Advertisement
U.S. markets open in 1 minute
  • S&P Futures

    5,309.50
    +1.25 (+0.02%)
     
  • Dow Futures

    40,185.00
    +41.00 (+0.10%)
     
  • Nasdaq Futures

    18,502.50
    -1.25 (-0.01%)
     
  • Russell 2000 Futures

    2,140.20
    +1.80 (+0.08%)
     
  • Crude Oil

    82.47
    +1.12 (+1.38%)
     
  • Gold

    2,232.80
    +20.10 (+0.91%)
     
  • Silver

    24.77
    +0.02 (+0.09%)
     
  • EUR/USD

    1.0810
    -0.0020 (-0.18%)
     
  • 10-Yr Bond

    4.2140
    +0.0180 (+0.43%)
     
  • Vix

    12.96
    +0.18 (+1.41%)
     
  • dólar/libra

    1.2633
    -0.0005 (-0.04%)
     
  • USD/JPY

    151.3200
    +0.0740 (+0.05%)
     
  • Bitcoin USD

    70,938.41
    -418.28 (-0.59%)
     
  • CMC Crypto 200

    885.54
    0.00 (0.00%)
     
  • FTSE 100

    7,953.19
    +21.21 (+0.27%)
     
  • Nikkei 225

    40,168.07
    -594.66 (-1.46%)
     

KemPharm (KMPH) Soars on FDA Nod for ADHD Treatment, Azstarys

KemPharm, Inc. KMPH announced that the FDA has approved its new drug application (“NDA”) for Azstarys a prodrug of methylphenidate for the treatment of attention deficit hyperactivity disorder (“ADHD”) in patients aged six years and above.

Notably, Azstarys [serdexmethylphenidate (“SDX”) and dexmethylphenidate capsules] for oral use was formerly known as KP415. Azstarys consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Methylphenidate is a stimulant medication used to treat ADHD, the most common mental disorder.

Shares of KemPharm were up 70% in pre-market trading on Wednesday following the announcement of the above news. However, the stock has declined 15.8% so far this year against the industry’s increase of 3.3%.

price chart for KMPH
price chart for KMPH


Please note that KemPharm has definitive collaboration and license agreement with Corium, Inc., a portfolio company of Gurnet Point Capital (“GPC”) for the commercialization of Azstarys. Per the deal, Corium will lead the commercialization of Azstarys which is expected to hit the United States market as early as the second half of this year.

Also, per the licensing agreement with GPC, KemPharm has earned a regulatory milestone payment following the FDA’s approval of Azstarys. The company may be eligible to receive up to $468 million in regulatory and sales-based milestone payments, as well as tiered royalties on the product net sales.

Per the press release, the ADHD market accounted for almost $17.9 billion of revenue in 2019 with a year-over-year prescription growth rate of greater than 4%. Also, the methylphenidate segment of the ADHD market accounted for around 20 million prescriptions and $4.9 billion in sales in 2019. The methylphenidate has seen little innovation in recent year. Accordingly, there is significant unmet need in the market which KemPharm can tap into with the launch of Azstarys.

Zacks Rank Stocks to Consider

KemPharm currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Can-Fite BioPharma Ltd. CANF, Ono Pharmaceutical Co., Ltd. OPHLF and Radius Health, Inc. RDUS, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Can-Fite BioPharma’s loss per share estimates have narrowed 60.8% for 2021 over the past 60 days. The stock has rallied 12.9% year to date.

Ono Pharmaceutical’s earnings estimates have been revised 10.4% upward for 2021 over the past 60 days. The stock has risen 2.4% year to date.

Radius Health’s loss per share estimates have narrowed 43% for 2021 over the past 60 days. The stock has increased 4.5% year to date.

Bitcoin, Like the Internet Itself, Could Change Everything

Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.

Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.

See 3 crypto-related stocks now >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

CanFite Biopharma Ltd (CANF) : Free Stock Analysis Report

Radius Health, Inc. (RDUS) : Free Stock Analysis Report

KemPharm, Inc. (KMPH) : Free Stock Analysis Report

Ono Pharmaceutical Co. (OPHLF) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

Advertisement