TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval bas ...

Core Insights - Instil Bio, Inc. has received FDA clearance for the Investigational New Drug (IND) application for AXN-2510, a bispecific antibody targeting PD-L1 and VEGF, aimed at treating multiple solid tumors [1][3] - The company plans to initiate a phase 1 trial of AXN-2510 as a monotherapy for patients with relapsed/refractory solid tumors before the end of 2025 [2] - Initial safety and efficacy results from a phase 2 trial of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) in China are expected to be shared in the second half of 2025 [1][2] Company Overview - Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies [3] - The lead asset, AXN-2510, is positioned as a differentiated treatment option for various solid tumors [3]

Core Insights - Roche announced positive phase I/II data for NXT007, a next-generation bispecific antibody for haemophilia A, supporting its progression to phase III clinical development [1][2] - NXT007 demonstrated a tolerable safety profile with no thromboembolic events reported, indicating its potential for haemostatic normalization in patients without factor VIII inhibitors [1][4] Company Overview - Roche has over 25 years of experience in developing medicines for blood diseases and is committed to advancing care for patients with haemophilia A [9] - The company aims to provide innovative treatment options, including NXT007, to enhance therapeutic choices and reduce treatment burdens for patients [2][6] Clinical Development - NXT007 is currently undergoing a robust clinical development program, with ongoing phase I/II trials and additional phase II data expected later this year [3] - Three phase III studies are planned for 2026, including a head-to-head study with Hemlibra, Roche's existing prophylactic treatment for haemophilia A [3][4] Product Details - NXT007 is engineered to optimize factor VIII-mimetic activity and enhance potency, efficacy, and administration convenience, aiming for sustained elevated bleed protection [6][5] - The clinical trials for NXT007 involve participants aged 12 to 65, with no treated bleeds observed in the highest dose cohorts [4][7] Market Context - Haemophilia A affects approximately 900,000 people globally, leading to significant health concerns due to uncontrolled bleeding [8][7] - The development of inhibitors to factor VIII replacement therapies presents a serious complication, highlighting the need for innovative treatments like NXT007 [8]

Core Insights - Instil Bio, Inc. has appointed John Maraganore, Ph.D., to the Board of Directors of its subsidiary Axion Bio, Inc., which is focused on developing AXN-2510, a PD-L1xVEGF bispecific antibody targeting solid tumors, particularly non-small cell lung cancer (NSCLC) [1][2] - The appointment is aimed at enhancing leadership to maximize the value of the AXN-2510 program for both patients and shareholders, with expectations of redefining the standard of care for solid tumors [2] - AXN-2510 is currently in a Phase 2 trial in combination with chemotherapy for first-line NSCLC, with early signs of safety and efficacy being reported [2] Company Overview - Instil Bio is a clinical-stage biopharmaceutical company dedicated to developing novel therapies, with AXN-2510 as its lead asset [3] - Axion Bio, a wholly-owned subsidiary of Instil Bio, is specifically focused on the development of AXN-2510 for multiple solid tumors [4] Leadership Background - Dr. John Maraganore brings over 30 years of biotechnology experience, having previously served as the founding CEO of Alnylam Pharmaceuticals, where he led the company to a market capitalization exceeding $40 billion [2] - His expertise spans drug discovery, clinical development, and strategic partnerships, making him a valuable asset for guiding the advancement of next-generation cancer therapies [2]

J P M O R G A N Asia Pacific Equity Research 05 June 2025 Akeso AK104 approval in 1L CC with catalysts ahead Akeso announced today that AK104, a PD-1/CTLA-4 bispecific antibody, has received approval in China for the first-line treatment of persistent, recurrent, or metastatic cervical cancer (CC). This treatment is to be used in combination with platinum-based chemotherapy, with or without bevacizumab, marking the third approved indication of AK104. Despite the market's focus on AK112, we believe AK104 is ...

Core Insights - Bristol Myers Squibb (BMY) has entered a strategic collaboration with BioNTech (BNTX) for the co-development and co-commercialization of the bispecific antibody BNT327, targeting multiple solid tumor types [1][9]. Company Developments - BNT327 is a next-generation bispecific antibody that targets PD-L1 and VEGF-A, currently in trials with over 1,000 patients, including phase III studies for extensive stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC) [2][4]. - BMY will make an upfront payment of $1.5 billion to BioNTech, with additional non-contingent anniversary payments of $2 billion through 2028, and up to $7.6 billion in potential milestone payments [3][9]. Financial Performance - BMY's shares have declined by 13.6% year-to-date, compared to a 3.3% decline in the industry [8]. - The company is trading at a price/earnings ratio of 7.31x forward earnings, lower than its historical mean of 8.55x and the large-cap pharma industry's average of 14.95x [10]. Earnings Estimates - The Zacks Consensus Estimate for BMY's 2025 earnings per share has increased to $6.85 from $6.75 over the past 60 days, while the estimate for 2026 has decreased [11].

Compass Therapeutics (CMPX) 2025 Conference June 05, 2025 11:05 AM ET Speaker0 And one of the biotech analysts at Jefferies. It's with great pleasure I'd like to welcome Tom Schutz, the CEO of Compass Therapeutics. Thanks so much for joining us today, Tom. Speaker1 Thanks, Maury. Thanks for inviting us. Appreciate it. Speaker0 And we're gonna do fireside chat format. So maybe for those who are new to this story, if you can give a one minute intro to Compass. Speaker1 Sure, thanks. Compass, we're based in Bo ...

Company Overview - Instil Bio (TIL) and its partner ImmuneOnco are advancing their bispecific antibody AXN-2510, targeting PD-1/VEGF for solid tumors treatment [2] Investment Analysis - The Biotech Analysis Central service offers extensive resources for investors, including over 600 articles and a model portfolio of small and mid-cap stocks [2]

Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][5] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% CI: 0.29–0.58) [2] - Among patients achieving complete remission (CR), 89% were alive and 82% maintained remission one year post-treatment [2][5] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [4] - The combination therapy has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [4] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [3] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher median number of treatment cycles (11 vs. 4) due to disease progression in the R-GemOx arm [2] - Common adverse events included cytokine release syndrome, generally of low grade [2] Group 4: Company Strategy - Roche aims to provide tailored treatment options through its CD20xCD3 bispecific antibody program, which includes Columvi and other therapies [6][8] - The company is also investigating Columvi in combination with other treatments for previously untreated DLBCL in ongoing studies [9]

Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][4] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) [2] - Among patients achieving complete remission (CR) at the end of treatment, 89% were alive and 82% maintained remission one year post-treatment [2][4] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [3] - The combination of Columvi and GemOx has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [3] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [2][9] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher rate of adverse events observed, including cytokine release syndrome, which was generally low grade [2][4] - Patients receiving the Columvi combination had a higher median number of treatment cycles (11 versus 4) due to disease progression in the R-GemOx arm [2] Group 4: Company Strategy - Roche is focused on developing tailored treatment options for blood cancers, including the CD20xCD3 bispecific antibody program, which includes Columvi and Lunsumio® [5][7] - The company is also investigating Columvi in combination with other therapies for previously untreated DLBCL in ongoing studies [8]