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Medigus ($MDGS) reported that it has performed ten MUSE procedures in China for the initial phase of its clinical study. The trial is designed to have nearly 62 patients. The procedures will be performed through this year. The MUSE system is a single-use transoral stapler that incorporates an ultrasonic sight and range finder and a micro ScoutCam CMOS camera, enabling a single doctor to perform an incisionless transoral fundoplication.
The news had positive impact on the company’s stock price as it gained close to 5 percent in its previous trading session, trimming its Year to Date losses to 57 percent. The stock has lost close to 84 percent of its value in the past 12 months.

Sanofi ($SNY) reported that the FDA has accepted its  resubmitted Biologics License Application for  Kevzara (sarilumab) for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA) who have not responded adequately or are intolerant of one or more disease modifying antirheumatic drugs (DMARDs). Sanofi is developing the treatment in collaboration with Regeneron Pharmaceuticals.
The company had received a Complete Response Letter (CRL) in late October 2016 from the FDA. It has also filed a marketing application in Europe and the company expects the decision to be made in June. The treatment was approve in Canada in February this year.

 

Syndax Pharmaceuticals ($SNDX) reported adding a cohort of patients with microsatellite stable (MSS) colorectal cancer  to Phase 2 ENCORE 601/KEYNOTE 142 study evaluating  the combination of entinostat and Keytruda (pembrolizumab). The study originally included patients with melanoma and non-small cell lung cancer who failed to adequately respond to PD-1 inhibitor therapy.

RenovaCare ($RCAR) announced that its SkinGun has shown impressive results treating wide-area and severe burn injuries. The retrospective analysis of 45 severe second-degree burn patients treated with the SkinGun showed complete or near-complete healing in all patients regardless of burn type.

BioMarin Pharmaceutical ($BMRN) announced that it has received the FDA approval for its Brineura (cerliponase alfa) for the treatment of symptomatic pediatric patients with a form of Batten disease called late infantile neuronal ceroid lipofuscinosis type 2. The company expects to receive a response to its marketing application in Europe in June.

Bayer ($BAYRY) reported that the FDA has approved the use of its Stivarga (regorafenib) for the treatment of patients with liver cancer who have been previously treated with sorafenib. The drug is already approved in the U.S. to treat certain colorectal cancer and gastrointestinal stromal tumor patients.

 

Clovis Oncology ($CLVS) announced its new collaboration with Myriad Genetics for a companion diagnostic test for germline BRCA mutations. The companion diagnostic test approved with Rubraca does not differentiate between somatic mutations and germline. The collaboration obligates Myriad to submit a supplemental PMA application with the U.S. regulator under its existing PMA for BRACAnalysis CDx to include Rubraca.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Robert W. Baird
Upgrades
Align Technology (ALGN)
Neutral -> Outperform

Low
Stephens
Upgrades
Invacare (IVC)
Equal Weight -> Overweight

Low
Cantor Fitzgerald
Reiterates
Ignyta (RXDX)
Buy
$18.00
Low
Cantor Fitzgerald
Reiterates
Tivity Health (TVTY)
Buy
$34.00
Low
Wells Fargo & Co
Downgrades
Zimmer Biomet Holdings (ZBH)
Outperform -> Market Perform

Low

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