Biotech Stock Roundup: Amgen Gets FDA Nod For Kanjinti, Regeneron Presents Data
Zacks Investment Research | Jun 18, 2019 10:29PM ET
It was a busy week for the biotech sector. The FDA approved Amgen’s (NASDAQ:AMGN) biosimilar for a leading breast cancer drug, Herceptin. Meanwhile, Alexion’s (NASDAQ:ALXN) Ultomiris was approved in Japan. Regeneron(REGN) presented positive data on an investigational bispecific monoclonal antibody for lymphoma.
Recap of the Week’s Top Stories:
Amgen Gets Approval for Biosimilar Kanjinti: Amgen and its biosimilar collaboration partner, Allergan (NYSE:AGN) announced that the FDA has approved Kanjinti (trastuzumab-anns), their biosimilar of Roche’s blockbuster breast cancer drug, Herceptin. The biosimilar was approved for all approved indications of the reference drug, Herceptin — HER2 overexpressing adjuvant and metastatic breast cancer, and HER2 overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Kanjinti is the second drug to receive FDA approval under this agreement.
In addition, Amgen announced five-year overall survival (OS) analysis from the single-arm, phase II BLAST study on leukemia drug, BLINCYTO. The study evaluated Blincyto in patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). Results from the study showed a median OS of 36.5 months for Blincyto-treated patients with a median follow-up of 59.8 months. More than half of the patients who achieved a complete MRD response following the first cycle of Blincyto treatment were alive at five years.
Amgen currently carries a Zacks Rank #3 (Hold). You can see )
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
This Could Be the Fastest Way to Grow Wealth in 2019
Research indicates one sector is poised to deliver a crop of the best-performing stocks you'll find anywhere in the market. Breaking news in this space frequently creates quick double- and triple-digit profit opportunities.
These companies are changing the world – and owning their stocks could transform your portfolio in 2019 and beyond. Recent trades from this sector have generated +98%, +119% and +164% gains in as little as 1 month.
Original post
Get The News You Want
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.