Neos Therapeutics Inc. (NASDAQ:NEOS) Trades Lower after FDA Approval

Neos Therapeutics Inc. (NASDAQ:NEOS)

Neos Therapeutics Inc. (NASDAQ:NEOS) shares fell 3.45% a day after the U.S. Food and Drug Administration (FDA) approved its treatment for Attention Deficit Hyperactivity Disorder, Adzenys. The approval brings the number of the company’s ADHD products approved in the past three years to three.

NEOS Stock Performance

Tuesday’s sell-off threatened to bring to an end a bullish that began last month. The stock has struggled to close above the $9 a share mark on two attempts. However, it is still up by more than 20% for the year, compared to the industry average of 2.9%.

Neos Therapeutics Inc. (NASDAQ:NEOS)
One month NEOS stock price chart

It awaits to be seen if investors will continue to push the stock higher in the wake of the FDA milestone. The FDA approval unlocks yet another treatment option for people struggling with Attention Deficit Disorder in addition to strengthening the company’s ADHD portfolio.

“Neos Therapeutics Inc. (NASDAQ:NEOS) has now successfully gained FDA approval of three ADHD products in just two years. We are very proud of this accomplishment and believe it speaks to the strength of our technology platform. Our commitment to ADHD and addressing the individual needs of patients is clear, and we look forward to the commercial launch of this product in early 2018,” said Vipin K. Garg, Ph.D.

ADHD Treatment Push

Adzenys is a once-daily extended release liquid medication that does not require refrigeration to reconstitute at the pharmacy level. It utilizes the same principle as Adzenys XR-ODT that allows healthcare providers to transition patients from liquid to ODT formulations.

Just like Adzenys XR-ODT, the newly approved drug is designed to stimulate the central nervous system of patients six years and older. Neos Therapeutics Inc. (NASDAQ:NEOS) plans to launch the drug in the first half of the year. Adzenys XR-ODT generated sales of $7.3 million in the first half of the year representing a 35.5% year-over-year growth.

While ADHD is one of the largest and fastest growing business segments, it continues to attract a number of companies, gunning for market share with novel treatments. Johnson & Johnson (NYSE:JNJ) is pushing for market share with its Concerti treatments and so is Pfizer Inc. (NYSE:PFE) with PFE Quilivant.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Alcobra Ltd. (Nasdaq: ADHD) Rebounds from Poor Clinical Trial Results and Accusations

Alcobra Ltd. – Nasdaq: ADHD

Shares of Israeli-based Alcobra Ltd. are up over 20% on heavy volume. ADHD, traded on the Nasdaq, ended Tuesday trading at $1.05 and has risen to $1.33 in today’s trading. Normal average daily trading volumeis less than 600k shares but today shares have traded over four million.

Alcobra is a pharmaceutical company focused on the development and commercialization of their proprietary drug, Metadoxine Extended Release (MDX), to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome (FXS).

On January 17, 2017 Alcobra released disappointing results from their Phase 3 clinical study. From Alcobra’s press release “In this trial, MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners’ Adult ADHD Rating Scales (CAARS).” Also on Janbuary 17, 2017 it was also announced by several law firms that they were initiating an investigation of the company relating to possible violations of federal securities laws. Shares ended down more than 50% for the day.

Alcobra has never achieved any sales. EPS for ADHD shares has been negative for the past five years and in 2015 ADHD shareholders experienced an EPS loss of $0.90.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol ADHD
Last Price a/o 3:51 PM EST  $                      1.28
Average Volume                    565,840
Market Cap (mlns)  $                    28.93
Sales (mlns)
Shares Outstanding (mlns) 27.55
Share Float (mlns) 23.56
Shortable Yes
Optionable Yes
Inside Ownership 30.00%
Short Float 5.96%
Short Interest Ratio 2.48
Quarterly Return -45.31%
YTD Return -50.00%
Year Return -79.92%