Rhythm Secures European Commission Marketing Authorization For Genetic Disease Candidate

The European Commission (EC) has expanded the marketing authorization for Rhythm’s RYTM lead drug product IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older.

Rhythm is now eligible to receive an additional investment of $37.5 million following EC marketing authorization for setmelanotide for BBS, based on the terms of the Revenue Interest Financing Agreement with HealthCare Royalty Partners.

Philip Beales, University College London, UCL Great Ormond Street Institute of Child Health, commented: "Patients and families have long endured a significant need for a therapy to address the burdens of hyperphagia and severe obesity often associated with BBS. Having new treatment options available can help address the physical and emotional aspects of this devastating disease, offering patients and their families relief and improved quality of life.”

IMCIVREE (setmelanotide) is now FDA approved and European Commission authorized candidate for the treatment of Bardet-Biedl syndrome (BBS).

Further, the Canadian regulatory agency has granted Priority Review for its New Drug Submission for setmelanotide, indicated in adult and pediatric patients 6 years of age and older with impairments in the MC4R pathway due to genetic diseases.

Bardet-Biedl syndrome (BBS) is a rare genetic disease that affects approximately 2,500 people in the European Union (EU) and United Kingdom (UK). BBS patients may experience insatiable hunger or hyperphagia, and severe obesity beginning early in life.

Price Action : Rhythm shares closed Tuesday’s regular trading down 14 percent at $21.68.