IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) Hit by FDA Decision

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI)

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI)

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) shares are down over 40% after independent advisers to the U.S. Food and Drug Administration (FDA) failed to support the approval of Intellipharmaceutics’ long-acting opioid painkiller, Rexista. On Tuesday, IPCI shares closed at $2.49 and gapped down Wednesday morning to open at $1.80 then reached a low of $1.31. At 10:45 AM EST IPCI shares were trading around $1.50 with over two million shares traded. The 30-day, daily volume average is just over 242,000. Today’s price drop easily established a new 52-week low which had been at $1.58.

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI)
10-day, 15 minute candle graph for $IPCI

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) is a Canadian pharmaceutical company that develops and manufactures proprietary and generic controlled-release and targeted-release oral solid dosage drugs. IntelliPharmaCeutics patented Hypermatrix™ technology is a drug delivery platform that can be applied to the development of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Applications (“ANDAs”) filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

It appears, however that the lack of support from the FDA advisors is not a death knell for Rexista. The committee expressed a desire to review additional safety and efficacy data. Accordingly, Intellipharmaceutics intends to conduct Category 3 abuse potential studies to provide data that the company believes supports the abuse-deterrent properties of Rexista. IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) has an FDA approved protocol for a human abuse potential study for the intranasal route of abuse, which it plans on beginning within weeks.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

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