Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics has signed a binding term sheet with Meta Healthcare Ltd. to acquire worldwide commercialization rights (excluding the UK and Ireland) for a novel dosage form of a prescription drug approved by the FDA for treating phenylketonuria (PKU). This agreement, expected to enhance Relief's PKU GOLIKE(R) product portfolio, includes responsibilities for bioequivalence studies and regulatory submissions. The product's launch in the U.S. and Europe is anticipated in the first half of 2024, following necessary regulatory approvals.

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received approval from the National Institutes of Health to continue the phase 3 trial of aviptadil for critical COVID-19 patients. The review by the Data Safety and Monitoring Board revealed no new safety concerns, allowing enrollment to expand from 448 to 640 patients. The trial's success could lead to a New Drug Application for aviptadil. Relief's diverse pipeline also includes partnerships for other treatments.

Relief Therapeutics has filed for a trademark of RLF-100 with the USPTO, expected to be registered by late April. This trademark will protect the drug's use in treating a variety of diseases, including respiratory and viral infections. The application faced no opposition, allowing for swift registration. RLF-100 is currently in late-stage clinical trials for COVID-19 related acute respiratory distress syndrome, having received FDA Fast Track Designation. This signifies progress in potential therapeutic applications amid ongoing health challenges.

Relief Therapeutics announces the appointment of Michelle Lock to its Board of Directors. Lock brings nearly 30 years of biopharmaceutical sales and commercialization experience from her roles at Covis Pharma, Acceleron Pharma, and Bristol-Myers Squibb. Her expertise aims to bolster Relief's growth strategy and advance its product pipeline, which includes RLF-100 for respiratory issues and ACER-001 for Urea Cycle Disorders. This addition increases the Board to five members, highlighting Relief's commitment to enhancing its operational leadership.

Relief Therapeutics announced that its collaboration partner Acer Therapeutics received a new patent (11,202,767) for ACER-001, covering methods of use related to this treatment for Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). This adds to a previous patent (11,154,521) for the pharmaceutical composition of ACER-001, with both patents expiring in 2036. Acer's New Drug Application (NDA) for ACER-001 is under review, with a target action date of June 5, 2022.

Relief Therapeutics Holding SA announced key resolutions approved at its Extraordinary General Meeting on January 28, 2022, with over 85% support. Notably, Michelle Lock was elected to the Board of Directors, bringing extensive experience from Acceleron Pharma. The meeting also approved a total compensation of CHF 2,500,000 for board members for the current term and revised the Articles of Association. Relief's lead drug candidate, RLF-100, is in late-stage testing for COVID-19 respiratory issues, while partnerships expand its pipeline for rare diseases.

Relief Therapeutics Holding SA announced that its partner, NRx Pharmaceuticals, received a safety report on aviptadil use in COVID-19 patients under the Federal Right to Try Law. Out of 19 treated patients, three died while 16 (84%) were alive by January 22, 2022. The report noted no serious adverse events during the Omicron surge. Relief focuses on developing therapies for serious conditions, with aviptadil in late-stage testing for respiratory failure due to COVID-19, alongside other pipeline projects including ACER-001.

Relief Therapeutics announced that its subsidiary, APR Applied Pharma Research, received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent on diclofenac potassium formulations, extending protection until December 13, 2039. This patent covers ready-to-use oral solutions in stick packs for treating pain and migraine. The new formulation aims to enhance patient compliance. Current commercial rights for diclofenac are held by Assertio Therapeutics in the U.S. and Miravo Healthcare in Canada. The patent strengthens Relief's position in the market for non-steroidal anti-inflammatory drugs.

Relief Therapeutics Holding SA reported enhancements to the Expanded Access and Right to Try programs for aviptadil, enabling COVID-19 patients with respiratory failure to access treatment. These changes are made by their collaboration partner, NRx Pharmaceuticals. Patients who have exhausted all approved therapies can receive aviptadil via physician prescription, continuing under FDA guidelines. Relief's product, RLF-100 (aviptadil), is in late-stage trials for respiratory issues caused by COVID-19, while the company diversifies its pipeline through collaborations and acquisitions.