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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company based in Boston, MA, focused on transforming the lives of patients and their families living with rare neuroendocrine diseases. The company's core mission is to develop and commercialize peptide therapeutics for treating gastrointestinal diseases and genetic deficiencies that result in metabolic disorders.
At the heart of Rhythm's portfolio is setmelanotide (IMCIVREE®), an MC4 receptor agonist designed to treat hyperphagia and severe obesity caused by specific genetic conditions. Setmelanotide is already approved by the U.S. Food and Drug Administration (FDA) for chronic weight management in adults and children aged 6 years and older with monogenic or syndromic obesity due to certain genetic deficiencies. The European Commission (EC) and the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) have also authorized setmelanotide for the treatment of obesity and hunger control associated with Bardet-Biedl syndrome (BBS) and other genetic deficiencies.
Rhythm is advancing a broad clinical development program for setmelanotide, including ongoing global Phase 3 trials for hypothalamic obesity. Recent achievements include the addition of a cohort of Japanese patients to this trial, with dosing expected to begin in the third quarter of 2024. The company has enrolled 120 patients in its pivotal Phase 3 trial, aiming to achieve top-line results by the first half of 2025.
In addition to setmelanotide, Rhythm is also advancing investigational MC4R agonists, such as RM-718, which targets hyperphagia and severe obesity without causing hyperpigmentation. The company recently dosed the first patients in a Phase 1 clinical trial for RM-718 and is committed to exploring its potential benefits.
Financially, Rhythm Pharmaceuticals is well-positioned with proceeds from recent financing and existing cash on-hand expected to fund operations into 2026. The company's global reach includes generating revenues from the United States, Germany, and other countries, with the majority coming from the U.S.
For more information, visit Rhythm's Investor Relations page or contact their corporate communications team.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the closing of its public offering of 5,750,000 common shares at $30.00 each on February 9, 2021, raising approximately $172.5 million in gross proceeds. This included the full exercise of a 750,000-share underwriter option. The offering was facilitated by Morgan Stanley, BofA Securities, Cowen, and Stifel as joint managers and was conducted under a previously filed shelf registration. Rhythm focuses on therapies for rare genetic obesity diseases and has FDA-approved treatment IMCIVREE for specific genetic deficiencies.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a public offering of 5,000,000 shares at $30.00 each, aiming to fund its efforts in treating rare genetic obesity diseases. Additionally, underwriters have a 30-day option for 750,000 more shares. The offering, structured under an SEC shelf registration filed in 2018, is set to conclude on February 9, 2021. Morgan Stanley, BofA Securities, Cowen, and Stifel are managing the offering. The company emphasizes that this announcement is not a sales offer and acknowledges potential risks, including market conditions and clinical trial outcomes.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a proposed public offering of $150 million of its common stock, with a potential additional $22.5 million if underwriters exercise their option. The offering is managed by Morgan Stanley, BofA Securities, Cowen, and Stifel, and is subject to market conditions. The shares will be offered under a shelf registration statement filed with the SEC. This move aims to bolster the company's capabilities to develop therapies for rare genetic obesity diseases.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced positive results from its Phase 2 Basket Study, demonstrating proof-of-concept for setmelanotide in patients with genetic obesity disorders. The study found that 34.3% of patients with HET obesity achieved significant weight loss. Updated data suggests that 100,000-200,000 patients in the U.S. could benefit from this treatment. Additionally, the pivotal Phase 3 trial for Bardet-Biedl Syndrome showed significant improvements in pediatric patients’ BMI-Z scores. Rhythm plans to initiate further studies to expand setmelanotide's application.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a virtual event on January 26, 2021, to present updates on its exploratory Phase 2 Basket Study and genetic sequencing efforts. Management will discuss data for setmelanotide in individuals with heterozygous obesity linked to genetic variants in POMC, PCSK1, or LEPR genes, as well as SRC1 and SH2B1 deficiency. The company has sequenced samples from approximately 37,500 individuals with severe obesity to enhance understanding and diagnosis of these conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $100M. This voucher was granted by the FDA following the approval of IMCIVREE™ (setmelanotide) for chronic weight management in patients with genetic deficiencies causing severe obesity. The sale will provide non-dilutive capital to further develop setmelanotide, which has been approved for patients aged 6 and older. The upfront payment is conditioned on customary closing requirements, with an expected transaction completion following U.S. antitrust clearance.
On January 5, 2021, Pharvaris announced the appointment of David Meeker, M.D., as Chair of the Board and Robert Glassman, M.D., as Director. Dr. Meeker, currently CEO of Rhythm Pharmaceuticals (RYTM), brings extensive experience in rare disease drug development, while Dr. Glassman, a venture partner at OrbiMed Advisors, offers financial expertise. Pharvaris aims to enhance treatment options for hereditary angioedema through novel oral bradykinin-B2-receptor antagonists. The leadership changes are expected to bolster the company's strategic initiatives and clinical programs.
Rhythm Pharmaceuticals (RYTM) announced positive topline results from its pivotal Phase 3 trial of setmelanotide for Bardet-Biedl syndrome (BBS) and Alström syndrome. The study achieved its primary endpoint, with 34.5% of participants showing at least a 10% weight reduction. All responders were BBS patients, while none of the Alström participants met this endpoint. Rhythm plans to submit a supplemental New Drug Application (sNDA) to the FDA for BBS in the second half of 2021. The trial enrolled 32 BBS and 6 Alström patients, and setmelanotide was generally well tolerated with mild side effects.
Rhythm Pharmaceuticals (Nasdaq:RYTM) announced the appointments of Camille L. Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors. Both leaders bring extensive experience in the pharmaceutical industry. Bedrosian, with a strong background in rare diseases, is EVP and CMO at Ultragenyx Pharmaceutical, while Tetrault has over two decades at AstraZeneca, including roles in executive leadership. Their addition is expected to enhance Rhythm's operational leadership and its commitment to developing therapies for rare genetic diseases of obesity.
Rhythm Pharmaceuticals announced FDA approval for IMCIVREE™ (setmelanotide) for chronic weight management in patients aged 6 or older with obesity caused by POMC, PCSK1, or LEPR deficiencies, confirmed by genetic testing. This marks the first therapy approved for these rare genetic diseases, expected to be commercially available in Q1 2021. The approval was based on two trials showing substantial weight loss in patients, alongside the issuance of a Rare Pediatric Disease Priority Review Voucher. The company aims to further explore the treatment's potential in related conditions.
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