Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals (NASDAQ:RYTM) announced significant regulatory progress for setmelanotide in treating acquired hypothalamic obesity. The FDA has accepted the company's sNDA with Priority Review, setting a PDUFA date of December 20, 2025. Additionally, the EMA validated the Type II variation submission for the same indication.

The applications are supported by the Phase 3 TRANSCEND trial results, which demonstrated a significant -19.8% placebo-adjusted reduction in BMI. The trial showed strong efficacy in both adult patients (-19.2% BMI reduction) and pediatric patients (-20.2% BMI reduction). Setmelanotide, already approved as IMCIVREE® for other rare genetic obesity conditions, was generally well-tolerated in the study.

Rhythm Pharmaceuticals (NASDAQ:RYTM) reported strong Q2 2025 financial results, with IMCIVREE® global sales reaching $48.5 million, up 29% from Q1 2025. The company successfully raised $189.2 million through a public offering of common stock at $85 per share.

Key clinical achievements include positive Phase 2 results for bivamelagon and Phase 3 TRANSCEND trial data for setmelanotide in acquired hypothalamic obesity. The Phase 2 trial showed significant BMI reductions of 9.3% in the 600mg cohort and 7.7% in the 400mg cohort. The company plans to complete regulatory submissions for setmelanotide in acquired hypothalamic obesity to FDA and EMA in Q3 2025.

Q2 2025 resulted in a net loss of $48.0 million ($0.75 per share), compared to $33.6 million ($0.55 per share) in Q2 2024. The company projects $285-315 million in Non-GAAP Operating Expenses for 2025.

Rhythm Pharmaceuticals (NASDAQ:RYTM), a global biopharmaceutical company specializing in rare neuroendocrine diseases, has scheduled two important investor events. The company will host its Q2 2025 earnings call on August 5, 2025, at 8:00 a.m. ET to discuss financial results and provide a corporate update.

Additionally, RYTM's management team will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 12:30 p.m. ET. Both events will be webcast live and archived on the company's investor relations website.

Rhythm Pharmaceuticals (NASDAQ:RYTM) presented significant clinical data for two MC4R agonists - setmelanotide and bivamelagon - in treating acquired hypothalamic obesity at ENDO 2025. The Phase 2 SIGNAL trial for bivamelagon showed significant BMI reductions of up to 9.3% in the highest dose cohort. The Phase 3 TRANSCEND trial for setmelanotide demonstrated a remarkable 19.8% placebo-adjusted BMI reduction across 120 patients.

Notably, setmelanotide showed consistent efficacy across age groups and genders, with significant results even in patients using GLP-1s. Patients with prior and concomitant GLP-1 use achieved a 25.1% BMI reduction compared to 2.0% in the placebo group. In patients under 18, the treatment led to a 26.2% reduction in the 95th percentile BMI at week 52.

Rhythm Pharmaceuticals (NASDAQ:RYTM), a global biopharmaceutical company focused on rare neuroendocrine diseases, has announced the pricing of its upsized public offering of 2,058,824 shares at $85.00 per share.

The company expects to raise approximately $175 million in gross proceeds before deducting underwriting costs and other expenses. Additionally, underwriters have a 30-day option to purchase up to 308,823 additional shares at the public offering price. The offering is expected to close around July 11, 2025.

Morgan Stanley, BofA Securities, Stifel, and Wells Fargo Securities are serving as joint book-running managers, while Canaccord Genuity and Citizens Capital Markets act as lead managers for the offering.

Rhythm Pharmaceuticals (NASDAQ: RYTM), a global biopharmaceutical company focused on rare neuroendocrine diseases, has announced a proposed public offering of $150 million of its common stock. The company will also grant underwriters a 30-day option to purchase up to an additional $22.5 million of shares.

The offering will be managed by joint book-runners Morgan Stanley, BofA Securities, Stifel, and Wells Fargo Securities, with Canaccord Genuity and Citizens Capital Markets acting as lead managers. The offering will be made through a shelf registration statement on Form S-3 that became effective on March 2, 2023.

Rhythm Pharmaceuticals (NASDAQ:RYTM) announced positive Phase 2 trial results for bivamelagon, their oral MC4R agonist, in treating acquired hypothalamic obesity. The trial demonstrated statistically significant BMI reductions of -9.3% and -7.7% in 600mg and 400mg cohorts respectively at 14 weeks, compared to a 2.2% increase in the placebo group.

The drug showed comparable efficacy to setmelanotide in post-hoc analysis, with both 400mg and 600mg cohorts achieving meaningful reductions in hunger scores (-2.8 points). Safety profile aligned with MC4R agonism, with limited instances of localized hyperpigmentation. The company plans to pursue regulatory discussions with FDA and EMA for Phase 3 trial design.

Rhythm Pharmaceuticals (NASDAQ:RYTM) has scheduled a conference call and webcast for July 9, 2025, at 8:00 a.m. ET to announce topline results from their Phase 2 clinical trial. The study evaluates bivamelagon, an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.

The trial represents a significant milestone as it involves a randomized, placebo-controlled study of their novel oral treatment for a rare neuroendocrine disease. The company, which focuses on transforming lives of patients with rare neuroendocrine diseases, will provide access to the webcast through their investor relations website.

Rhythm Pharmaceuticals (NASDAQ:RYTM) announced the acceptance of three late-breaking abstracts for presentation at ENDO 2025 in San Francisco. The presentations will showcase data from multiple clinical trials focused on acquired hypothalamic obesity treatments.

Key presentations include: the Phase 3 TRANSCEND trial results evaluating setmelanotide, patient experience interviews from the TRANSCEND trial, and results from a Phase 2 trial of bivamelagon, an oral MC4R agonist. The presentations will take place between July 12-15, 2025, with all materials becoming available on the company's healthcare professional website afterward.