IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI)’s Shares Spike on Tentative FDA Approval

Shares of IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI) advanced significantly on Monday following the announcement that the company has received a tentative approval from the U.S. Food and Drug Administration for the company’s abbreviated new drug application (ANDA) for quetiapine fumarate.

IntelliPharmaCeutics International Inc. (IPCI) is watching its shares jump on Monday after the company announced that it received a tentative approval from the U.S. Food and Drug Administration. Specifically, the tentative approval was for the company’s abbreviated new drug application (ANDA) for quetiapine fumarate extended-release tablets in varying doses.

The tentatively-approved product is a generic equivalent for the corresponding strengths of the branded product Seroquel XR sold in the U.S. by AstraZeneca.

For some quick background, Seroquel XR, and the drug active quetiapine fumarate, are indicated for use in the treatment of schizophrenia and bipolar disorder.

According to the settlement between IntelliPharmaCeutics and AstraZeneca from July 2012, the company is permitted to launch its generic version of Seroquel XR in certain varying doses on November 1, 2016.

There are currently no generics of Seroquel XR available in the U.S. market as the product is still under Astra Zeneca’s patent protection until November 1, 2017.

Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, commented:

We are thrilled the FDA has granted tentative approval of our generic version of Seroquel XR®, which should further demonstrate our core drug development competency in controlled-release delivery technologies.  As Seroquel XR® has yet to come off patent protection, we believe the tentative approval represents a substantial commercial opportunity for the Company.

Excluding Monday’s move, the stock has outperformed the broad markets rising about 18% year to date. Over the past 52-weeks the stock is up nearly 29%.

Shares were last trading up nearly 18% at $2.80, with a consensus analyst price target of $6.67 and a 52-week trading range of $1.41 to $3.19.

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IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI) shares are trading +19.33% on the news and in the range of $2.76 – 3.14 during the current trading session.  When taking a look at which direction the stock might be headed, investors often look to brokerage analysts who cover the stock.  Sell-side research firms on Wall Street currently have a consensus one-year price target of $6.67 on the stock.  This is according to brokerage analysts polled by Thomson Reuters First Call.

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Sell-side analysts are projecting earnings per share of $-0.04 for the next fiscal quarter.  For the current year, analysts are predicting earnings of $-0.28 per share according to First Call.

In looking at where the stock is trading on a technical level, the stock is trading +43.85% away from its 50 day moving average of $1.97.  Based on the most recent available data, the equity is -10.97% off of its 52-week high of $3.19 and +101.42% away from its 52-week low which is $1.41.  In looking further ahead, potential investors should note that the company’s price to next year’s EPS estimates is $11.36.

Today, the stock opened at $2.80 and the last bid at the time of writing stood at $2.84.  During the session thus far, the equity dipped down to $2.76 and touched $3.14 as the high point. IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI) has a market cap of $81.64M and has seen an average daily volume of 312328 over the past three months.

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