Pain Therapeutics, Inc. (NASDAQ:PTIE) saw its shares crater over 50% today on exceptionally high volume. This drop was triggered by the announcement that the U.S. Food and Drug Administration issued a Complete Response Letter in response to PTIX’s New Drug Application, or NDA, for REMOXY.
The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.
Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants. (Original Source)
On the ratings front, Gabelli analyst Kevin Kedra downgraded PTIE to Hold, with a price target of $2.50, in a report issued on September 13. The current price target represents a potential upside of 88.% from where the stock is currently trading. According to TipRanks.com, Kedra has a yearly average return of 19.2%, a 75.0% success rate, and is ranked #1691 out of 4183 analysts.
Pain Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of novel drugs. Its drug candidate includes REMOXY, which is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use.