Core Insights - Silo Pharma has entered into a non-binding letter of intent to form a 50:50 joint venture with Hoth Therapeutics to develop a treatment for obesity and metabolic diseases based on technology licensed from the U.S. Department of Veterans Affairs [1][3] - The joint venture aims to leverage a novel therapeutic platform centered on glial cell line-derived neurotrophic factor (GDNF), which has shown anti-obesity effects in preclinical models [2][4] - The obesity market is valued at approximately $16 billion, with the potential for significant impact on veterans and civilians suffering from metabolic disorders [3][4] Unmet Need - Over 40% of U.S. adults are affected by obesity, which is a leading risk factor for various health issues, including diabetes and cardiovascular disease [4] - Veterans face unique challenges related to obesity, including chronic inflammation and PTSD-related metabolic disruptions, highlighting the need for effective treatments [4] Strategic Alignment - The partnership will utilize the exclusive U.S. license from the Department of Veterans Affairs, ensuring comprehensive coverage for all fields of use [7] - The joint venture structure allows for equal equity and governance participation between Silo Pharma and Hoth Therapeutics [7] - The collaboration combines the clinical infrastructure of the VA, Hoth's regulatory expertise, and Silo's translational capabilities [8]

Core Viewpoint - Adial Pharmaceuticals has executed agreements with Cambrex and Thermo Fisher to support the production of its lead investigational drug AD04, aimed at treating Alcohol Use Disorder (AUD) in the U.S. [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a genetically targeted serotonin-3 receptor antagonist [4]. - The company recently conducted the ONWARD™ pivotal Phase 3 clinical trial for AD04, which showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [4]. Agreements and Collaborations - The collaboration with Thermo Fisher as the Contract Development and Manufacturing Organization (CDMO) and Cambrex as the drug substance supplier has commenced, focusing on the completion of demonstration batches necessary for clinical trials [2][3]. - The agreements encompass all manufacturing phases for clinical supplies and the Chemistry, Manufacturing, and Controls (CMC) documentation required for the NDA submission to the FDA [2]. Strategic Importance - The selection of CDMOs with proven track records in both drug substance development and manufacturing was crucial for the agreements [2]. - The partnerships are expected to be vital for meeting timelines for the upcoming Phase 3 clinical trials and addressing commercial demands for AD04, especially considering recent tariff implications [3]. Future Potential - AD04 is not only targeted for AUD but is also believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4].

June 25, 2025 Biodexa Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The tria ...

Core Viewpoint - Hepion Pharmaceuticals has successfully transitioned to the OTCQB Venture Market, with its common stock trading under the symbol HEPA starting June 25, 2025 [1]. Company Overview - Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing and commercializing diagnostic tests for various conditions, including celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC) [2].

Core Insights - Oryzon Genomics is hosting a virtual KOL event to discuss the unmet medical needs in Borderline Personality Disorder (BPD) and the design of vafidemstat's Phase III PORTICO-2 trial [1] - The event will address the lack of approved pharmacological treatments for BPD and the limitations of off-label medications, emphasizing the importance of addressing agitation and aggression in BPD and other psychiatric conditions [1] - Vafidemstat is highlighted as a promising treatment option due to its novel epigenetic mechanism of action, with ongoing discussions about its potential applications in BPD, schizophrenia, and autism spectrum disorder (ASD) [1] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics and personalized medicine for CNS disorders and oncology [9] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [9] - Oryzon is also focused on biomarker identification and target validation for various malignant and neurological diseases [9] Vafidemstat Details - Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor that has shown efficacy in reducing cognitive impairment and neuroinflammation, as well as having neuroprotective effects [10] - The drug has demonstrated positive results in multiple Phase IIa clinical trials, including studies on aggression in psychiatric disorders and Alzheimer's disease [10] - Vafidemstat is advancing towards a Phase III trial in BPD following the completion of the Phase IIb PORTICO trial, with plans to investigate its effects on agitation and aggression [10]

Core Insights - Amneal Pharmaceuticals has announced positive topline results from a clinical trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab), which is expected to be a significant growth driver for the company in the U.S. biosimilar market valued at $3.9 billion [1][4] - The Biologics License Application (BLA) for ADL-018 is anticipated to be filed with the FDA in Q4 2025, with Amneal holding exclusive U.S. commercialization rights pending regulatory approval [3] Group 1: Clinical Trial Results - The confirmatory clinical trial for ADL-018 was a randomized, double-blind, multicenter study that evaluated its efficacy, safety, and immunogenicity compared to XOLAIR in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) [1][2] - The study met its primary and secondary endpoints, demonstrating equivalence in therapeutic outcomes and comparable safety profiles between ADL-018 and XOLAIR [2] Group 2: Market Context - Omalizumab, the reference product, is indicated for severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria, with U.S. annual sales reaching approximately $3.9 billion for the 12 months ending April 2025 [4] - The successful development of ADL-018 is part of Amneal's broader strategy to commercialize six biosimilars across eight product presentations by 2027 [3] Group 3: Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, focusing on both affordable medicines and specialty branded pharmaceuticals [5] - Kashiv BioSciences, the developer of ADL-018, is a vertically integrated biopharmaceutical company with a focus on delivering cost-effective, high-quality therapies [6][7]

Core Insights - Rhythm Pharmaceuticals, Inc. announced the acceptance of three late-breaking abstracts for presentation at The Endocrine Society's Annual Meeting (ENDO 2025) scheduled for July 12-15 in San Francisco, CA [1] Group 1: Clinical Trials and Presentations - Dr. Susan Phillips will present data from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for acquired hypothalamic obesity, marking it as the largest randomized, placebo-controlled trial in this area to date [2] - A poster presentation will be given by Dr. Christian Roth detailing exit interviews from 30 patients or caregivers in the US who participated in the Phase 3 TRANSCEND trial [2] - Dr. Vidhu Thaker will present results from a 14-week Phase 2 trial of bivamelagon, an oral MC4R agonist, in participants with acquired hypothalamic obesity [2] Group 2: Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead asset, IMCIVREE® (setmelanotide), approved by the FDA for treating obesity related to specific genetic conditions [3][4] - Setmelanotide is indicated for reducing excess body weight and maintaining weight reduction in patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome or POMC, PCSK1, or LEPR deficiencies [4][5][6] - The company is advancing a broad clinical development program for setmelanotide and other investigational MC4R agonists, including bivamelagon and RM-718, as well as a preclinical suite for congenital hyperinsulinism [3]

Core Viewpoint - Ovid Therapeutics has entered into a definitive agreement with Immedica Pharma for the sale of future royalties related to ganaxolone sales outside of China, providing Ovid with a non-dilutive capital infusion of $7 million to support its ongoing operations [1][2]. Group 1: Transaction Details - Immedica will pay $7 million in cash to acquire 100% of the royalty rights held by Ovid, enhancing Immedica's focus on ganaxolone by gaining control of additional intellectual property rights [1]. - The transaction includes royalties associated with a previous agreement Ovid had with Marinus Pharmaceuticals regarding ganaxolone for CDKL5 deficiency disorder [4]. - Ovid recorded approximately $566,000 in ganaxolone royalty revenues in 2024, indicating the current revenue scale from this asset [2]. Group 2: Company Backgrounds - Ovid Therapeutics is a biopharmaceutical company focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline of novel candidates targeting neurological disorders [7]. - Immedica is a pharmaceutical company dedicated to the commercialization of medicines for rare diseases, with a global distribution network serving patients in over 50 countries [6].

Trial will be conducted by Angel Pharma and will study 12-week dosing of soquelitinib in patients with moderate-to-severe atopic dermatitisSOUTH SAN FRANCISCO, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Admin ...

MIAMI and JERUSALEM, June 25, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA. Oral OPK-88006 is being developed pursuant to a collaboration and license agreement between OPKO and Ente ...