Trevena Submits NDA for OLINVYK Injection in China

Trevena, Inc.(Nasdaq: TRVN) disclosed that it has submitted a New Drug Application for OLINVYK (oliceridine) injection, designed to treat acute pain in adults, to China’s National Medical Products Administration (NMPA). The biopharmaceutical company focuses on the development of treatment for diseases affecting the central nervous system.

Shares of the company declined 5.4% on Thursday but gained 10.4% in the extended trading session.

The application was submitted by Trevena’s partner, Jiangsu Nhwa Pharmaceutical, post-completion of a Phase 3 bridging trial for OLINVYK. Notably, the injection has already been approved by the U.S. Food and Drug Administration.

The injection is given to adults with pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

Trevena also disclosed to have signed a license agreement with Nhwa in 2018, which enables it to develop, manufacture and commercialize OLINVYK in China and receive regulatory and commercial milestone payments, along with 10% royalty on net sales in China.

The President and CEO of Trevena, Carrie Bourdow, said, “We are pleased to see the data presented in Nhwa’s NDA submission are consistent with data from our registration studies in the US. We are confident that Nhwa is the right strategic partner to advance OLINVYK in China and believe that this collaboration has the potential to create significant value for our stakeholders over the years ahead.”

Stock Rating

The Street is cautiously optimistic about the stock with a Moderate Buy consensus rating based on 2 Buys. With a return potential of over 800%, Trevena stock price prediction stands at $4.50. Shares of the penny stock declined 78% over the past year. Read more: penny stocks news on TipRanks.

Negative Sentiment

TipRanks’ Stock Investors tool shows that investors currently have a Very Negative stance on Trevena, with 12.9% of investors decreasing their exposure to TRVN stock over the past 30 days.

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