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BridgeBio to Host Limb-girdle Muscular Dystrophy Type 2I/R9 Investor Webinar on Friday, July 11th at 8:00 am ET
Globenewswire· 2025-06-26 11:30
PALO ALTO, Calif., June 26, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced the Company will host an investor webinar on Friday, July 11, 2025 at 8:00 am ET with Matthew Wicklund, M.D., FAAN, Professor of Neurology and Vice Chair for Research, Department of Neurology at the University of Texas (UT) Health Science Center San Antonio. Dr. Wicklund will provide an overview of limb ...
Excelitas Appoints Lynn Swann to Board of Directors
GlobeNewswire News Room· 2025-06-25 14:41
Excelitas is a leading provider of advanced, life-enriching technologies that make a difference, serving global market leaders in the life sciences, advanced industrial, next-generation semiconductor and avionics end markets. Headquartered in Pittsburgh, PA, USA, Excelitas is an essential partner in the design, development and manufacture of advanced technologies, offering leading-edge innovation in sensing, detection, imaging, optics and specialty illumination for customers worldwide. Excelitas is at the f ...
ACADIA Pharmaceuticals (ACAD) Update / Briefing Transcript
2025-06-25 13:30
ACADIA Pharmaceuticals (ACAD) Update / Briefing June 25, 2025 08:30 AM ET Speaker0 All right. Speaker1 Good morning, everybody, and thank you so much for joining us for Acadia's inaugural R and D Day. Welcome to the people in the room here at our hotel. Welcome to everybody online. We're delighted that you took time today to join us because today marks an exciting milestone for the company as we open the curtain on the innovation engine driving our future. We're here to share meaningful insights into our pi ...
Minovia Therapeutics Ltd. and Launch One Acquisition Corp. Announce Proposed Business Combination to Create Nasdaq-Listed Mitochondrial Therapy Company in $1 Trillion+ Mitochondrial and Longevity Markets
Globenewswire· 2025-06-25 12:30
Minovia’s mitochondrial augmentation technology (MAT) targets multi-organ clinical benefits; lead program MNV-201 has both FDA Fast Track Designation and Rare Pediatric Disease designation and is preparing for its first pivotal clinical trialHAIFA, Israel, and GEORGE TOWN, Cayman Islands, June 25, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing what it believes to be first-in-class therapies to treat mitochondrial diseases an ...
ORYZON to Host Virtual KOL Event on July 9, 2025
Globenewswire· 2025-06-25 12:00
To discuss the unmet medical need in Borderline Personality Disorder (BPD) and the design of vafidemstat's Phase III PORTICO-2 trial in BPD MADRID and CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today that it will host a virtual KOL event on Wednesday, July 9, 2025 at 12:00 pm ET. The event, moderated by Michael Ropacki, PhD and Oryzon's CMO for CNS, will f ...
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
GlobeNewswire News Room· 2025-06-25 08:00
Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) who were symptomatic despite H1 antihistamine treatment [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a confirmatory dose of 300 mg over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of the study results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted the milestone in expanding patient access to specialty medicines in key markets [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing to the European Medicines Agency (EMA) expected by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with a pipeline that includes nine disclosed biosimilar candidates targeting various therapeutic areas [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a robust infrastructure for R&D, clinical, manufacturing, and regulatory capabilities [16] - Advanz Pharma aims to improve patient lives through specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [14]
X @Tesla Owners Silicon Valley
Tesla Owners Silicon Valley· 2025-06-24 17:36
Starlink is expanding into Vietnam with a focus on improving healthcare connectivity.The goal: enable telemedicine, remote consultations, and digital health infrastructure. https://t.co/zVYfzTycQo ...
Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Globenewswire· 2025-06-24 10:30
Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS program addres ...
EXACT Therapeutics announces first patient dosed in Phase 2 trial in patients with locally advanced pancreatic cancer
Globenewswire· 2025-06-24 06:00
Core Insights - EXACT Therapeutics has initiated its ENACT trial, marking the first patient dosed in a Phase 2 clinical trial for Acoustic Cluster Therapy (ACT) in pancreatic cancer patients [1][2] - The trial aims to address the significant unmet medical need in treating pancreatic cancer, which has over 500,000 new diagnoses globally each year and is known for its high mortality rate [2] - The Phase 2 trial will enroll up to 25 patients across the U.S., U.K., and Europe, following positive results from a Phase 1 trial involving patients with liver metastases of colorectal origin [3] Company Overview - EXACT Therapeutics is a clinical-stage precision medicine company focused on utilizing ultrasound and microbubbles for targeted drug delivery in oncology [4] - The company’s Acoustic Cluster Therapy (ACT) represents a novel approach that may be applicable to various therapeutic agents in oncology and other medical indications, including brain diseases [4] - Shares of EXACT Therapeutics are traded on Euronext Growth Oslo under the ticker EXTX [4]
iBio Presents Next-Generation Obesity and Cardiometabolic Pipeline Candidates on June 24 Conference Call
Globenewswire· 2025-06-23 20:15
Review of promising Myostatin and Activin E antibody data iBio to announce 3rd target in Astral Bio Collaboration Conference call Tuesday, June 24 at 8:30 a.m. ET SAN DIEGO, June 23, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (Nasdaq: IBIO), an AI-driven innovator of precision antibody therapies, today announced the Company will host a conference call on Tuesday, June 24, at 8:30 a.m. ET to review its latest advances in obesity and cardiometabolic disease treatments and announce a third target in the AstralBio Col ...