UPDATE: PTIE falls hard as Remoxy is rejected! Our prediction was correct once again. You could be in the know. Join PDUFA watch to get these posts a week before the PDUFA date!

Don't Miss The Next FDA Approval

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August 7th is likely to be a big day for biotechnology investors as three tickers are likely to see some strong movement as the result of FDA news. First and foremost, we have a PDUFA date for DURECT Corporation (NASDAQ: DRRX) and Pain Therapeutics, Inc. (NASDAQ: PTIE). On the other hand, there is a scheduled advisory committee meeting surrounding an Insmed Incorporated (NASDAQ: INSM) New Drug Application. Here’s what we’ll be watching for:

DRRX And PTIE To Hear News On Remox

DURECT licensed Remoxy from Pain Therapeutics quite a while ago. Unfortunately, the licensing fees are not likely to pay for themselves. There was already one NDA surrounding Remoxy. However a Complete Response Letter (CRL) was issued by the FDA, informing the company that it could not approve the treatment in September of last year.

Ultimately, the FDA rejected the treatment based on one primary factor, abuse. Remoxy is supposed to be an abuse deterent pain medication. However, clinical data does not suggest that the medication is a deterent. As a result, the FDA asked for further data supporting this claim.

Once the data was combed together, PTIE and DRRX resubmitted the New Drug Application, but it doesn’t look like it’s going to be approved this time either. At the end of the day, the clinical data provided simply doesn’t substantiate a new drug aproval. This opinion was clearly outlined by the FDA’s advisory committee when they voted 14-3 against the approval of the treatment on June 26, 2018.

For the reasons mentioned above, we believe that Remoxy will be rejected once again by the FDA, sending DRRX and PTIE back to the drawing board and likely leading to large declines in the value of the stock on the seventh of August.

Insmed Incorporated Advisory Committee Meeting

While Insmed’s PDUFA date isn’t on the 7th, there will be some big FDA news on that date. That’s because the FDA has scheduled a meeting with the advisory board surrounding ARIKAYCE.

ARIKAYCE is an investigational liposomal formulation of the antibiotic known as amikacin, which is currently approved for intravenous or intramuscular use to treat serious bacterial infections.  The data surrounding ARIKAYCE has been overwhelmingly positive. For this reason, we believe that the FDA’s advisory committee will vote for the approval of ARIKAYCE, proving to be a massively positive catalyst for INSM. So, be ready for the potential gains in the stock that we could see on August 7th as a result.

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Don't Miss The Next FDA Approval

Subscribe to PDUFA Watch from iWatch Markets and you'll receive alerts a week before the PDUFA date. We'll tell you if the drug is likely to be approved and when to be watching!

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