Trevena, Inc. ((TRVN - Free Report) announced the resubmission of its new drug application (NDA) to the FDA for its lead investigational product - IV oliceridine — for the management of moderate-to-severe acute pain.
Oliceridine is an opioid-based analgesic administered intravenous and also a G protein biased ligand of the mu receptor, which is being developed for managing moderate-to-severe acute pain.
In November 2018, the FDA issued a complete response letter (CRL) with respect to the company’s NDA for oliceridine. In the CRL, the FDA requested additional clinical data on the QT interval and indicated that the submitted safety database was not of adequate size for the proposed labeling. The FDA also requested certain additional nonclinical data and validation reports. In January 2019, the company announced the receipt of the official Type A meeting minutes from the FDA regarding the CRL, wherein the agency agreed that its current safety database will support labeling at a maximum daily dose of 27 mg. The resubmission package included data from the multi-dose healthy volunteer QT study, nonclinical data that confirmed levels of an inactive metabolite and drug product validation reports. The resubmission package also specified a maximum daily dose of 27 mg, as previously acknowledged by FDA in the Type A meeting minutes.
Shares of Trevena have slumped 50% in the past year compared with the industry’s decline of 1.3%.
Meanwhile, the company is also developing two G protein biased ligand candidates — TRV250 as a non-narcotic treatment for migraine in partnership with the National Institute on Drug Abuse (NIDA) and TRV734 for maintenance treatment of opioid use disorder .
Zacks Rank and Stocks to Consider
Currently, Trevena is a Zacks Rank #3 (Hold) stock.
A few better-ranked stocks in the biotech sector are Anavex Life Sciences Corp. (AVXL - Free Report) , Guardant Health Inc. (GH - Free Report) and Oncolytics Biotech Inc. (ONCY - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anavex’s loss per share estimates have narrowed from 64 cents to 48 cents for 2020 and from 67 cents to 42 cents for 2021 in the past 90 days. The company delivered a positive earnings surprise in two of the trailing four quarters by 8.26%, on average.
Guardant’s loss per share estimates have narrowed from $1.18 to $1.13 for 2020 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 39.21%, on average.
Oncolytics’ loss per share estimates have narrowed from 79 cents to 74 cents for 2019 and from 67 cents to 59 cents for 2020 in the past 60 days.
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