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 ...

Core Insights - Soleno Therapeutics presented new data on VYKAT XR (diazoxide choline) extended-release tablets at the 2025 International Prader-Willi Syndrome Conference, highlighting its potential benefits for individuals with Prader-Willi Syndrome (PWS) [1][2] Group 1: Efficacy of VYKAT XR - VYKAT XR significantly reduces hyperphagia symptoms in PWS patients managed with strict food controls, showing statistically significant reductions in HQ-CT Total scores (p ≤ 0.0001) [5] - Participants in highly food-restricted environments benefited from VYKAT XR treatment similarly to those in less restricted environments, indicating broad applicability of the treatment [5] Group 2: Safety and Efficacy in Co-Morbid Conditions - 60% of study participants had evidence of pre-diabetes or diabetes (PD/DM) at baseline, with efficacy outcomes at Week 156 showing similar results for both PD/DM and normoglycemic groups (p<0.0001) [7] - Although a higher proportion of hyperglycemia-related adverse events were reported in the PD/DM group (42.7% vs 24.0%), these events were generally manageable, and treatment discontinuation rates were low (4.0% in PD/DM vs 6.0% in normoglycemic) [8][9] Group 3: Background on Prader-Willi Syndrome - Prader-Willi Syndrome is a rare genetic neurodevelopmental disorder affecting approximately 1 in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [10][11] - Hyperphagia in PWS can result in significant mortality and long-term co-morbidities such as diabetes, obesity, and cardiovascular disease [12] Group 4: Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with PWS [13][18]

Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 Submission Has the Potential to Trigger Exercise of up to $7.6 million in Gross Proceeds from 2023 Financing Warrants Tied to FDA Acceptance of NDA for Review PRINCETON, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-sta ...

Company Overview - ZyVersa Therapeutics, Inc. is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with significant unmet medical needs [5] - The company is advancing a therapeutic development pipeline that includes Cholesterol Efflux Mediator™ VAR 200 for kidney diseases and Inflammasome ASC Inhibitor IC 100 for inflammatory diseases [5] Share Purchase Agreement (SPA) - ZyVersa has entered into a share purchase agreement with Williamsburg Venture Holdings, allowing the company to sell up to $10 million worth of common stock over a 24-month period [3] - The SPA provides ZyVersa with flexibility in planning the timing and amount of equity sales, aiming to minimize dilution while sustaining shareholder value [2][3] - ZyVersa retains control over the timing and amount of all common stock sales, with no associated warrants or derivatives [3] Market Potential - The global drug market for kidney diseases was valued at $18 billion in 2024 and is projected to reach $30 billion by 2034 [1]

Core Viewpoint - Phio Pharmaceuticals has received a positive recommendation from the Safety Monitoring Committee to advance its clinical trial for PH-762, a siRNA compound targeting skin cancer, to the fifth dose escalation cohort, indicating a supportive safety profile through the fourth cohort [1][6]. Group 1: Clinical Trial Progress - The Phase 1b clinical trial (NCT 06014086) has enrolled five patients in the fourth cohort, with four diagnosed with cutaneous squamous cell carcinoma (cSCC) and one with Merkel cell carcinoma, all of whom tolerated the injections well without serious adverse events [2][4]. - A total of 15 patients have been treated across the first four cohorts, including 13 with cSCC, one with metastatic melanoma, and one with Merkel cell carcinoma [4]. - The company anticipates completing enrollment in the final cohort by the third quarter of 2025 [6]. Group 2: Efficacy and Safety Profile - Pathological responses at Day 36 showed a complete response (100% tumor clearance) in 4 out of 9 patients with cSCC, with one patient showing near complete response (>90% clearance) and another showing partial response (>50% clearance) [5]. - No patients exhibited clinical progression of disease, and the continuing favorable safety profile of PH-762 suggests it may be a well-tolerated treatment option for skin cancer [6][3]. Group 3: Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [7][8]. - PH-762 is designed to silence the PD-1 gene, which is implicated in various forms of skin cancer, and represents a potential non-surgical treatment option [8].

Core Insights - Arbutus Biopharma Corporation has reacquired the rights to its lead compound, imdusiran, from Qilu Pharmaceutical, concluding their strategic partnership for the development and commercialization of imdusiran in Greater China [1][2] - The decision to terminate the partnership was influenced by Qilu's pipeline reprioritization and Arbutus' focus on advancing its pipeline efficiently [2] - Imdusiran has shown promising results, achieving functional cure in eight patients during Phase 2a trials [2][3] Company Overview - Arbutus Biopharma is a clinical-stage biopharmaceutical company focused on infectious diseases, particularly chronic hepatitis B virus (cHBV) [7] - The company is also developing an oral PD-1 inhibitor (AB-101) for cHBV treatment and is involved in legal actions to protect its intellectual property related to its patented LNP technology [7] Product Details - Imdusiran is designed to reduce all HBV viral proteins and antigens, which is essential for reawakening the immune system to control the virus [5] - The treatment has been reported to be generally safe and well-tolerated, with significant reductions in hepatitis B surface antigen (HBsAg) and HBV DNA [5] Scientific Advisory Board - Arbutus has established a new Scientific Advisory Board consisting of experts in chronic hepatitis B treatment to guide its strategic evaluation of the cHBV pipeline [2]

Core Insights - Cognition Therapeutics, Inc. is advancing zervimesine (CT1812) into a Phase 3 program for mild-to-moderate Alzheimer's disease and has filed for breakthrough therapy designation for dementia with Lewy bodies (DLB) [1][2] Group 1: Clinical Development - An end-of-Phase 2 meeting with the FDA is scheduled for July 9, 2025, to discuss the Phase 2 'SHINE' study results and plans for a Phase 3 program for zervimesine in Alzheimer's disease [1] - The company is also progressing with an expanded access program for zervimesine in DLB, which has garnered high interest from former SHIMMER study participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating neurodegenerative diseases, specifically Alzheimer's disease and DLB, by potentially interrupting the toxic effects of protein buildup in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] Group 3: Company Overview - Cognition Therapeutics, Inc. focuses on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and has completed Phase 2 studies for zervimesine in multiple conditions [6]

Core Viewpoint - Cognition Therapeutics, Inc. is advancing its investigational drug zervimesine (CT1812) for the treatment of mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB), with an end-of-Phase 2 meeting scheduled with the FDA to discuss Phase 2 study results and plans for a Phase 3 program [1][2][8] Group 1: Clinical Development - The company will hold an end-of-Phase 2 meeting with the FDA on July 9, 2025, to review the Phase 2 'SHINE' study results of zervimesine in Alzheimer's disease [1] - Cognition is also moving forward with plans for a registrational program for DLB based on positive results from the Phase 2 'SHIMMER' study [2] - An expanded access program for zervimesine in DLB is underway, with high interest from former SHIMMER participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an oral, once-daily investigational drug targeting neurodegenerative diseases, specifically Alzheimer's and DLB, by potentially interrupting the toxic effects of harmful proteins in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] - The USAN Council has adopted zervimesine as the official name for CT1812 [5] Group 3: Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in multiple conditions, including DLB and Alzheimer's disease, and is currently conducting an ongoing Phase 2 study in early Alzheimer's disease [6]

Core Insights - Oncotelic Therapeutics has published a peer-reviewed research article identifying TGFB2 gene methylation as a positive prognostic biomarker for pancreatic ductal adenocarcinoma (PDAC) [1][2] - The study highlights the potential of TGFB2 methylation to improve overall survival in patients with low CD8+ T-cell infiltration [2][3] Group 1: Research Findings - PDAC is characterized as one of the most lethal cancers with limited treatment options, primarily relying on cytotoxic regimens like FOLFIRINOX [2] - High TGFB2 methylation combined with low expression of immune markers such as CD3D, LCK, and HLA-DRA correlates with a median overall survival exceeding 50 months [3] - The study emphasizes the need to profile TGFB1, TGFB2, and TGFB3 methylation to better understand tumor immune status and select candidates for immunotherapy in resistant "cold" tumors [4] Group 2: Company Commentary - Dr. Sanjive Qazi, the lead author, stated that the discovery enhances understanding of the TGFB gene complex in PDAC, particularly in immunologically cold tumors, supporting further clinical development of OT-101 [5] - Scott Myers highlighted the role of the AI-powered chatbot platform PDAOAI in accelerating scientific discovery through literature mining and analysis [5] - Dr. Michael Potts noted that large language models like PDAOAI are transforming the identification and interpretation of biomedical insights [5] Group 3: Company Background - Oncotelic Therapeutics, originally formed as OXiGENE, Inc. in 1988, has undergone several name changes and is focused on oncology drug development, particularly for rare pediatric cancers [7] - The company has a 45% stake in GMP Biotechnology Limited, which is involved in the development of therapies for various cancers, including Diffuse Intrinsic Pontine Glioma (DIPG) and Acute Myeloid Leukemia (AML) [7] - Oncotelic also acquired PointR Data Inc. to build an AI-driven biotechnology company, further expanding its capabilities in drug development [7]