Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals announced that IMCIVREE (setmelanotide) is now available for patients in Germany. This precision medicine targets obesity linked to rare genetic disorders such as POMC and LEPR deficiencies. The European Commission previously granted marketing authorization for IMCIVREE, making it eligible for national coverage and reimbursement following a decision by the German Federal Joint Committee. Rhythm is committed to improving care for patients with these conditions through ongoing clinical research and regulatory submissions.

BOSTON, June 22, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the European Commission's authorization for a dosing variation of IMCIVREE® (setmelanotide) in patients with POMC or LEPR deficiency experiencing mild to severe renal impairment. This authorization allows treatment for patients 6 years and older, with no dose adjustments required for mild or moderate renal impairment. Additionally, Rhythm's Type II application for setmelanotide for Bardet-Biedl syndrome is under review, with a recommendation expected in Q3 2022.

Rhythm Pharmaceuticals has secured a $100 million Revenue Interest Financing Agreement with HealthCare Royalty Partners to enhance its commercialization efforts for IMCIVREE (setmelanotide). The initial investment of $37.5 million follows FDA approval for IMCIVREE for treating obesity linked to Bardet-Biedl syndrome (BBS). Another $37.5 million is expected post-European marketing authorization, with a final $25 million contingent on sales milestones in 2023. This funding will extend Rhythm's cash runway into 2H 2024.

Rhythm Pharmaceuticals announced the FDA approval of IMCIVREE for chronic weight management in patients 6 years and older with monogenic or syndromic obesity linked to Bardet-Biedl syndrome (BBS). This marks the first FDA-approved therapy targeting the MC4R pathway, addressing severe obesity and hyperphagia. The approval is based on successful Phase 3 trial data showing significant weight and hunger reduction. The company also launched the Rhythm InTune program for patient support. However, a complete response letter was issued for the sNDA regarding Alström syndrome.

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced positive long-term results from its extension trial showing sustained weight loss in patients with Bardet-Biedl syndrome (BBS) and POMC or LEPR deficiency obesity after 18 to 36 months of setmelanotide therapy. Data reveal a mean BMI reduction of 9.5% and 14.3% at 18 and 24 months for BBS patients. Among patients with POMC or LEPR deficiency, BMI decreased by 16.7% and 17.5% after 24 and 36 months. Setmelanotide was well-tolerated, supporting its use as a chronic treatment. A PDUFA goal date for BBS is set for June 16, 2022.

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) reported positive results from its long-term extension trial of setmelanotide, demonstrating sustained reductions in body mass index (BMI) among patients with specific genetic obesity disorders such as SH2B1 and SRC1 deficiencies, as well as POMC and LEPR insufficiencies. Initial findings indicated mean BMI changes of -3.4% to -9.7% over 12 months. The ongoing Phase 3 EMANATE trial aims to further evaluate the efficacy of setmelanotide, targeting patients with impaired signaling in the melanocortin-4 receptor pathway. No significant safety concerns were raised.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the grant of inducement equity awards on June 1, 2022, covering 27,100 shares to three new employees. The inducement includes stock options for 18,065 shares at an exercise price of $3.37 each and RSUs for 9,035 shares, according to the 2022 Employment Inducement Plan. Stock options vest progressively over four years, while RSUs vest annually. Rhythm is focused on treating obesity linked to rare genetic diseases and has launched the FDA-approved drug IMCIVREE, with ongoing developments and regulatory submissions for expanded indications.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced equity grants for 10 new employees on May 3, 2022, totaling 50,730 shares. This includes 16,915 stock options and 33,815 restricted stock units (RSUs). The stock options have an exercise price of $6.13 per share, vesting over four years, while RSUs vest over four years as well. The Inducement Plan was established to attract new talent and complies with Nasdaq rules. Rhythm's precision medicine, IMCIVREE, is FDA-approved for treating certain genetic obesity conditions.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 5:20 p.m. PT (8:20 p.m. ET) in Las Vegas, NV. A live audio webcast will be available on the company’s website, with replays for 30 days.

Rhythm is dedicated to addressing rare genetic diseases of obesity, with its drug IMCIVREE (setmelanotide) already FDA-approved for certain conditions. The company is also pursuing additional regulatory approvals and expanding its clinical programs.