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Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata
Prnewswire· 2026-02-27 13:11
Core Viewpoint - Eli Lilly's Olumiant (baricitinib) has received a positive opinion from the European Medicines Agency's CHMP for expanded use in adolescents aged 12 to under 18 with severe alopecia areata, based on promising data from the Phase 3 BRAVE-AA-PEDS study [1][2]. Group 1: Clinical Study Results - The Phase 3 BRAVE-AA-PEDS study showed that 42.4% of adolescents treated with Olumiant achieved 80% or more scalp hair coverage at 36 weeks, compared to 4.5% in the placebo group [1]. - Near-complete scalp hair coverage (90%) was achieved by 36.5% of patients on Olumiant, while only 2.3% of those on placebo reached this level [1]. - Significant eyebrow regrowth was observed in 50% of patients on Olumiant, compared to 0% in the placebo group [1]. - Eyelash regrowth was reported in 42.9% of patients treated with Olumiant, versus 14.0% in the placebo group [1]. Group 2: Regulatory and Market Implications - The positive CHMP opinion is a step towards European regulatory approval, with a decision from the European Commission expected in the next one to two months [1]. - Lilly has also submitted Olumiant for approval in the U.S. for treating severe alopecia areata in adolescents, with a decision anticipated in the second half of 2026 [1][2]. - Olumiant is already approved for adult patients with severe alopecia areata in the U.S. and Europe, marking it as the first JAK inhibitor approved for this indication [1][2]. Group 3: Safety and Efficacy Profile - The safety profile of Olumiant in adolescents aligns with previous clinical trials for other conditions, such as juvenile idiopathic arthritis and atopic dermatitis [1]. - Over 14,600 patients have participated in clinical trials involving Olumiant, with more than 1,200 being children and adolescents [1]. - The ongoing BRAVE-AA-PEDS trial includes a cohort of children aged 6 to under 12 years, further expanding the understanding of Olumiant's safety and efficacy in younger populations [1].
OPKO Health(OPK) - 2025 Q4 - Earnings Call Transcript
2026-02-26 22:32
OPKO Health (NasdaqGS:OPK) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Company ParticipantsAdam Logal - SVP and CFOElias Zerhouni - Vice Chairman and PresidentGary Nabel - CIOPhillip Frost - Chairman and CEOYvonne Briggs - Director of Investor RelationsNone - Company RepresentativeConference Call ParticipantsBrian Cheng - Executive Director and Senior Biotech AnalystEdward Tenthoff - Managing Director and Senior Research AnalystMaury Raycroft - Equity Research AnalystYale Jen - Senior Biotech Analys ...
OPKO Health(OPK) - 2025 Q4 - Earnings Call Transcript
2026-02-26 22:32
OPKO Health (NasdaqGS:OPK) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Company ParticipantsAdam Logal - SVP and CFOElias Zerhouni - Vice Chairman and PresidentGary Nabel - CIOPhillip Frost - Chairman and CEOYvonne Briggs - Director of Investor RelationsNone - Company RepresentativeNone - Company RepresentativeConference Call ParticipantsBrian Cheng - Executive Director and Senior Biotech AnalystEdward Tenthoff - Managing Director and Senior Research AnalystYale Jen - Senior Biotech AnalystOperatorHe ...
GoodRx(GDRX) - 2025 Q4 - Earnings Call Transcript
2026-02-26 14:02
GoodRx (NasdaqGS:GDRX) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsAubrey Reynolds - Director of Investor RelationsCameron Harbilas - Equity Research AssociateChris McGinnis - CFOJohn Ransom - Managing DirectorLaura Jensen - Chief Commercial Officer and President of Pharma DirectLisa Gill - Managing DirectorSteven Valiquette - Managing DirectorWendy Barnes - CEOConference Call ParticipantsAllen Lutz - Senior Equity Research AnalystDaniel Grosslight - Senior Research AnalystGeorge ...
礼来公司:Orforglipron在Achieve-3研究中表现优于口服司美格鲁肽
Jin Rong Jie· 2026-02-26 12:24
礼来公司:Orforglipron在Achieve-3研究中表现优于口服司美格鲁肽,达成所有主要及关键次要终点。 ...
Eli Lilly reports additional data on weight-loss pill from diabetes trial
Reuters· 2026-02-26 11:32
Core Insights - Eli Lilly released new data from a head-to-head trial comparing its experimental weight-loss pill orforglipron with Novo Nordisk's oral semaglutide in diabetes patients, highlighting the competitive landscape in the weight-loss medication market [1] Group 1: Trial Results - The trial demonstrated that orforglipron led to a greater percentage of weight loss compared to semaglutide, with patients on orforglipron losing an average of 15% of their body weight over a 16-week period [1] - Eli Lilly's orforglipron showed a favorable safety profile, with fewer gastrointestinal side effects reported compared to semaglutide [1] Group 2: Market Implications - The results position Eli Lilly to potentially capture a significant share of the growing weight-loss medication market, which is increasingly competitive with the presence of established players like Novo Nordisk [1] - Analysts suggest that the positive trial outcomes could enhance Eli Lilly's market valuation and investor interest in its pipeline of weight-loss treatments [1]
Schrodinger(SDGR) - 2025 Q4 - Earnings Call Transcript
2026-02-25 22:32
Schrödinger (NasdaqGS:SDGR) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsConor MacKay - Equity Research AssociateJaren Madden - Chief Corporate Affairs Officer and Head of Investor RelationsKaren Akinsanya - President, Head of Therapeutics R&D, and Partnerships Chief Strategy OfficerRamy Farid - CEORichie Jain - CFONone - Company RepresentativeNone - Company RepresentativeNone - Company RepresentativeNone - Company RepresentativeConference Call ParticipantsBrendan Smith - Director ...
Novo Nordisk and Eli Lilly shares both fall after Ozempic price-cut plan
MarketWatch· 2026-02-24 12:51
Group 1 - Shares of Novo Nordisk and Eli Lilly experienced a decline on Tuesday due to a report indicating that price cuts are forthcoming for their popular weight-loss drugs [1]
Novo's stumbles burnish Lilly's widening lead in weight-loss drugs
Reuters· 2026-02-24 05:09
Core Insights - Novo Nordisk's recent trial data for its obesity drug CagriSema has underperformed compared to Eli Lilly's Zepbound, raising concerns about Novo's competitiveness in the weight-loss drug market [1] - Following the trial results, Novo's shares dropped by 16%, while Lilly's shares increased by 5%, indicating a shift in market sentiment towards Lilly's products [1] - Analysts express skepticism about Novo's ability to regain market share, citing repeated disappointments with CagriSema and the strong positioning of Lilly's portfolio [1] Novo Nordisk's Performance - CagriSema achieved a 23% reduction in body weight over 84 weeks, compared to a 25.5% reduction for Lilly's tirzepatide [1] - The trial results align with previous data for CagriSema but are seen as inferior to Lilly's offerings, which could solidify Lilly's dominance in the obesity market [1] - Novo's management attempted to downplay the trial results, but analysts and investors remain unconvinced, questioning the drug's value proposition [1] Market Dynamics - The obesity drug market is increasingly favoring Lilly, which has a stronger product range and is expected to receive U.S. approval for its weight-loss pill in April [1] - Novo's historical lead in the obesity drug market, particularly with the launch of Wegovy in 2021, has diminished as Lilly's valuation has surged to a trillion dollars [1] - Analysts suggest that Novo may struggle to compete effectively against Lilly's Zepbound, which is already well-established in the market [1]
Eli Lilly's Zepbound Gets FDA OK for Multi-Dose Pen
WSJ· 2026-02-23 17:06
Core Viewpoint - The company announced that its weight-loss drug will be available at the same self-pay price in both single-dose vial format and multi-dose pen format, which allows for four weekly injections from a single device [1] Group 1 - The weight-loss drug will be offered in two formats: single-dose vials and multi-dose pens [1] - The multi-dose pen format enables patients to receive four weekly injections from one device [1]