Sotyktu

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BMY Reports Positive Data on Sotyktu From Arthritis Study
ZACKS· 2025-06-12 14:16
Core Insights - Bristol Myers (BMY) announced that the late-stage study on Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) met its primary endpoint, indicating significant efficacy [1][4] - Sotyktu is an oral, selective tyrosine kinase 2 (TYK2) inhibitor, representing a new class of small molecules and is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases [1][4] - The drug is already approved in numerous countries for the treatment of adults with moderate-to-severe plaque psoriasis [2] Study Results - The phase III POETYK PsA-1 study involved 670 patients and showed a significantly greater proportion of patients treated with Sotyktu achieving ACR20 response compared to placebo at week 16 [4] - Key secondary endpoints met include Psoriasis Area and Severity Index (PASI) 75 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score, and Minimal Disease Activity (MDA) response [5] - The late-stage PsA program includes two phase III trials, POETYK PsA-1 and POETYK PsA-2, with the latter enrolling approximately 730 patients [6] Licensing and Strategic Moves - BMY's subsidiary RayzeBio entered into a $1.35 billion licensing deal with Philochem for the prostate cancer therapy OncoACP3, which includes a $350 million upfront payment and potential milestones of $1 billion [9][10] - BMY is looking to expand its portfolio and pipeline due to generic competition faced by legacy drugs, with a potential label expansion of Sotyktu to broaden its target patient population [11] - A strategic collaboration agreement was announced with BioNTech for the co-development and co-commercialization of the investigational bispecific antibody BNT327 [12] Market Performance - Shares of Bristol Myers have declined by 15.9% over the past three months, while the industry has seen a decline of 5.3% [2] - BMY has experienced pipeline setbacks recently, negatively impacting its share price [13]
J&J Oral Psoriasis Drug Meets Primary Goal in Late-Stage Study
ZACKS· 2025-05-12 13:15
Core Insights - Johnson & Johnson (J&J) announced positive results from the phase III ICONIC-TOTAL study for its investigational oral peptide, icotrokinra, aimed at treating plaque psoriasis in patients with moderate severity affecting sensitive areas [1][7]. Study Results - The study met its primary endpoint, with 57% of patients treated with icotrokinra achieving significant skin clearance compared to only 6% in the placebo group, as measured by the Investigator's Global Assessment (IGA) [2]. - In specific subgroups, 66% of patients with scalp psoriasis achieved clear or almost clear skin with icotrokinra versus 11% in the placebo group; 77% of patients with genital psoriasis achieved significant clearance compared to 21% in the placebo group; and 42% of patients in the hand/foot subgroup achieved clearance compared to 26% in the placebo group [4]. Stock Performance - Year to date, J&J's shares have increased nearly 7%, contrasting with a 6% decline in the industry [5]. Development and Collaboration - Icotrokinra is being developed in collaboration with Protagonist Therapeutics, with J&J holding exclusive worldwide rights for development beyond phase II studies [7]. - The ICONIC-TOTAL study is part of a broader late-stage ICONIC clinical program evaluating icotrokinra for psoriasis and psoriatic arthritis [8]. Additional Studies and Comparisons - J&J and Protagonist have reported positive results from two other phase III studies, ICONIC-ADVANCE 1 and 2, which demonstrated icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu [9]. - A phase III ICONIC-ASCEND study has been initiated to compare icotrokinra with J&J's own drug Stelara, aiming to provide a more convenient treatment option [10]. Market Potential - J&J believes icotrokinra has the potential to achieve peak non-risk-adjusted operational sales of $5 billion, with ongoing exploration of its use in inflammatory bowel disease [11].
Artiva Biotherapeutics Appoints Subhashis Banerjee, M.D., as Chief Medical Officer
Globenewswire· 2025-04-08 20:05
Core Insights - Artiva Biotherapeutics has appointed Dr. Subhashis Banerjee as Chief Medical Officer, enhancing its development team focused on autoimmune diseases and cell therapy [1][2] - Dr. Banerjee has over 20 years of clinical development experience, previously holding significant roles at Bristol Myers Squibb and VYNE Therapeutics [1][2] - The company aims to advance its AlloNK® program for treating B-cell driven autoimmune diseases, leveraging Dr. Banerjee's expertise in regulatory approval of major therapies [2][5] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company dedicated to developing safe and effective cell therapies for autoimmune diseases and cancers [5][6] - The lead program, AlloNK®, is a non-genetically modified NK cell therapy designed to enhance the efficacy of monoclonal antibodies for B-cell depletion [5] - Artiva was founded in 2019 as a spin-out from GC Cell, holding exclusive rights to NK cell manufacturing technology outside of Asia, Australia, and New Zealand [5] Recent Appointments - Dr. David Moriarty has been appointed as SVP of Clinical Operations, bringing nearly 25 years of experience in clinical research related to cell therapy and autoimmune diseases [3][4] - Benjamin Dewees has joined as SVP of Regulatory Affairs, with over 25 years of experience in regulatory affairs across various therapeutic areas [9] - Feng Xu has been appointed as SVP of Biometrics, contributing over 20 years of clinical development experience, including successful global regulatory filings [9]