Analyst Ritu Baral of Cowen & Co was out today with research notes on drug makers Sarepta Therapeutics Inc (NASDAQ:SRPT) and Cempra Inc (NASDAQ:CEMP), discussing the FDA decision delay for SRPT’s Eteplirsen, and CEMP’s experimental drug results in a Japanese trial.
Sarepta Therapeutics Inc
Sarepta shares have been on a roller coaster ride today following the news that the FDA will be unable to complete its review of Sarepta’s Eteplirsen, a controversial therapy for a rare form of muscular dystrophy.
In reaction, Baral reiterated a Market Perform rating on the stock. The analyst commented, “We do not believe today’s delay has meaningful impact (positive or negative) on the chances of success for the current eteplirsen data package, but do think if a CRL is issued, FDA would take the time to develop and specify additional requirements for a potential Subpart H accelerated approval (to include data from PROMOVI and the Ph2 safety study). We believe near-term approvability of eteplirsen hinges upon a demonstrable increase in dystrophin, a measure which the company has noted they are actively seeking to improve technically.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Ritu Baral has a yearly average return of 4.2% and a 41% success rate. Baral has a -20% average return when recommending SRPT, and is ranked #615 out of 3958 analysts.
Out of the 13 analysts polled by TipRanks (in the past 3 months), 4 rate Sarepta stock a Buy, 5 rate the stock a Hold and 4 recommends to Sell. With a downside potential of 28%, the stock’s consensus target price stands at $16.83.
In addition, Baral reiterated an Outperform rating on shares of Cempra, with a price target of $39, following the news that the company’s experimental drug showed positive results in a clinical trial run in Japan. The Japanese trial tested Cempra’s solithromycin against levofloxacin, an existing treatment for infections caused by bacteria, in patients with mild to moderate community-acquired pneumonia (CABP).
Baral noted, “CEMP this morning announced successful Ph2 CABP topline data for solithromycin in Japanese patients in a trial run by partner Toyama. The dose-ranging study was not powered for noninferiority, but all efficacy measures favored solithromycin, with good safety. In fact, highest ALT elevation were actually seen in the levo group. All of this bodes well for soli’s NDA currently under FDA review.”
“Toyama will meet with regulators and CEMP expects to press release the Japanese Phase 3 design in 2H16. We expect the trial to be designed for non-inferiority and likely commence enrollment before the next Japanese flu season. Once commercialized in Japan, CEMP expects to receive mid to high double digit royalties,” the analyst added.
Out of the 5 analysts polled by TipRanks (in the last 3 months), 3 are bullish on Cempra stock, while 2 remain sidelined. With a return potential of 83%, the stock’s consensus target price stands at $32.80.