Core Insights - Teva Pharmaceutical Industries Ltd has initiated IND-enabling studies for BD9, a dual-specific multibody targeting TSLP and IL-13, aimed at treating TH2-driven inflammatory diseases like atopic dermatitis and asthma [1][2][3] - The development of BD9 is expected to improve patient outcomes in conditions where current treatments are inadequate [2] - Teva holds an exclusive license to develop BD9 globally, with Biolojic Design Ltd eligible for milestone payments based on various achievement criteria [3][4] Financial and Market Impact - Teva's stock has seen a positive response, increasing by 6.01% to $17.98 following the announcement of the IND-enabling studies [7] - The FDA's recent approval of Teva's ALVO Selarsdi as interchangeable with Johnson & Johnson's Stelara indicates a favorable regulatory environment for Teva's product pipeline [4] Legal and Regulatory Developments - Teva has resolved patent litigation with Axsome Therapeutics regarding the generic version of Auvelity, which is approved for major depressive disorder [6][7] - The FDA issued a warning about the risk of anaphylaxis associated with glatiramer acetate, a medication sold by Teva, highlighting ongoing regulatory scrutiny [5]

Cardiol Therapeutics to Webcast Virtual Annual General Meeting of Shareholders on May 28th at 4:30 p.m. EDTMay 27, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.Toronto, Ontario--(Newsfile Corp. - May 27, 2025) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the Company's virtual Annual General M ...

Core Insights - Tiziana Life Sciences has made advancements in treating moderate Alzheimer's disease with its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which targets brain inflammation [1][2][4] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [6] - The company’s lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in previous studies [5][6] Clinical Developments - The first patient treated with intranasal foralumab, Joe Walsh, showed significant reduction in brain inflammation, indicating a promising step forward in Alzheimer's treatment [2][3] - Foralumab is also being studied in a Phase 2a trial for patients with non-active secondary progressive multiple sclerosis, with positive outcomes observed in an open-label program [4][5] Treatment Mechanism - Foralumab works by stimulating T regulatory cells through intranasal dosing, which helps mitigate inflammation in the brain, a critical factor in the progression of Alzheimer's disease [4][5]

JENA, Germany, May 22, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in multiple investor conferences in June and July 2025. Jefferies Global Healthcare ConferenceJune 3 - 5, 2025 in New York, NY InflaRx will conduct an investor presentation on June 4th at 7:35 AM ET and will participate in one-on-one investor meetings. A link to register for the ...

First Oral Presentation of the Tanruprubart Real-World Evidence (RWE) Study by International Guillain-Barré Syndrome Outcomes Study (IGOS) Researchers Highlights Benefits over Current Standard of Care in Matched Patient Populations Poster Presentations on New Pivotal Phase 3 Analyses Underscore Tanruprubart’s Rapid and Sustained Treatment Effect and Improvement in Quality of Life Compared to Placebo BRISBANE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company ...

Core Insights - Annexon, Inc. is advancing a late-stage clinical platform of novel therapies targeting classical complement-mediated neuroinflammatory diseases, with significant progress in its portfolio and financial results for Q1 2025 [1][2][9] Group 1: Clinical Development Updates - The FDA meeting for Tanruprubart (formerly ANX005), a potential treatment for Guillain-Barré Syndrome (GBS), is scheduled for Q2 2025 ahead of a planned Biologics License Application (BLA) submission [1][2] - The open-label Tanruprubart FORWARD study is set to initiate in Q2 2025, aimed at broadening patient and healthcare community experience in North America and Europe [1][8] - The Phase 3 ARCHER II trial for ANX007, targeting dry age-related macular degeneration (AMD) with geographic atrophy (GA), is on track for completion in Q3 2025, with pivotal topline data expected in the second half of 2026 [1][2][8] - Completion of the proof-of-concept trial for ANX1502, an oral C1s inhibitor for cold agglutinin disease, is anticipated by mid-2025 [1][2][8] Group 2: Financial Performance - As of March 31, 2025, the company reported $263.7 million in cash, cash equivalents, and short-term investments, providing a runway into the second half of 2026 [1][7] - Research and development expenses for Q1 2025 were $48.2 million, significantly higher than $21.0 million in Q1 2024, reflecting the advancement of priority programs [7][13] - General and administrative expenses increased to $9.2 million in Q1 2025 from $7.6 million in Q1 2024 [7][13] - The net loss for Q1 2025 was $54.4 million, or $0.37 per share, compared to a net loss of $25.2 million, or $0.21 per share, in Q1 2024 [7][13] Group 3: Market Potential and Strategic Positioning - Tanruprubart is positioned as the first potential therapy for GBS, addressing a significant unmet need with no FDA-approved treatments currently available [2][3] - ANX007 aims to be the first vision-preserving treatment for dry AMD with GA, potentially benefiting over eight million patients globally [2][5] - The company's innovative C1 platform is designed to halt harmful neuroinflammation, with a focus on addressing the unmet needs of nearly 10 million people worldwide [2][9]

Core Insights - The International Guillain-Barré Syndrome Outcomes Study (IGOS) presented real-world evidence showing improved outcomes with tanruprubart compared to current standards of care in matched patient populations [1][2] - Tanruprubart, a first-in-kind monoclonal antibody, is designed to block C1q to halt neuroinflammation and nerve damage in Guillain-Barré Syndrome (GBS) [2][3] - The drug has received Fast Track and Orphan Drug designations from the U.S. FDA and the European Medicines Agency for GBS treatment [5] Company Overview - Annexon, Inc. is focused on developing novel therapies for classical complement-mediated neuroinflammatory diseases affecting the body, brain, and eye [1][7] - The company aims to deliver innovative treatments targeting C1q to prevent tissue damage and loss in various neuroinflammatory conditions [7] - Annexon's pipeline includes investigational drug candidates addressing unmet needs in autoimmune, neurodegenerative, and ophthalmic diseases, potentially benefiting over 8 million people globally [7] Industry Context - GBS is a rare autoimmune disease with no FDA-approved therapies, characterized by rapid progression and severe weakness, often leading to paralysis [2][6] - The disease results in over 22,000 hospitalizations annually in the U.S. and Europe, contributing to significant morbidity and economic costs to the healthcare system [6] - The long-term burden of GBS has led to a multi-billion-dollar annual economic impact on the U.S. healthcare system [6]

Core Insights - Spyre Therapeutics is advancing its clinical pipeline with planned Phase 2 studies in ulcerative colitis (UC) and rheumatoid arthritis (RA), aiming for over 7 proof-of-concept readouts by 2026 and 2027 [1][2] - The company reported strong financials with $565 million in cash and equivalents as of March 31, 2025, providing a runway into the second half of 2028 [1][9] Development Pipeline Overview - The company is focused on developing best-in-class therapies for inflammatory bowel disease (IBD) and other immune-mediated diseases, with a pipeline that includes SPY001, SPY002, and SPY003 [1][3] - IBD affects approximately 2.4 million individuals in the U.S., while RA impacts over 1.5 million individuals [3] Clinical Programs - SPY001 is a monoclonal antibody targeting α4β7, showing a favorable safety profile and a pharmacokinetic (PK) profile that supports infrequent dosing [5][6] - SPY002 consists of two investigational anti-TL1A monoclonal antibodies, with potential to become a first-in-class treatment for IBD and RA [6][11] - SPY003 targets the p19 subunit of IL-23, also engineered for infrequent dosing [7] Financial Performance - For Q1 2025, the company reported R&D expenses of $41.6 million, an increase from $34.9 million in Q1 2024, driven by higher clinical development costs [10] - General and administrative expenses were $11.9 million for Q1 2025, slightly down from $12.8 million in Q1 2024 [10] - The net loss for Q1 2025 was $44.8 million, compared to $43.9 million in Q1 2024, including non-cash stock-based compensation [13][20] Future Outlook - The company plans to initiate two fully funded Phase 2 trials in mid-2025, targeting markets with annual revenues totaling approximately $50 billion [2][11] - Interim data for SPY002 is expected later in Q2 2025, which may demonstrate a superior product profile compared to first-generation TL1A antibodies [2][11]

Topline data from multiple Phase 2 studies expected throughout 2025 • Q2 readout from VTX3232 study in patients with early Parkinson’s disease • H2 readout from VTX2735 study in patients with recurrent pericarditis • H2 readout from VTX3232 study in participants with obesity and cardiometabolic risk factors Cash, cash equivalents and marketable securities balance of $228.8M as of March 31, 2025 expected to fund planned operations into at least H2 2026 SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Ventyx Bio ...

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company is advancing its lead program, Enobosarm, which is in the Phase 2b QUALITY study, aimed at improving body composition and physical function in obesity treatment [2][3] - The Virtual Investor KOL segment features discussions on obesity treatment, GLP-1s, and the unmet needs in the current treatment landscape [2] Company Overview - Veru's drug development program includes two late-stage novel small molecules: Enobosarm and Sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) designed to enhance weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed as a microtubule disruptor for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Development - The Phase 2b QUALITY study of Enobosarm aims to provide topline clinical data that could inform future Phase 3 studies [2][4] - Discussions in the Virtual Investor segment highlight the potential of Enobosarm to help prevent fat regain and improve outcomes for obesity patients [2][4] - The company is also exploring the development of a modified-release formulation of Enobosarm, with plans for a Phase 1 study [4][5]