RYTM - Rhythm stock rises 20% as Imcivree gets early access nod in France for rare disorder

Rhythm Pharmaceuticals ( NASDAQ: RYTM ) stock rose ~20% on July 20 after its drug Imcivree was granted early access authorization in France for patients with genetically-confirmed Bardet-Biedl syndrome (BBS) to treat obesity and control of hunger.

The company said that the French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) granted pre-marketing authorization AP1 to Imcivree (setmelanotide) for the these patients.

AP1 allows for early access to therapies in France prior to regulatory approval when a positive benefit/risk ratio is seen and when other alternatives are not available, the company said in a July 20 press release.

Rhythm added that the AP1 for Imcivree  was granted after review of data from studies by the ANSM and HAS.

The company noted that it can expect to be reimbursed for any patients receiving treatments through this program as products included under AP1 programs are fully covered by France's National Health System.

BBS is a genetic condition that impacts multiple body systems. Besides insatiable hunger and obesity, the disorder can also cause cognitive impairment, kidney dysfunction and visual impairment, among other things. Rhythm estimates that there are ~700 patients diagnosed with BBS in France.

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