Sarepta Therapeutics Inc (NASDAQ:SRPT) is down over 45% in pre-market trading following a negative vote by an FDA advisory panel regarding the effectiveness of its muscular dystrophy drug, eteplirsen. While the FDA does not have to follow the advice of the panel, it does in most instances. The panel voted 7-3 that results from a clinical trial of 12 patients were not substantial enough to prove effectiveness. Specifically, the panel stated that the trial was not properly conducted to prove that the drug provided some of the benefits reported by patients.
Following the vote, Sarepta’s interim CEO Edward Kaye, stated, “We appreciated the opportunity to present our data to the advisory committee panel and will continue to work with FDA as they complete their review of the eteplirsen NDA. Today more than ever, we remain committed to our mission of bringing a treatment to the Duchenne community.”
In reaction, analyst Christopher Marai of Oppenheimer downgraded the stock from Outperform to Perform without a price target following the vote. He states, “We’d have viewed even a positive vote on the final question as supportive of approval. The scope of the data-package, lack of placebo control and inability of the panel to recognize an efficacy signal contributed to the outcome in our view. The FDA typically follows the advice of the panel and given outcome we believe chances of approval are increasingly slim, thus we are moving to the sidelines.”
According to TipRanks, out of the 12 analysts who have rated the company in the past 2 months, 3 are bullish, 1 is bearish, and 8 remain on the sidelines .The average 12-month price target for the stock is $25.42, marking a 70% upside from where shares last closed.
NXP Semiconductors NV (NASDAQ:NXPI) is up 3% in pre-market trading up to $85.85 after the company reported first quarter earnings yesterday after market close. The company, most known for supplying chips to Apple, posted non-GAAP diluted EPS of $1.14 and revenue of 2.224 billion, marking a 16% year-over-year decrease and a 52% year-over-year increase, respectively. Many were worried that decelerating iPhone sales would hurt the semiconductor company, but this has not seem to be the case. Going forward, the company posted second quarter revenue guidance between $2.29 billion to $2.39 billion, and EPS between $1.30 and $1.40.
NXP completed its acquisition of Freescale in December, and CEO Richard Clemmer commented that the merger is “proceeding smoothly.” He adds, “We are on track to achieve our cost synergy targets as laid out at the time of the merger announcement. Our major accomplishments include the integration of our customer facing teams, clear alignment within our internal product development groups, and very positive progress on the integration of our operations and supply organizations.”
According to TipRanks, all 11 analysts covering the stock are bullish with an average 12-month price target of $106.20, marking a 27% potential upside from where shares last closed.
Exelixis, Inc. (NASDAQ:EXEL) is up nearly 9% in pre-market to $5.07 after the company gained FDA approval yesterday for CABOMETYX tablets, adding on to the 5% the stock rose yesterday. CABOMETYX is indicated to treat patients with specific forms of renal cell carcinoma (RCC), which is a common form of kidney cancer. The drug was granted Fast Track and Breakthrough Therapy designations by the FDA. Subsequently, Prakhar Verma of Stifel reiterated a Buy rating on the company today with an $8 price target.
Approval for the drug was based on Phase 3 results, which showed that the drug demonstrated overall survival benefit. The company’s CEO, Michale Morrissey, commented, “With today’s announcement, patients with previously treated advanced kidney cancer now have a new option, the first and only approved product demonstrated to help patients live longer while also delaying the progression of their cancer.”
According to TipRanks, both analysts who have rated the stock in the last 3 months are bullish.
Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) is down over 47% after providing regulator updates on its NDA for Firdapse, intended to treat LEMS. The FDA requested additional positive results following its Phase 3 LMS-002 trial in order to accept the candidate NDA for filing. The FDA also requested more short-term toxicology studies, and is willing to work with the company on how to design an effective study to accomplish the requested requirements.
Following the news, CEO Patrick McEnay stated, “While we are very disappointed by this delay, Catalyst and our employees remain committed to working with the FDA and bringing Firdapse to market for patients suffering with LEMS and congenital myasthenic syndromes (CMS). We are surprised with the FDA’s request for an additional clinical study for Firdapse, but are encouraged that the agency is open to an efficient, small short-term study design. We are currently in discussions with the FDA, and our clinical experts regarding the protocol and logistics for this confirmatory study.”
According to TipRanks, both of the analysts who have rated the stock in the past 3 months are bullish. The average 12-month price target for the stock is $4.63, marking a 274% upside from where shares last closed.