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July 28, 2014
16:19 EDTFLXNFlexion signs worldwide exclusive license with Southwest Research Institute
Flexion Therapeutics announced that it has executed an exclusive worldwide licensing agreement with the Southwest Research Institute, or SwRI, to utilize proprietary microsphere manufacturing technologies for production of Flexion's sustained-release drug candidates, including leading candidate FX006. The SwRI technologies employ a uniquely controlled and continuous atomizing technology that Flexion believes may facilitate efficient scale-up of phase 3 clinical trial material and commercial supply. Flexion has successfully used this technology to produce clinical trial microsphere product for its lead drug candidate FX006, which has been tested in more than 200 patients.
News For FLXN From The Last 14 Days
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September 18, 2014
09:07 EDTFLXNFlexion trial likely to be allowed to continue, says Summer Street
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06:19 EDTFLXNFlexion to host conference call
Conference call to discuss clinical hold of FX006 phase 2b clinical trial in Osteoarthritis of the knee will be held on September 18 at 9 am. Webcast Link
September 17, 2014
18:29 EDTFLXNOn The Fly: After Hours Movers
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16:10 EDTFLXNFlexion drops 18% to $15.83 after FDA places clinical hold on study
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16:08 EDTFLXNFlexion announces clinical hold on Phase 2b trial enrollment
Flexion Therapeutics announced that the FDA informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis of the knee. FX006 is a novel, non-opioid, sustained-release, intra-articular formulation of triamcinolone acetonide targeting moderate-to-severe OA pain. Flexion said it has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to a single occurrence of an infection in the injected knee joint of a patient in the Phase 2b clinical trial.

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