Trevena's NDA for Pain Drug Oliceridine Gets FDA Acceptance

Trevena, Inc. 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.

Trevena, Inc. Price

 

Trevena, Inc. Price

Trevena, Inc. price | Trevena, Inc. Quote

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. CHRS, Clovis Oncology, Inc. CLVS and Halozyme Therapeutics, Inc. 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.

Biggest Tech Breakthrough in a Generation

Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.

A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.

See 8 breakthrough stocks now>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report
 
Coherus BioSciences, Inc. (CHRS) : Free Stock Analysis Report
 
Clovis Oncology, Inc. (CLVS) : Free Stock Analysis Report
 
Trevena, Inc. (TRVN) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research