NEW YORK, May 7, 2025 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced today that it will release its financial results for the 1st quarter ended March 31st, 2025 and will host a conference call and webcast at 8:30 a.m. Eastern Time, on Wednesday, May 14th, 2025, before the market opens. Erez Raphael, Chief Executive Officer, and Steven Nelson, Chief Commercial Officer, will host the call. Conference Call Details Date: Wedne ...

Announces successful completion of sub-chronic and chronic toxicology studies for INF904, supporting long-term dosing in future clinical trialsMultiple near-term catalysts anticipated with the potential to substantially de-risk the Company's pipeline addressing multiple sizable marketsInterim analysis for vilobelimab Phase 3 trial in pyoderma gangrenosum (PG), to determine trial size adaptation or futility, remains on schedule with a recommendation expected to be announced at the end of May to early JuneTop ...

This collaboration represents a pivotal step in the advancement of immuno-oncology therapies, highlighting the powerful synergy between Genenta's innovative platform and Anemocyte's proven expertise in the production of high-quality starting materials. Forward-Looking Statements MILAN and NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a collaboration with Anemocyte, a leading Biotech Manufacturi ...

Recent Highlights In line with recent FDA feedback, Seres expects to submit a Phase 2 study protocol to FDA in the coming weeks for SER-155 for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for the treatment of hematological malignancies SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, consistent with clinical results that showed a significant reduction ...

Company Overview - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of adult stem cell therapeutics aimed at treating neurodegenerative diseases [3][4] - The company's proprietary NurOwn® platform utilizes autologous mesenchymal stem cells (MSCs) to create neurotrophic factor-secreting cells (MSC-NTF cells) [3][4] Upcoming Conference Call - A conference call is scheduled for May 15, 2025, at 8:30 a.m. Eastern Time to discuss the financial results for Q1 2025 and provide a corporate update [1][2] - The call will feature BrainStorm's President & CEO Chaim Lebovits, along with Dr. Bob Dagher, Chief Medical Officer, and Alla Patlis, Interim CFO [2] Clinical Development - NurOwn® is the lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the FDA and EMA [4] - A Phase 3 trial for ALS has been completed, and a confirmatory Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA [4] - The clinical program has provided insights into ALS disease biology, including pharmacogenomic responses and biomarker data [4] Additional Research and Development - BrainStorm has completed a Phase 2 open-label multicenter trial of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society [4] - The company is also advancing an allogeneic exosome-based platform for delivering therapeutic proteins and nucleic acids, with a foundational patent recently allowed by the U.S. Patent and Trademark Office [4]

Core Insights - AnaptysBio reported strong Phase 2b efficacy data for its lead program, rosnilimab, in rheumatoid arthritis, with plans to present updated data in June 2025 and initial ulcerative colitis data in Q4 2025 [2][7][8] - The company is advancing its autoimmune portfolio with multiple catalysts expected in the coming years, including ongoing Phase 1 trials for ANB033 and ANB101 [2][4][5] - AnaptysBio remains well-capitalized with a cash runway extending through the end of 2027, supported by a $75 million stock repurchase program and anticipated royalties from collaborations [2][11][12] Financial Updates - For Q1 2025, AnaptysBio reported collaboration revenue of $27.8 million, a significant increase from $7.2 million in Q1 2024, driven by royalties from Jemperli and revenue from the Vanda license agreement [11][19] - Research and development expenses rose to $41.2 million in Q1 2025 from $37.0 million in Q1 2024, primarily due to costs associated with Phase 2 trials for rosnilimab and Phase 1 trials for ANB033 and ANB101 [11][19] - The net loss for Q1 2025 was $39.3 million, or $1.28 per share, compared to a net loss of $43.9 million, or $1.64 per share, in the same period of 2024 [11][16][19] Portfolio Updates - Rosnilimab is in a Phase 2b trial for rheumatoid arthritis and a Phase 2 trial for ulcerative colitis, with positive results reported in a 424-patient Phase 2b RA trial [3][8][14] - ANB033, a CD122 antagonist, and ANB101, a BDCA2 modulator, are both in Phase 1 trials, with enrollment ongoing for healthy volunteers [4][5][7] - The company has a collaboration with GSK, which includes anticipated milestone payments and royalties from the sales of Jemperli [9][12][14]

Announced focused registrational clinical development plans for lead programs, extended cash runway, and accelerated/augmented corporate milestones Presented preclinical data supporting potential best-in-class profile of ORIC-944 in combination with AR inhibitors to treat prostate cancer at the 2025 AACR Annual Meeting Announced clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC pati ...

Corporate Update January 2024 Developing Therapeutic Antibodies Targeting Allergic, Inflammatory and Proliferative Disease Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the financial position of Allakos Inc. ("Allakos," the "Company," "we" or "our"); estimated lirentelimab closeout, severance and other costs; the timing of payment of restructuring expenditures; estimated ...

Core Insights - Werewolf Therapeutics, Inc. announced the efficacy of its IL-10 INDUKINE molecule, WTX-921, in reducing tissue damage and inflammatory cytokine production in a mouse colitis model [1][3] - The findings provide a deeper understanding of WTX-921's anti-inflammatory effects on the immune landscape in the inflamed colon [1] Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics aimed at stimulating the immune system for cancer and immune-mediated conditions [1][7] - The company utilizes its proprietary PREDATOR platform to design molecules that activate selectively in the tumor microenvironment, addressing limitations of conventional therapies [7] Product Development - WTX-921 is engineered to selectively deliver IL-10 to inflamed tissues, minimizing systemic toxicity while providing therapeutic exposure [6] - The molecule has shown potential in blocking disease-driving effector molecules and cytokines, impacting both innate and adaptive immune responses [6] Clinical Findings - The data presented at the AAI Annual Meeting indicate that WTX-921 effectively masks IL-10, preventing off-tissue effects and demonstrating efficacy in preventing weight loss and reducing Disease Activity Index (DAI) scores in a colitis model over four weeks [4][3] - The treatment resulted in decreased immune cell infiltration and reduced RNA levels of inflammatory cytokines in treated animals [4] Market Context - The CDC estimates that 7 million people worldwide had Inflammatory Bowel Disease (IBD) in 2024, highlighting the need for improved treatment options [3]

Core Insights - Nanobiotix presented full results from a Phase 1 study of JNJ-1900 (NBTXR3) for locally advanced or borderline resectable pancreatic cancer at the 2025 ESTRO Annual Meeting [1][3] - The study showed promising safety and efficacy outcomes, indicating a potential new treatment option for patients with high unmet needs in this area [5][9] Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative nanotherapeutic approaches to enhance cancer treatment outcomes [15][16] - The company is headquartered in Paris, France, and is listed on Euronext Paris and NASDAQ [16] Study Details - The Phase 1 study evaluated JNJ-1900 (NBTXR3) activated by radiotherapy in patients with locally advanced or borderline resectable pancreatic cancer, replacing standard concurrent chemoradiation [3][6] - The study was conducted by The University of Texas MD Anderson Cancer Center, with Dr. Eugene Koay as the principal investigator [1][3] Key Results - The study involved 22 patients, with a median overall survival of 23 months from diagnosis and a median local progression-free survival of 13.3 months from completion of radiation [5][6] - Notable findings included a 59% normalization rate of CA19-9, a biomarker associated with overall survival, and an association between increased circulating tumor mutational burden (cTMB) and improved survival outcomes [5][12] Future Directions - Investigators concluded that further evaluation of JNJ-1900 (NBTXR3) is warranted in a randomized study, with ongoing recruitment for a new cohort combining JNJ-1900 with standard-of-care concurrent chemotherapy [8][9] - The collaboration with MD Anderson aims to explore innovative treatment approaches for patients with high unmet needs in pancreatic cancer [9][14]