Biotech Stock News (ATHX) (FLXN)

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Athersys (NASDAQ:ATHX)

In after-hours trade on February 18, 2016 shares of Athersys were up 21% after the company announced that it had obtained positive phase 2 results for its stroke trial. The phase 2 trial was broken down into two different parts. The first part was a dose selection phase of 16 patients split into two cohorts — groups. The other part with 118 patients was the efficacy portion of the study.

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Patients in this study were either given Athersys’ Multi-stem cell therapy — intravenously into the body — or a placebo drug instead. The patients enrolled in this study, were patients who had Strokes. More specifically though these patients had a type of stroke, known as Ischemic stroke. With these patients with Ischemic stroke, they sustain obstructions in the bloodstream leading to the brain.

This phase 2 data presented is one in which patients were followed for at least one year. For the 65 patients that took Multistem Cell therapy about 23% of them achieved an excellent outcome score at the one year mark, on the other hand about 8% of the placebo patients achieved an excellent outcome score. This means that the Multistem cell therapy compound performed better than the placebo compound. That is that the Multistem cell therapy was statistically significant over the placebo compound.

Flexion Therapeutics (NASDAQ:FLXN) 

In After-hours trade on February 17, 2016 Flexion Therapeutics  went up 28% in after-hours trade on Tuesday after it had announced that its phase 3 trial hit the primary endpoint of the study. The phase 3 trial recruited up to  486 patients and split them up into three different groups with different dose amounts. One group of patients took a single IA injection of 40 mg of Zilretta, one group of patients took saline — a placebo– and the last set of patients took 40 mg of an active drug known as immediate-release TCA.

The primary endpoint was looking for the amount of pain relief a patient would achieve taking Zilretta over the placebo compound. The primary endpoint of the study was met with patients achieving statistically significant pain relief taking Zilretta compared to the placebo compound from week 1 through week 16– p <0.0001. In addition, Zilretta obtained a statistical significance in a couple of scores on a Knee Injury and Osteoarthritis Outcome Score — KOOS — quality of life subscale. The drug performed better against placebo and active in WOMAC-A — pain –, WOMAC-B — stiffness, and WOMAC-C — function.

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Zilretta has already received FDA Fast Track Designation. This means that it is possible for Zilretta to obtain a quicker review time over many other types of drugs. If all goes well with current filings and communications between the FDA, Flexion expects to file a New Drug Application — NDA — by the second half of 2016.

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