Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics announced on September 13, 2021, that it received scientific advice from the MHRA regarding its lead drug candidate, RLF-100 (aviptadil), aimed at treating respiratory deficiency in severe COVID-19 cases. The MHRA suggested a conditional marketing approval (CMA) pathway, allowing for early access to treatments. Relief also discussed the regulatory path with the EMA and indicated ongoing dialogue with the MHRA for necessary data from a Phase 2b/3 study conducted by NeuroRx. However, NeuroRx has yet to provide all required data, presenting potential risks.

Relief Therapeutics has announced the launch of PKU GOLIKE(R) KRUNCH, a chewable tablet designed for the dietary management of phenylketonuria (PKU), a rare genetic disorder affecting around 350,000 individuals globally. This new product aims to enhance patient adherence to therapy, providing a convenient 'on-the-go' option. The launch, taking place in Germany and Italy, leverages the Physiomimic Technology(TM) to offer a prolonged-release formulation that masks the product's unpleasant taste. Future expansion plans include additional markets across Europe.

Relief Therapeutics Holding AG (RLFTF) announced participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CFO Jack Weinstein will present a company overview, available on-demand starting September 13 at 7:00 AM ET on Relief's website. The presentation will be archived for 90 days. Relief focuses on clinical-stage programs, particularly RLF-100^TM for COVID-19 respiratory deficiency. Additionally, Relief has collaborated with Acer Therapeutics on ACER-001 for treating Urea Cycle Disorders.

Relief Therapeutics (OTCQB: RLFTF) has responded to assertions made by NRx Pharmaceuticals in their September 3, 2021, Registration Statement. Relief disputes claims regarding the collaboration surrounding RLF-100 (aviptadil), specifically challenging accusations of misleading financial obligations and instability in the drug's formulation. Relief insists it has met all financial responsibilities and has requested transparency from NRx on clinical trial data and invoices. Relief also believes it can enforce its rights under the Collaboration Agreement if disputes remain unresolved.

Relief Therapeutics announced regulatory clearance for its subsidiary, AdVita Lifescience, to initiate a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for treating sarcoidosis. This follows a proof-of-concept trial that showed potential benefits in 20 patients. The trial will be randomized, double-blind, and multicenter, focusing on alleviating sarcoidosis-related cough, which significantly impacts patient quality of life. This milestone supports Relief’s strategy of advancing treatment options for serious diseases with unmet needs.

Relief Therapeutics announced new findings from the phase 2b/3 trial of ZYESAMI (aviptadil) by its U.S. partner, NRx Pharmaceuticals, indicating significant improvements in blood oxygen levels in patients with acute respiratory failure due to COVID-19. This analysis may support NRx's application for Breakthrough Therapy Designation from the FDA, which could streamline the drug's pathway to market. Relief's collaboration with NRx aims to address the unmet needs in treating critically ill patients, enhancing its position in the biopharmaceutical landscape.

Relief Therapeutics (OTCQB: RLFTF) reported a safety update from NRx Pharmaceuticals regarding ZYESAMI(TM) (aviptadil) in the NIH-sponsored ACTIV-3 study. This drug is in late-stage clinical testing for respiratory deficiency due to COVID-19. Relief is also advancing its pipeline through a collaboration with Acer Therapeutics to develop ACER-001 for Urea Cycle Disorders. Recent acquisitions have diversified its portfolio, enhancing the company’s market position. Relief is committed to providing therapeutic relief from serious diseases.

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.