H.C. Wainwright downgraded Trevena (NASDAQ:TRVN) to “neutral” from “buy” and slashed its price target to 75 cents from $3 after the company received a complete response letter (CRL) on Nov. 2 from the FDA for oliceridine, its mu-opioid analgesic for moderate-to-severe acute pain. The stock closed at 71 cents on Nov. 2.
Last month, the FDA’s advisory committee voted seven in favor and eight against oliceridine. “Not only did we point to the closely split AdCom vote, but we also viewed two main areas of contention at the meeting as manageable: efficacy vs. morphine (more of a commercial differentiation issue than one of approvability), and a potential claim of lower risk of respiratory depression vs. morphine (largely an issue of labeling),” writes analyst Ed Arce.
“Thus, we are gratified to learn (at least based on Trevena’s press release) that the FDA appears to have put to the side questions of comparative efficacy and safety, and decided on the question of oliceridine’s approvability based on the drug’s own merits,” he added.
According to the CRL, the FDA has requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. Both of these issues were discussed during the AdCom meeting. However, the CRL also included FDA requests for certain additional nonclinical data and validation reports.
Mr. Arce expects Trevena to meet with the FDA early in the first quarter of 2019, followed by at least six months to resubmit the NDA, depending on the data and analyses necessary, then six months for a FDA review of the Class 2 resubmission and leading to a new PDUFA data in the first quarter of 2020.
But he said that pushing back the drug’s timeline by at least 15 months or more is beyond Trevena’s current cash runway.
