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Catalyst Pharmaceuticals completes merger with Angelini Pharma; shareholders receive $31.50/share
Merger closed July 15, 2026; each share converted to $31.50 cash, no interest.
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Catalyst shareholders approve merger with Angelini Pharma; all directors to resign at closing
Stockholders approved merger with Angelini Pharma: 97,340,180 votes for, 1,143,815 against, 242,616 abstentions.
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Catalyst Pharma: Vamorolone Phase 1 shows glucocorticoid activity without immunosuppression at clinical doses
Phase 1 study: vamorolone 300 mg vs deflazacort 0.9 mg/kg showed comparable cortisol suppression.
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FTC grants early termination of HSR waiting period for Catalyst-Angelini merger
FTC early termination of HSR Act waiting period granted June 16; Catalyst aware June 22.
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Catalyst Q1 2026 revenue $149.4M; FIRDAPSE up 18%, AGAMREE up 67% YoY
Product revenue net $149.3M for Q1 2026, up 5.6% YoY from $141.4M.
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Angelini Pharma to acquire Catalyst Pharma for $4.1B ($31.50/share), premium 28% to VWAP
All outstanding shares acquired for $31.50 cash per share; total equity value ~$4.1B (21% premium to unaffected close).
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Catalyst Pharma patent trial delayed to May 18, 2026 in NJ district court
District Court of NJ delayed bench trial between Catalyst and Hetero USA from Mar 23 to May 18, 2026.
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Catalyst reports record FY2025 revenue $589M (+20% YoY); FY2026 guidance $615-645M
Full year 2025 total revenues $589.0M, up 19.8% YoY; GAAP diluted EPS $1.68 vs $1.31.
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Catalyst Pharma Q3 rev $148.4M (+17% YoY); raises FY25 revenue guidance to $565-$585M
GAAP net income $52.8M ($0.42 diluted EPS); non-GAAP net income $86.1M ($0.68 diluted EPS).
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Catalyst Pharma announces $200M share repurchase program through Dec 2026
Board authorized up to $200M share repurchase from Oct 1, 2025 to Dec 31, 2026.
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Catalyst settles FIRDAPSE patent suit with Lupin; generic entry delayed to Feb 2035
Lupin receives license to market generic FIRDAPSE no earlier than February 25, 2035, if FDA-approved.
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Catalyst settles Lupin patent litigation; generic FIRDAPSE launch no earlier than Feb 2035
Lupin granted license to market generic FIRDAPSE beginning February 25, 2035, if FDA-approved.
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NCCN SCLC guidelines add LEMS testing and amifampridine (FIRDAPSE) treatment recommendation
NCCN guidelines for SCLC updated to recommend VGCC antibody testing for LEMS diagnosis.
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Catalyst Pharma reports Q2 2025 revenue of $146.6M (+19.4% YoY); GAAP net income $52.1M
FIRDAPSE Q2 net revenue $84.8M (+9.7% YoY); first-half 2025 net revenue $168.6M (+16.9% YoY).
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Catalyst Pharma appoints Dr. William Andrews as CMO; Dr. Ingenito retires
Gary Ingenito retired as Chief Medical and Regulatory Officer effective June 1, 2025; no disagreement with management.
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Catalyst Q1 revenues $141.4M (+43.6% YoY); GAAP EPS $0.45; reaffirms FY outlook
Total product revenue $141.4M, up 43.6% YoY; FIRDAPSE $83.7M (+25.3%), AGAMREE $22.0M (from $1.2M).
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Catalyst Pharmaceuticals: Health Canada accepts AGAMREE NDS with Priority Review for DMD
Health Canada accepted New Drug Submission for AGAMREE (corticosteroid) for Duchenne muscular dystrophy.
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Catalyst Pharma reports FY2024 revenue $491.7M (+23.5% YoY), guides FY2025 $545-565M
Q4 net product revenue $141.8M; full-year FIRDAPSE revenue $306M (+18.4%), AGAMREE $46M (new launch).
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Catalyst settles FIRDAPSE patent suit with Teva; generic entry barred until Feb 2035
Teva agrees not to market generic FIRDAPSE in the U.S. before February 25, 2035, if FDA approved.
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Catalyst Pharma Q3 revenue $128.7M (+25% YoY); GAAP EPS $0.35; raises FY guidance
Total revenue $128.7M, up 25.3% YoY; GAAP net income $43.9M ($0.35 diluted).
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Catalyst earns $2.1M milestone as Japan approves FIRDAPSE for LEMS
Japan's Ministry of Health approved DyDo's NDA for FIRDAPSE (amifampridine) 10 mg to treat Lambert-Eaton myasthenic syndrome (LEMS).
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Catalyst Q2 revenue $122.7M (+23% YoY); GAAP EPS $0.33, non-GAAP $0.56; guides upper end of $455-475M
Total Q2 2024 revenue $122.7M, up 23.3% YoY; FIRDAPSE $77.4M (+19.2%), FYCOMPA $36.5M (+5.7%), AGAMREE $8.7M (new launch).
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Catalyst grants Kye exclusive Canadian rights to AGAMREE for DMD
Kye Pharmaceuticals gets exclusive Canadian rights to commercialize AGAMREE (vamorolone) for Duchenne Muscular Dystrophy.
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FDA approves higher max daily dose of FIRDAPSE for LEMS to 100 mg
FDA approved sNDA increasing FIRDAPSE max daily dose from 80 mg to 100 mg for adults and peds >45 kg with LEMS.
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Catalyst Q1 revenue $98.5M (+15.4% YoY); AGAMREE launch adds $1.2M
Total Q1 2024 net product revenue $98.5M, up 15.4% YoY; FIRDAPSE net revenue $66.8M (+16.2%).
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Catalyst launches AGAMREE (vamorolone) in US for Duchenne Muscular Dystrophy
AGAMREE (vamorolone) oral suspension 40 mg/mL now commercially available by prescription for DMD patients aged 2+.
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Catalyst Pharma reports record 2023 revenue of $398.2M (+85.9% YoY); non-GAAP EPS $1.96
Q4 2023 total revenue $110.6M (+82% YoY); full-year GAAP net income $71.4M ($0.63 diluted).
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Catalyst announces VISION-DMD vamorolone study published in Neurology
Peer-reviewed journal Neurology published Santhera's VISION-DMD study on vamorolone (AGAMREE) for DMD.
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Catalyst Pharmaceuticals closes $150M public offering of 10M shares at $15; net proceeds ~$140.1M
Sold 10,000,000 shares of common stock at $15.00 per share in an underwritten public offering.
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Catalyst Pharmaceuticals prices public offering of 10M shares at $15.00, raising $150M gross
Offering of 10,000,000 shares at $15.00 each, gross proceeds $150M; net proceeds ~$140.1M.
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Catalyst partner DyDo submits NDA in Japan for FIRDAPSE; milestone payment triggered
DyDo Pharma submitted NDA to PMDA for FIRDAPSE (amifampridine) 10 mg for LEMS in Japan.
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Catalyst Pharma appoints Michael Kalb as CFO; Alicia Grande to retire at year-end 2023
Alicia Grande to retire as CFO at end of 2023; will remain as consultant through Dec 31, 2024.
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Catalyst Q3 net revenues $102.7M (+79% YoY); non-GAAP EPS $0.49; raises FY revenue guidance to $390-395M
GAAP net loss per diluted share $(0.29) reflects $81.5M one-time IPR&D expense from AGAMREE license acquisition.
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Catalyst Pharma receives two new US patent allowances for FIRDAPSE, extending IP protection to mid-2032
USPTO allowed two patents covering FIRDAPSE bioavailability under fasting/fed conditions; expected grant within two months.
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Catalyst reports FDA approval of AGAMREE for DMD; expects Q1 2024 launch
Santhera received FDA approval for AGAMREE (vamorolone) oral suspension 40 mg/mL for DMD in patients aged 2+.
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Catalyst Pharmaceuticals appoints Richard J. Daly as CEO, effective Jan 1, 2024
Patrick J. McEnany retires as CEO effective Dec 31, 2023, remains Chairman of the Board.
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FDA accepts Catalyst's sNDA to increase FIRDAPSE max dose to 100 mg; PDUFA June 4, 2024
FDA accepted supplemental NDA to increase FIRDAPSE maximum daily dose from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome.
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Catalyst Q2 revenue $99.6M, GAAP EPS $0.33 (vs $0.20), raises FY2023 guide to $380M-$390M
Q2 net product revenue $99.5M: FIRDAPSE $64.9M (+22% YoY); FYCOMPA $34.6M first-time contribution.
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Catalyst CEO Patrick J. McEnany to retire by end of 2023; remains Chairman
CEO Patrick J. McEnany informed board of intention to retire as CEO by end of 2023.