Reneo Pharmaceuticals, Inc. - RPHM STOCK NEWS

Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM) reported financial results for Q4 and full year 2022, highlighting significant progress in its clinical development. The company achieved target enrollment of 200 patients in its pivotal STRIDE study for mavodelpar, expecting topline results by Q4 2023. Reneo also received FDA and EMA confirmation that data from STRIDE studies may support registration of mavodelpar for adult patients with mitochondrial diseases. Despite a net loss of $13.6 million in Q4 2022, up from $10.6 million in Q4 2021, Reneo maintains a strong cash position of $101.2 million for continued development and operational enhancements.

Reneo Pharmaceuticals, Inc. (RPHM) announces successful enrollment in the pivotal STRIDE study.

The company has achieved its target of enrolling 200 patients in the STRIDE study of mavodelpar (REN001) for primary mitochondrial myopathies (PMM). Topline data is expected in Q4 2023, with additional patients pending enrollment. Approximately 85% of eligible participants have also opted into the STRIDE AHEAD safety study.

The STRIDE trial is a global Phase 2b study aimed at assessing efficacy and safety over 24 weeks, with results submitted to the FDA and EMA planned for 2024.

Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM) announced participation at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in Salt Lake City from Mar. 18-21, 2023. The company will present a preclinical poster titled PPARδ Agonist REN001 Improves Mitochondrial Function in Skeletal Muscle on Mar. 19, highlighting studies on mavodelpar (REN001) as a selective PPARδ agonist that enhances fatty acid metabolism. Currently, mavodelpar is under evaluation in the pivotal clinical trial REN001-201 for patients with primary mitochondrial myopathies. The poster will be available on Reneo's website post-event.

Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM) announced its participation in the upcoming SVB Securities Global Biopharma Conference on February 15, 2023, at 3:40 p.m. EST. This virtual event will showcase Reneo's focus on developing therapies for rare genetic mitochondrial diseases. Their lead product candidate, mavodelpar (REN001), targets mitochondrial dysfunction and aims to enhance ATP production. Webcast links will be available on the company's website.

Reneo Pharmaceuticals (Nasdaq: RPHM) recently announced that the FDA has granted Fast Track designation for mavodelpar (REN001) to treat long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, a key condition within long-chain fatty acid oxidation disorder (LC-FAOD). This designation is significant as it allows faster development and review processes for therapies addressing serious conditions. Mavodelpar is also being evaluated in a pivotal study for primary mitochondrial myopathies (PMM), with topline data expected in Q4 2023. The Fast Track designation underscores the potential of mavodelpar in treating rare genetic mitochondrial diseases.

Reneo Pharmaceuticals (Nasdaq: RPHM) reported Q3 financial results with a net loss of $13 million, or $0.53 per share, slightly increasing from $12.7 million, or $0.52 per share, the previous year. The company has successfully enrolled over 80% of patients in its pivotal STRIDE study targeting primary mitochondrial myopathy (PMM) with mitochondrial DNA defects, with topline data expected in Q4 2023. Reneo also announced advancements in its Phase 1b studies and plans for a Phase 2 study in long-chain fatty acid oxidation disorders (LC-FAOD). As of September 30, 2022, Reneo reported $116 million in cash and investments.

Reneo Pharmaceuticals (NASDAQ: RPHM), a clinical-stage firm focused on therapies for rare genetic mitochondrial diseases, announced its participation in three upcoming healthcare conferences. These events include the Jefferies Global Healthcare Conference from November 15-17, 2022, in London, the Piper Sandler Healthcare Conference from November 29-December 1, 2022, in New York, with a fireside chat on November 30, and the LifeSci Partners Corporate Access Event from January 9-11, 2023, in San Francisco. Presentation links will be available on their website.

Reneo Pharmaceuticals (NASDAQ: RPHM) announced its management team will participate in three key healthcare conferences this September. The conferences are the Baird Global Healthcare Conference on September 13-14 in New York, the 11th Annual SVB Securities Healthcare Summit from September 21-23 in California, and the Ladenburg Thalmann Annual Healthcare Conference on September 29 in New York. Links to the presentations will be available on the company’s website. Reneo focuses on therapies for rare genetic mitochondrial diseases, with its lead candidate, REN001, targeting mitochondrial function.