Core Viewpoint - Day One Biopharmaceuticals is set to report its financial results and corporate progress for Q4 and full-year 2025 on February 24, 2026, highlighting its commitment to developing targeted therapies for life-threatening diseases, particularly in pediatric cancer [1]. Group 1: Company Overview - Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company focused on addressing the unmet needs in pediatric cancer treatment [3]. - The company aims to redefine cancer drug development and improve outcomes for patients of all ages from the moment of diagnosis [3]. Group 2: Pipeline and Development - Day One's pipeline includes tovorafenib (OJEMDA™), DAY301, and Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate targeting the B7-H4 protein, currently in clinical development for adenoid cystic carcinoma (ACC) [4]. - The recent acquisition of Mersana Therapeutics enhances Day One's capabilities in developing targeted cancer treatments [4]. Group 3: Communication and Accessibility - A live conference call and webcast will be available for stakeholders to access financial results and corporate updates [2]. - An archived version of the webcast will be accessible for 30 days post-event, ensuring continued engagement with investors and the public [2].

Core Insights - Hoth Therapeutics announced positive preclinical results for its HT-VA GDNF treatment, showing superior efficacy over semaglutide in weight loss, glucose control, and liver health in obesity models [1] Study Design and Results - The study was conducted at the Srinivasan Lab with support from the Veterans Administration, using CF-1 mice to model human obesity over a 12-week period [1] - GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in female mice, outperforming semaglutide [1] - GDNF fully normalized fasting glucose levels and improved glucose response, showing broader metabolic benefits in both female and male models [1] - In female mice on a high-fat diet, GDNF reduced weight gain by 10-15%, leading to a plateau in weight, unlike semaglutide which had no significant impact [1] Market Potential - GDNF's differentiated mechanism could address limitations of current GLP-1 agonists, such as gastrointestinal side effects and muscle loss, positioning it as a potential gamechanger in the $200 billion obesity market [1] - With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms [1] Future Plans - Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027 [1] - The GDNF program is part of a robust pipeline that includes HT-001 for cancer-related skin toxicities, HT-KIT for mast cell cancers, and HT-ALZ for Alzheimer's [1]

AGOURA HILLS, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- via IBN — Oncotelic Therapeutics, Inc. (OTCQB: OTLC) (“Oncotelic” or the “Company”), a clinical-stage biopharmaceutical company focused on oncology, immunotherapy, and CNS-related diseases, today provided an update on key development progress achieved during 2025 and outlined its strategic direction as the Company enters 2026 with continued momentum across its pipeline. 2025: Continued Execution Across a Late-Stage, Diversified Pipeline Oncotelic trans ...

Core Viewpoint - Aardvark Therapeutics has received IRB approval for an amended protocol in its Phase 3 HERO trial, allowing participation of children aged 7 and older with Prader-Willi Syndrome (PWS) in the United States, aiming to enhance access and capture the potential impact of ARD-101 on hyperphagia in this population [1][2][3] Group 1: Trial Details - The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled study assessing ARD-101 for hyperphagia in PWS patients, with plans to enroll 90 patients across multiple countries including the U.S., Australia, Canada, the UK, and South Korea [4] - The primary endpoint of the trial is the change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12, with secondary measures including changes in Caregiver Global Impression of Severity (CaGI-S) and Clinical Global Impression of Severity (CGI-S) scores [4] Group 2: Drug Information - ARD-101 is a gut-restricted small molecule agonist targeting specific taste receptors, stimulating the release of gut-peptide hormones like GLP-1 and cholecystokinin (CCK) to mediate hunger [5] - The drug has shown potential in reducing hunger both alone and in combination with existing GLP-1 therapies, and has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for PWS [5][6] Group 3: Company Overview - Aardvark Therapeutics is focused on developing small-molecule therapeutics aimed at suppressing hunger for the treatment of PWS and other metabolic diseases, with ARD-101 being the lead compound in Phase 3 clinical development [7] - The company is also working on ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials to address limitations of current GLP-1 therapies [8]

Core Insights - OKYO Pharma Limited has appointed Dr. Flavio Mantelli as Chief Medical Officer, who has extensive experience in ocular surface drug development and previously led the successful launch of Oxervate® [1][2][4] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [14] - The company recently completed a successful Phase 2 trial of its drug urcosimod for NCP and plans to initiate a Phase 2b/3 study involving approximately 150 subjects in the first half of 2026 [14] Leadership and Strategy - Dr. Mantelli will oversee the clinical development strategy for urcosimod, aiming to advance it through planned clinical trials and leverage its FDA Fast Track designation [3][12] - The appointment of Dr. Mantelli follows the recent hiring of CEO Robert Dempsey, strengthening the leadership team in ophthalmology [4][12] Product Development - Urcosimod is a lipid-conjugated chemerin peptide agonist that has shown anti-inflammatory and pain-reducing effects in preclinical models for dry eye disease and neuropathic corneal pain [9] - There are currently no FDA-approved therapies specifically for NCP, highlighting the unmet medical need that urcosimod aims to address [8] Market Context - Neuropathic corneal pain is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, and is inadequately treated with existing medications [8]

Core Insights - Milestone Pharmaceuticals has appointed David Sandoval as General Counsel and Chief Compliance Officer, coinciding with the launch of CARDAMYST™ (etripamil) nasal spray, the first self-administered treatment for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults [1][3] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular medicines, with CARDAMYST™ as its lead product [16] - CARDAMYST™ is a novel calcium channel blocker nasal spray approved by the FDA for converting acute symptomatic episodes of PSVT to sinus rhythm in adults [5][16] Product Details - CARDAMYST™ is designed as a self-administered rapid response therapy, allowing patients to manage their condition without immediate medical oversight [5] - The product has undergone a robust clinical trial program, including a completed Phase 3 clinical-stage program for PSVT treatment [6] Leadership Appointment - David Sandoval brings over 15 years of experience in legal and compliance functions within the life sciences sector, focusing on late-stage development and regulatory approval [2] - His previous roles include Senior Vice President and General Counsel at MaxCyte, where he oversaw global legal and compliance activities and played a key role in strategic transactions [2][4] Strategic Importance - The appointment of Mr. Sandoval is seen as critical for Milestone as it prepares for the commercialization of CARDAMYST, with expectations of scaling operations and building infrastructure for long-term growth [3]

Core Insights - ARS Pharmaceuticals is showcasing the clinical advancements and real-world usability of neffy, a needle-free epinephrine delivery system, at the 2026 AAAAI Annual Scientific Meeting [1][2] - The nasal epinephrine has a longer shelf life compared to auto-injectors, leading to a more affordable price point [1] - Patient preference for the nasal option increased by over 25% due to the aversion to needle-based administration [1] Group 1: Clinical Presentations - Five poster presentations and one healthcare professional case report will focus on neffy, highlighting health-economic analyses, patient preference research, and pharmacokinetic comparisons with injectable epinephrine [1][2] - The presentations will demonstrate that neffy 2 mg exposure is comparable to 0.5 mg intramuscular injection, indicating potential cost-effectiveness and patient preference [2] Group 2: Poster Presentation Details - The first poster will discuss the societal value of nasal epinephrine due to needle aversion [3] - The second poster will compare the pharmacokinetics and pharmacodynamics of nasal spray and intramuscular injection [3] - The third poster will focus on treatment preferences between nasal epinephrine and autoinjectors among food-allergic patients [3][4] - Additional posters will address the importance of characteristics of epinephrine treatments and treatment adherence related to nasal versus autoinjector options [4] Group 3: HCP Case Report and Partner Presentations - A healthcare professional case report will evaluate the effectiveness of intranasal epinephrine in routine allergy practice [5] - Late-breaking partner presentations will explore device portability and user preferences between epinephrine autoinjectors and nasal delivery systems [6]

Core Insights - Septerna, Inc. is set to present data from its Phase 1 clinical trial of SEP-631 at the 2026 AAAAI Annual Meeting, highlighting its focus on G protein-coupled receptor drug discovery [1] - SEP-631 is a selective oral small molecule negative allosteric modulator targeting MRGPRX2, aimed at treating chronic spontaneous urticaria and other mast cell-driven diseases [2][3] Group 1: Clinical Trial and Presentation - The Phase 1 clinical trial data for SEP-631 will be presented during the Late Breaking Poster Session II on March 1, 2026, at the Pennsylvania Convention Center [2] - The study utilizes short wave infrared imaging to assess responses to an Icatibant skin challenge, indicating innovative methodologies in clinical research [2] Group 2: Drug Mechanism and Development - SEP-631 targets MRGPRX2, which is crucial for mast cell activation and degranulation, contributing to symptoms in various diseases including asthma and atopic dermatitis [2] - Preclinical studies have shown that SEP-631 effectively inhibits MRGPRX2 and prevents mediator-induced skin extravasation in mice, demonstrating its potential efficacy [2] Group 3: Company Overview - Septerna, Inc. is a clinical-stage biotechnology company with expertise in GPCR therapies, aiming to address significant unmet medical needs through its proprietary Native Complex Platform™ [3] - The company is advancing a diverse pipeline of novel oral small molecule drug candidates across multiple therapeutic areas, including endocrinology and immunology [3]

Core Insights - Cogent Biosciences, Inc. is set to present multiple posters on bezuclastinib results from the SUMMIT trial for NonAdvanced Systemic Mastocytosis at the 2026 AAAAI Annual Meeting [1][2] Group 1: Upcoming Presentations - The posters will cover various aspects of bezuclastinib, including expanded results from the Phase 2 SUMMIT trial, evaluation of bone formation marker changes, patient experiences, symptom burden improvement, and results in subgroups with unmet needs [3] Group 2: Drug Development and Regulatory Status - In December 2025, Cogent submitted a New Drug Application for bezuclastinib to the FDA, based on positive clinical data from the SUMMIT trial and following its Breakthrough Therapy Designation [2] - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is significant in systemic mastocytosis and other related conditions [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases and has an ongoing Phase 1 study of a novel FGFR2/3 inhibitor [4][5]

Core Insights - INmune Bio Inc. has submitted a pre-submission package for CORDStrom™ to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), aiming to expedite the approval process for a potential systemic therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][3] - CORDStrom is being developed as a disease-modifying treatment for RDEB, a rare genetic disorder affecting approximately 1 in 1 million births globally, with no approved systemic therapies currently available [2][5] - The company has completed three commercial pilot-scale manufacturing runs, confirming readiness for commercial supply and plans to file a full Marketing Authorization Application (MAA) with MHRA by mid-summer 2026 [3][4] Regulatory and Legislative Context - CORDStrom has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation in the U.S., which are significant due to the recent reauthorization of the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029 [4][5] - The reauthorization of the PRV program strengthens incentives for developing therapies for rare pediatric diseases, potentially benefiting INmune Bio as it prepares for a Biologics License Application (BLA) submission later this year [5] Product and Technology Overview - CORDStrom™ is a patent-pending cell medicine utilizing pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs), designed for injection or infusion to treat complex inflammatory and autoimmune diseases [7] - The platform allows for the creation of indication-specific products that can be optimized for various therapeutic characteristics, addressing severe unmet needs in RDEB patients [7][8]