Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company ...

Core Insights - BridgeBio Pharma, Inc. is hosting an investor webinar on September 10, 2025, focusing on its Phase 3 clinical trial for autosomal dominant hypocalcemia type 1 (ADH1) [1][2] - Dr. Rachel Gafni will discuss the pathophysiology of ADH1, the unmet medical needs, and the rationale for evaluating encaleret as a treatment [2] - The ongoing CALIBRATE study is expected to provide topline results in fall 2025 [2] Company Overview - BridgeBio Pharma is a biopharmaceutical company established to develop transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [4] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient treatment [4] Webinar Access - The investor webinar can be accessed via the "Events & Presentations" section on BridgeBio's website, with a replay available for 30 days post-event [3]

C4T to Host Webcast on September 20, 2025 at 3 pm ETWATERTOWN, Mass., Sept. 03, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that data from its Phase 1 dose escalation clinical trial of cemsidomide in multiple myeloma (MM) will be shared in an oral presentation at the International Myeloma Society (IMS) Annual Meeting on September 20, 2025 at 11:10 am ET in Toronto, ...

Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a clinical-stage biotechnology company developing next-generation therapies for Alzheimer ...

SEATTLE, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that its Board of Directors has appointed Maya Martinez-Davis as an independent director to the Company’s Board of Directors, effective today. Ms. Martinez-Davis currently serves as President of GSK’s U.S. Commercial business, a position she has held since September 2019 ...

LA JOLLA, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), announces that Yuichi Iwaki, MD., Ph.D., President and CEO, and David H. Crean, PhD, Chief Business Officer will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference. The conference is being held on September 8 – 10, 2025 at the Lotte ...

Core Points - Pharming Group N.V. will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York from September 8-10, 2025 [1] - CEO Fabrice Chouraqui is scheduled to present on September 8 at 1:30pm EDT/19:30 CEST [1] - A live webcast and replay of the presentation will be available on Pharming's website [1] Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing innovative medicines for patients with rare and life-threatening diseases [3] - The company is headquartered in Leiden, the Netherlands, and operates in over 30 markets across North America, Europe, the Middle East, Africa, and Asia-Pacific [3]

Core Insights - BioArctic AB's partner Eisai has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous autoinjector, following the FDA granting Fast Track Status [1][15] - Leqembi Iqlik, if approved, would be the first anti-amyloid treatment allowing at-home injection from the start, enhancing treatment accessibility for Alzheimer's disease patients [1][2] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, having developed Leqembi, the first drug proven to slow Alzheimer's disease progression [11] - The collaboration between BioArctic and Eisai dates back to 2005, with Eisai responsible for clinical development and commercialization, while BioArctic retains rights for commercialization in the Nordic region [4][10] Product Details - Leqembi is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, and is currently approved in 48 countries, with regulatory reviews ongoing in 10 countries [2][7] - The sBLA submission is based on Phase 3 clinical studies evaluating subcutaneous administration of lecanemab, which could offer a weekly starting dose as an alternative to bi-weekly intravenous dosing [2][3] Clinical Development - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and aims to assess the efficacy of lecanemab [9] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing, incorporating lecanemab as a key anti-amyloid therapy [9] Treatment Mechanism - Leqembi targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][14] - The subcutaneous formulation of Leqembi has the potential to reduce healthcare resource utilization associated with intravenous dosing, streamlining the treatment pathway for Alzheimer's disease [2]

Core Viewpoint - Mineralys Therapeutics, Inc. has announced an upsized underwritten public offering of 9,803,921 shares at a price of $25.50 per share, aiming to raise approximately $250 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 9,803,921 shares priced at $25.50 each, with expected gross proceeds of around $250 million [1]. - Mineralys has granted underwriters a 30-day option to purchase an additional 1,470,588 shares [1]. - The offering is anticipated to close on or about September 4, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes [3]. Group 3: Underwriters - BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities are serving as joint book-running managers for the offering [2]. - LifeSci Capital is acting as the lead manager, while H.C. Wainwright & Co. is the co-manager for the offering [2]. Group 4: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [6].

Core Insights - The company has achieved progress with two approved traditional disease-modifying treatment options available for patients [1] - The development of Sabirnetug as an A-beta oligomer-directed antibody is seen as a distinct approach to address disease pathology, potentially offering better efficacy and safety [1] - Sabirnetug has been intentionally developed to neutralize toxic species, indicating a unique position in the treatment landscape [1] - The company envisions that the field will continue to evolve, with oligomer-directed treatment approaches like Sabirnetug being the best option for patients [1]