Investor Contact:Dan FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com(617) 430-7576, Company Contact:Bob YoderSVP and Chief Business OfficerTrevena, Inc.(610) 354-8840. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug 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, FDA’s acknowledgement of the submitted NDA for oliceridine and the timing of FDA’s decision on the oliceridine NDA; available funding; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. The price did not have a significant surge post-FDA approval, indicating the possibility that the value was already accounted for in the stock price. Backed by 16,000 investors and 4 corporations since it’s inception, we’re excited for this company's upcoming IPO. On a more salient note TRVN has formidable competition in the treatment of moderate to acute pain market. Trevena Inc (NASDAQ:TRVN) has come up with its own opioid agonist that is supposed to take care of moderate to severe pains in adults. There are quite a few regulatory news to be announced next month. The company received a Complete Response Letter (CRL) in November 2018. FDA considers NDA resubmission a complete Class 2 response, Updated guidance on extended cash runway, funding operations into Q1 2021. October is no exception. He co-discovered the anti-androgen drug enzalutamide, which was approved by the FDA in 2012 for treatment of advanced prostate cancer. But the first hurdle is an FDA advisory committee meeting scheduled for October 11 to discuss the NDA for oliceridine, which has a November 2 PDUFA date. Long-Term Outlook. Every month brings plenty of catalysts for several biotech stocks. This represents the crucial next step to bringing oliceridine to patients,” said Carrie Bourdow, President and Chief Executive Officer of Trevena. The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. An approval from the United States Food and Drug Administration almost always comes as a major boost for any pharmaceutical or biotech company. We anticipate a significant point of discussion of the panel will be the differentiated safety profile of oliceridine, particularly strong trends in the phase 3 dataset that suggest improved respiratory safety (as well as stat sig improvements in GI tolerability). CHESTERBROOK, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and … Article Related Press Releases (1) Related Articles (1) Stock Quotes (1) The information above related to the Company's expected operating results for the year ended and as of December 31, 2019, including revenue and cash, cash equivalents, and marketable securities, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company's financial statements as of and for the year ended December 31, 2019. 02/22/21 Gevo, Scandinavian Airlines System amend agreement increase off-take of SAF 01/27/21 Gevo announces key … FDA Approved: Yes (First approved August 7, 2020) Brand name: Olinvyk. JMP analyst Jason Butler commented, “An AdComm has always been expected for the NDA, and we view the timing as consistent with expectations. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. New supply contracts imply current 2021 guidance of 600M doses is "much too conservative," said Yee, who notes that the company now has line of sight into greater than 800M doses. Company: Trevena, Inc. The Company anticipates that subsequent events and developments may cause the Company’s views to change. We think positive discussions and conclusions from the panel could be a major driver for TRVN shares.”. Over the course of a decade in industry, she oversaw the approval of 15 new medicines across a variety of diseases, including cancer, multiple sclerosis, influenza and blindness. The most advanced drug candidate in the pipeline is Oliceridine, an intravenous analgesic, for the management of moderate to severe acute pain. Price and Volume Movers Trevena, Inc. (Nasdaq: TRVN) announced that the FDA has set a PDUFA date of August 7, 2020 for the resubmitted New Drug Application (NDA) for IV oliceridine, 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. “I am pleased that FDA considers our resubmission to be a complete response to the Agency’s 2018 letter. CHESTERBROOK, PA — 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 announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic … One biotech in particular could enjoy boosts to its stock if all goes well — Trevena (NASDAQ:TRVN). CHESTERBROOK, Pa., June 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN) ... the Company’s lead investigational drug candidate for … ... (TRVN) Pain Management Drug Will Get FDA Approval Jason Cohen ... Butler reiterates a Buy rating on TRVN … Trevena (TRVN) PT Raised to $6 at JMP Securities, After FDA Approval Received Article Stock Quotes (1) FREE Breaking News Alerts from StreetInsider.com! The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders. We expect some debate at the meeting regarding the appropriate balance between ensuring patients’ medical pain management needs are met while avoiding misuse. Net net, when it comes to Wall Street’s bet, the odds are on this small-cap biotech stock. 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. Following the advisory committee’s 8-7 vote against the approval, the drug was originally rejected by the FDA in late 2018 on grounds of insufficient safety data. Given that oliceridine will be used in a controlled procedural setting, and there are no robust data supporting the use of opioids in the hospital with the risk of misuse in the community setting – we believe patients whose pain is well controlled on discharge are less likely to abuse pain control medicines in the community setting – we think the panel will support approval. As a sign of confidence in Trevena, Baral maintains an Outperform rating on the stock with a price target of $10.00. CHESTERBROOK, Pa., Jan. 28, 2021 (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 announced the publication of a new analysis of respiratory safety data from the OLINVYK Phase 3 multi-site "real world" safety study in Pain and … In addition, the Company today announced that it is updating and extending its cash runway guidance. Trevena NASDAQ Updated Feb 24, 2021 12:00 AM. Because of this high correlation, a positive recommendation by the advisory committee should result in a nice bump for Trevena stock. The company had a $50 million public offering of common stocks at lower valuations despite the company sitting on over $100 million in cash. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance. Trevena (TRVN) Confirms FDA Approval of OLINVYK injection. 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. Invest in Knighscope now.As the Coronavirus pandemic wreaked havoc on […] “There remains a significant clinical need in the hospital setting for an effective and well-tolerated IV analgesic to help manage patients’ moderate-to-severe pain. Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. Based on seven analysts polled in the last 12 months, six are bullish on TRVN, while one remains sidelined. The gains… Read More » Trevena (TRVN) Stock Rockets On FDA Approval About TrevenaTrevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The most advanced drug candidate in the pipeline is Oliceridine, an intravenous analgesic, for the management of moderate to severe acute pain. About OliceridineOliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. To find a list of pharmaceutical stocks under $1, visit Pharmaceutical Penny Stocks.For a list of medical penny stocks invovling medical services, hospital equipment, surgical and medical instruments, medical laboratories, general medical … 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 … (RTTNews) - Shares of Trevena Inc. (TRVN) are gathering steam in the run-up to a regulatory catalyst, which is only just days away. Medical Penny Stocks. Find the latest Nabriva Therapeutics plc (NBRV) stock quote, history, news and other vital information to help you with your stock trading and investing. Histogen Receives US FDA IND Approval to Initiate Phase 1b/2a Trial of HST 001 in Androgenic Alopecia May 11, 2020 | finance.yahoo.com The Conatus Pharmaceuticals Special Meeting of Stockholders Seeking Approval for Proposed Merger with Histogen Inc. will Reconvene on May 21, 2020 Trevena’s novel pipeline includes five product candidates that are being developed for areas of critical need in CNS and other disorders. (To watch Butler’s track record, click here), Echoing Butler’s bullish views is Cowen’s Ritu Baral: “We expect a positive outcome from the panel and anticipate approval on the PDUFA with a broad label. All of the company’s assets are new chemical entities with unique mechanisms of action that target well-known receptors. OLINVYK™ is approved by the FDA. Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults. “We continue to believe in the strength of the data and the ultimate approvability of oliceridine ” Carrie L. Bourdow , the CEO had said while expressing her disappointment at the time. TRVN Stock Is Climbing On FDA Approval In the press release, Trevena said that the FDA has approved OLINVYK. Generic name: oliceridine. While the advisory committee’s vote doesn’t automatically mean the FDA will decide on oliceridine in the same way, it should be a pretty good predictor. Dosage form: Injection. Mar 6, 2020 3:47PM EST Trevena, Inc. TRVN announced that the FDA has accepted its new drug application seeking approval for intravenous (“IV”) … Wall Street analysts have given Interpace Biosciences a "Buy" rating, but there may be better short-term opportunities in the market. CHESTERBROOK, Pa., March 05, 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 announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain. Post-Market 0.03 (1.37%) Copyright © 2021 Smarter Analyst - All Rights Reserved, 3 Biotech Stocks Under $2 With Massive Upside Potential, Trevena (TRVN) Stock Roars Back to Life; Analysts Dive In, Trevena (TRVN) Stock Is the Latest Biotech Bottle Rocket. Trevena could be on track to win FDA approval for its lead candidate oliceridine, a potential treatment for moderate to severe acute pain. That is what happened with the Trevena stock on Friday. Corporate News, FDA, Hot FDA News. Treatment for: Pain. Historically, the FDA goes along with the advisory committee recommendation close to 90% of the time. 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. Her picks average a 30.8% one-year return, and she’s ranked #56 out of 4,874 analysts, according to TipRanks. FDA considers NDA resubmission a complete Class 2 response . Baral is one of the top analysts on Wall Street covering the Biotechnology sector. Furthermore, we continue to believe that the Phase 2/3 trials for oliceridine support that it is a novel, differentiated opioid with more favorable respiratory and GI safety.”, As such, Butler reiterates a Buy rating on TRVN with a $15 price target (the highest on Wall Street), which implies a huge upside of over 800% from Tuesday’s closing price. The 12-month consensus mean price target for the stock is $8.58, reflecting a 420% upside from current levels. CHESTERBROOK, Pa., March 05, 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, … A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. The biotech's innovative painkiller is the first new drug in its class in decades. TRVN 2.19 0.04 (1.79%). SILVER SPRING, Md., Aug. 7, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. CHESTERBROOK, Pa., Aug. 10, 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 announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe … Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future 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. If Oliceridine is approved by 2020 TRVN will need to raise capital somehow for a commercial launch. OLINVYK has a superior safety and tolerability profile to IV morphine, as well as rapid onset of pain relief and ease of use. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. Trevena Inc (NASDAQ: TRVN) is making a run for the top in the market this morning, trading on gains of more than 40%. In their acknowledgement letter, FDA stated that the Company’s resubmission is a complete, Class 2 response to the Agency’s action letter dated November 2, 2018. The treatment has been approved for adult patiemtns dealing with acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments simply don’t work. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Updated guidance on extended cash runway, funding operations into Q1 2021. There are quite a few regulatory news to be announced next. Knightscope build autonomous security robots in Silicon Valley (made in the USA) that are patrolling across the country 24/7/365 to secure the places you live, study, work, and visit. 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. Some of MarketBeat's past winning trading ideas have resulted in 5-15% weekly gains. GEVO Gevo $10.71 / -0.52 (-4.63%). The list of medical penny stocks is updated daily after market close and is for research purpose only. Anavex Life Sciences Announces Fast Track Designation Granted by U.S. FDA for ANAVEX®2-73 (blarcamesine) Clinical Development Program for the Treatment of Rett Syndrome GlobeNewswire +14.69% Jan-31-20 11:30AM He also thinks potentially positive Phase I/II "variant" 2.0 vaccine data by Spring could lead to fast FDA approval in the second half of this year, Yee tells investors. Aug 10, 2020, 10:39am EDT The Food and Drug Administration on Monday approved a new pain medicine developed by Chesterbrook-based Trevena Inc. … We are committed to delivering oliceridine to these patients and their healthcare providers, and we look forward to supporting the Agency’s review of our application.”. Previous Name: Olinvo. After receiving approval for their lead drug Copiktra the stock plummeted even though it was supported by insider buys.