It’s a very rewarding trading day for investors in Trevena (TRVN) with shares up over 70%, making the stock Wall Street’s bull of the day.
Why the excitement? The drug maker announced receipt of formal Type A Meeting minutes from the FDA relating to its New Drug Application (NDA) for oliceridine, the Company’s lead product candidate for the treatment of moderate to severe acute pain. Importantly, the Company is not required to provide any additional efficacy data to resubmit the oliceridine NDA.
Recall, the company has received a CRL from the FDA on the NDA for oliceridine back in November. The CRL noted that: (1) the FDA has requested additional clinical data on QT prolongation; and (2) indicated that the submitted safety database is not of adequate size for the proposed dosing. Both of these issues were discussed during the AdCom. However, the CRL also included FDA requests for certain additional: (3) nonclinical data; and (4) validation reports.
In the formal FDA meeting minutes, the FDA has agreed that the Company’s current safety database will support labeling at a maximum daily dose of 27 mg. Furthermore, the FDA has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms. The Company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year. To address other items in the CRL, FDA has indicated that the Company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted.
CEO Carrie L. Bourdow commented, “We are encouraged by the productive discussion with FDA, which we believe has provided a path to resubmit the oliceridine NDA […] We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain.”
Wall Street Verdict
Ultimately, the word on the Street points to a sidelined majority on Trevena. In the last 12 months, the drug maker has landed 2 ‘buy’ ratings vs. 3 ‘hold’ ratings. It’s clear that Wall Street is largely divided between the bulls and the fence sitters when it comes to Trevena’s market opportunity. That said, the consensus average price target points to $1.92, or nearly 106% upside potential for the stock. This suggests that by consensus expectations, for now, the bulls win on TRVN. (See TRVN’s price targets and analyst ratings on TipRanks)