Get 40% Off
🤯 This Tech Portfolio is up 29% YTD! Join Now to Get April’s Top PicksGet The Picks – Just 99 USD

Teva's Leukemia Drug SNDA Granted Priority Review By The FDA

Published 09/12/2017, 10:51 PM
Updated 07/09/2023, 06:31 AM

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that the FDA has accepted the supplemental New Drug Application (sNDA) for Trisenox on a priority review basis.

The company is looking to expand the label of Trisenox to include its use in combination with all-trans retinoic acid for the treatment of newly diagnosed patients with low-to-intermediate risk of acute promyelocytic leukemia (APL)

The eligible APL patients should have t(15;17) translocation or PML/RAR-alpha gene expression.

With the FDA granting priority review, a decision is expected in the first quarter of 2018.

We remind investors that Trisenox is currently approved for induction of remission and consolidation in refractory/relapsed APL patients with t(15;17) translocation or PML/RAR-alpha gene expression. The patients should have received prior treatment with retinoid and anthracycline chemotherapy.

The drug is approved in the EU as both first-line and second-line treatment for this indication.

Shares of the company were up almost 4.5% on Tuesday, riding on the momentum following the appointment of H. Lundbeck’s (OTC:HLUYY) chief Kare Schultz as its new CEO and sale of Paragard devices to Cooper Companies, Inc. (NYSE:COO) for $1.1 billion. However, shares of Teva have underperformed the industry so far this year due to challenges in the U.S. generic industry. The company’s shares have plunged 46.7% while the industry has lost 14.5% in that period.

According to the company, Trisenox, in combination with retinoic acid, can increase survival rates, dramatically reduce the risk of relapse, and help avoid chemotherapy-related side effects in low-to-intermediate risk APL patients. It has been seen in clinical studies that Trisenox, in combination with retinoic acid, can lead to a 99% overall survival rate with almost no relapse after more than four years (50 months) of median follow-up.

Zacks Rank & Stocks to Consider

Teva currently has a Zacks Rank #5 (Strong Sell). Aduro Biotech, Inc. (NASDAQ:ADRO) is a better-ranked stock in the healthcare sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro’s loss estimates have narrowed 9.6% to $1.32 for 2017 and 20% to $1.24 for 2018 over the last 60 days. The company delivered an average earnings beat of 2.53% for the four trailing quarters.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple (NASDAQ:AAPL) sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>



H Lundbeck A/S (HLUYY): Free Stock Analysis Report

Aduro Biotech, Inc. (ADRO): Free Stock Analysis Report

Teva Pharmaceutical Industries Limited (TEVA): Free Stock Analysis Report

Cooper Companies, Inc. (The) (COO): Free Stock Analysis Report

Original post

Zacks Investment Research

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.