Iovance Biotherapeutics (NasdaqGM:IOVA) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAndrew Tsai - Managing DirectorBrian Gastman - EVP of Transitional Medicine and ResearchCorleen Roche - CFODan Kirby - Chief Commercial OfficerDavid Dai - DirectorFrederick Vogt - Interim CEO and PresidentIgor Bilinsky - COOReni Benjamin - Managing DirectorSara Pellegrino - SVP of Investor Relations and Corporate CommunicationsNone - Company RepresentativeConference Call ParticipantsAsthika Goonew ...

Iovance Biotherapeutics (NasdaqGM:IOVA) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAndrew Tsai - Managing DirectorBrian Gastman - EVP of Transitional Medicine and ResearchCorleen Roche - CFODan Kirby - Chief Commercial OfficerDavid Dai - DirectorFrederick Vogt - Interim CEO and PresidentFriedrich Finckenstein - Chief Medical OfficerIgor Bilinsky - COOReni Benjamin - Managing DirectorSara Pellegrino - SVP of Investor Relations and Corporate CommunicationsNone - Company Representa ...

Apellis Pharmaceuticals (NasdaqGS:APLS) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAnupam Rama - Biotechnology Equity ResearchCaroline Baumal - CMOCedric Francois - Co-Founder, CEO, and PresidentDavid Acheson - EVP of CommercialEllie Merrill - Biotechnology Equity Research AssociateEva Stroynowski - Investor Relations and Corporate Affairs Biotechnology ExecutiveJayed Momin - Biopharma Equity Research AssociateJonathan Miller - Equity Research, Biotech and PharmaceuticalsTazeen ...

Core Insights - The FDA has approved Dupixent (dupilumab) as the first and only treatment for allergic fungal rhinosinusitis (AFRS) in patients aged 6 years and older with a history of sino-nasal surgery, marking a significant advancement in the treatment of this condition [2][3][4] Group 1: Approval and Indications - Dupixent is now approved for treating nine distinct diseases driven by type 2 inflammation, including sino-nasal, skin, gut, and respiratory system diseases [6] - The approval was based on the LIBERTY-AFRS-AIMS phase 3 study, which demonstrated significant improvements in sinus opacification scores and nasal symptoms compared to placebo [4][10] Group 2: Clinical Study Results - In the LIBERTY-AFRS-AIMS study, Dupixent improved sinus opacification scores by 50% compared to 10% for placebo at Week 52, with a significant reduction also observed at Week 24 [4][11] - Patient-reported nasal congestion improved by 67% at Week 24 and 81% at Week 52 compared to 25% and 11% for placebo, respectively [7][13] - Dupixent reduced the risk of systemic corticosteroid use and/or surgery by 92%, with only 3% of patients on Dupixent requiring systemic corticosteroids compared to 31% on placebo [13] Group 3: Safety Profile - The safety profile of Dupixent in the LIBERTY-AFRS-AIMS study was consistent with its known safety profile in chronic rhinosinusitis with nasal polyps (CRSwNP), with common adverse reactions including injection site reactions and conjunctivitis [8][9] Group 4: Market Impact and Future Plans - Dupixent's approval is expected to establish a new standard of care for patients with AFRS, addressing a high unmet need in the treatment landscape [9] - Sanofi and Regeneron plan to submit additional applications to regulatory authorities worldwide to expand access to Dupixent [9][17]

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis Approval in adults and children aged 6 years and older supported by phase 3 study demonstrating Dupixent significantly reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placeboAFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurr ...

Iovance Biotherapeutics (NasdaqGM:IOVA) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Speaker9Good day. Thank you for standing by. Welcome to the Iovance Biotherapeutics fourth quarter and full year 2025 financial results and corporate updates conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one one on your telephone. You will hear ...

Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery compared to placebo AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurrence Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 inflammation, i ...

Beam Therapeutics (NasdaqGS:BEAM) Q4 2025 Earnings call February 24, 2026 08:00 AM ET Company ParticipantsAditya Lonial - Senior Managing DirectorAlec Stranahan - VP of Equity ResearchAmy Simon - Chief Medical OfficerGiuseppe Ciaramella - PresidentGopi Shanker - Chief Scientific OfficerHolly Manning - Vice President of Investor Relations and External CommunicationsJohn Evans - CEOKiran Musunuru - Professor of MedicineSravan Emany - CFOYannan Liu - Equity Research AssociateConference Call ParticipantsBrian C ...

Fulcrum Therapeutics (NasdaqGM:FULC) Q4 2025 Earnings call February 24, 2026 08:00 AM ET Company ParticipantsAlex C. Sapir - President and CEOCorinne Johnson - VPGregory Renza - Managing DirectorIain Fraser - SVP of Early DevelopmentJames Condulis - VP of Biotechnology Equity ResearchMartin Steinberg - Professor of Medicine, Pediatrics, Pathology, and Laboratory MedicineMatthew Biegler - Managing DirectorConference Call ParticipantsAnupam Rama - Managing Director and Senior Equity AnalystJoseph Schwartz - M ...

Beam Therapeutics (NasdaqGS:BEAM) Q4 2025 Earnings call February 24, 2026 08:00 AM ET Company ParticipantsAditya Lonial - Senior Managing DirectorAlec Stranahan - VP of Equity ResearchAmy Simon - Chief Medical OfficerGiuseppe Pino Ciaramella - PresidentGopi Shanker - Chief Scientific OfficerHolly Manning - Vice President of Investor Relations and External CommunicationsJohn Evans - CEOKiran Musunuru - Professor of MedicineSravan Emany - CFOYannan Liu - Equity Research AssociateConference Call ParticipantsBr ...