Rhythm Pharma Higher After FDA Approves Supplemental NDA
June 17 2022 - 12:06PM
Dow Jones News
By Michael Dabaie
Rhythm Pharmaceuticals Inc. shares continued to make gains for a
second day, recently up 17% at $4.56 after the company received
federal approval for a supplemental new drug application.
The commercial-stage biopharmaceutical company after the bell
Thursday said the U.S. Food and Drug Administration approved the
supplemental new drug application for Imcivree in patients with
Bardet-Biedl syndrome.
With the approval, Imcivree is indicated for chronic weight
management in adult and pediatric patients 6 years and older with
monogenic or syndromic obesity due to proopiomelanocortin,
proprotein convertase subtilisin/kexin type 1 or leptin receptor
deficiency, or BBS. BBS is a rare genetic disease that affects
approximately 1,500 to 2,500 people in the U.S. People living with
BBS may experience insatiable hunger.
Stifel analysts in a research report note the approval expands
the addressable market.
"We are positive on the uptake for 3 reasons: 1) lack of
approved therapies, 2) inclusive label (includes patients with
severe renal impairment), and 3) possible jumpstart in commercial
activities with 350+ patients identified/diagnosed," the analysts
said.
Rhythm Pharmaceuticals also said Thursday it has entered into a
revenue interest financing agreement with HealthCare Royalty
Partners for a total investment amount of up to $100 million.
Rhythm will receive an initial investment of $37.5 million with the
FDA approval in BBS. Rhythm will get an additional $37.5 million
following European Commission marketing authorization for Imcivree
for BBS, which is seen in the second half of 2022. The final
investment amount of $25 million will be payable upon Rhythm's
achievement of sales milestones in 2023.
"All eyes will now be focused on the important BBS launch. We
model $16.5M...in 2022 WW sales, but are slightly lowering our
2023+ estimates," Needham analysts Joseph Stringer and Ben Ricard
said in a note.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 17, 2022 11:51 ET (15:51 GMT)
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