Relief Therapeut Stock Price, News & Analysis

Relief Therapeutics (OTCQB:RLFTF) reported positive pivotal bioequivalence results for RLF-OD032, a ready-to-use liquid sapropterin formulation for phenylketonuria (PKU). The randomized, open-label, two-way crossover study met its primary pharmacokinetic endpoints and demonstrated bioequivalence to KUVAN Powder under fed conditions.

RLF-OD032 was well tolerated with no serious adverse events reported in the pre-database lock analysis. The company expects to complete final data verification, finish CMC activities, and file a 505(b)(2) NDA in early 2026 with a planned 10-month FDA review.

Relief Therapeutics (OTCQB:RLFTY) has published its 2025 half-year report, highlighting progress in its pharmaceutical pipeline. The company received Rare Pediatric Disease designation for RLF-TD011 in epidermolysis bullosa and held a successful pre-IND meeting with the FDA.

Relief is advancing RLF-OD032, a next-generation liquid sapropterin formulation for phenylketonuria, with a pivotal trial expected to commence this quarter. The company's cash position is projected to sustain operations into late 2026, extending beyond the planned regulatory submission for RLF-OD032 in the United States. Additionally, Relief is pursuing a business combination with NeuroX to establish an AI-driven health tech company.

Relief Therapeutics (OTCQB:RLFTY), a biopharmaceutical company focused on specialty and rare diseases, has moved up the publication date of its 2025 half-year report. The report will now be released on August 14, 2025, before market opening, instead of the originally planned date of August 27, 2025.

The earlier publication is attributed to the anticipated early completion of the report. The half-year report will contain interim financial statements and a shareholder update, which will be accessible on Relief's website upon release.

Relief Therapeutics (OTCQB:RLFTY) has announced a significant business combination with NeuroX, the successor company to MindMaze, through a binding term sheet. The transaction values Relief at CHF 100 million and NeuroX at CHF 1 billion. Post-merger, Relief shareholders will own approximately 9% of the combined entity, while NeuroX shareholders will hold 91%.

NeuroX, which recently acquired MindMaze's assets and operations, brings a clinically validated portfolio of AI-based digital neurotherapeutics for treating neurological diseases and brain disorders. The company has invested over $350 million in developing its platform, which combines software-delivered behavioral treatments with drugs, devices, and AI technology.

The transaction is expected to close in Q4 2025, subject to customary conditions including shareholder approvals, due diligence, and regulatory clearances.

Relief Therapeutics announced that the FDA did not grant Qualified Infectious Disease Product (QIDP) designation for RLF-TD011, their treatment for epidermolysis bullosa (EB). Despite this setback, the company's development strategy remains unchanged as RLF-TD011 maintains both Orphan Drug and Rare Pediatric Disease designations, offering potential seven-year market exclusivity in the US upon approval. The company holds a European patent for RLF-TD011 valid through 2040. Relief also reported a productive pre-IND meeting with the FDA regarding the development pathway for RLF-TD011, with written responses expected in the coming weeks.

Relief Therapeutics (RLFTY) held its Annual General Meeting on June 12, 2025, where shareholders approved all proposed resolutions with over 85% support. Key approvals included the 2024 annual report and financial statements, carrying forward the 2024 financial year net result, and granting discharge to the board and executive committee. The meeting re-elected Dr. Raghuram Selvaraju as chairman, along with board members Gregory Van Beek, Peter de Svastich, and Thomas Elzinga. Shareholders approved compensation packages for the board and executive committee, the 2024 compensation report, and re-appointed Thomas Hua as independent proxy and FORVIS MAZARS SA as statutory auditor.

Relief Therapeutics (RLFTY) has received FDA Rare Pediatric Disease (RPD) designation for RLF-TD011, targeting epidermolysis bullosa (EB), a rare genetic skin disorder. RLF-TD011 is a hypotonic acid-oxidizing solution with hypochlorous acid, designed to provide antimicrobial and anti-inflammatory benefits for wound healing. The treatment previously received Orphan Drug Designation and has shown promising clinical results in modulating wound microbiome. The RPD designation applies to diseases affecting fewer than 200,000 people under 18 in the US. If approved, Relief could receive a Priority Review Voucher (PRV), which can be sold - notably, a similar PRV for an EB treatment was recently sold for $155 million in May 2025.

Relief Therapeutics (RLFTY) has announced its upcoming 2025 Annual General Meeting (AGM) scheduled for June 12, 2025 at 10:00 a.m. CEST in Geneva, Switzerland. The AGM agenda includes standard items such as approval of the 2024 annual report and financial statements, earnings appropriation, board and executive committee discharge, and re-election of board members and chairman.

Additional agenda items cover re-election of nomination and compensation committee members, approval of maximum compensation for board and executive committee, a consultative vote on the 2024 compensation report, and re-election of independent voting rights representative and auditors. Formal convocation notice will be mailed to registered shareholders on May 21, 2025.

Relief Therapeutics (RLFTY) has released its 2024 Annual Report, highlighting operational achievements and pipeline progress. The company's chairman, Dr. Raghuram Selvaraju, emphasized their strengthened financial position and commitment to treating rare diseases.

Key developments include advancement of two core pipeline products:

• RLF-OD032: A next-generation liquid sapropterin formulation for phenylketonuria
• RLF-TD011: A proprietary hypochlorous acid solution for epidermolysis bullosa

The company anticipates significant clinical and regulatory milestones in 2025 as they continue to focus on delivering treatments for unmet medical needs.