CALABASAS, Calif. and ABU DHABI, United Arab Emirates, Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, announces a landmark development for global healthcare innovation, His Highness Sheikh Nahyan bin Zayed Al Nahyan, Chairman of the Zayed Charitable and Humanitarian Foundation, will formally assume the role of Executive Chairman of Nu ...

Financial Data and Key Metrics Changes - Alkermes reported total revenues of $394.2 million for Q3 2025, driven by proprietary products generating net sales of $317.4 million, reflecting a 16% year-over-year growth [9][10] - The company raised its full-year 2025 guidance to total revenues of $1.43 to $1.49 billion, GAAP net income of $230 to $250 million, EBITDA of $270 to $290 million, and adjusted EBITDA of $365 to $385 million [11] - GAAP net income for Q3 was $82.8 million, with EBITDA of $96.9 million and adjusted EBITDA of $121.5 million [10] Business Line Data and Key Metrics Changes - Vivitrol net sales for Q3 were $121.1 million, with full-year expectations now in the range of $460 to $470 million [16] - Aristada net sales for Q3 were $98.1 million, with full-year expectations raised to $360 to $370 million [17] - Lybalvi net sales grew 32% year-over-year to $98.2 million, with full-year expectations now in the range of $340 to $350 million [17] Market Data and Key Metrics Changes - The company experienced strong underlying demand across its proprietary product portfolio, with gross-to-net favorability primarily related to Medicaid utilization rates [9][10] - The expansion of the psychiatry sales force earlier in the year significantly increased the frequency of call volume for high-priority prescriber targets [16] Company Strategy and Development Direction - Alkermes announced a proposed acquisition of Avadel Pharmaceuticals, which is expected to diversify its commercial portfolio and strengthen profitability [4][5] - The acquisition will accelerate entry into the sleep medicine market and support the development of Elixerextant, an orexin-2 receptor agonist [5][6] - The company is focused on advancing its pipeline of orexin-2 receptor agonists, with plans to initiate a global phase 3 program for Elixerextant early next year [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the business and the strong commercial execution observed in Q3 [4][8] - The company is operating from a position of financial strength and is well-positioned to deliver long-term value for shareholders [12][22] - Management highlighted the importance of maintaining a disciplined contracting strategy consistent with the significant value of their medicines [18] Other Important Information - Alkermes entered Q3 with $1.14 billion in cash and total investments, planning to use cash and bank debt to finance the acquisition of Avadel [11] - The company is committed to neuroscience and aims to support a diversified development strategy in sleep disorders [6] Q&A Session Summary Question: Can you talk about Lybalvi's performance and gross-to-net expectations? - Management noted strong performance driven by an expanded psychiatry footprint and increased call volume, with gross-to-net lower due to deductible resets and lower copay utilization [25][27] Question: What are the expectations for the NT2 Elixerextant data and Vivitrol heading into Q4? - Management expects data from the NT2 study in November, which will inform the next steps with the FDA, while Vivitrol is expected to continue strong AD growth in Q4 [30][32] Question: Can you confirm details about the top-line release for Vibrance II data? - Management indicated that top-line data will be released soon, with a focus on safety and efficacy across various parameters to inform phase 3 design [39][41] Question: What are the expectations for ocular monitoring in phase 3 programs? - Management stated that while there were mild ocular events in previous studies, it is too early to determine if monitoring will be necessary in phase 3 [48] Question: How does the company view the potential impact of ACA subsidy lapses? - Management expressed that there is a strong political reason to maintain ACA subsidies, particularly for patients with serious mental illness and addiction [75][77]

Core Insights - Palisade Bio has appointed Sharon Skare, PhD(c), as Vice President, Global Head of Clinical Operations, bringing over 24 years of experience in clinical development across various therapeutic areas [1][3][4] - The company is focused on advancing PALI-2108 for ulcerative colitis and fibrostenotic Crohn's disease, with a Phase 2 IND submission planned for the first half of 2026 [1][7] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases [8] - The company aims to transform the treatment landscape by utilizing a targeted approach with its novel therapeutics [8] Product Development - PALI-2108 is an orally administered prodrug designed for local delivery of phosphodiesterase-4 (PDE4) inhibition specifically to the terminal ileum and colon [5] - The prodrug is engineered to be gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is activated by bacterial enzymes [5][6] - A Phase 1a/1b study of PALI-2108 for ulcerative colitis has been completed with positive data, and a Phase 1b study for fibrostenotic Crohn's disease is currently underway [7] Leadership and Expertise - Sharon Skare has a strong background in global clinical development, having previously held senior positions at Abivax, Pfizer, and Arena Pharmaceuticals [3][4] - Her experience includes overseeing global Phase 3 and Phase 2 programs in ulcerative colitis and Crohn's disease, as well as leading clinical operations for Etrasimod, now approved as Velsipity™ [3][4]

NEW YORK, Oct. 28, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Oncotelic Therapeutics Inc. (OTCQB: OTLC) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, “Nanomedicine Breakthrough Technology Redefining Drug D ...

Q3 2025 net product revenue for ZORYVE® (roflumilast) was $99.2 million, a 122% increase compared to Q3 of 2024, and a 22% increase compared to Q2 of 2025 ZORYVE cream 0.05% received U.S. Food and Drug Administration (FDA) approval for the treatment of atopic dermatitis in children down to 2 years of age in October Company provides initial 2026 full year net product sales guidance of $455–$470 million WESTLAKE VILLAGE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) ...

IBSRELA patients reported treatment satisfaction in real-world survey Post-hoc analysis of T3MPO-1 and T3MPO-2 studies demonstrates effectiveness of IBSRELA in reducing abdominal bloating for patients with IBS-C Analysis of electronic health records suggests IBSRELA may reduce burden to healthcare system WALTHAM, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines ...

Two oral presentations to highlight biomarker, imaging and quality-of-life data from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of RezdiffraPoster of distinction examines the impact of Rezdiffra interruption on patients, underscoring the need for continued treatment to prevent disease progressionFurther poster presentations examine early real-world experience with Rezdiffra and the clinical burden of MASH CONSHOHOCKEN, Pa., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Madr ...

To enhance and accelerate regulatory dialogue with the FDA To provide strategic guidance across clinical development programsTo bring deep expertise in CNS and immuno-oncology MADRID and CAMBRIDGE, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, BME: ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, is pleased to announce the strategic collaboration with Dr. Iman Barilero, PharmD, PhD, as Senior Advisor for Regulatory Affairs to suppo ...

– Leading Cardiovascular Physician Experts to Explore Real-World Challenges and Impact on Patient Outcomes – ANN ARBOR, Mich., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it will host a virtual key opinion leader (KOL) event for investors to discuss the clinical and real-world challenges of statin intolerance, its impact on patient outcomes, and the Company’s continued commitment to addressing this significant unmet need. The event will be led by LeAnne Bloedon, VP, Head of Cli ...

First patient dosed in Phase 1/2a study with novel immune rejuvenator, a trispecific antibody-fusion protein Two MDX2004 abstracts accepted for poster presentation at SITC Annual Meeting 2025 WESTON, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune ...