Cassava Sciences Inc.
416 Browning Way
South San Francisco
177 articles with Cassava Sciences Inc.
Investors are not happy after Austin, Texas-based Pain Therapeutics announced that it was no closer to seeing its drug candidate Remoxy ER, an abuse-deterrent, extended-release gel formulation of oxycodone, approved by the U.S. Food and Drug Administration.
Texas-based Pain Therapeutics is urging the FDA to reconsider the Complete Response Letter it issued in August for the company’s opioid-treatment, Remoxy. Representatives from Pain Therapeutics will meet with the FDA on Jan. 31. 2019 to discuss the request, the company announced late Monday.
NIH Grant Will Enable Clinical Tests of PTI-125 in Patients with Alzheimer’s Disease
Pain Therapeutics Announces Investor Call to Provide Strategic UpdateCall to be Held on Thursday, October 4th, 10:00 AM Eastern Time
Pain Therapeutics, Inc. today announced that it will host a live conference call to provide a strategic update regarding its business, its science and its pipeline.
The biotech industry is fast-moving and dynamic, and staying on top of all the news can be hard for our busy readers. Here’s a look back at some of the top stories you may have missed this month.
DURECT's Licensee Pain Therapeutics Receives Complete Response Letter from FDA for REMOXY® ER (oxycodone) Extended-Release Capsules CII
DURECT Corporation announced that its licensee, Pain Therapeutics reported that it received a Complete Response Letter from the U.S. FDA for Pain Therapeutics' New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII, which concluded that "The data submitted in [the] NDA do not support the conclusion that the benefits of [REMOXY] Extended-Release Capsules outweigh the risks."
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter—basically a rejection—to Austin, Texas-based Pain Therapeutics for Remoxy ER for pain.
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE), reported yesterday that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting to discuss the New Drug Application (NDA) for REMOXY ER (extended release oxycodone CII).
Pain Therapeutics Resubmits NDA for REMOXY ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain
The Company expects a six-month review cycle by FDA.
Net loss in 2017 was $11.9 million, or $1.82 per share, compared to a net loss in 2016 of $14.9 million, or $2.28 per share.
All study subjects reported reduced ‘Drug Liking’ ‘Take Drug Again’ and ‘Drug High’ for REMOXY compared to oxycodone IR.
Pain Therapeutics today announced that it has successfully concluded a regulatory meeting with the FDA regarding REMOXY, a drug candidate for severe chronic pain.
The new publication in Neuroimmunology and Neuroinflammation describes an altered form of a protein called filamin A (FLNA) that is critical to the formation of neuropathologies associated with Alzheimer’s disease.
The Company still expects net cash usage in the calendar year 2017 may be approximately $10 million.
The meeting is planned for November 14, 2017 at FDA headquarters.
PTI-125 is well-tolerated in first-in-human clinical study.
NIH Awards $1.8 Million Research Grant To Pain Therapeutics In Support Of A Blood-Based Diagnostic For Alzheimer’s Disease