Home / Biopharma / Biotech Facing Wrath of Sarepta Therapeutics Inc (SRPT) on FDA Negative Remarks

Biotech Facing Wrath of Sarepta Therapeutics Inc (SRPT) on FDA Negative Remarks

US benchmarks were unable to attract investors’ attention on Thursday, striving hard to develop a three-day bullish run which would take them to their maximum levels of the year. Declining oil prices left an impact on the energy sector, while the situation of corporate earnings reports was varied. The blue chip index Dow Jones Industrial Average (DJIA) lost 23 points, or 0.1%, to 18,072 while The S&P 500 (SPX) surged 1 point, or not more than 0.1%, to 2,102. The tech fellow Nasdaq Composite (COMP) was unchanged at 4,948. Among individual gainers, US vehicle maker General Motors Co. (NYSE:GM) shares were on rise with almost 2% and American Express Co. (NYSE:AXP) were up +1.25% thanks to rosy earnings overtaking targets, while Verizon Communications Inc. (NYSE:VZ) were sliding -2.43% after declaring unimpressive results.

Healthcare sector was so far the only sector accompanying Energy on the bullish chart. Healthcare sector was up 0.21% with 57% companies posting gains in a range of 0-2% while 11% were rallying above 2%. But on biotech side, things were looking not so good as shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) were down to knees with 39.37% on unusual higher volume of 8.17 million after the U.S. Food and Drug Administration declared an updated but yet passive clinical review of eteplirsen, the Duchenne muscular dystrophy drug from Sarepta Therapeutics. The stock settled on Wednesday at $19.71. The FDA is carrying an external advisory panel on April 25 to assess the eteplirsen data, postponed from Jan. 21 because of a snowstorm. But as in January, the internal evaluation by the agency’s review team seems to once again seem doubtful on the drug’s approval opportunities.

In alliance with biotech firm Intrexon Corporation (NYSE:XON), Fibrocell Science, Inc., (FCSC), an autologous cell and gene therapy firm declared that the final patient visit for main endpoint analysis has been finalized in its Phase II clinical trial of azficel-T for the cure of vocal cord scarring resulting in chronic or severe dysphonia. Fibrocell’s azficel-T has the prospective to meet the primary cause of chronic dysphonia by using the patient’s personal cells for localized cure of the damaged vocal cords to enhance voice quality. Getting this landmark in their Phase II trial is momentous in the production of azficel-T for the cure of vocal cord damaging resulting in chronic dysphonia, David Pernock stated, Chairman and Chief Executive Officer of Fibrocell. Shares of Intrexon were plunging almost 12% among leading laggards on unusual volume of 2.01M.

On the positive side shares of Illumina, Inc.(NASDAQ:ILMN) recovered from previous session losses  and were up 1.33%. The stock plummeted on Wednesday after shareholder Rights Law Firm Johnson & Weaver, LLP is looking into possible violations of the federal securities laws by Illumina, Inc.(NASDAQ:ILMN) and few of its officers. Illumina gives sequencing and array-based solutions for genetic analysis. Particularly, Johnson & Weaver’s investigation wants to check whether few statements concerning Illumina’s business and scenarios were false and ambiguous when made. On April 18, 2016, Illumina declared preliminary initial-quarter revenue well lower than targets. The company reported that it predicts revenues of $572 million, well lower than the $596 million previously estimated, referring to sluggish device sales. Illumina also reported that it wants 2016 revenue growth of 12 percent; it’s poorest in four years.


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