Core Insights - Esperion has appointed Craig Thompson, CEO of Cerevance, as an independent director on its Board of Directors, expanding the board to eight members [1][2]. Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing innovative medicines for cardiovascular disease, specifically targeting patients with elevated low-density lipoprotein cholesterol (LDL-C) [7]. - The company has developed the only FDA-approved oral, once-daily, non-statin medications for at-risk cardiovascular patients, supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial [7]. Leadership Experience - Craig Thompson brings over 20 years of biopharmaceutical leadership experience, with a strong background in pharmaceutical commercialization and clinical development, which aligns with Esperion's mission [2][3]. - Prior to joining Esperion, Mr. Thompson held leadership roles at various biotechnology companies, including Cerevance, Neurana Pharmaceuticals, and Anthera Pharmaceuticals, and has experience in global marketing at Pfizer and Merck [4][5][6]. Strategic Focus - The appointment of Mr. Thompson is expected to enhance Esperion's strategic insight and operational expertise as the company aims to expand its impact in cardiovascular and cardiometabolic drug development [2][3]. - Esperion is advancing its pre-clinical pipeline and focusing on developing ATP citrate lyase inhibitors (ACLYi), which are expected to enable rational drug design and the development of highly potent inhibitors [7][8].

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]

Abeona will receive a license payment and potential development, regulatory, and sales milestones, and royaltiesCLEVELAND, July 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, has exercised its option to license Abeona's patented AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases that result in blindness. This worldwide, non-exclus ...

Active Ingredient Manufacturing Transfer to the U.S. Complete PRINCETON, N.J., July 1, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient under its partnership agreement with Sterling Pharma So ...

PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. Christopher van Dyck, ...

Core Insights - BioXcel Therapeutics, Inc. received a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia [1][2] - The trial is fully enrolled with 178 patients dosed as of the May 28, 2025 cutoff date, and topline data is expected in Q3 2025 [2][7] - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently under investigation for treating agitation in various conditions, including Alzheimer's dementia and bipolar disorders [5][6] Company Overview - BioXcel Therapeutics utilizes artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [13] - The company aims to address a significant unmet medical need for patients experiencing agitation related to bipolar disorders and schizophrenia, with no FDA-approved therapies currently available for at-home treatment [3][5] Trial Details - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients [6] - Patients are self-administering the drug during agitation episodes over a 12-week period, with safety data collected throughout the trial [6][3] - The trial's exploratory endpoints include assessments of severity and change in agitation two hours post-dosing [6] Regulatory and Market Potential - The trial data is intended to support a potential supplemental New Drug Application (sNDA) submission to expand the IGALMI® label for at-home use [3][16] - BXCL501 has received Breakthrough Therapy designation for treating agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [5]

Core Viewpoint - Apellis Pharmaceuticals has entered into a capped royalty purchase agreement with Sobi, allowing Apellis to receive up to $300 million in exchange for 90% of its future ex-U.S. royalties for Aspaveli, which is a treatment for rare diseases [1][2][3] Transaction Details - Apellis will receive $275 million upfront and may earn up to $25 million in milestone payments upon EMA approval for Aspaveli in treating C3G and IC-MPGN [3][7] - The agreement includes defined caps tied to Aspaveli's performance, after which 100% of ex-U.S. royalties will revert to Apellis [4] Product Information - Aspaveli (systemic pegcetacoplan) is approved in the EU and the U.S. for treating paroxysmal nocturnal hemoglobinuria (PNH) and is under review for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5] - Approximately 50% of patients with C3G and IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgency for effective treatments [6] Strategic Implications - The transaction is seen as a non-dilutive funding method that strengthens Apellis' balance sheet and provides operational flexibility as the company approaches sustainable profitability [2][7] - Sobi's expertise in rare diseases and its commercial footprint are expected to enhance the reach of Aspaveli globally following regulatory approvals [3]

Financing Overview - atai Life Sciences has entered into subscription agreements for the purchase of 18,264,840 ordinary shares and pre-funded warrants to purchase an additional 4,566,210 shares, expected to generate gross proceeds of approximately $50 million [1][2] - The financing is co-led by Ferring Ventures S.A. and Apeiron Investment Ltd., with participation from healthcare-focused institutional investors such as Ally Bridge Group and ADAR1 [2][4] Use of Proceeds - The net proceeds from the financing will be utilized for general corporate purposes, including working capital and advancing the clinical development of atai's product candidates and programs [1][3] Clinical Development and Future Plans - atai aims to accelerate its efforts in delivering new therapeutic options for mental health challenges, with a clear Phase 3 plan anticipated by early 2026 [3] - The company is advancing its pipeline of psychedelic-based therapies, including VLS-01 for treatment-resistant depression and EMP-01 for social anxiety disorder, both in Phase 2 clinical development [7] Investment Rationale - Ferring Ventures S.A. emphasizes the transformative potential of psychedelics for mental health conditions and supports atai's innovation in this space [4] - The financing is seen as a strategic move to position atai for future commercialization as it transitions from a clinical-stage biotech to a fully integrated commercial company [3][4]

Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single doseBoth 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8BPL-003 was generally well-tolerated at all doses, with 99% of treatment-emergent adverse events being mild or moderate, and no drug-relat ...