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PTIE

Pain Therapeutics

$2.38

0.01 (0.42%)

07:11
08/06/18
08/06
07:11
08/06/18
07:11

Pain Therapeutics receives CRL from FDA for Remoxy

Pain Therapeutics announced it had received a Complete Response Letter, or CRL, from the FDA for its New Drug Application, or NDA, for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to FDA, "The data submitted in [the] NDA do not support the conclusion that the benefits of Remoxy Extended-Release Capsules outweigh the risks." Remi Barbier, President & CEO said, "This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgement call that is vague in nature but conclusive in its damaging effects."

  • 07

    Aug

PTIE Pain Therapeutics
$2.38

0.01 (0.42%)

03/06/18
HCWC
03/06/18
UPGRADE
Target $3.5
HCWC
Buy
Durect upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright analyst Ed Arce upgraded Durect (DRRX) to Buy with a $3.50 price target. Investor sentiment has begun to shift to a positive bias, based on the broad preclinical and Phase 1 data set, and large commercial opportunity, of DUR-928, Acre tells investors in a research note. In addition to two Phase 2 data catalysts this year, investors can look to two near-term potential FDA approvals on partnered assets, Indivior's RBP-7000 and Pain Therapeutics' (PTIE) Remoxy, the analyst adds.

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HYMTF

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AYI

Acuity Brands

$123.00

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  • 03

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HYAC

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SAGE

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NVDA

Nvidia

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CURLF

Curaleaf Holdings

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  • 25

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PETQ

PetIQ

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T

AT&T

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SGSOY

SGS SA

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CLX

Clorox

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BA

Boeing

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