Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals (Nasdaq: RYTM) reported a net loss of $52.8 million for Q1 2022, compared to net income of $43.8 million in Q1 2021. Revenue from the sales of IMCIVREE reached $1.5 million, up from $35,000 a year prior. The company prepares for the U.S. launch of setmelanotide for Bardet-Biedl and Alström syndromes pending FDA approval by June 16, 2022. They also initiated multiple clinical trials with focus on rare genetic obesity, while cash reserves stood at approximately $241 million as of March 31, 2022.

Rhythm Pharmaceuticals (RYTM) presented new data on setmelanotide at the PES 2022 Virtual Annual Meeting, highlighting its potential to treat Bardet-Biedl syndrome (BBS) with clinically meaningful improvements in lipid parameters and weight management in pediatric and adolescent patients. The 52-week Phase 3 trial showed significant reductions in body weight, cholesterol, and triglycerides without affecting vital signs. Cumulative safety data from 561 patients indicated the treatment was well tolerated. The company anticipates a potential U.S. approval for setmelanotide for BBS later this quarter.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a live conference call on May 3, 2022, at 8:30 a.m. ET to discuss its Q1 2022 financial results and provide corporate updates. The company is known for its innovative treatment IMCIVREE (setmelanotide), approved for chronic weight management in patients with specific obesity-related genetic disorders. Additionally, Rhythm's supplemental New Drug Application for treating Bardet-Biedl Syndrome is under review by the FDA, with a decision expected by June 16, 2022.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the grant of 14,380 shares of its common stock to two new employees as part of an inducement equity grant on April 4, 2022. The grant includes inducement stock options for 9,585 shares and restricted stock units (RSUs) for 4,795 shares, governed by the Inducement Plan adopted on February 9, 2022. The stock options have an exercise price of $12.25 per share, and vesting is scheduled over four years. Rhythm focuses on transforming the care for people with rare genetic obesity diseases, highlighted by its FDA-approved treatment, IMCIVREE.

Rhythm Pharmaceuticals (RYTM) announced strategic modifications to its Phase 3 EMANATE and Phase 2 DAYBREAK clinical trials, focusing on rare patient populations to enhance success rates for setmelanotide, a treatment for genetic obesity disorders. The EMANATE trial has commenced with its first patient enrolled and now includes four independent sub-studies targeting specific genetic variants. The changes are aimed at optimizing trial design and extending the company's cash runway into Q4 2023, with anticipated enrollment of approximately 400 patients over 12-18 months.

Wren Therapeutics has appointed Bart Henderson as the new Chief Executive Officer. With extensive experience in biotechnology, including co-founding Rhythm (Nasdaq: RYTM), he aims to advance Wren's innovative drug discovery platform targeting toxic protein intermediates related to neurodegenerative diseases. Under the leadership of outgoing CEO Samuel Cohen, Wren has made significant progress in drug discovery, focusing on Alzheimer’s and Parkinson’s diseases. Henderson's experience is expected to strengthen the company's pipeline as they move towards clinical applications.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that its CEO, David Meeker, M.D., will participate in a fireside chat at the Cowen & Co. 42nd Annual Health Care Conference on March 8, 2022, at 10:30 a.m. ET. A live audio webcast will be accessible through the Investor Relations section of their website, with a replay available for 30 days post-event. Rhythm focuses on treating rare genetic diseases of obesity, having received FDA approval for IMCIVREE (setmelanotide) in 2020 for chronic weight management related to certain genetic deficiencies.

Rhythm Pharmaceuticals reported a net loss of $42.9 million in Q4 2021 with IMCIVREE sales of $1.8 million and total 2021 sales of $3.2 million. The company is preparing for a U.S. launch of IMCIVREE for Bardet-Biedl syndrome and Alström syndrome expected in June 2022, along with first sales in Germany and France anticipated in Q2 2022. Rhythm announced completion of enrollment in a Phase 2 trial for hypothalamic obesity, and recent increases in R&D expenses to $31.6 million in Q4 2021, attributed to expanded clinical trials and hiring. Cash reserves at year-end stood at approximately $294.9 million.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced an extension of the FDA review period for its supplemental New Drug Application (sNDA) for IMCIVREE^® (setmelanotide) to June 16, 2022, due to a request for additional subgroup analyses from its Phase 3 trial data. The company also withdrew the proposed Alström syndrome indication from its Type II variation application under EMA review to maintain the timeline for Bardet-Biedl Syndrome (BBS). Rhythm remains committed to bringing this treatment to market for patients with these rare genetic obesity disorders.