FDA AdCom Meeting Cancellation for Neurocrine Biosciences, Inc. (NBIX) Ingrezza NDA Positive News: Needham Analyst

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) shares are on a 7% rise after the company revealed yesterday the FDA has cancelled its prior-scheduled Advisory Committee meeting regarding the Ingrezza NDA for Tardive Syskinesia, initially set for February 16, 2017. This seems to be a win from investors’ standpoint as well as from Needham analyst Alan Carr‘s eyes, who remains steadfastly bullish, reiterating a Buy rating on NBIX with a price target of $62, which represents a just under 41% increase from where the shares last closed.

The analyst believes, “Mgmt views the news as a positive, which appears to be a reasonable assumption. FDA reportedly stated in short emails to the company that ‘upon further review and discussion amongst the team, we have decided to cancel the mtg.’ Furthermore, ‘the review is progressing as planned.’ The PDFUA date is unchanged (4/11/16). Mgmt also noted the cancellation notice comes after submission of additional safety data from the Ingrezza development program [….]”

Moreover, Carr highlights, “We note that no notable differences in suicidal behavior were reportedly observed w/ Ingrezza in Kinect-2 […] or Kinect-3 trials (no suicidal behavior) and no clinically relevant differences relative to placebo were observed with Ingrezza in movement disorders.”

Overall, “Our expectation for Ingrezza approval on or before the PDUFA date is unchanged, based on overall safety and efficacy data from development program. There does not appear to be any indication that approval is at risk due to the cancellation,” Carr contends.

NBIX closed the third quarter of 2016 with $385.3 million in cash, a decline from second-quarter of $414.6 million. The firm’s prior guidance for the year-end of 2016 for cash circled $340 million. Moving forward, management anticipates FDA approval, hoping to launch in early June of 2017 a few weeks following if Ingrezza wins the agency’s favor.

According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, five-star analyst Alan Carr is ranked #382 out of 4,348 analysts. Carr has a 46% success rate and realizes 9.2% in his yearly returns. However, when recommending NBIX, Carr loses 3.1% in average profits on the stock.

TipRanks analytics demonstrate NBIX as a Strong Buy. Based on 12 analysts polled by TipRanks in the last 3 months, 11 rate a Buy on NBIX stock, while 1 maintains a Hold. The 12-month average price target stands at $64.89, marking a nearly 47% upside from where the stock is currently trading.

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