Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals (NASDAQ: RYTM) announced its participation in three upcoming investor conferences in September 2022. David Meeker, CEO, will present at the Wells Fargo Healthcare Conference on September 8, followed by the Morgan Stanley 20th Annual Global Healthcare Conference on September 12. Hunter Smith, CFO, will present at the Ladenburg Thalmann Healthcare Conference on September 29. The live webcasts will be available on the company’s website for 30 days post-event. Rhythm focuses on treatments for hyperphagia and severe obesity linked to rare genetic conditions.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced inducement equity grants for three new employees on August 2, 2022. The grants total 63,035 shares, including stock options for 38,690 shares and 24,345 restricted stock units (RSUs), under the 2022 Employment Inducement Plan. The stock options have an exercise price of $14.17 and vest over four years, while RSUs vest 25% annually. Rhythm focuses on treating severe obesity linked to rare genetic disorders with its FDA-approved therapy, IMCIVREE (setmelanotide), which shows promising clinical advancements.

BOSTON, Aug. 03, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 12:30 p.m. ET in Boston, MA. The presentation will be accessible via a live audio webcast on Rhythm's website, with a replay available for 30 days. Rhythm focuses on treating hyperphagia and severe obesity linked to MC4R pathway diseases, with IMCIVREE (setmelanotide) approved for chronic weight management in specific genetic obesity cases. The company is advancing clinical programs for additional rare genetic disorders.

Rhythm Pharmaceuticals received FDA approval for IMCIVREE (setmelanotide), the first therapy for Bardet-Biedl syndrome (BBS). In the first six weeks post-approval, over 50 prescriptions were written. The EMA recommended expanding IMCIVREE's authorization for obesity and hunger control in genetically confirmed BBS patients, with EC approval expected in Q4 2022. Positive interim results from a Phase 2 trial in hypothalamic obesity were announced, and a Phase 3 trial is planned for early 2023. Additionally, a $100 million non-dilutive revenue financing agreement has been secured, extending cash runway into H2 2024.

Rhythm Pharmaceuticals (RYTM) announced a live conference call on August 2, 2022, at 8:00 a.m. ET to discuss its Q2 2022 financial results and provide a corporate update. The biopharmaceutical company focuses on treatment for hyperphagia and severe obesity linked to rare MC4R pathway diseases. Its FDA-approved therapy, setmelanotide, is intended for chronic weight management in specific pediatric and adult populations. Setmelanotide has also received authorizations from the EC and MHRA for similar indications. A positive CHMP opinion regarding BBS treatment is expected in Q4 2022.

Rhythm Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanding marketing authorization for setmelanotide to treat obesity and control hunger in patients with genetically confirmed Bardet-Biedl syndrome. The positive opinion is a significant step towards offering a precision medicine therapy for severe obesity in patients aged six and older. About 1,500 patients in Europe are currently diagnosed with this syndrome. The final decision from the European Commission is expected in Q4 2022.

Rhythm Pharmaceuticals has received pre-marketing authorization AP1 from the French National Agency for Medicines and Health Products Safety (ANSM) for setmelanotide, facilitating access for patients with Bardet-Biedl syndrome (BBS). This program allows early access to innovative therapies when no alternatives are available. Setmelanotide aims to tackle severe obesity and hyperphagia related to BBS, impacting approximately 700 patients in France. Coverage under France’s National Health System is assured, enabling reimbursement for treatments.

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.