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Rhythm Pharmaceuticals, Inc. develops and commercializes therapies for rare neuroendocrine diseases, centered on IMCIVREE (setmelanotide), an MC4R agonist for hyperphagia and severe obesity linked to rare MC4R pathway disorders. Company updates commonly cover U.S. and international commercialization of setmelanotide, regulatory authorizations and label expansions for acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC/PCSK1 deficiency and LEPR deficiency, and safety information tied to approved uses.
Rhythm news also follows clinical data from setmelanotide studies, including acquired hypothalamic obesity and genetically caused MC4R pathway diseases, along with development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism. Recurring corporate items include financial results, specialty-pharmacy access arrangements, healthcare conference presentations and board governance changes.
Rhythm Pharmaceuticals (RYTM) has announced a public offering of 4,800,000 shares at $26.00 each, set to close on September 19, 2022. All shares are being offered by the company, with an option for underwriters to purchase an additional 720,000 shares. Cowen, Stifel, and Wells Fargo Securities serve as joint book-running managers. The offering is registered under a shelf registration statement filed with the SEC.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced a proposed public offering of $100 million in common stock. All shares will be offered by Rhythm, with an option for underwriters to purchase an additional $15 million of shares. The offering is managed by Cowen, Stifel, and Wells Fargo Securities. It is subject to customary market conditions, and completion timelines are uncertain. The offering is made under a shelf registration statement declared effective by the SEC in November 2021, with further details to be included in a preliminary prospectus supplement.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the grant of inducement equity covering 84,800 shares of its common stock to 15 new employees on September 2, 2022. The grants include stock options for 56,520 shares at an exercise price of $25.20 and restricted stock units (RSUs) for 28,280 shares, aimed at incentivizing new hires under the 2022 Employment Inducement Plan. Options vest 25% after one year, with the remainder vesting quarterly, while RSUs vest 25% annually over four years. This plan aligns with Nasdaq Listing Rule 5635(c)(4).
Rhythm Pharmaceuticals announced that setmelanotide has received marketing authorization from the European Commission for treating obesity and hunger control in patients with Bardet-Biedl syndrome (BBS). This approval makes Rhythm eligible for a $37.5 million tranche under its agreement with HealthCare Royalty Partners. Additionally, Health Canada has granted Priority Review for setmelanotide to treat obesity related to BBS and other genetic deficiencies, shortening the review time to 180 days.
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.