MAINZ, Germany, October 28, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), will host an edition of the Company’s Innovation Series R&D Day at 09:00 a.m. Eastern Standard Time (3:00 p.m. CET) on Tuesday, November 11, 2025 in New York City, U.S. On the day, members of BioNTech’s leadership team will provide an overview of the Company’s strategy and clinical progress across its pipeline. Investors, analysts and the interested public are invited to join the event online via t ...

Study met primary and secondary endpointsParidiprubart demonstrated a relative reduction in the risk of death of 25%Treatment provided patients with clinically meaningful improvement in survival and recovery Paridiprubart exhibited consistent safety and tolerability profile TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, today announced positive r ...

Oct 28, 2025 7:34 AM Eastern Daylight Time Alto Neuroscience to Participate in Upcoming Investor Conferences Share MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto†) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that members of the Company's management team will present at the following upcoming investor conferences: Available presentations will be accessible via a live w ...

Core Insights - TG Therapeutics has completed enrollment in the randomized cohort of the Phase 3 ENHANCE trial for IV BRIUMVI, aimed at evaluating a consolidated dosing schedule for patients with relapsing forms of multiple sclerosis (RMS) [1][3][4] - The primary endpoint of the trial is to demonstrate non-inferior exposure in terms of area under the curve (AUC) at week 16 compared to the existing regimen [1][4] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI being its primary product approved for RMS [28] - BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody designed for efficient B-cell depletion at low doses, currently approved in the U.S. and several other countries [2][5][6] Trial Details - The ENHANCE Phase 3 trial is a randomized, double-blind, placebo-controlled study assessing the pharmacokinetics, safety, and efficacy of a modified BRIUMVI regimen [4] - Participants are divided into two arms, with one group receiving a single Day 1 infusion and the other receiving infusions on both Day 1 and Day 15 [4] Market Potential - If the trial data is positive, the new dosing regimen could be launched in 2027, enhancing patient convenience and efficiency for infusion centers [3][4] - The current one-hour infusion of BRIUMVI is already considered best-in-class among available IV anti-CD20 therapies [3] Patient Demographics - It is estimated that nearly 1 million people in the U.S. are living with multiple sclerosis, with approximately 85% initially diagnosed with relapsing-remitting multiple sclerosis (RRMS) [27] - The majority of RRMS patients eventually transition to secondary progressive multiple sclerosis (SPMS), indicating a significant market for effective treatments [27]

Core Insights - Kiniksa Pharmaceuticals reported a significant increase in net product revenue for ARCALYST, reaching $180.9 million in Q3 2025, which represents a 61% year-over-year growth [1][7] - The company raised its 2025 net sales guidance for ARCALYST to between $670 million and $675 million, up from a previous estimate of $625 million to $640 million [2][13] - KPL-387 received Orphan Drug Designation from the FDA for the treatment of pericarditis, indicating potential for expanded treatment options in this area [1][15] Financial Results - Total revenue for Q3 2025 was $180.9 million, compared to $112.2 million in Q3 2024 [7][22] - Net income for Q3 2025 was $18.4 million, a turnaround from a net loss of $12.7 million in Q3 2024 [13][22] - Cash balance increased by $44.3 million in Q3 2025, totaling $352.1 million as of September 30, 2025 [1][13] Portfolio Execution - The average total duration of ARCALYST therapy for recurrent pericarditis increased to approximately 32 months by the end of Q3 2025, up from 27 months at the end of 2024 [7] - Kiniksa is on track to report data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 trial in the second half of 2026 [2][7] - KPL-1161 is undergoing IND-enabling development activities, targeting quarterly subcutaneous dosing [5][16] Market Position - Over 3,825 prescribers have written ARCALYST prescriptions for recurrent pericarditis since its launch, indicating strong market adoption [7] - The company aims to enhance its IL-1α & IL-1β inhibition franchise with the development of KPL-387, potentially expanding its market penetration [2][15]

NEW HAVEN, Conn., Oct. 28, 2025 (GLOBE NEWSWIRE) -- WHAT: Invivyd, Inc. (Nasdaq: IVVD) is hosting the previously announced live webcast to present an overview of the company’s REVOLUTION clinical program, Invivyd’s development program for VYD2311, a vaccine-alternative monoclonal antibody candidate for the prevention of COVID. The session will feature key members of the Invivyd team. WHEN: Thursday, October 30, 2025, at 8:30 a.m. ET WHERE: Listeners are advised to join the webcast via the following link 15 ...

BOSTON, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced the Company will participate in two upcoming investor conferences. Jefferies Global Healthcare Conference in LondonDipal Doshi, Chief Executive Officer, will deliver a company presentation on Tuesday, November 18, 2025, at 5:00 p.m. Greenwich Mean Time in London. 8th Annual Evercore Healthcare ConferenceDipal Doshi, Chief Executive Officer, will participate in a fireside chat on Wednesday, December 3, 2025, a ...

BEDFORD, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Tuesday, November 4, 2025 at 8:00 AM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2025. Conference Call and Webcast Information: Date: Tuesday, November 4, 2025, at 8:00 AM ET Participant Dial-In ...

AC Immune Appoints Renowned Neurologist Catherine Mummery as Chair of Clinical Advisory Board Brings substantial expertise in development of first-in-class disease-modifying therapies in dementia across multiple novel modalitiesIncludes immunotherapies and small molecule drugs targeting intracellular proteinopathiesLeadership in groundbreaking early-stage clinical trials reinforces Company’s competencies Lausanne, Switzerland, October 28, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceut ...

Core Insights - BioMarin Pharmaceuticals (NASDAQ: BMRN) shares have been underperforming, currently trading at their lowest levels since 2013, indicating significant challenges for the company [1] Group 1 - The company is a large biopharmaceutical entity that does not pay dividends, which exacerbates the negative impact of its stock performance [1] - The investing group "Value In Corporate Events" focuses on identifying opportunities in major corporate events such as IPOs, mergers & acquisitions, and earnings reports, providing coverage of 10 significant events monthly [1]