Trevena's 30% Plunge, Explained

Trevena IncTRVN
, a clinical-stage biopharmaceutical company that focuses on therapeutics that use an approach to target G protein coupled receptors (GPCRs), saw its
shares
plummet around 30 percent Tuesday morning despite a positive development in Phase 3 trials.

Trevena announced positive top-line results from ongoing Phase 3 trials called "APOLLO-1" and "APOLLO-2." The studies evaluated the safety of Trevena's oliceridine therapy in patients for 48 hours following bunionectomy and 24 hours following abdominoplasty.

In both studies, all dose regiments achieved their primary endpoint of demonstrating a statistically greater analgesic efficacy compared to a placebo. Moreover, oliceridine showed dose-related trends of improvements versus morphine on numerous measures of respiratory safety and gastrointestinal tolerability.

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The company also intends to submit oliceridine for marketing approval with the U.S. Food and Drug Administration as soon as the fourth quarter.

"We believe the data for all three dose regimens will support FDA approval of IV oliceridine with a broad indication of management of moderate-to-severe acute pain. These successful trials cap a development program that has shown consistent differentiation of oliceridine from morphine in multiple clinical trials," said Maxine Gowen, Ph.D., chief executive officer. "We look forward to submitting a new drug application with the goal of bringing this innovative product to patients."

Why The Plunge?

TheStreet's biotech expert Adam Feuerstein noted several concerning aspects of Tuesday's announcement which may explain the stock's decline.

First, some of the doses of oliceridine demonstrated lower rates of depressed breathing versus morphine and the only statistically significant observation was found in the lowest dose.

Feuerstein continued that the therapy did cause less vomiting and nausea versus morphine but the improved tolerability was not deemed to be statistically significant at all the different dose levels.

Finally, if approved, oliceridine could be more expensive versus generic morphine so the company needs to "make a convincing case" that it boasts a better tolerability and the safety associated with the therapy will be a net cost saver.

Posted In: Analyst ColorBiotechNewsHealth CareFDAMoversMediaTrading IdeasGeneralAdam FeuersteinApollo 1apollo 2Clinical StudiesMaxine GowenoliceridinePhase 3 TrialsTheStreet
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