Pharma Stock Roundup: J&J Drug Gets CRL, Label Expansion For Merck And BMY Drugs
Zacks Investment Research | Sep 26, 2017 06:52AM ET
Key highlights in the pharma sector include a complete response letter (“CRL”) from the FDA for Johnson & Johnson’s (NYSE:JNJ) investigational rheumatoid arthritis (“RA”) treatment and FDA approval for Merck’s (NYSE:MRK) and Bristol-Myers Squibb’s (NYSE:BMY) cancer drugs.
Recap of the Week’s Most Important Stories
CRL for J&J RA Drug: J&J’s Janssen Biotech got a CRL from the FDA for sirukumab for the treatment of moderately to severely active RA. The agency has asked for additional data on the safety of sirukumab. This does not come as a surprise considering the investigational treatment failed to get the support of an FDA advisory panel last month. Given the safety concerns raised by the panel, the request for additional data was more or less expected. J&J intends to meet with the agency to determine the requirements for gaining approval for the IL-6 inhibitor.
Meanwhile, the company has submitted a new drug application (“NDA”) for the first darunavir-based single tablet regimen for the treatment of HIV. Approval would make this combination the only complete regimen with the potential to deliver the advantages of a single table regimen with the high genetic barrier to resistance of darunavir and the demonstrated safety profile of TAF.
Another FDA Nod for Merck’s Keytruda: Merck’s anti-PD-1 therapy, Keytruda, has gained FDA approval for yet another indication. The cancer therapy, which is already available for a wide range of indications, can now be used in previously-treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1. This marks the tenth new indication for Keytruda over a three-year period.
Keytruda is a key product in Merck’s portfolio with the drug bringing in sales of $1.5 billion in the first half of 2017. The company is working on expanding the label of the drug which is currently in more than 550 studies covering a wide range of cancers and treatment settings (Read more: industry it belongs to.
Priority Review for Aradigm Drug: Aradigm got priority review for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with pseudomonas aeruginosa (P. aeruginosa). A response from the agency regarding the approval status of the drug should be out by Jan 26, 2018. NCFBE, a severe, chronic and rare disease, affects more than 150,000 people in the United States and over 200,000 people in Europe. With no drug currently approved for the treatment of this condition, there is significant unmet need. Aradigm’s shares were up 32.8% on the news.
Get The News You Want
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Pfizer Files Suit against J&J, Supernus Hit by Study Update ).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
Can Hackers Put Money INTO Your Portfolio?
Earlier this month, credit bureau Equifax (NYSE:EFX) announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Zacks Investment Research
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.