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May 23, 2014
09:09 EDTMNK, FLXN, INSYBMO Capital specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Maris, along with President & CEO Nathaniel Katz, MD of Analgesic Solutions, discuss whether the FDA is looking for alternatives to complement the opioid pain relief medications on the market, including Mallinckrodt’s Xartemis and MNK-155, Flexion’s FX005 and Insys’s Subsys on an Analyst/Industry conference call to be held on May 23 at 10 am.
News For MNK;FLXN;INSY 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.
September 16, 2014
07:30 EDTMNKCRT Capital to hold a conference
2nd Annual Investor Conference to be held in Greenwich, CT on September 16.
September 15, 2014
12:58 EDTINSYInsys retreats after receiving second subpoena from U.S.
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08:23 EDTINSYInsys subpoena should not overshadow bigger picture, says Wells Fargo
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07:41 EDTINSYInsys new subpoena an extension of previous probe, says Oppenheimer
After Insys received a subpoena from the Department of Justice after previously receiving a subpoena from an Inspector General's office, the firm thinks the second subpoena is related to the same investigation as the first one. Oppenheimer views the second subpoena as a headline risk but does not expect it to impact the company's business. It keeps a $40 price target and Outperform rating on the shares.
September 12, 2014
18:03 EDTINSYInsys Therapeutics receives subpoena over Subsys sales, marketing practices
On September 8, Insys Therapeutics, Inc. received a subpoena issued pursuant to the Health Insurance Portability and Accountability Act of 1996, as amended, from the U.S. Attorney’s Office for the District of Massachusetts. The subpoena requests documents regarding Subsys, including Insys’ sales and marketing practices related to this product. Insys intends to cooperate with the investigation.
September 10, 2014
10:25 EDTINSYInsys Therapeutics management to meet with JMP Securities
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September 9, 2014
16:12 EDTFLXNFlexion issued composition of matter patent for lead candidate FX006
Flexion Therapeutics announced that the U.S. Patent and Trademark Office has issued a composition of matter patent, entitled "Corticosteroids for the Treatment of Joint Pain," which provides coverage for FX006, the company's lead clinical product candidate. FX006 is a novel, non-opioid, sustained-release, intra-articular formulation of triamcinolone acetonide.

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