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 ground-breaking medicines. Its novel approach to drug discovery has established it as pioneers in acute care medicine.

Recent developments/milestone: Company announced initial path forward /clarity on oliceridine NDA.

On 19th Jan, the company announced the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the oliceridine New Drug Application (NDA).

FDA also has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms.  The Company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year.  The Company is not required to provide any additional efficacy data to resubmit the oliceridine NDA.  

To address other items in the CRL, FDA has indicated that the Company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted.

Management commentary:

“We are encouraged by the productive discussion with FDA, which we believe has provided a path to resubmit the oliceridine NDA,” said Carrie L. Bourdow, President and Chief Executive Officer.  “We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain.”

Near term Catalysts: The company discussed the minutes of Type A meetings and its plan in its conference call and webcast on January 28, 2019.

• The company is now aiming to finalise a study protocol and analysis plan and submit it to FDA for feedback.
• The company plans to commence study in the first half of 2019
• After the company receives FDA feedback, it will begin enrolment and will update the investors about the projected study timelines and cost. It said the company expects a relatively short and cost-effective study

The management strongly believes in 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 and has laid out a detailed plan to capitalize this opportunity and gain approval for Oliceridine:

• The company continues to prioritize and reduce expenses, including, reduction in workforce by about one-third.
• In addition, the company is actively working with external clinical experts in the area of cardiac electrophysiology and with seasoned regulator consultant who has experience working on NDAs and complete response letters, with companies as well as with the agency.
• Third, Trevena will pause spending on its early pipeline until it finalizes the path forward and has a better understanding of the investment needed for oliceridine. 
• The Company also announced that it expects cash, cash equivalents, and marketable securities as of December 31, 2018, to be approximately $61.5 million, which the Company anticipates will be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020. In March 2019, the Company expects to announce full financial results for the fourth quarter and full year ended December 31, 2018.
•  

As a result of this most recent announcement, TRVN stock has started showing enormous strength and strong momentum. 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 $6.35, suggesting that the stock has a possible upside of 433.61%. The high price target for TRVN is $15.00, and the low-price target for TRVN is $0.75. There are currently three hold ratings, and 3 buy ratings for the stock, resulting in a consensus rating of “Buy.”

Per Yahoo, 7 out of 8 ratings, recommends buying including two strong buy ratings.

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 three novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for pain and/or management of opioid dependence.  In its preclinical programs, Trevena is evaluating a set of novel S1P receptor modulators that may offer a new, non-opioid 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 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:

Industry Potential: Significant unmet need in a large addressable market

Quarterly Financial Results (in, thousands):

• Net Loss: For the third quarter of 2018, Trevena reported a net loss attributable to common stockholders of $4.5 million, or $0.06 per share, compared with a net loss attributable to common stockholders for the third quarter of 2017 of $16.0 million, or $0.27 per share. Research and development expenses were $3.4 million in the third quarter of 2018 compared to $10.2 million for the same period in 2017; general and administrative expenses were $3.9 million, compared to $5.2 million for the third quarter of 2017.
• Liquidity and Financial Flexibility: Cash, cash equivalents, and marketable securities were $70.0 million as of September 30, 2018.  The Company expects this amount, together with interest thereon, to be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020.

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/approval 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:

Comments:

• On Tuesday, Jan 29th, 2019, TRVN was at $1.25, with a robust volume of 19.9 million shares exchanging hands. Market capitalization is $96.57 million. The current RSI is 84.60
• In the past 52 weeks, shares of TRVN have traded as low as $0.38 and as high as $3.58
• At $1.25, shares of TRVN are trading above its 50-day moving average (MA) at $0.59 and below its 200-day moving average (MA) at $1.34
• The present support and resistance levels for the stock are at $0.48 & $1.56 respectively. 

_______________________________________________________________

About Traders News Source

Over 75% in realistic bookable gains so far in 2019

Any trader in any market would fall all over themselves to book gains like this. So, if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in class. We know with a large following comes a large responsibility as we have everyone from the institutional investor to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

View our track record, currently featured reports and updates here- https://tradersnewssource.com/traders-news-source-new-members/

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Traders” to the phone number 25827 from your cell phone.

Pay attention, if you’re just joining us you are about to see why everyone wants to be like us. There are a lot of imitators but only one Traders News Group.

The Traders News Team

______________________________________________________________________________

Disclaimer

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.