Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company, on January 4 announced it had completed enrollment for its Phase 3 Apollo Pivotal Efficacy Trials of oliceridine for moderate to severe pain.
Oliceridine (TRV 130) is Trevena’s lead product candidate. It was deemed “a breakthrough therapy by the U.S. Food and Drug Administration,” based on the results of earlier clinical trials, the company said (http://dtn.fm/5zmYr).
“We are pleased to have completed enrollment in these important studies and to confirm that the Apollo trials remain on schedule to report top-line results in the first quarter of 2017,” Maxine Gowen, Ph.D., chief executive officer of Trevena, stated in a news release. “We look forward to sharing these data when they become available.”
Trevena expects that, compared to morphine and placebo, these results will show that oliceridine shows tolerability, safety and efficacy. Additionally, Trevena announced that patient enrollment for its Phase 3 Athena safety study is on track.
The company noted plans to file a New Drug Application (NDA) for oliceridine with the U.S. Food & Drug Administration in the second half of this year.
Trevena also has a portfolio, in the early stages, of more drug discovery programs. The company has also discovered additional drugs, such as TRV027 for acute heart failure, TRV734 for pain and TRV250 for migraine.
In its 10-Q Securities and Exchange Commission filing for November 2016, Trevena reported revenues of $3.75 million for the nine-month period ended September 30, 2016 (http://dtn.fm/hf4AH). By comparison, its revenue was $4.375 million for the same period a year earlier.
In an 8-K filing on January 4, 2017, Trevena reported that its net cash on hand should fund its operations until at least March 31, 2018. The company had cash equivalents, cash and marketable securities of $110.6 million as of December 31, 2016, the report said (http://dtn.fm/6OjhM).
Earlier this month, Aegis Capital Corp. gave Trevena a ‘Buy’ rating and a target price of $14 per share (http://dtn.fm/exE4N). Differ Yang, Ph.D., research analyst, said that the target price was determined through a DCF analysis. Aegis set a seven-time multiple of the 2022 EBITDA of $168 million. Yang said Aegis further assumed a clinical success probability of 70% for Trevena’s phase III program.
The company’s share price was $6.49 at market close on January 10, 2017, and its 52-week range was $10.00 – $3.76.
For more information, visit the company’s website at www.Trevena.com
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