What’s Next for Trevena, Pipeline and Analysts Review

Trevena, Inc. (NASDAQ: TRVN) is a biopharmaceutical company focused on providing better, safer therapies to patients in pain.  The Company has leveraged breakthrough science to discover and develop its investigational product, oliceridine injection, for the management of moderate-to-severe acute pain.

Trevena was founded to translate Nobel Prize-winning research into a new generation of groundbreaking medicines. Its novel approach to drug discovery has established it as pioneers in acute care medicine.


ON August 2, 2018, the company announced financial results for the quarter ended June 30, 2018 and provided an update on its pipeline of differentiated new chemical entities, including its lead asset, oliceridine, currently under review by the U.S. Food and Drug Administration (FDA) for potential approval this year.


Our members have booked up to 800% with our recent (2018) NASDAQ and NYSE small cap alerts. View our recent picks, track record, this week’s feature report and sign up for our real time mobile/text alerts here – https://tradersnewssource.com/traders-news-source-new-members/


“The second quarter saw important progress towards Trevena’s long-term success,” said Maxine Gowen, Ph.D., President, and Chief Executive Officer. “We remain confident that the oliceridine NDA remains on track for an FDA decision by the November 2, 2018 PDUFA date.   In addition, the second quarter saw us secure two important ex-US licensing transactions for oliceridine, strengthen our leadership team with important medical and commercial hires, and continue a smooth transition to Carrie Bourdow’s assumption of the CEO role.”


More recently, on 11th October the company announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the meeting, the Advisory Committee voted eight against, and 7 in favor of, the approval of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.


Notwithstanding this adverse outcome, the management strongly believes that the totality of the evidence presented and discussed supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings. Trevena is working closely with the FDA as they complete their review of the NDA for oliceridine.


Near-term Catalyst: Trevena’s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018, with a Prescription Drug User Fee Act (PDUFA) target date for completion of review by the FDA of November 2, 2018.




Financial profile is marked by comfortable liquidity: So far liquidity and financial position are concerned, TRVN had $63.5 million as of June 30, 2018.  The Company expects this amount, together with interest thereon and proceeds from oliceridine ex-U.S. licensing activities, to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months. Furthermore, this would also ensure that the company does not suffer any unforeseen liquidity related contingencies over the near to medium term.


TRVN stock has started showing enormous strength and strong momentum in the recent past. The momentum is likely to continue as the company approaches PDUFA target date next month. Moreover, the company presently has a low market cap, with sufficient liquidity, efficient/promising product pipeline in a very high growth industry. Driven by factors as mentioned earlier, traders and investors seem to be pricing TRVN positively.


Analyst views and brokerage actions:

Per www.marketbeat.com, their average twelve-month price target is $6.8333, suggesting that the stock has a possible upside of 538.63%. The high price target for TRVN is $15.00, and the low-price target for TRVN is $1.00. There are currently two hold ratings, and 4 buy ratings for the stock, resulting in a consensus rating of “Buy.”


Below are the excerpts of recent ratings by brokerage house:

Source – www.marketbeat.com


About the Company: Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of new and innovative treatment options for patients in pain. The Company has discovered three novel and differentiated drug candidates using its proprietary platform, including intravenous (IV) oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of an acute migraine, and TRV734 for pain and/or management of opioid dependence.  In its preclinical programs, Trevena is evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain.


About Oliceridine: Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted.  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. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.


The pipeline, its present stage, and upcoming milestone:



Other recent announcements/achievements:

  • Licensed oliceridine for development and commercialization in South Korea and China.
  • Successful completion of Phase 1 study of TRV250 for acute migraine.
  • National Institute on Drug Abuse studying TRV734 as a potentially differentiated therapy for maintenance treatment of opioid dependence.
  • Continued advancement of preclinical non-narcotic analgesic program.
  • Carrie Bourdow selected as next CEO.
  • Strengthened leadership team.


Litigation/ Complaint, filed in the United States District Court – As per public sources, there are class action lawsuits initiated/filed against the company and certain of its officers alleging violations of the federal securities laws. However, there is no recent press release/response from the management about the same.


Quarterly Financial Results (in, thousands):


Net Loss: For the second quarter of 2018, Trevena reported a net loss attributable to common stockholders of $9.3 million, or $0.13 per share, compared with a net loss attributable to common stockholders for the second quarter of 2017 of $20.4 million, or $0.35 per share.

R&D Expenses: Research and development expenses were $5.1 million in the second quarter of 2018 compared to $15.5 million for the same period in 2017; general and administrative expenses were $5.9 million, compared to $4.4 million for the second quarter of 2017.

Liquidity: Cash, cash equivalents, and marketable securities were $63.5 million as of June 30, 2018.  The Company expects this amount, together with interest thereon and proceeds from oliceridine ex-U.S. licensing activities, to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from today’s date.


Key risk factors and potential stock drivers:

  • Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Successful completion of the upcoming milestones would lead future direction for the company. Any adversities might adversely impact the overall investor sentiments.
  • The FDA decision for oliceridine is crucial for TRVN, as the company needs to establish a steady stream of revenue to maintain its financial flexibility and fund its ongoing studies.
  • TRVN has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
  • Notwithstanding the expected improvement in the business and financial risk profile of the company, TRVN is still a loss-making entity. Therefore, the company’s ability to achieve successful commercialization will continue to remain a long-term stock sensitivity factor.


Stock Performance:


  • On Wednesday, Oct 17th, 2018, TRVN was at $.91, with a volume of 3.9 million shares exchanging hands. Market capitalization is $81.408 million. The current RSI is 35.95
  • In the past 52 weeks, shares of TRVN have traded as low as $0.76 and as high as $3.58
  • At $1.07, shares of TRVN are trading below its 50-day moving average (MA) at $1.74 and below its 200-day moving average (MA) at $1.72
  • The present support and resistance levels for the stock are at $0.74 & $1.26 respectively.


Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.