We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
RYTM Stock Rises on Upbeat Acquired Hypothalamic Obesity Study Data
Read MoreHide Full Article
Key Takeaways
RYTM soared 36.6% after positive Phase II data for oral bivamelagon in acquired hypothalamic obesity.
Bivamelagon cut BMI by up to 9.3% in patients with acquired hypothalamic obesity.
Rhythm plans FDA talks to design a Phase III trial and pursue a registrational path for bivamelagon.
Shares of Rhythm Pharmaceuticals (RYTM - Free Report) were up 36.6% yesterday after it reported positive top-line data from a phase II study evaluating the investigational oral melanocortin-4 receptor (MC4R) agonist, bivamelagon (formerly LB54640), in patients with acquired hypothalamic obesity.
Acquired hypothalamic obesity is a severe and debilitating condition caused by hypothalamic damage, often resulting from brain tumors, their treatment or other injuries. This leads to rapid weight gain, uncontrollable hunger (hyperphagia) and decreased energy expenditure.
Data from the study showed that treatment with bivamelagon led to statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment. The BMI reduction seen with bivamelagon was similar to that seen with setmelanotide in comparable patient populations from previous studies.
Rhythm Pharmaceuticals markets setmelanotide, also an MC4R agonist, by the brand name of Imcivree in the United States and the European Union for chronic weight management in adult and pediatric patients aged two years and older with certain genetic conditions.
Year to date, shares of Rhythm Pharmaceuticals have risen 59% against the industry’s decline of 1.9%.
Image Source: Zacks Investment Research
More on Rhythm Pharmaceuticals’ Phase II Study Results
The double-blind, placebo-controlled study evaluated the efficacy and safety of bivamelagon for treating acquired hypothalamic obesity in patients aged 12 years and older. Patients were randomized to take oral doses of either bivamelagon (200 mg, 400mg, 600mg) or placebo.
Treatment with bivamelagon led to BMI reductions of 9.3%, 7.7% and 2.7% in the 600mg, 400mg and 200mg cohorts, respectively, in patients with acquired hypothalamic obesity at 14 weeks. Patients who received a placebo experienced a BMI increase of 2.2% over 14 weeks.
Additionally, patients receiving bivamelagon at doses of 600mg and 400mg experienced notable reductions in hunger levels. After 14 weeks of treatment, both cohorts reported a mean decrease of more than 2.8 points in their peak hunger scores, measured on a standardized 10-point scale.
These findings indicate that bivamelagon may effectively help manage excessive hunger in individuals with acquired hypothalamic obesity.
RYTM’s Next Steps of Development for Bivamelagon
Building on the encouraging data from the phase II study, Rhythm Pharmaceuticals intends to engage with regulatory authorities in the United States and the European Union to discuss the design of a phase III study aimed at advancing bivamelagon for the treatment of acquired hypothalamic obesity.
The study data underlines bivamelagon’s strong efficacy with minimal safety concerns.
The company is planning to request an end-of-phase II meeting with the FDA to pursue a registrational path for bivamelagon in the given indication.
RYTM’s Zacks Rank & Other Key Picks
Rhythm Pharmaceuticals currently carries a Zacks Rank #2 (Buy).
In the past 60 days, Amarin's 2025 loss per share estimates have improved from $3.85 to $2.30. Loss per share estimates for 2026 have narrowed from $3.59 to $1.50 during the same period. AMRN stock has surged 78.7% year to date.
AMRN’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed on the other occasion, delivering an average surprise of 29.11%.
In the past 60 days, estimates for Alkermes’ earnings per share have increased from $1.74 to $1.79 for 2025. During the same time, earnings per share estimates for 2026 have risen from $1.79 to $1.91. Year to date, shares of ALKS have gained 4.2%.
ALKS earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the negative average surprise being 8.24%.
In the past 60 days, Keros Therapeutics’ 2025 loss per share estimates have narrowed from 79 cents to 29 cents. Loss per share estimates for 2026 have narrowed from $4.52 to $4.29 during the same period. KROS stock has lost 9.6% year to date.
KROS’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the average surprise being 9,065.97%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
RYTM Stock Rises on Upbeat Acquired Hypothalamic Obesity Study Data
Key Takeaways
Shares of Rhythm Pharmaceuticals (RYTM - Free Report) were up 36.6% yesterday after it reported positive top-line data from a phase II study evaluating the investigational oral melanocortin-4 receptor (MC4R) agonist, bivamelagon (formerly LB54640), in patients with acquired hypothalamic obesity.
Acquired hypothalamic obesity is a severe and debilitating condition caused by hypothalamic damage, often resulting from brain tumors, their treatment or other injuries. This leads to rapid weight gain, uncontrollable hunger (hyperphagia) and decreased energy expenditure.
Data from the study showed that treatment with bivamelagon led to statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment. The BMI reduction seen with bivamelagon was similar to that seen with setmelanotide in comparable patient populations from previous studies.
Rhythm Pharmaceuticals markets setmelanotide, also an MC4R agonist, by the brand name of Imcivree in the United States and the European Union for chronic weight management in adult and pediatric patients aged two years and older with certain genetic conditions.
Year to date, shares of Rhythm Pharmaceuticals have risen 59% against the industry’s decline of 1.9%.
Image Source: Zacks Investment Research
More on Rhythm Pharmaceuticals’ Phase II Study Results
The double-blind, placebo-controlled study evaluated the efficacy and safety of bivamelagon for treating acquired hypothalamic obesity in patients aged 12 years and older. Patients were randomized to take oral doses of either bivamelagon (200 mg, 400mg, 600mg) or placebo.
Treatment with bivamelagon led to BMI reductions of 9.3%, 7.7% and 2.7% in the 600mg, 400mg and 200mg cohorts, respectively, in patients with acquired hypothalamic obesity at 14 weeks. Patients who received a placebo experienced a BMI increase of 2.2% over 14 weeks.
Additionally, patients receiving bivamelagon at doses of 600mg and 400mg experienced notable reductions in hunger levels. After 14 weeks of treatment, both cohorts reported a mean decrease of more than 2.8 points in their peak hunger scores, measured on a standardized 10-point scale.
These findings indicate that bivamelagon may effectively help manage excessive hunger in individuals with acquired hypothalamic obesity.
RYTM’s Next Steps of Development for Bivamelagon
Building on the encouraging data from the phase II study, Rhythm Pharmaceuticals intends to engage with regulatory authorities in the United States and the European Union to discuss the design of a phase III study aimed at advancing bivamelagon for the treatment of acquired hypothalamic obesity.
The study data underlines bivamelagon’s strong efficacy with minimal safety concerns.
The company is planning to request an end-of-phase II meeting with the FDA to pursue a registrational path for bivamelagon in the given indication.
RYTM’s Zacks Rank & Other Key Picks
Rhythm Pharmaceuticals currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the biotech sector are Amarin Corporation (AMRN - Free Report) , Alkermes (ALKS - Free Report) and Keros Therapeutics (KROS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Amarin's 2025 loss per share estimates have improved from $3.85 to $2.30. Loss per share estimates for 2026 have narrowed from $3.59 to $1.50 during the same period. AMRN stock has surged 78.7% year to date.
AMRN’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed on the other occasion, delivering an average surprise of 29.11%.
In the past 60 days, estimates for Alkermes’ earnings per share have increased from $1.74 to $1.79 for 2025. During the same time, earnings per share estimates for 2026 have risen from $1.79 to $1.91. Year to date, shares of ALKS have gained 4.2%.
ALKS earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the negative average surprise being 8.24%.
In the past 60 days, Keros Therapeutics’ 2025 loss per share estimates have narrowed from 79 cents to 29 cents. Loss per share estimates for 2026 have narrowed from $4.52 to $4.29 during the same period. KROS stock has lost 9.6% year to date.
KROS’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the average surprise being 9,065.97%.