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Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline
Globenewswire· 2025-06-30 20:05
Long-term efficacy and safety data on PALSONIFYTM (paltusotine) in acromegaly to be presented, including evidence of both biochemical and symptom control with a well-tolerated safety profile in patients switching treatments and those not previously pharmacologically treated Atumelnant Phase 2 trial results in congenital adrenal hyperplasia (CAH) to be featured in oral presentation Data from early-stage development program in Graves’ hyperthyroidism and orbitopathy also to be featured SAN DIEGO, June 30, 2 ...
Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain
Benzinga· 2025-06-30 15:52
INmune Bio Inc. INMB stock is trading lower on Monday, with a session volume of 23.2 million, compared to the average volume of 1.45 million, as per data from Benzinga Pro. The company announced results from its Phase 2 MINDFuL trial evaluating XPro, a selective soluble TNF inhibitor, in early Alzheimer's Disease with biomarkers of inflammation. Also Read: Europe Approves Eisai-Biogen's Alzheimer's Drug 'Under Strict Conditions' After Initial Negative Opinion Despite showing no effects in the modified inten ...
Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings
Globenewswire· 2025-06-30 12:00
SALT LAKE CITY, June 30, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today provided a regulatory update following a Type C meeting with the U.S. Food and Drug Administration (FDA), and announced two additional meetings scheduled with the FDA in the 3rd quarter of 2025. In th ...
Neurocrine Biosciences Presents New Post-Hoc Data Analyses from KINECT®-HD Study Demonstrating Significant Reduction in Disease Burden with INGREZZA® (valbenazine) Capsules for Huntington's Disease Chorea
Prnewswire· 2025-06-27 12:30
Patient-reported analyses demonstrated greater reduction in both cognitive and motor-related disease burden for INGREZZA compared with placebo Findings to be presented at the 2025 Advanced Therapeutics in Movement & Related Disorders (ATMRD) CongressSAN DIEGO, June 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new patient-reported post-hoc data from the KINECT®-HD study highlighting significant reductions in both cognitive and motor-related burdens among adults treate ...
Acumen Pharmaceuticals (ABOS) Earnings Call Presentation
2025-06-27 11:15
Corporate Presentation May 2025 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen's goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as "believes," "expects," "anticipates," "could," "would," "seeks," "aims," "plans," "potential," "will" and similar expres ...
Ocular Therapeutix™ Unveils New Corporate Branding, Reflecting its Transformation to a Retina-Focused Company
Globenewswire· 2025-06-26 17:54
Core Insights - Ocular Therapeutix has launched a new corporate branding and website, marking a significant transformation towards becoming a retina-focused company [1][8] - The new branding reflects the company's innovative vision and commitment to redefining the retina experience, particularly in the treatment of retinal diseases [3][6] Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company dedicated to redefining the retina experience, with a focus on innovative treatments for retinal diseases [9] - The investigational therapy AXPAXLI™ (OTX-TKI) is an axitinib hydrogel designed for intravitreal injection, aimed at improving treatment durability and long-term outcomes for patients with wet age-related macular degeneration (wet AMD) [7][9] Market Context - Wet AMD affects approximately 1.8 million people in the U.S., and current treatment options often require up to 12 injections per year, leading to patient burden and potential treatment discontinuation [6] - The company aims to disrupt existing treatment paradigms for retinal diseases, addressing the high burden associated with current pulsatile treatments [6][3] Product Pipeline - Ocular's pipeline includes AXPAXLI™, currently in Phase 3 clinical trials for wet AMD, and DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [10] - The investigational product OTX-TIC is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension, leveraging the company's proprietary ELUTYX™ technology [10]
Zevra Therapeutics (ZVRA) Earnings Call Presentation
2025-06-26 12:39
June 2025 NasdaqGS: ZVRA 1 A Rare Approach to Therapeutics Cautionary Note Regarding Forward-Looking Statements Presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements relate to future events or our future financial performance. We generally identify forward-looking statements by terminology such as "may," "will," "would," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," " ...
Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
Globenewswire· 2025-06-25 20:45
Core Insights - Vor Bio has secured exclusive global rights (excluding Greater China) to develop and commercialize telitacicept, a dual-target recombinant fusion protein for autoimmune diseases [1][6] - RemeGen has received an initial payment of $125 million, which includes a $45 million upfront payment and $80 million in warrants, along with potential milestones exceeding $4 billion and tiered royalties [1][5] - Jean-Paul Kress, MD, has been appointed as the new CEO and Chairman of Vor Bio, bringing extensive experience in clinical development and commercialization [3][4] Company Developments - Vor Bio is focused on advancing telitacicept through Phase 3 clinical development to address serious autoantibody-driven conditions globally [7] - RemeGen is conducting a global Phase 3 clinical trial for telitacicept, with initial results expected in the first half of 2027 [2][6] - The strategic out-licensing of telitacicept's ex-China rights is aimed at maximizing its clinical and commercial potential on a global scale [5] Product Information - Telitacicept targets key immune pathways by inhibiting BlyS (BAFF) and APRIL, which are critical for B cell survival, thereby reducing autoreactive B cells and autoantibody production [2][5] - In a Phase 3 trial in China for generalized myasthenia gravis, telitacicept showed a 4.8-point improvement in the MG-ADL scale compared to placebo at 24 weeks [5]
Novartis completes acquisition of Regulus Therapeutics
Globenewswire· 2025-06-25 13:13
Basel, June 25, 2025 – Novartis today announced that it has successfully completed its acquisition of Regulus Therapeutics Inc. (“Regulus”). With the completion of the acquisition, shares of common stock, par value $0.001 per share (the “Shares”), of Regulus, have ceased trading on the Nasdaq Stock Market LLC and Regulus is now an indirect wholly owned subsidiary of Novartis. “We are pleased to complete this transaction and take the next step in advancing clinical development for a potential first-in-class ...
InMed's INM-901 Significantly Reduces Neuroinflammation in Alzheimer's Disease Ex Vivo Study
Newsfile· 2025-06-24 11:00
June 24, 2025 7:00 AM EDT | Source: InMed Pharmaceuticals Vancouver, British Columbia--(Newsfile Corp. - June 24, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential a ...