Patent portfolio now includes protection for manufacture, methods and compositions Provides AIM with patent protection for manufacturing Ampligen until 2041 OCALA, Fla., June 12, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (OTC Pink: AIMID) (“AIM” or the “Company”) today announced the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled “Therapeutic Double Stranded RNA and Methods for Producing the Same.” The patent expires January 25, 2041. The new pa ...

Core Viewpoint - Acadia Pharmaceuticals' shares increased by 26.5% following a favorable ruling from the U.S. District Court regarding the patent for its lead drug, Nuplazid, which protects the company from generic competition until 2038 [1][3]. Company Performance - Nuplazid is the only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis in the U.S. [2] - In Q1 2025, Nuplazid generated $159.7 million in revenue, marking a 23% year-over-year increase driven by volume growth [3]. - Year-to-date, Acadia's shares have risen by 21.3%, contrasting with a 6.9% decline in the industry [4]. Product Portfolio - Acadia's other marketed drug, Daybue, approved for treating Rett syndrome, generated $84.6 million in revenue in Q1 2025, an 11% increase year-over-year [5]. - Daybue reached a record high of 954 unique patients receiving shipments in Q1 2025 [7]. Pipeline Developments - Acadia is awaiting EU regulatory approval for trofinetide to treat Rett syndrome, expected in Q1 2026 [8]. - The company anticipates top-line results from the phase III COMPASS PWS study of ACP-101 for Prader-Willi Syndrome in early Q4 2025, with plans to submit a regulatory application to the FDA in Q1 2026 [9]. - Enrollment for the phase II RADIANT study of ACP-204 for Alzheimer's disease psychosis is expected to be completed in Q1 2026, with top-line data anticipated in mid-2026 [10]. - Acadia and Saniona have completed the phase I study of ACP-711, which showed a strong safety profile, and are focusing on essential tremor as the lead indication [11][12].

Summary of Halozyme Therapeutics (HALO) 2025 Conference Call Company Overview - **Company**: Halozyme Therapeutics (HALO) - **Date of Conference**: May 13, 2025 - **Key Speaker**: Helen Torley, President and CEO Core Industry Insights - **Industry**: Biotechnology and Specialty Pharmaceuticals - **Focus**: Drug delivery technologies, particularly subcutaneous (subcu) delivery systems Key Points and Arguments Financial Performance and Growth - Halozyme reported strong first-quarter performance driven by three blockbuster products: DARZALEX, subcutaneous FEZZO, and VIBEKAR HYTRUL, with expectations for continued growth for many years [2][5] - Revenue guidance for the year was increased to $1.2 billion to $1.28 billion, with EBITDA projected between $790 million and $840 million, reflecting a 75% increase in free cash flow [5][6] Product Pipeline and Launches - Four new products have recently launched, including Tecentriq subcutaneous, Ocrevus subcutaneous, Opdivo, and Amivantamab subcutaneous, which are expected to significantly contribute to revenue starting in 2026 as reimbursement processes are completed [3][4] - There are 11 growth catalysts anticipated, including new indications and regions, as well as important reimbursement milestones [4] Mergers and Acquisitions Strategy - The company is considering mergers and acquisitions (M&A) to enhance its drug delivery platforms and create long-term revenue streams [2][6] - Halozyme has historically signed approximately one deal per year, often involving multiple targets, which contributes to a robust ongoing pipeline [18][19] Intellectual Property and Legal Matters - Halozyme's composition of matter patent is set to expire in 2029, but the company has applied for a new patent that could extend royalty rates for DARZALEX and Amivantamab until 2029 [41][42] - Ongoing litigation with Merck regarding KEYTRUDA involves claims of patent infringement related to modified hyaluronidases, with potential for significant royalty income if successful [45][46] Clinical Benefits and Market Position - Halozyme's ENHANZE technology is recognized as the gold standard for rapid large volume subcutaneous delivery, with 10 products approved and over 1 million patients treated [10] - The subcutaneous delivery of drugs like DARZALEX significantly reduces administration time from four to six hours (IV) to three to five minutes (subcu), enhancing patient experience and reducing infusion-related reactions [23][25] Future Trends and Market Dynamics - The shift towards subcutaneous delivery is expected to continue, particularly for oncology therapies, as it allows for more convenient patient administration and reduces the burden on healthcare facilities [57][61] - The company anticipates that the increasing demand for non-IV therapies will drive growth, especially in the context of infusion capacity constraints in healthcare settings [62] Capital Allocation and Share Repurchase - Halozyme has returned $1.55 billion to shareholders since 2019 and announced an additional $250 million share repurchase program, indicating a strong position for capital deployment [6][36] Regulatory Environment - Recent updates to the IRA guidance are seen as favorable for Halozyme, particularly regarding the treatment of fixed combination drugs in price negotiations [21][22] Additional Important Insights - The company is actively engaging with Congress and Senate members to ensure the clinical benefits of their subcutaneous delivery systems are recognized in regulatory discussions [32][33] - The potential for new co-formulation patents is high, with ongoing efforts to innovate in the area of drug delivery technologies [55] This summary encapsulates the key insights and strategic directions discussed during the Halozyme Therapeutics conference call, highlighting the company's growth trajectory, product pipeline, and market positioning within the biotechnology sector.

Core Viewpoint - Appili Therapeutics has secured new patents for its oral formulation of metronidazole, LIKMEZ, enhancing its market protection and supporting its commercialization efforts [1][2][3] Patent Protection - The newly granted patents will expire in 2039 and provide comprehensive protection for LIKMEZ, covering its unique taste-masked composition and therapeutic applications [2] - The U.S. patent has been listed in the FDA's Orange Book, which is crucial for ensuring additional protection for the formulation [2][3] Product Overview - LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, specifically designed for treating antimicrobial-resistant infections, particularly beneficial for patients with dysphagia [4] - The formulation aims to improve stability and palatability, which are essential for patient adherence to medication and better treatment outcomes [3] Commercialization Efforts - Saptalis Pharmaceuticals, the partner of Appili, is planning to re-launch LIKMEZ under its own label in May 2025, leveraging the newly granted patent for commercialization activities [3][4] - The collaboration with Saptalis emphasizes the commitment to bringing innovative pharmaceutical solutions to market [5][6] Company Background - Appili Therapeutics focuses on developing therapies for infectious diseases and aims to address urgent medical needs through a diverse pipeline of anti-infectives [7][9] - The company is strategically positioned to tackle life-threatening infections, with a proven management team leading its initiatives [9]