Trevena's NDA For Pain Drug Oliceridine Gets FDA Acceptance

Trevena, Inc. (NASDAQ:TRVN) announced that the FDA has accepted its new drug application seeking approval for intravenous (“IV”) oliceridine for management of moderate-to-severe acute pain. A decision is expected by Aug 7, 2020.

Please note that the FDA had issued a complete response letter (“CRL”) in November 2018, requesting additional clinical and safety data for oliceridine. The company re-submitted oliceridine NDA to the FDA last month. Oliceridine is an opioid-based analgesic and also a G protein biased ligand of the mu receptor.

The FDA also acknowledged that resubmission of the NDA was a complete and Class II response to the previously issued CRL.

Trevena also updated its cash runway guidance in the same press release. The company now expects its $35.8 million cash resources to be sufficient to fund its operations in the first quarter of 2021.

Shares of Trevena have slumped 48% in the past year compared with the industry’s decline of 2.1%.

Meanwhile, Trevena is also developing two G protein biased ligand candidates — TRV250 as a non-narcotic treatment for migraine and a partnership with the National Institute on Drug Abuse (NIDA) for TRV734 — for the management of opioid use disorder.

The company is also developing another pipeline candidate, TRV045 — a novel S1P modulator — for the non-opioid treatment of chronic pain. The company is working on filing an investigational new drug application on the product soon.

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 Coherus BioSciences, Inc. (NASDAQ:CHRS) , Clovis Oncology, Inc. (NASDAQ:CLVS) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Coherus’ earnings per share estimates have moved up from $1.67 to $1.89 for 2020 and from $1.13 to $1.32 for 2021 in the past 30 days. The company delivered average positive earnings surprise of 147.48% in the trailing four quarters.

Clovis’ loss per share estimates have narrowed from $4.73 to $4.67 for 2020 and from $3.33 to $2.90 for 2021 in the past 30 days.

Halozyme’ earnings per share estimates have moved up from 58 cents to 63 cents for 2020 and from $1.30 to $1.42 for 2021 in the past 30 days.

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