SAN FRANCISCO, May 29, 2025 (GLOBE NEWSWIRE) -- A year ago, Bay Area biotech firm Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) was riding high on the promise of its newly approved cell therapy, Amtagvi. Today, the mood has shifted dramatically. On May 16, 2025, UBS analysts reportedly slashed their rating on Iovance shares from Buy to Neutral and issued a stark price target cut—from $17 to just $2—citing mounting concerns over the drug’s commercial rollout and the company’s ability to meet market expectatio ...

SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, announced today that management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 9:20 a.m. EDT. Members of the Artiva management team will also be available to participate in investo ...

– Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – LOS ANGELES, CA, May 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or "IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enrolling in U.S. multi-site study ...

Core Viewpoint - Autolus Therapeutics plc has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of its therapy, obecabtagene autoleucel (obe-cel), for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][6]. Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [9]. - The company has a pipeline of product candidates and has received FDA approval and MHRA authorization for obe-cel [9]. Product Details - Obe-cel is an autologous CD19 CAR T cell therapy designed to target B-cell precursor acute lymphoblastic leukemia [4]. - The therapy has shown a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of the FELIX study [2]. - The median response duration for patients treated with obe-cel was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. Clinical Study Insights - The CHMP recommendation was based on the results of the FELIX study, which was an open-label, multi-center, single-arm study involving adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia [2][10]. - The study enrolled over 100 patients across 30 leading academic and non-academic centers in the U.S., U.K., and Europe [10]. Safety Profile - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3]. - Cytokine release syndrome occurred in 68.5% of patients, with severe cases in 2.4% [3]. Market Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [5]. - Conventional treatments for adult B-ALL have a median overall survival of only eight months, highlighting the need for effective therapies like obe-cel [5]. Regulatory Status - The positive CHMP opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a final decision within approximately two months [6][8]. - Obe-cel has already received FDA approval in November 2024 and MHRA conditional marketing authorization in April 2025 [4][6].

Core Insights - Legend Biotech Corporation is presenting new data on CARVYKTI (ciltacabtagene autoleucel) for multiple myeloma at the 2025 ASCO and EHA meetings, highlighting its status as a market leader in CAR-T therapy for this condition [1][2] - The company is also showcasing preliminary results from ongoing Phase 1 studies targeting solid tumors, specifically lung and gastric cancers, indicating an expansion of its cell therapy pipeline [1][2] CARVYKTI Data - Long-term data from the CARTITUDE-1 study will be presented, showing that heavily pretreated patients with relapsed or refractory multiple myeloma achieved a median progression-free survival of over 5 years after a single CARVYKTI infusion, with a median follow-up of 60.3 months [3][10] - Data from the CARTITUDE-4 study will support a positive benefit-risk ratio for CARVYKTI across various patient subgroups, including those with high-risk cytogenetics [4][10] Solid Tumor Pipeline - Preliminary results from Phase 1 studies of LB2102 and LB1908, targeting small-cell lung cancer and gastroesophageal adenocarcinoma respectively, will be featured in poster presentations at ASCO [6][10] - LB2102 has been licensed to Novartis for further development, with Legend Biotech responsible for the Phase 1 clinical trial in the U.S. [7][8] Clinical Presentations - The company will present data at ASCO and EHA, including an oral presentation on long-term survival outcomes for CARVYKTI and poster presentations on subgroup analyses and preliminary results from solid tumor studies [10][12]

Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. – NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) – – No relapses recorded to-date; no safety signals identified – – Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL ev ...

Summary of Biocardia (BCDA) FY Conference Call Company Overview - Biocardia is a late-stage development company focused on autologous stem cell therapy for ischemic heart failure and chronic myocardial ischemia, located in Sunnyvale, California [1][2][5] - The company has four clinical programs at various stages of advancement [5] Core Points and Arguments Heart Failure Program - The lead indication is heart failure, specifically the BCDA DAO one cardiac phase three trial [6] - Heart failure is described as an enormous unmet medical need, with the therapy aiming to treat microvascular dysfunction by delivering high dosages of autologous cells directly into the heart muscle [6][7] - Preclinical models have shown that the therapy can reduce fibrosis and enhance capillary density [7] - The therapy includes a selection diagnostic to screen out patients who are not appropriate for treatment [7][8] Clinical Trial Data - In March, data from the heart failure one trial was presented, showing reduced mortality and improved quality of life, despite not hitting the primary endpoint [10][11] - The trial involved 115 patients and demonstrated statistical significance in secondary endpoints, including survival and reduction in major adverse cardiac events [11][12] - A one-time dosage of cells is administered, with a two-year follow-up showing robust effects [12] Upcoming Trials and Regulatory Submissions - The FDA approved a subsequent trial (Heart Failure II) to address previous enrollment challenges, with modifications to the study design [14][15] - The new trial will focus on patients with elevated markers of heart stress and aims to double the enrollment rate [19] - Biocardia is pursuing expedited approval from Japan's PMDA for cardiac cell therapy, with a submission expected within the year [21][24] - The company is also working on FDA submissions for its delivery system, which has shown excellent safety data [25] Chronic Myocardial Ischemia Program - The CardiAmp CMI program targets chronic myocardial ischemia with refractory angina, a condition poorly met by existing therapies [26][28] - There are at least one million patients in the U.S. with this condition, and Biocardia's approach aims to be the least expensive cardiac cell therapy available [30][31] - The company is working on a manuscript for early data from the low dose cohort of the CMI trial [32] Other Important Information - Biocardia has an allogeneic platform and is exploring partnerships for both cardiac and pulmonary indications [38][40] - The partnership environment is currently challenging due to market stability concerns, but Biocardia's assets are proven and in the clinic [41] - The company is focused on advancing its lead program while also exploring opportunities in other areas [39][41]

– Virtual KOL Event Tuesday, June 3, 2025 3:00pm ET – – Attend the event here: https://lifescievents.com/event/immix-asco – LOS ANGELES, CA, May 21, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial ...

Bayer AG (BAYRY) announced that it has initiated a phase I study, which is evaluating its investigational highly selective GIRK4 inhibitor, BAY 3670549, for the treatment of patients with atrial fibrillation (AFib).The double-blind, placebo-controlled first-in-human dose escalation study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 3670549 in healthy participants.AFib is a common heart rhythm disorder that affects around 60 million people across the world. AFib is a notab ...

Lineage Cell Therapeutics (LCTX) FY 2025 Conference May 20, 2025 02:30 PM ET Speaker0 Hey. Good afternoon, everybody. I'm gonna turn this on. Good afternoon, everybody. My name is Joe Pangenis, managing director here at HC Wainwright. Welcome back to our next fireside chat. Very happy to have with us Brian Culley, chief executive officer of Lineage Cell Therapeutics. And, so thank you very much for being here. And little before this presentation, I thought of a little analogy. Think, feel like I'm in front ...