Trevena Announces FDA Acceptance Of Olinvo NDA, Shares Up
Zacks Investment Research | Jan 02, 2018 10:03PM ET
Shares of Trevena, Inc. (NASDAQ:TRVN) rallied almost 24.5% in after-market trading on Jan 2, following the company’s announcement that the FDA has accepted the new drug application (“NDA”) for its pain therapy, Olinvo injection. Olinvo is an opioid-based analgesic administered intravenous and also the first G protein biased ligand of the mu receptor.
The company expects a decision from the FDA in the fourth quarter of 2018.
Shares of Trevena have lost 71.3% in the past year, significantly underperforming the industry ’s gain of 2.8%. A potential approval from the FDA can give a boost to the stock.
The NDA included data from three phase III studies – APOLLO-1, APOLLO-2 and ATHENA – and a phase II study, which evaluated Olinvo in patients with moderate-to-severe acute pain.
Data from phase II & ATHENA studies have shown that Olinvo has achieved rapid and powerful analgesic efficacy and a wider therapeutic window versus morphine. Data from APOLLO-1 and APOLLO-2 also showed that the drug achieved statistically greater analgesic efficacy compared to placebo.
Trevena does not have any approved product in its portfolio and did not record any revenues in the third quarter of 2017.
The company believes that upon a potential approval it will incur significant expenses for commercialization of the drug. The company will have to seek various ways to raise funds. Also, it will face competition from currently marketed drugs, which include AcelRx Pharmaceuticals, Inc.’s (NASDAQ:ACRX) Dsuvia and Mallinckrodt Public Limited Company’s (NYSE:MNK) Exalgo.
Meanwhile, the company is also developing two G protein biased ligand candidates — TRV250, as a non-narcotic treatment for migraine and TRV734 for moderate-to-severe acute and chronic pain.
Trevena, Inc. Price
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