News Breaks |
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| March 8, 2013 |
| 09:00 EDT |  | PTIE | Pain Therapeutics falls 20.8%
Pain Therapeutics is down 20.8%, or 67c, to $2.55 |
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News For PTIE From The Last 14 Days Check below for free stories on PTIE the last two weeks. |
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| May 10, 2013 |
| 16:29 EDT |  | PTIE | On The Fly: Closing Wrap
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| 12:31 EDT | | PTIE | On The Fly: Midday Wrap
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| 12:00 EDT | | PTIE | Pain Therapeutics falls 48.3%
Pain Therapeutics is down 48.3%, or $2.57, to $2.75 |
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| 10:00 EDT | | PTIE | Pain Therapeutics falls 47.2%
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| 09:21 EDT |  | PTIE | On The Fly: Pre-market Movers
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| 09:00 EDT | | PTIE | Pain Therapeutics falls 46.8%
Pain Therapeutics is down 46.8%, or $2.49, to $2.83 |
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| 08:08 EDT | | PTIE | Pain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence. |
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| 07:46 EDT | | PTIE | DURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39. |
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| 07:41 EDT | | PTIE | Pain Therapeutics plummets after Pfizer comments on Remoxy
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| May 8, 2013 |
| 09:31 EDT |  | PTIE | Pain Therapeutics downgraded to Hold from Buy at Gabelli
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| May 6, 2013 |
| 07:24 EDT |  | PTIE | Drug companies attempt to make painkillers that can't be abused, WSJ reports
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