5M shares at $17.50, plus pre-funded warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering: 5,000,000 ordinary shares at $17.50/share plus 1,142,857 pre-funded warrants at $17.499 each.","Gross proceeds expected to be approximately $107.5 million before underwriting discounts and expenses.","Underwriters granted a 30-day option to purchase up to an additional 921,428 ordinary shares.","Closing expected on June 20, 2024, subject to customary conditions.","TD Cowen and Guggenheim Securities are joint book-running managers; Oppenheimer & Co. is lead manager."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":227289,"accession_number":"0001193125-24-160413","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-06-13T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["12-month DOR KM estimate for CR patients: 82.3% (95% CI: 75.9%-87.1%); predicted median DOR of 40 months.","ENVISION met primary endpoint with 79.6% CR rate at 3 months; safety profile mild-to-moderate.","Rolling NDA submission to FDA for UGN-102 to complete Q3 2024; potential acceptance Q4 2024, approval Q1/Q2 2025.","If approved, UGN-102 would be first FDA-approved medicine for LG-IR-NMIBC; addressable market over $5B (82K patients, $16-19K/dose).","UGN-102 offers a non-surgical alternative to TURBT; ~68% of patients have 2+ recurrences and repeated TURBT carries adverse event risks."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":227288,"accession_number":"0001193125-24-136728","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-05-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Q1 net loss $32.3M; JELMYTO revenue up 10% to $18.8M; UGN-102 NDA on track","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $32.3M ($0.97/share) vs $30.2M ($1.30) in Q1 2023; JELMYTO revenue $18.8M, +10% YoY.","FY2024 guidance reiterated: JELMYTO revenue $95-102M; operating expenses $175-185M.","UGN-102 rolling NDA submission to complete Q3 2024; ENVISION 12-month DOR data event June 13.","IND accepted for UGN-103; Phase 3 in LG-IR-NMIBC planned for 2024.","Cash $164.5M; OLYMPUS post-hoc shows JELMYTO median duration of response 47.8 months."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":18781000.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246170,"accession_number":"0001193125-24-067432","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-03-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"UroGen Pharma FY2023: JELMYTO revenue $82.7M (+28% YoY), net loss narrows, UGN-102 NDA on track","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Full year JELMYTO net revenue $82.7M, up ~28% YoY from $64.4M; Q4 revenue $23.5M (+30% YoY).","Net loss narrowed to $102.2M ($3.55/share) for FY2023 from $109.8M ($4.81/share) in 2022.","Rolling NDA for UGN-102 initiated Jan 2024; completion target Sep 2024, potential FDA decision Q1 2025.","Licensed next-gen mitomycin formulations (UGN-103/104) from medac with IP protection until Dec 2041.","Restructured Pharmakon loan: lower interest rate, deferred payback, up to $100M additional credit facility."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246169,"accession_number":"0001193125-24-056770","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-03-04T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"UroGen presents at TD Cowen conference; no material updates provided","summary_kind":"llm","event_type":"other","confidence":"low","bullets":["Presentation furnished as Exhibit 99.1 for TD Cowen 44th Annual Health Care Conference on March 4, 2024.","Title slide states: 'Developing Innovative Medicines to Treat Urothelial Cancers'.","No specific financial, clinical, or guidance data included in the filing or exhibit excerpt.","Filing is procedural Regulation FD disclosure; no new material events reported."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246168,"accession_number":"0001193125-24-054393","cik":1668243,"company_name":"UroGen Pharma Ltd.","ticker":"URGN","form_type":"8-K","filed_at":"2024-03-01T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"UroGen receives Teva Paragraph IV notice challenging two Jelmyto patents expiring 2031","summary_kind":"llm","event_type":"litigation","confidence":"high","bullets":["Teva filed ANDA seeking FDA approval for a generic version of Jelmyto (mitomycin) for pyelocaliceal solution.","Teva alleges U.S. Patent Nos. 9,040,074 and 9,950,069 (expire January 2031) are invalid, unenforceable, or not infringed.","CEO Liz Barrett states UroGen is prepared and confident in the strength and breadth of its patent portfolio.","This is the first Paragraph IV challenge to Jelmyto; litigation under the Hatch-Waxman Act expected."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1376880000.0,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}