Welcome to our dedicated page for Rhythm Pharmaceu news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceu stock.
Rhythm Pharmaceuticals (RYTM) is a commercial-stage biopharmaceutical company pioneering precision medicines for rare neuroendocrine diseases, including genetic obesity disorders. This page aggregates all official announcements, press releases, and verified news coverage related to RYTM's therapeutic advancements and operational developments.
Investors and stakeholders will find timely updates on regulatory milestones, clinical trial outcomes, financial disclosures, and strategic partnerships. The curated collection prioritizes primary-source materials including FDA submissions, research publications, and executive communications to ensure informational accuracy.
Track RYTM's progress in developing MC4R pathway therapies like IMCIVREE® (setmelanotide), with updates spanning global approvals, research expansions, and market access initiatives. Content is organized chronologically to facilitate efficient monitoring of the company's progress in addressing rare genetic conditions.
Bookmark this page for direct access to Rhythm Pharmaceuticals' latest verified updates. For complete market analysis, combine these resources with broader sector research and regulatory filings.
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.
Rhythm Pharmaceuticals, focused on therapies for rare genetic obesity diseases, announced David Meeker, M.D., will speak at the Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 8 a.m. ET. A live audio webcast will be accessible on their website.
The company's drug IMCIVREE (setmelanotide), approved by the FDA and European Commission, targets obesity linked to specific genetic deficiencies. The ongoing development program leverages a vast obesity DNA database to enhance understanding and treatment.
Rhythm Pharmaceuticals (RYTM) received European Commission approval for IMCIVREE, aiding obesity treatment linked to genetic deficiencies. The company plans to submit supplemental applications to the FDA and EMA for setmelanotide targeting Bardet-Biedl and Alström syndromes in H2 2021. Additionally, five new Phase 2 and Phase 3 trials are set to initiate. Financially, RYTM reported Q2 2021 revenues of $0.3 million with a net loss of $35.4 million. Cash reserves stood at $368.2 million as of June 30, 2021, sufficient to support operations through at least H2 2023.
Rhythm Pharmaceuticals (RYTM) announces a significant expansion in its clinical development program for setmelanotide with five new trials. The pivotal Phase 3 EMANATE trial targets patients with specific genetic deficiencies related to obesity, expecting to enroll around 110 patients per sub-study. The company also plans to conduct a Phase 2 DAYBREAK trial and additional studies for pediatric patients and a new weekly formulation. Approximately 100,000-200,000 patients in the U.S. could benefit. All trials are expected to begin in the second half of 2021.
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