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MindMaze Therapeutics Holding SA develops and commercializes precision digital treatments for neurological diseases and brain disorders. Its brain technology platform integrates software, proprietary sensors, telehealth, and AI-driven data analytics to support care from acute hospital treatment to outpatient and home-based therapy.
Company news covers FDA-cleared and CE-marked neurotherapeutics for areas such as stroke and Parkinson's disease, reimbursement strategy across healthcare systems, clinical validation, and R&D expansion into adjacent neurological indications. Updates also include the completed business combination that formed the MindMaze Therapeutics identity, along with shareholder voting, governance, capital-structure, and financial-reporting matters.
Relief Therapeutics (OTCQB: RLFTF) announced that its subsidiary, AdVita Lifescience GmbH, received Orphan Drug Designation from the FDA for RLF-100 (aviptadil), aimed at treating sarcoidosis, a rare disease affecting about 140,000 patients in the U.S. This marks the company's third Orphan Drug Designation and is seen as a significant milestone, enhancing its drug development pipeline. The designation confers substantial benefits, including marketing exclusivity for up to seven years in the U.S. This development is part of Relief's strategy to diversify its portfolio and address high unmet medical needs.
Relief Therapeutics announced a definitive agreement to acquire AdVita Lifescience GmbH, enhancing its capabilities in developing an inhaled formulation of aviptadil for treating rare lung diseases. The acquisition involves the issuance of 135,741,063 shares valued at EUR 25 million and potential milestone payments up to EUR 20 million based on regulatory achievements. The integration is expected to accelerate development of therapies targeting conditions like COVID-19 related ARDS. This strategic move aligns with Relief's long-term growth objectives and strengthens its clinical pipeline.
Relief Therapeutics (OTCQB: RLFTF) announced that its partner, NRx Pharmaceuticals, received an Emergency Use Authorization for aviptadil in Georgia for treating critical COVID-19 patients. The first doses are expected to arrive shortly. Relief’s RLF-100 (aviptadil) is in late-stage clinical testing in the U.S. for respiratory issues due to COVID-19. The company also established a collaboration with Acer Therapeutics to develop ACER-001 for Urea Cycle Disorders. Relief continues to diversify its pipeline following the acquisition of APR Applied Pharma Research.
Relief Therapeutics (OTCQB: RLFTF) announced a definitive agreement with two U.S. institutional investors for a private placement of 71,428,572 shares at CHF 0.21 each, anticipating gross proceeds of approximately CHF 15 million. The offering, set to close around July 28, 2021, will finance the acquisition of further assets and support milestone payments. CFO Jack Weinstein highlighted the financing's role in expanding the pipeline, particularly the development of RLF-100 amidst ongoing COVID-19 challenges. The placement shares will list on the SIX Swiss Exchange.
Relief Therapeutics announced that its U.S. partner, NRx Pharmaceuticals, has validated a commercial formulation of aviptadil for intravenous use, enabling high-volume manufacture with over a year's stability. NRx achieved a significant 30-to-50-fold increase in its manufactured lot size. This development is crucial for addressing the continued demand for effective treatments for respiratory failure amid COVID-19, especially given vaccination disparities and emerging variants. The company is optimistic about aviptadil's potential availability for critical patients.
Relief Therapeutics will issue 1 billion new shares from its authorized capital around July 27, 2021, as part of a strategic transformation into a diversified commercial-stage pharmaceutical company. Approximately 140 million shares will be used for the acquisition of AdVita, and about 206.8 million shares for APR. The remaining shares are reserved for future financing and corporate purposes. The acquisitions bolster Relief's pipeline, particularly its lead candidate, RLF-100, targeting respiratory deficiency due to COVID-19.
Relief Therapeutics reported a significant finding from its partner, NRx Pharmaceuticals, indicating that aviptadil effectively prevents cytokine surges in critically ill COVID-19 patients. This data, derived from a U.S. Phase 2b/3 trial, has been submitted to the U.S. FDA as a supplement for Emergency Use Authorization. NRx is also addressing FDA requests for additional data on this application. Relief is focused on clinical-stage programs, with aviptadil as a lead candidate in late-stage testing against COVID-19 respiratory failure, while also expanding its pipeline through collaborations and acquisitions.
Relief Therapeutics is collaborating with NRx Pharmaceuticals and Quantum Leap Healthcare Collaborative to treat COVID-19 patients using inhaled aviptadil in the I-SPY COVID Trial. This phase 2 trial targets those severely affected by the virus. Relief's lead candidate, RLF-100 (aviptadil), is undergoing late-stage testing for respiratory issues due to COVID-19. Recently, Relief also partnered with Acer Therapeutics to develop ACER-001, aimed at treating Urea Cycle Disorders. Relief is traded on the SIX Swiss Exchange under RLF and OTCQB as RLFTF.
NRx Pharmaceuticals (Nasdaq: NRXP) announced the initiation of clinical training for ICU physicians in Georgia on using intravenous ZYESAMI™ (Aviptadil-acetate) for emergency COVID-19 treatment. Additionally, the ongoing phase 2/3 trial for inhaled ZYESAMI™ will be extended to Georgia and potentially neighboring countries. Clinical drug supplies are expected to ship within two weeks. The partnership is partially funded through Relief Therapeutics. ZYESAMI™ aims to address COVID-19-related respiratory failure by targeting cellular mechanisms affected by the virus.
Relief Therapeutics announced the acquisition of APR Applied Pharma Research for CHF 21.5 million in cash and CHF 45 million in shares, with contingent payments based on milestones. This acquisition aims to diversify Relief's pipeline with commercial and clinical-stage products, enhancing its infrastructure for future launches. Relief gains access to APR's R&D expertise, which includes the marketed product Golike for PKU and the promising APR-TD011 for epidermolysis bullosa. The deal is viewed as a significant step in Relief's transformation into a robust commercial-stage biopharmaceutical firm.