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Trevena Reports First Quarter 2020 Results
FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020
IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain
Company to host conference call today, May 7, 2020, at 8:00 a.m. ET
CHESTERBROOK, Pa., [May 7], 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.
“In the first quarter, we reached a significant milestone for the oliceridine program, with our resubmission and FDA’s acceptance of the NDA. I am very pleased with FDA’s engagement in the review process, and we look forward to receiving their decision in August,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc.
First Quarter 2020 and Recent Corporate Highlights:
|·||Resubmitted NDA for oliceridine, with FDA review ongoing. In March 2020, the Company announced that the U.S. Food and Drug Administration (FDA) had set a Prescription Drug User Fee Act (PDUFA) goal date of August 7, 2020 for oliceridine, and the Agency considered the resubmitted New Drug Application (NDA) to be a complete response to their 2018 action letter.|
FDA’s review of the NDA resubmission is ongoing, and the Company continues to expect a decision from the Agency by August 7.
|·||Further expanded body of peer-reviewed literature. The Company recently announced the publication of a comprehensive review of the nonclinical and clinical data for oliceridine. The monograph provides an overview of the data the Company has published over the past 18 months, including head-to-head data versus IV morphine in hard- and soft-tissue surgical models and safety / tolerability data in high-risk patients from an open-label, “real world” safety study. These high-risk patients – elderly, obese, renally impaired and / or co-morbid – make up the initial target market for oliceridine.|
|·||Initiated collaboration with NIH to evaluate TRV045 for epilepsy and non-addictive treatment for pain. In March 2020, the Company announced it had entered into a collaboration with NIH to evaluate the potential of TRV045, the lead candidate for its novel S1P receptor modulator program, as a treatment for epilepsy. NIH has initiated the first round of assays for TRV045 within its Epilepsy Treatment Screening Program.|
The following information was filed by Trevena Inc (TRVN) on Thursday, May 7, 2020 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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