Here’s Why Pain Therapeutics (PTIE) Stock Crashed 70% Today


In this article, we walk investors through today’s Pain Therapeutics (NASDAQ:PTIE) bloodbath. Shares are down 70% as an FDA advisory committee voted overwhelmingly against the company’s pain drug Remoxy ER. And currently, PTIE investors need a pain treatment more than ever.

Specifically, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 14 to 3 against the approval of Remoxy ER (oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The FDA has set a PDUFA target action date of August 7, 2018 for completion of its review of the New Drug Application for REMOXY ER. While the FDA is not bound by the Advisory Committee recommendations, in most cases, the FDA does follow the recommendations.

In its latest first-quarter report, PTIE reported a net loss of $2.2 million, or a net loss per share of $0.33. This compared to a net loss of $2.7 million, or $0.42 per share, for the same period in the prior year, representing a 19% decrease. The company ended the quarter with cash and cash equivalents of $10.7 million, compared to $10.5 million in the prior quarter, representing a 2% increase.

What’s next? PTIE continues to advance its early-stage candidate PTI-125, an oral, small molecule drug candidate that was designed in-house and characterized by outside collaborators. PTI-125 has been shown to significantly improve AD neuropathologies in mouse models of the disease and in post-mortem brain tissue from AD patients, including receptor dysfunctions, neuroinflammation, tau hyperphosphorylation, insulin resistance and plaques and tangles that are hallmarks of AD. PTI-125 completed a Single Ascending Dose Phase I clinical trial in healthy volunteers with no drug-related side effects and dose-proportional pharmacokinetics. The PTI-125 program is supported by research grants from the National Institute on Aging of the NIH.

 

 

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