Rhythm Pharmaceu - RYTM STOCK NEWS

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the submission of a Type II variation application to the European Medicines Agency for its obesity treatment, IMCIVREE (setmelanotide), targeting Bardet-Biedl syndrome (BBS) and Alström syndrome. This submission leans on positive data from a Phase 3 trial showing significant weight loss and hunger control. The company estimates around 1,500 patients in the EU with BBS could benefit, enhancing its position in the rare genetic obesity market.

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) reported promising findings from the Obesity Medicine Association’s Overcoming Obesity 2021 Conference. Setmelanotide, an obesity treatment for POMC and LEPR deficiencies, showed significant improvements in health-related quality of life and hunger management for patients. Updated data from the Uncovering Rare Obesity program revealed that 64.5% of participants with early-onset obesity may carry genetic variants linked to rare obesity diseases. Rhythm plans to launch Phase 3 EMANATE and Phase 2 DAYBREAK trials, furthering its commitment to treating genetic obesity.

Rhythm Pharmaceuticals, Inc. (RYTM) presented promising data from its Phase 2 and 3 trials of setmelanotide aimed at treating rare genetic obesity disorders at the 59th Annual ESPE Meeting. A subgroup analysis of the Phase 3 trial in Bardet-Biedl syndrome showed significant weight loss (3.8 kg) and hunger reduction. The Phase 2 Basket Study indicated 30% and 43% weight loss responses for SRC1 and SH2B1 deficiencies, respectively. These findings support the ongoing EMANATE Phase 3 trial, expanding setmelanotide's potential to treat obesity linked to genetic variants, with a targeted patient population of approximately 100,000-200,000 in the U.S.

Rhythm Pharmaceuticals announced that its drug IMCIVREE (setmelanotide) received marketing authorization in Great Britain for treating obesity linked to specific genetic deficiencies, including POMC, PCSK1, and LEPR. This marks the first authorized treatment option for these rare conditions in Great Britain. IMCIVREE, already approved in the EU and the US, showed significant efficacy in clinical trials, with notable weight loss results. It is set for review by NICE in December 2021, and NHS coverage guidance is expected in Q2 2022.

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the completion of its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) to treat obesity and control hunger in patients aged 6 and older with Bardet-Biedl syndrome (BBS) or Alström syndrome. This application is based on a pivotal Phase 3 trial demonstrating significant weight and hunger reductions. Rhythm has requested priority review, potentially leading to a six-month review period. The company also plans to submit a marketing authorization application to the European Medicines Agency by Q4 2021.

Rhythm Pharmaceuticals announces an Expanded Access Program (EAP) for setmelanotide, targeting eligible patients in the U.S. with severe obesity and hyperphagia due to Bardet-Biedl Syndrome (BBS). The company plans to submit a supplemental new drug application (sNDA) to the FDA by the end of September 2021. This initiative is part of Rhythm's commitment to address the unmet needs of BBS patients, allowing access to a potential treatment option for those unable to participate in clinical trials.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the promotion of Linda Shapiro Manning, M.D., Ph.D., to Chief Medical Officer effective September 10, 2021. She succeeds Murray Stewart, M.D., who will become Senior Medical Advisor. This transition comes as the company prepares for pivotal clinical trials, including the EMANATE Phase 3 trial and DAYBREAK Phase 2 trial of setmelanotide. Dr. Shapiro brings over 20 years of experience in obesity medicine and has previously led clinical development at several major biopharmaceutical companies.

BOSTON, Sept. 2, 2021 – Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 8:45 a.m. ET. A live webcast will be available on the company’s website, with a replay for 30 days post-event. Rhythm focuses on therapies for rare genetic obesity diseases, with its precision medicine IMCIVREE® (setmelanotide) approved by the FDA in November 2020 and by the European Commission in July 2021. The company is advancing research in this field.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the acceptance of seven abstracts for presentation at the 59th Annual European Society for Paediatric Endocrinology (ESPE) Meeting, taking place virtually from September 22-26, 2021. The abstracts will showcase data from various clinical trials evaluating setmelanotide for rare genetic obesity disorders, including pivotal results from a Phase 3 trial in Bardet-Biedl Syndrome and a Phase 2 trial on SRC1 variants. Notable presentations will occur on September 22, focusing on obesity-related genetic deficiencies and management strategies.