"In addition, the Company today announced that it is updating and extending its cash runway guidance. Cash, cash equivalents, and marketable securities were approximately $35.8 million as of December 31, 2019, which the Company believes will be sufficient to fund the Company?s operating expenses, debt service, and capital expenditure requirements into the first quarter of 2021."
?I am pleased to have the opportunity to provide a comprehensive overview of the data we have amassed over the entire oliceridine development program from over 1,800 individuals,? said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. ?This monograph is the latest addition to the compelling body of peer-reviewed published literature for oliceridine, and summarizes the novel characteristics that make it a potentially differentiated treatment option for moderate-to-severe acute pain in hospital settings.?
the journal Circulation published online an article titled: ?-Arrestin-Biased Angiotensin II Receptor Agonists for COVID-19, Manglik A, Wingler LM, Rockman, HA, Lefkowitz, RJ. This article hypothesizes that targeting the AT1 receptor with a selective agonist, such as TRV027, may offer a new approach to disrupting the cellular pathway that contributes to COVID-19-related acute respiratory distress syndrome (ARDS). It also proposes the potential therapeutic advantage of this approach compared to angiotensin receptor blockers (ARBs) and ACE inhibitors currently being investigated in clinical trials, due to the unique downstream signaling effects of an AT1 receptor selective agonist. Trevena, Inc. (the ?Company?) has received interest from multiple institutions regarding potential studies that could evaluate the use of its investigational new drug, TRV027, in COVID-19 patients. TRV027 has previously been studied in 691 patients, completed a Phase 2b trial in acute heart failure, and has a well-established safety profile.
Any statements in this Current Report on Form 8-K about future expectations, plans and prospects for the Company, including statements about the Company?s strategy, future operations, clinical development and trials of its product candidates, and other statements containing the words ?anticipate,? ?believe,? ?estimate,? ?expect,? ?intend,? ?may,? ?plan,? ?predict,? ?project,? ?suggest,? ?target,? ?potential,? ?will,? ?would,? ?could,? ?should,? ?continue,? and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to the global COVID-19 pandemic; the status, timing, costs, results and interpretation of the Company?s clinical trials or any future trials of any of the Company?s product candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company?s assessment of the discussions with FDA and the timing of FDA?s decision on the oliceridine NDA; available funding; and other factors discussed in the Risk Factors set forth in the Company?s Annual Report on Form 10-K filed with the SEC and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this report represent the Company?s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company?s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
Studies regarding Covid-19: "Both angiotensin II converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) have repeatedly, but not consistently, been documented to slow progression of pulmonary complications in vulnerable patients. These seemingly beneficial findings of renin angiotensin system (RAS) blockade on outcomes in pneumonia resurfaced in the recent literature in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection." "Experimentally and in humans, RAS blockade has been shown to up-regulate ACE2 activity, thereby potentially antagonizing some effects of COVID-19."
Studies regarding TRV027: "In theory, TRV027 would allow the beneficial effects of RAAS blockade while avoiding potentially negative effects on cardiac performance".
Up coming PDUFA on August 7th Has been trading strong amidst the chaos recently supported by studies of TRV027 on COVID-19 patients Recently announced the advancement of their Oliceridine Clinical Development in China $28.1m Cash & equivalents on hand Recently ignited collaboration with NIH to evaluate TRV045 for epilepsy and non addictive treatment for pain
Der Run-up vor der Zulassungsentscheidung fand bereits am Dienstag ein Ende. Von 0,50$ im März auf fast 3,50$ im August war ein ziemlich steiler Anstieg. Da sind Gewinnmitnahmen vor diesem wichtigen Event gut nachvollziehbar.