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Milestone Pharma shareholders approve 6.8M share increase to equity plan
Shareholders approved 2019 Equity Plan amendment to increase authorized shares by 6,800,000.
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Milestone Q1 2026 net loss $26.1M; CARDAMYST launch yields $0.2M revenue, 600 scripts
Product revenue of $0.2M from first quarter of CARDAMYST launch; no prior-year revenue.
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Milestone Pharma FY2025 net loss $63.1M; CARDAMYST launch on track; cash runway into late 2027
Net loss of $63.1M ($0.75 per share) for FY2025 vs $41.5M ($0.67) prior year.
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Milestone launches CARDAMYST nasal spray for PSVT via U.S. retail pharmacies
CARDAMYST (etripamil) is now available through U.S. retail pharmacies as first self-administered PSVT treatment.
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Milestone closes $75M royalty sale to RTW for etripamil US net sales
Closed sale of royalty interest under Royalty Purchase Agreement with RTW Royalty I DAC.
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Milestone Pharma announces EMA acceptance of MAA for etripamil in PSVT; decision expected Q1 2027
EMA accepted Marketing Authorization Application for etripamil nasal spray (TACHYMIST) for PSVT; decision expected Q1 2027.
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Milestone receives FDA approval for CARDAMYST (etripamil) nasal spray for PSVT
FDA approved CARDAMYST (etripamil) on Dec 12, 2025 for self-administration in adults with PSVT; first new treatment in 30+ years.
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Milestone reports Q3 net loss $11.9M; PDUFA target Dec 13 for CARDAMYST in PSVT
Cash, equivalents and short-term investments $82.6M at Sept 30, up from $69.7M at Dec 31, 2024.
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Milestone Pharma: FDA accepts CRL response for CARDAMYST; new Dec 13 PDUFA date; Q2 net loss $13M
FDA accepted CRL response for CARDAMYST (etripamil) for PSVT; new PDUFA target Dec 13, 2025.
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Milestone Pharmaceuticals prices $52.5M public offering of common shares and warrants
Priced $52.5M offering of 31.5M common shares + Series A and B warrants at $1.50/unit; 3.5M pre-funded warrants at $1.499/unit.
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FDA accepts Milestone's CRL response for CARDAMYST; new PDUFA Dec 13, 2025
FDA accepted Milestone's response to CRL for CARDAMYST (etripamil) nasal spray for PSVT; new PDUFA target date Dec 13, 2025.
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Milestone submits CRL response for CARDAMYST (etripamil) PSVT NDA after Type A meeting
Submitted CRL response to FDA on June 16, 2025, following a productive Type A meeting.
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Shareholders approve 2019 EIP amendment, increase share pool by 4M; directors elected
Proposal to amend 2019 EIP to remove evergreen provision and add 4,000,000 shares approved (8.04M for, 4.74M against, 14.9M broker non-votes).
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Milestone Pharma Q1 net loss $20.8M; CRL issues unresolved; Type A meeting requested
Q1 net loss $20.8M vs $10.4M YoY; no revenue; cash $56.0M down from $69.7M.
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FDA issues Complete Response Letter for etripamil PSVT NDA; no clinical issues raised
CRL focuses on CMC: additional nitrosamine impurity data and facility inspection required.
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Milestone Pharmaceuticals sets June 10, 2025 as annual meeting date; record date April 15
2025 annual meeting scheduled for June 10, 2025; record date for voting is April 15, 2025.
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Milestone Pharmaceuticals amends ATM sales agreement with Jefferies to up to $77.8M
Amended Open Market Sale Agreement replaces prior $50M facility; total capacity increased to $77.8M including ~$2.8M already sold.
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Milestone reports Q4 2024 net loss $12.4M; FDA PDUFA date for CARDAMYST is March 27, 2025
FDA PDUFA goal date for CARDAMYST (etripamil) in PSVT is March 27, 2025; launch targeted for mid-2025 if approved.
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Milestone Pharma provides corporate presentation ahead of March 27 PDUFA for CARDAMYST
NDA for CARDAMYST (etripamil) nasal spray remains under FDA review with PDUFA date of March 27, 2025.
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Milestone reports Q3 net loss of $9.4M; PDUFA for CARDAMYST set for March 27, 2025
PDUFA target date for CARDAMYST (etripamil) in PSVT is March 27, 2025.
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Milestone Pharmaceuticals appoints Joseph Papa to Board of Directors
Joseph Papa, CEO of Emergent BioSolutions, appointed director effective Sept 3, 2024; over 35 years pharma experience.
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Milestone Q2 net loss $9.4M; FDA acceptance of CARDAMYST NDA with PDUFA March 2025
FDA accepted CARDAMYST (etripamil) NDA for PSVT; PDUFA target date set for March 2025.
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Milestone adds two directors, plans third under agreement with Alta activist investor
Appointed Stuart Duty and Andrew Saik as independent directors effective July 14, 2024.
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Milestone Pharma gets FDA NDA acceptance for CARDAMYST (etripamil) nasal spray for PSVT
FDA accepted NDA on May 26, 2024 for CARDAMYST (etripamil) nasal spray for paroxysmal supraventricular tachycardia (PSVT).
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Milestone restarts PSVT NDA for etripamil; cash of $89.5M funds into 2026
NDA for etripamil in PSVT resubmitted after FDA Type A meeting; standard review expected, potential approval in H1 2025.
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Milestone Pharma reports positive Phase 3 etripamil data for PSVT self-treatment
NODE-303 open-label study: etripamil nasal spray restored sinus rhythm with median time-to-conversion 17.0 minutes.
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Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray to FDA for PSVT
NDA resubmission for self-administered etripamil nasal spray to treat paroxysmal supraventricular tachycardia (PSVT).
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Milestone Pharma reports Q4 net loss of $13.6M; on track to resubmit NDA for etripamil in PSVT early Q2 2024
Net loss of $13.6M in Q4 2023, full year net loss $59.7M; Q4 revenue was $0 (vs $3.5M in Q4 2022).
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Milestone Pharmaceuticals prices $30M public offering; net proceeds ~$32.4M
Offering of 16,666,667 common shares at $1.50/share and 3,333,333 pre-funded warrants at $1.499/warrant.
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Milestone Pharma plans to resubmit NDA for etripamil in 2Q2024 after FDA Type A meeting
FDA indicated that timing of adverse events had minimal impact on overall etripamil safety profile.
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Milestone Pharma receives FDA refusal to file for etripamil NDA for PSVT
FDA issued Refusal to File letter for etripamil NDA submitted October 2023.
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Milestone's etripamil Phase 2 meets primary endpoint; 30 bpm ventricular rate reduction vs placebo
Mean ventricular rate reduction of 29.91 bpm vs placebo (p<0.0001); absolute max reduction 35 bpm etripamil vs 5 bpm placebo.
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Milestone Pharma reports Q3 2023 results; NDA submitted for etripamil in PSVT
Cash $75.7M as of Sep 30, 2023; expected to fund operations into mid-2025.
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Milestone to host webcast Nov 13 on etripamil Phase 2 AFib-RVR study results
Webcast on Monday Nov 13, 2023 at 8:00 a.m. ET to discuss ReVeRA Phase 2 results of etripamil in AFib-RVR.
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Milestone files NDA for etripamil; Phase 3 showed 2x efficacy, 3x speed vs placebo
Submitted NDA to FDA for etripamil (CARDAMYST) for paroxysmal supraventricular tachycardia (PSVT) on Oct 24, 2023.
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Milestone Pharma Q2 2023: cash $87.6M, NDA for etripamil due Oct 2023
Cash, equivalents & short-term investments of $87.6M; runway into mid-2025.
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Milestone Pharmaceuticals holds 2023 annual meeting; all director nominees elected
All seven director nominees elected with substantial votes for; highest withheld was Robert J. Wills with 1,317,985 withheld.
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Milestone Pharma Q1 operating loss $15M; etripamil NDA on track for Q3 2023
Cash of $101M as of March 31, 2023; with $125M RTW financing, runway into mid-2025.
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Milestone Pharma raises $50M in convertible notes and $75M contingent royalty sale
Issued $50M principal of 6.0% Convertible Senior Notes due 2029 to RTW Investments.
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Milestone reports FY2022 operating loss of $58.4M; NDA for etripamil on track for Q3 2023
Cash, equivalents, and short-term investments of $64.6M as of Dec 31, 2022; plus $50M from March 2023 private placement expected to fund into mid-2025.
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Milestone Pharmaceuticals secures $125M financing from RTW for etripamil PSVT program
$50M in 6.0% convertible senior notes due 2029, convertible at $5.23/share (50% premium over VWAP).
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Milestone exchanges 1.06M shares with RTW for pre-funded warrants; adds director Fischer
Exchanged 1,059,000 common shares with RTW Investments for pre-funded warrants at $0.001 exercise price, no expiration.
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Milestone Pharmaceuticals confirms no deposits or accounts at Silicon Valley Bank
Company states it does not hold any deposits or securities at Silicon Valley Bank.
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Milestone Pharmaceuticals provides updated corporate presentation at Cowen Healthcare Conference
Presentation filed as Exhibit 99.1; no financial figures or material updates disclosed in filing body.
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CSO Francis Plat to retire Dec 31; company details etripamil commercial plan with NDA in mid-2023
CSO Francis Plat retires Dec 31, 2022; consulting agreement at $15k/month (Stage 1) or $300/hr (Stages 2/3).
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Milestone reports Q3 operating loss $14.6M; Phase 3 RAPID trial meets primary efficacy endpoint
Phase 3 RAPID trial met primary endpoint: 64.3% etripamil vs 31.2% placebo conversion to sinus rhythm within 30 min (HR=2.62, p<0.001).
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Milestone Pharma announces positive Phase 3 RAPID trial results for etripamil in PSVT
Primary endpoint met: 64.3% of etripamil patients converted to sinus rhythm within 30 min vs 31.2% placebo (HR=2.62, p<0.001).
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Milestone Pharma: Phase 3 RAPID PSVT trial reaches 180 events; topline data on track for mid-H2 2022
Q2 2022 operating loss $16.8M vs income $0.7M prior year due to $15M one-time revenue from Ji Xing in 2021; cash $86.2M.
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Milestone Pharmaceuticals shareholders elect directors, approve auditor and equity plan amendment at 2022 meeting
All six director nominees elected: Joseph Oliveto, Lisa M. Giles, Richard Pasternak, Debra K. Liebert, Michael Tomsicek, Robert J. Wills. Votes for each ranged 19,105,725 – 19,110,012.
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Milestone Pharma reports FY2021 net loss of $42.9M; revenue of $15M from collaboration
Net loss for FY2021 was $42.9M ($1.02 loss per share) vs $50.0M ($1.70 loss per share) in FY2020.