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RYTM

Rhythm Pharmaceuticals

$32.95

-0.38 (-1.14%)

08:16
06/14/18
06/14
08:16
06/14/18
08:16

Rhythm completes enrollment in two ongoing Phase 3 trials of setmelanotide

Rhythm Pharmaceuticals announced that it has completed enrollment of the pivotal cohorts of 10 patients in two separate, ongoing, registration-enabling Phase 3 clinical trials evaluating setmelanotide in pro-opiomelanocortin and leptin receptor deficiency obesity. POMC and LEPR deficiency obesity are two ultra-rare genetic disorders that result in excess hunger, also known as hyperphagia, and severe, early-onset obesity. Setmelanotide is a first-in-class melanocortin-4 receptor agonist, for which the U.S. Food and Drug Administration has granted both Breakthrough Therapy Designation and Orphan Drug Designation in POMC and LEPR deficiency obesity. Rhythm expects to report initial data from the Phase 3 trials of both POMC and LEPR deficiency obesity in the third quarter of 2019. Rhythm then plans to submit concurrent New Drug Application filings to the FDA for setmelanotide in patients with these indications based on one-year data from these pivotal cohorts of 10 patients. In addition, the Company plans to continue enrolling supplemental patients in both trials who may not complete one year of treatment at the time of NDA filing, including patients between six and 11 years of age, to provide additional data regarding the use of setmelanotide in people living with POMC and LEPR deficiency obesity. The open-label, single-arm, multinational Phase 3 trials evaluating the safety and efficacy of setmelanotide in POMC and LEPR deficiency obesity share the same trial design. The primary endpoint in both trials is a responder analysis for weight, defined as patients achieving a 10 percent change from baseline. The first secondary endpoint in both trials is the mean percentage change in weight. Hunger scores are also key secondary endpoints. Rhythm is also evaluating setmelanotide in four additional rare genetic disorders of obesity. Rhythm expects to initiate a Phase 3 study evaluating setmelanotide in Bardet-Biedl Syndrome in 2018. The Company has treated a number of the first patients in a Phase 2 proof-of-concept basket study evaluating setmelanotide in Alstrom Syndrome, POMC epigenetic disorders and POMC heterozygous deficiency obesity and expects to announce initial data in each indication in the second quarter of 2018. In addition, Rhythm has launched efforts to build a patient registry, Tracing the Effect of the MC4R Pathway in Obesity, and is supporting The Genetic Obesity Project and the Go-ID Genotyping Study.

  • 25

    Jun

RYTM Rhythm Pharmaceuticals
$32.95

-0.38 (-1.14%)

10/30/17
COWN
10/30/17
INITIATION
Target $40
COWN
Outperform
Rhythm Pharmaceuticals initiated with an Outperform at Cowen
Cowen analyst Phil Nadeau started Rhythm Pharmaceuticals with an Outperform rating and $40 price target. The company's setmelanotide has produced "compelling data" in rare, genetic, life-threatening obesity disorders, the analyst tells investors in a research note. He sees wide adoption and estimates peak sales of $750M-$1B.
10/30/17
BOFA
10/30/17
INITIATION
Target $30
BOFA
Buy
Rhythm Pharmaceuticals initiated with a Buy at BofA/Merrill
Tazeen Ahman initiated Rhythm Pharmaceuticals with a Buy and $30 price target to reflect the opportunity in rare genetic obesity. Rhythm's lead asset. RM-493, is in late-stage development to treat extreme early onset obesity and he estimates peak sales could reach $1.7B in 2029 across five orphan indications.
10/30/17
10/30/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Sotheby's (BID) initiated with a Buy at Aegis. 2. Alnylam (ALNY) initiated with a Buy at FBR Capital. 3. Adamas Pharmaceuticals (ADMS) initiated with an Outperform at Evercore ISI. 4. Vipshop (VIPS) initiated with a Neutral at UBS. 5. Rhythm Pharmaceuticals (RYTM) initiated with a Buy at BofA/Merrill. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
11/01/17
MSCO
11/01/17
NO CHANGE
Target $23
MSCO
Equal Weight
Rhythm update in BBS patients mixed, says Morgan Stanley
Morgan Stanley analyst Andrew Berens noted that Rhythm Pharmaceuticals announced the presentation of updated data from its Phase 2 trial of setmelanotide in Bardet-Biedl syndrome, or BBS, at the ObesityWeek 2017 meeting. While he anticipated a substantive update on the program by year end, he did not expect this minor update now, noted Berens. One patient lost additional weight and became the first to exceed the 10% weight loss bar, which is an incremental positive, but another discontinued due to a lack of efficacy, an incremental negative, added Berens, who maintains an Equal Weight rating and $23 price target on Rhythm after having initiated coverage of the stock with that rating and target earlier this week.

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OHGI

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$0.18

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CYTX

Cytori Therapeutics

$0.41

-0.033 (-7.38%)

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NEM

Newmont Mining

$31.56

0.05 (0.16%)

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CB

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-0.05 (-0.04%)

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Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.