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Trevena (TRVN) Just Days Away From FDA Decision

trevena july29 lt

Shares of Trevena Inc. (TRVN) are gathering steam in the run-up to a regulatory catalyst, which is only just days away.

Trevena is a biopharmaceutical company focused on the development of novel medicines for patients with central nervous system conditions. The most advanced drug candidate in the pipeline is Oliceridine, an intravenous analgesic, for the management of moderate to severe acute pain.

Oliceridine was refused approval by the FDA in November 2018, and the company was asked to submit additional clinical data on QT prolongation and certain additional nonclinical data and validation reports if it had to be approved.

Addressing the issues raised by the regulatory agency, the company resubmitted the New Drug Application for Oliceridine in February this year, which now has a decision date of August 7.

In clinical trials, Oliceridine's efficacy was comparable to IV morphine and was associated with improved GI tolerability and lower respiratory depression, thanks to its unique pharmacokinetic profile.

The addressable market opportunity for Oliceridine is large, according to the company. It is estimated that over 45 million patients each year in U.S. hospitals receive drugs like IV morphine for acute pain.

Trevena is not just only about Oliceridine. There are other products in the pipeline as well.

-- TRV250, being studied in a proof-of-concept study, to reduce the occurrence of headaches and also to reduce symptomatic anxiety.
-- TRV734 for opioid use disorder, under a proof-of-concept study being conducted in collaboration with the National Institute on Drug Abuse.
-- TRV045 for the treatment of epilepsy, being developed in collaboration with the NIH. An Investigational New Drug (IND) application for TRV045 is expected to be submitted in the first half of next year.

The company has also joined the fight against the novel SARS-coronavirus-2 that causes COVID-19. Last month, Trevena entered into a collaboration with Imperial College London to evaluate the potential of its drug candidate TRV027 to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients.

TRV027 was previously evaluated as a treatment for acute heart failure. In 2016, TRV027 failed to meet primary or secondary endpoints in a phase IIb study.

A phase Ib proof-of-concept study that will involve 60 hospitalized, non-ventilated patients aged 65 or older with confirmed or suspected Covid-19 is due to start in UK hospitals.

The company had cash of $28.1 million at the end of the first quarter of 2020.

Over the last three months, the share price of Trevena has gained over 230%. TRVN touched a new 52-week high of $2.39 in intraday trading yesterday (Jul.28), before closing at $2.27, up 5.58%.

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