2019 Should Be A Good Year For Trevena, But What’s Next?

Introduction

Trevena Inc. (Nasdaq:TRVN) spiked 119% from the $.5 range to $1.19 on January 28th. The catalyst being positive regulatory updates from the FDA Type A meeting minutes.

In a nut-shell the FDA deemed that TRVN’s safety database sufficiently supported a maximum labeling dose of 27 mg. Additionally, no more efficacy studies are required. TRVN can resubmit their New Drug Application (NDA) after completing a study to collect QT-interval data (i.e. how the drugs affect on cardiac rhythm) planned for the first half of 2019.

Two points of significance are: 1) That the QT-interval study will only be 24 hours in duration and 2) It can be conducted on healthy volunteers. The implication is that TRVN could potentially re-submit their NDA this year and get another PDUFA as early as late 2019 or early 2020. The FDA also requested nonclinical data regarding Oliceridine’s 9662 metabolite and product validation reports be submitted with the NDA. The 9662 metabolite data can be generated in a single nonclinical species expediting the process. Pharmacokinetic work is already underway.

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Source: StockTwits

The Type A meeting followed a complete response letter (CRL) issued by the FDA in response to a NDA filed for Oliceridine in 2018. Investors were elated by the recent news as it means TRVN can resubmit their NDA much sooner than anticipated. Additionally, investors can find some peace in knowing TRVN forecasts sufficient funding through the second quarter of 2020.

The 52-week price action for TRVN reveals a high of $3.58 and a low of $.38. It appears that many bulls are trapped near the higher end prior to the November 2018 CRL. This was undoubtedly a factor in the stock not retracing as one would expected after a 119% run. On 1/30/19 the company announced a direct offering of 10 million shares in common stock, reducing the risk of such action again this year.

About TRVN

TRVN Revised Investor Presentation

TRVN is a clinical stage biotech company headquartered in Chesterbrook, Pennsylvania. They focus primarily on the discovery and development of G-Protein coupled inhibitors. The companies lead molecule Oliceridine injection is a G-Protein biased mu-opioid receptor being developed for management of moderate to severe pain in controlled settings such as hospitals. If approved, the company has stated they wish for Oliceridine to be a schedule 2 drug. Drugs in this class have a high potential for abuse and potentially lead to severe psychological damage or physical dependence. A regulatory advantage though was achieved in February of 2016 when TRVN received breakthrough designation status (BTD). And the commercial emphasis on its intended use in an in-patient setting mitigates the risk for abuse.

You may recall our previous article on TRVN. In this we argued the company would trend upwards in anticipation of their PDUFA date. Our move was to swing the stock and get out before the decision. Unfortunately, some investors did not take the same approach. In this article we’ll discuss the implications of the Type A meeting for TRVN in 2019, long-term outlook scenarios, and TRVN’s fitness in a competitive landscape.

Near-Term Analysis of TRVN

Subsequent to the Type A FDA meeting insider buying accelerated the share price even further reaching a high of $1.40 on February 5th. The most recent insider purchase was by the president & CEO on 02/01/2019 scooping up 50,000 shares at $1.02. Fellow director Maxine Gowen also bought 50,000 shares at 1.02 while TRVN board chairman Leon Moulder bought 100,000 shares at the same price.

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