Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the National Institute for Health and Care Excellence (NICE) has recommended IMCIVREE (setmelanotide) for treating obesity related to POMC and LEPR deficiencies. This recommendation allows for its funding and availability within 90 days in the National Health Service in England and Wales. IMCIVREE is the first approved therapy addressing the underlying causes of these rare genetic conditions. The recommendation aligns with existing EU and UK market approvals, offering hope for many affected families.

Rhythm Pharmaceuticals (RYTM) announced promising interim results from a Phase 2 trial of setmelanotide, focusing on treating severe obesity and hyperphagia in hypothalamic obesity patients. Positive outcomes include a mean BMI reduction of 17.2% and a weight decrease of 15.8% after 16 weeks. Notably, all evaluable patients experienced over a 5% BMI decrease. The company plans to advance to Phase 3 development. Setmelanotide was well-tolerated, with common side effects including nausea and vomiting. The results suggest potential transformation in treatment for this rare condition.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on July 6, 2022, the grant of equity awards as inducement to six new employees, totaling 33,135 shares. This includes inducement stock options for 22,085 shares at an exercise price of $4.74 per share, and RSUs for 11,050 shares, vesting over four years. The grants adhere to the company's 2022 Employment Inducement Plan and comply with Nasdaq rules. Rhythm is focused on treating obesity linked to genetic disorders through its FDA-approved product, IMCIVREE (setmelanotide), which targets the melanocortin-4 receptor pathway.

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.