Rhythm Pharmaceu Stock Price, News & Analysis

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.

Rhythm Pharmaceuticals (Nasdaq: RYTM) has announced the promotions of key executives, including Joe Shulman to Chief Technical Officer, Patrick Kleyn, Ph.D., to Senior Vice President and Head of Translational Research and Development, and Elisabeth Crönert-Bendell, M.D., to Senior Vice President and Head of Strategy. These promotions aim to strengthen the company's leadership as it focuses on advancing its lead product, IMCIVREE (setmelanotide), approved for chronic weight management in rare genetic obesity diseases. IMCIVREE is the first FDA-approved therapy for these conditions.

Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a live conference call on March 1, 2022, at 8:00 a.m. ET to discuss its Q4 and full-year 2021 financial results. The call can be accessed via phone or through a webcast available on their Investor Relations website. Rhythm is focused on treating rare genetic diseases of obesity, with its drug IMCIVREE (setmelanotide) being the first FDA-approved therapy for specific genetic deficiencies related to obesity. The company is advancing its clinical development program while managing risks including regulatory approval uncertainties.

Rhythm Pharmaceuticals announced promising interim results from its long-term study of setmelanotide for Bardet-Biedl Syndrome (BBS), revealing sustained weight loss over 24 months. The mean BMI reduction was -14.3%, with significant improvements in older patients as well. The results showcased that setmelanotide was well-tolerated, with no new safety concerns identified. Rhythm is preparing for the potential U.S. commercial launch of IMCIVREE, pending FDA approval, where a supplemental NDA has a PDUFA goal date of March 16, 2022. Detailed results will be presented at an upcoming medical meeting.

Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a virtual event on February 16, 2022, to discuss the patient experience of Bardet-Biedl Syndrome (BBS) and its commercialization plans for setmelanotide, aimed at addressing obesity and hyperphagia in BBS patients. The event features key opinion leaders and updates on the FDA review of the supplemental New Drug Application (sNDA) for setmelanotide, with a PDUFA goal date of March 16, 2022. The company aims to enhance awareness and understanding of BBS and its treatments.

Rhythm Pharmaceuticals (RYTM) announced the initiation of the DAYBREAK Phase 2 clinical trial, the most extensive of its kind for rare genetic obesity diseases, dosing the first patient with setmelanotide. This trial aims to treat severe obesity and hyperphagia linked to variants in 31 genes. Concurrently, a Phase 3 switch trial evaluates a weekly setmelanotide formulation for patients currently on a daily dosage. DAYBREAK is set to enroll approximately 500 participants across 12 countries, with significant potential to shape future treatments for obesity linked to genetic variants.

Rhythm Pharmaceuticals (RYTM) announced an exclusive licensing agreement with RareStone for IMCIVREE (setmelanotide) to treat genetic obesity in China, including Hong Kong and Macau. Rhythm will receive a $12 million upfront payment, with potential future payments of up to $63.5 million plus sales royalties. The agreement aims to enhance patient access in China for severe genetic obesity, addressing a significant unmet medical need. This partnership marks Rhythm's first expansion into the Asian market, enhancing its global outreach.