We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Flexion (FLXN) Zilretta Gets Positive FDA Guidance; Stock Up
Read MoreHide Full Article
Shares of Flexion Therapeutics, Inc. surged 50.5% after the company announced that it has received written responses from the FDA stating that the safety and efficacy data from the registration program on its lead candidate, Zilretta (FX006), are acceptable to support the filing of a New Drug Application (NDA).
The written responses from the agency were related to the questions that the company had submitted ahead of a pre-NDA meeting regarding Zilretta. Flexion stated that the positive feedback from the FDA eliminates the need for an in-person pre-NDA meeting and the responses will serve as the official meeting minutes.
We note that Zilretta is being developed as the first intra-articular, sustained-release, non-opioid treatment of patients suffering from moderate-to-severe osteoarthritis (OA) pain.
The company plans to file an NDA in the fourth quarter of 2016. Zilretta has Fast Track status in the U.S., which should expedite its development and review process.
We remind investors that in Feb 2016, the company announced positive data from a pivotal phase III study on Zilretta, which revealed that patients with moderate-to-severe OA knee pain witnessed a highly significant, durable and clinically meaningful pain relief against placebo at week 12. The news on the development front was encouraging after the company’s setback on the candidate, which had failed to meet the primary endpoint in a phase IIb study in patients with moderate-to-severe OA knee pain.
Meanwhile, last month, the company initiated a phase II study on Zilretta to assess the effects of the candidate on blood glucose levels in adults with OA of the knee who also have type II diabetes.
Given that Flexion has no approved product in its portfolio at the moment and Zilretta is the company’s lead pipeline candidate, investor focus is expected to remain on updates pertaining to its development.
Flexion currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Flexion (FLXN) Zilretta Gets Positive FDA Guidance; Stock Up
Shares of Flexion Therapeutics, Inc. surged 50.5% after the company announced that it has received written responses from the FDA stating that the safety and efficacy data from the registration program on its lead candidate, Zilretta (FX006), are acceptable to support the filing of a New Drug Application (NDA).
The written responses from the agency were related to the questions that the company had submitted ahead of a pre-NDA meeting regarding Zilretta. Flexion stated that the positive feedback from the FDA eliminates the need for an in-person pre-NDA meeting and the responses will serve as the official meeting minutes.
We note that Zilretta is being developed as the first intra-articular, sustained-release, non-opioid treatment of patients suffering from moderate-to-severe osteoarthritis (OA) pain.
The company plans to file an NDA in the fourth quarter of 2016. Zilretta has Fast Track status in the U.S., which should expedite its development and review process.
We remind investors that in Feb 2016, the company announced positive data from a pivotal phase III study on Zilretta, which revealed that patients with moderate-to-severe OA knee pain witnessed a highly significant, durable and clinically meaningful pain relief against placebo at week 12. The news on the development front was encouraging after the company’s setback on the candidate, which had failed to meet the primary endpoint in a phase IIb study in patients with moderate-to-severe OA knee pain.
Meanwhile, last month, the company initiated a phase II study on Zilretta to assess the effects of the candidate on blood glucose levels in adults with OA of the knee who also have type II diabetes.
Given that Flexion has no approved product in its portfolio at the moment and Zilretta is the company’s lead pipeline candidate, investor focus is expected to remain on updates pertaining to its development.
Flexion currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>