Shares of Trevena (TRVN) came back to life.
The struggling biotech stock took a rare leap upward last week, as well as today, as resolution with the FDA on two clinical requests paved path for oliceridine NDA resubmission. Oliceridine was developed to help adult patients manage moderate to severe acute pain.
Trevena proposed reducing the maximum daily dose to 27 mg on the label, from the 40 mg proposed in the original NDA, and the FDA agreed that the current safety database supports labeling at a maximum daily dose of 27 mg, thereby avoiding any additional trials in patients. Furthermore, the FDA has agreed to allow Trevena to collect the requested QT interval data in healthy volunteers (HVs), instead of requiring a clinical trial in analgesic patients.
Management is currently planning to conduct a threeperiod crossover study (placebo- and positive-control ECG arms) with multiple doses of oliceridine in at least 20 HVs with exposure up to the maximum 27 mg over 24 hours. Trevena expects to initiate this study in 1H19, but at this time, it can offer no further guidance on its regulatory timeline.
JMP analyst Jason Butler commented, “We believe the additional information requested by the FDA can be generated in a time and capital efficient manner and likely enable NDA resubmission by YE 2019 or in early 2020. We are confident in the potential near-term approval and remain enthusiastic about the commercial opening for oliceridine in higher-risk procedures/patient populations.”
As such, Butler reiterates an Outperform rating on TRVN shares, with a $4.00 price target, which implies nearly 200% upside from today’s closing price. (To watch Butler’s track record, click here)
H.C. Wainwright’s Ed Arce is a bit more cautious though: “Overall, we are pleased with the path offered to resolve the two main issues from the CRL, and in aggregate, view them as the best-case scenario for Trevena. No additional clinical trials or patient data on either efficacy or safety is required. However, while we view this announcement as a positive first step, we still have no definitive clarity on the ultimate approval timeline.”
Waiting for Clarity, Arce remains sidelined on TRVN with a Neutral rating and a $1.25 price target, representing about 7% downside from current levels. (To watch Arce’s track record, click here)