The Bionomics Ltd (ASX: BNO) share price has been on fire on Monday morning.
The clinical stage biopharmaceutical company's shares rocketed over 43% higher to 13.5 cents in early trade.
They have since dropped back a touch but are still up over 27% at the time of writing.
Why is the Bionomics share price on fire today?
Investors have been fighting to get hold of the company's shares this morning after the U.S. FDA granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.
Fast Track designation is an FDA program intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.
The company's executive chairman, Dr. Errol De Souza, appears to believe this is a big positive for BNC210.
He said: "FDA's decision to grant Fast Track designation is an important recognition of the high unmet medical need in PTSD and potential benefits of BNC210 with a novel mechanism of action in the treatment of this disorder."
"We are pleased with the progress that we have made over the last year in getting BNC210 back on track by carrying out extensive pharmacometric analysis and two pharmacokinetic studies demonstrating that the target blood levels predictive of efficacy in the treatment of PTSD can be achieved with our new solid dose formulation. We look forward to taking advantage of the Fast Track designation and working closely with FDA in the design and initiation of the next Phase 2b study in PTSD patients," he added.
Should you invest?
This certainly is a positive, but I would suggest investors wait to see how things develop over the coming quarters.
After all, just over a year ago Bionomics released the data for its phase 2 clinical trial of its BNC210 in patients with PTSD.
That trial did not meet its primary endpoint of a decrease in PTSD symptoms as measured by Clinician-Administered PTSD Scale (CAPS-5) at 12 weeks.
Perhaps the new solid dose formulation will save the day, but for now, I intend to watch on from the safety of the sidelines.