Core Viewpoint - Outlook Therapeutics has submitted a Type A Meeting request to the FDA to discuss the complete response letter (CRL) regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational treatment for wet AMD [1][2]. Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab aimed at optimizing the standard of care for retinal diseases [7]. - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for the treatment of wet AMD [7]. Product Details - ONS-5010/LYTENAVA™ is an investigational product in the U.S. and has received centralized Marketing Authorization in the EU and the UK for treating wet AMD [4][5]. - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that targets human vascular endothelial growth factor (VEGF) to reduce endothelial cell proliferation and vascular leakage in the retina [6]. Regulatory Context - The FDA's CRL acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but requested additional confirmatory evidence of efficacy for ONS-5010 [2]. - The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA to address the deficiencies noted in the CRL [2][3].

Company Overview - Fortress Biotech, Inc. is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings, and dividend and royalty income [2] - The company has eight marketed prescription pharmaceutical products and multiple programs in development across various therapeutic areas including oncology, dermatology, and rare diseases [2] - Fortress leverages its significant biopharmaceutical industry expertise and network to expand and advance its portfolio of product opportunities [2] Partnerships and Collaborations - Fortress has established partnerships with leading academic research institutions and biopharmaceutical companies, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children's Hospital, Columbia University, Dana Farber Cancer Center, and Sentynl Therapeutics [2] Upcoming Events - Lindsay A. Rosenwald, M.D., Chairman, President, and CEO of Fortress, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference, with the presentation available for on-demand viewing starting September 5, 2025 [1] - The company will also participate in virtual one-on-one meetings during the conference from September 8-11, 2025 [1]

Core Insights - Lexicon Pharmaceuticals presented a post-hoc analysis of sotagliflozin's efficacy among older adults at the ESC 2025 Congress, highlighting improvements in heart failure endpoints and major adverse cardiovascular events (MACE) [1][2][3] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program for genomics target discovery [8] Study Details - The analysis pooled data from two pivotal Phase 3 studies, SCORED and SOLOIST-WHF, involving nearly 12,000 participants, with approximately 70% aged 65 or older [2][4] - The primary endpoint was total cardiovascular death, hospitalization for heart failure, or urgent visits for heart failure, with additional endpoints including total MACE [2] Efficacy Results - Sotagliflozin reduced the primary endpoint rate compared to placebo: 8.5 vs 11.8 events per 100 person-years (HR: 0.72) overall, and 8.9 vs 12.4 events per 100 person-years (HR: 0.73) for those aged 65 and older [5] - Total MACE was similarly reduced with sotagliflozin: 5.7 vs 7.1 events per 100 person-years (HR: 0.80) overall, and 5.9 vs 7.4 events per 100 person-years (HR: 0.80) for those aged 65 and older [6] Future Research Directions - Future research may focus on the benefits of sotagliflozin in heart failure patients with preserved ejection fraction (HFpEF), a demographic that is generally older and includes more women [3]

Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics [2] - The company utilizes its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology to enable precise delivery of drugs at optimal release rates over durations ranging from several days to months [2] Recent Developments - Dalit Hazan, Deputy CEO, will present at the 14th meeting of the Israel Controlled Release Society (ICRS) Conference from September 7-9, 2025 [1] - The presentation will cover the topic "Novel Local Prolonged Drug Delivery: From Platform Idea to a Successful Phase III Trial" on September 7, 2025 [2] Product Pipeline - PolyPid's lead product candidate, D-PLEX₁₀₀, aims to prevent abdominal colorectal surgical site infections, with a New Drug Application (NDA) submission expected in early 2026 following positive phase 3 results [2] - The company also has an innovative pipeline targeting oncology, obesity, and diabetes [2]

Company Overview - Structure Therapeutics Inc. is a clinical-stage global biopharmaceutical company focused on developing novel oral small molecule therapeutics for metabolic diseases, particularly obesity [1][3] - The company utilizes a next-generation structure-based drug discovery platform to create a robust GPCR-targeted pipeline, featuring multiple proprietary clinical-stage oral small molecule compounds [3] Upcoming Events - Management will participate in the Cantor Global Healthcare Conference on September 3 at 3:55 p.m. ET in New York, NY, featuring a fireside chat and 1x1 meetings [2] - The company will also attend the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10 at 10:45 a.m. ET, also in New York, NY, with a similar format [2] - Live and archived webcasts of these events will be available on the company's website for 90 days [2]

Core Insights - Candel Therapeutics, Inc. has appointed Dr. Carl H. June to its Research Advisory Board, enhancing its expertise in cancer immunotherapy [1][2][3] - Dr. June is recognized for his contributions to CAR-T cell therapy and will support Candel's development of its lead candidates, CAN-2409 and CAN-3110 [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal viral immunotherapies to combat cancer [4] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [4] Product Development - CAN-2409 is the lead candidate from the adenovirus platform, currently advancing through clinical trials for various solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5][6] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including stage III/IV NSCLC and localized prostate cancer [5] - CAN-3110, the lead candidate from the HSV platform, is in a phase 1b clinical trial for recurrent high-grade glioma and has also received Fast Track and Orphan Drug Designations from the FDA [6] Future Plans - Candel anticipates submitting a Biologics License Application (BLA) for CAN-2409 for prostate cancer in Q4 2026 [3]

Group 1 - Nkarta, Inc. is participating in the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 8:30 a.m. ET, featuring a fireside chat [1] - A simultaneous webcast of the event will be available on Nkarta's website, with a replay archived for approximately 90 days [1] - Nkarta is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases [2] Group 2 - The company utilizes a cell expansion and cryopreservation platform combined with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities [2] - Nkarta aims to build a pipeline of future cell therapies designed for deep therapeutic activity and broad access in outpatient treatment settings [2]

Core Insights - Opus Genetics, Inc. has appointed Rob Gagnon as Chief Financial Officer, bringing over two decades of financial and operational leadership experience in the biotech sector [1][2][3] Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [5] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [5] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, targeting BEST1-related retinal degeneration [5] - Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and being studied in two Phase 3 programs for presbyopia and visual disturbances [5] Leadership Experience - Rob Gagnon has raised over $2 billion in capital and has experience in guiding companies through IPOs, late-stage clinical development, and M&A [2][3] - Prior to joining Opus, Gagnon served as CFO at Remix Therapeutics and held senior roles at Verastem Oncology, Harvard Bioscience, Clean Harbors, and Biogen [2][3][4] - Gagnon holds an MBA from MIT Sloan School of Management and a BA in Accounting from Bentley College, and is a Certified Public Accountant [4]

Management’s presentation will take place on Wednesday, September 3rd, 2025 at 1:30 pm (ET)DURHAM, N.C., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company (“Pelthos” or the “Company”) committed to commercializing innovative therapeutic products for high unmet patient needs, today announced that Scott Plesha, CEO, and Frank Knuettel, CFO, will participate in the Wells Fargo Healthcare Conference. Management’s presentation will take place on Wednes ...

WATERTOWN, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer and Randi Isaacs, M.D., Chief Medical Officer, both of Werewolf Therapeutics, ...