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Trevena Reports Second Quarter 2019 Results
Enrollment for healthy volunteer QT study ongoing, topline data on schedule for Q4 2019 readout
Company remains on track to resubmit NDA for oliceridine in Q1 2020
Cash runway as of June 30, 2019 continues to sufficiently fund operations into Q3 2020
Company to host conference call today, August 7, 2019 at 8:00 a.m. ET
CHESTERBROOK, PA, August 7, 2019 Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today reported its financial results for the second quarter ended June 30, 2019, and provided an overview of its recent operational highlights.
We made substantive progress in the second quarter on the key activities to support resubmission of the NDA for oliceridine and advancement of our pipeline, said Carrie Bourdow, President and Chief Executive Officer. Subject enrollment in our healthy volunteer study for oliceridine is progressing well, and we remain focused on delivering topline data next quarter. Were also excited to continue development efforts for our other pipeline assets, including the acute migraine study for TRV250, which is slated to start next quarter.
Second Quarter and Recent Corporate Highlights:
· Strengthened leadership team. The Company recently announced the appointment of Barry Shin as Senior Vice President and Chief Financial Officer. Mr. Shin brings over 17 years of investment banking and corporate advisory experience focused in the biopharmaceuticals sector, including in the Healthcare Investment Banking groups of Mizuho Securities, Guggenheim Securities, and Piper Jaffray.
· Initiated healthy volunteer QT interval study for oliceridine. In June, the Company announced initiation of its single-site, three-period crossover, healthy volunteer study for oliceridine. The primary objective of the study is to collect the additional QT interval data requested by the U.S. Food and Drug Administration (FDA) for the resubmission of the NDA for oliceridine.
Study enrollment is on track to support topline data readout in the fourth quarter of 2019. As of today, over half of study subjects have begun dosing, with more than 20 subjects receiving the maximum daily dose of 27 mg of oliceridine, a key FDA requirement of the study design. The Company continues to expect to resubmit the NDA for oliceridine as early as possible in the first quarter of 2020.
· Advanced acute migraine proof-of-concept study protocol for TRV250. This double-blind, placebo-controlled clinical study will enroll approximately 120 migraineurs in a validated
The following information was filed by Trevena Inc (TRVN) on Wednesday, August 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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