Flexion Therapeutics Stumbles on Clinical Hold

The FDA informed the company that a clinical hold on the patient enrollment and dosing will be placed on the ongoing Phase 2b clinical trial evaluating FX006, which is indicated in osteoarthritis treatment. This is based on verbal communication; the company has not yet received written notice.

The clinical hold was placed due to a single occurrence of an infection within a knee joint of a patient in the trial.

Michael Clayman, M.D., president and CEO of Flexion, had this to say about the FDA’s impending clinical hold:

We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation of this event. Once the FDA has completed its review, we can better assess the impact this clinical hold will have on our development program timeline for FX006.

The stock fell to $15.00 in the after-hours, following the initial announcement. This was a total decrease of 22.6% from the close of $19.38. However, since the open on Thursday, the stock is only down to $17.62, roughly 9% from the previous close.

Flexion has a consensus price target of $31.50, and it has a 52-week trading range of $11.06 to $21.23.

ALSO READ: Analyst Sees Incyte Worth 70% More