Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. plans to offer shares of its common stock and warrants in a public offering to fund research and development activities and for general corporate purposes [1][2]. Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [5]. - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house and have been granted composition of matter patents in multiple regions [5]. Offering Details - The offering will be conducted under an effective shelf registration statement on Form S-3, filed with the U.S. Securities and Exchange Commission (SEC) [3]. - A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering [2].

Châtillon, France, June 25, 2025 DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal InvestigatorAdditional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings DBV Technologies (Eu ...

Châtillon, France, June 25, 2025 DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal InvestigatorAdditional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings DBV Technologies (Eu ...

Core Viewpoint - Idorsia Ltd. successfully held bondholder meetings to approve amendments to the terms of its convertible bonds, extending their maturity dates significantly [1][2][3]. Group 1: Bondholder Meetings - Two bondholder meetings were conducted for Idorsia's CHF 200 million convertible bonds maturing in 2025 and CHF 600 million convertible bonds maturing in 2028 [2]. - The amendments include extending the maturity date of the CB 2025 to July 17, 2034, and the CB 2028 to August 4, 2038 [2]. Group 2: Voting Outcomes - A significant majority of 89.5% of CB 2025 holders and 93.5% of CB 2028 holders voted in favor of the amendments, surpassing the required two-thirds majority [3]. - The amendments will become binding upon approval by the higher cantonal composition authority and are contingent on the completion of the repurchase offer for both bonds [3]. Group 3: Company Overview - Idorsia Ltd. aims to challenge medical paradigms and develop transformative medicines, positioning itself as a leading biopharmaceutical company [6]. - The company is headquartered near Basel, Switzerland, and has a strong focus on small-molecule drug discovery [7].

MIAMI, June 25, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq: OPK) today announced its participation in the 3rd Annual Piper Sandler Obesity Symposium being held virtually on June 26, 2025. Management will be participating in a fireside discussion moderated by Edward Tentoff, Managing Director, Senior Biotechnology Analyst. Investors can register for the symposium by contacting their Piper Sandler representative. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that ...

Core Insights - Aprea Therapeutics announced promising preclinical data and an initial clinical update for APR-1051, a next-generation oral WEE1 inhibitor targeting HPV+ head and neck squamous cell carcinoma (HNSCC) [1][2] - The findings suggest that APR-1051 may provide significant differentiation in oncology, both as a single agent and in combination with checkpoint inhibitors [2] Preclinical Data - Preclinical studies conducted in collaboration with MD Anderson Cancer Center demonstrated robust antiproliferative effects of APR-1051 across various human and murine head and neck cancer cell lines, with IC₅₀ values ranging from 8.9 to 230 nM [6] - Significant anti-tumor synergy was observed when combining APR-1051 with anti–PD-1 therapies in HPV+ HNSCC models, indicating its potential for combination-based clinical trials [6] - Mechanistically, APR-1051 activates cGAS/STING-mediated immunogenic cell death and exploits the HPV E6-driven G2 checkpoint dependency in HPV+ tumors, highlighting a biomarker-driven strategy for patient selection [6] Clinical Update - In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV-positive oropharyngeal squamous cell carcinoma showed stable disease and a 5% tumor reduction after treatment with a subtherapeutic 70 mg oral dose of APR-1051 [7] - The patient tolerated the therapy well, with no dose-limiting toxicities reported [7] Future Development - Experts from MD Anderson Cancer Center expressed optimism regarding APR-1051 as a promising addition to the treatment portfolio for HPV-associated head and neck cancers, supported by robust preclinical data [8] - Aprea is committed to advancing APR-1051 as a precision oncology agent, leveraging biomarker insights to optimize patient outcomes [8][9] - Enrollment in the ACESOT-1051 trial is ongoing, with plans to evaluate APR-1051 in combination with checkpoint inhibitors for distinct patient populations [12]

Thiogenesis Receives Confirmatory Guidance on IMPD for Pediatric MASH Phase 2a Clinical Trial in Europe and Core Patent Granted in EUJune 25, 2025 9:00 AM EDT | Source: Thiogenesis Therapeutics, Corp.San Diego, California--(Newsfile Corp. - June 25, 2025) - Thiogenesis Therapeutics, Inc. (TSXV: TTI) (OTCQX: TTIPF), a clinical-stage biopharmaceutical company developing next-generation thiol-based therapies for mitochondrial disease and pediatric metabolic conditions, today announced that the Co ...

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 ...