For Immediate Release
Chicago, IL – Jan 03, 2018 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Synergy Pharmaceuticals Inc. , Aradigm Corporation and Sucampo Pharmaceuticals, Inc. .
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Tuesday’s Analyst Blog:
3 Biotech and Pharma Stocks with FDA Catalysts this January
2017 turned out to be a pretty good year for pharma and biotech stocks where FDA decisions are concerned. The regulatory body approved 46 novel drugs last year, easily surpassing 2016’s total tally of 22.
Landmark decisions last year include the approval of a couple of gene-based therapies for cancer – Novartis’s Kymriah and Gilead Sciences’s Yescarta. These therapies have the potential to change the way we look at cancer treatments.
Other key approvals included Lilly’s Verzenio (advanced or metastatic breast cancer), Gilead’s Vosevi (hepatitis C virus), Puma’s Nerlynx (to reduce the risk of breast cancer returning), J&J’s Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Many of these drugs have blockbuster potential.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of January.
Label Expansion for Synergy’s Trulance? Biopharma company, Synergy Pharmaceuticals Inc., will get to know about the approval status of Trulance for use in adult patients with irritable bowel syndrome with constipation (IBS-C) this month. The regulatory body is expected to deliver a decision regarding Trulance’s label expansion into this indication on Jan 24, 2018. Trulance, the company’s first and only commercial product, was approved last year in January for the treatment of adults with chronic idiopathic constipation (“CIC”). According to information provided by the company, about 33 million adults suffer from CIC while 12 million adults suffer from IBS-C in the United States alone. Synergy’s shares have declined 63.4% over the last one year.
Advisory Panel & January PDUFA Date for Aradigm’s Linhaliq: Emerging specialty pharmaceutical company, Aradigm Corporation’s regulatory application for Linhaliq will be reviewed by an FDA advisory panel (the Antimicrobial Drugs Advisory Committee) on Jan 11, 2018, a few days ahead of the PDUFA (Prescription Drug User Fee Act) goal date of Jan 26, 2018. Aradigm is looking to get Linhaliq approved for the treatment of non-cystic fibrosis bronchiectasis (“NCFBE”) patients with chronic lung infections with Pseudomonas aeruginosa. According to information provided by Aradigm, there is unmet medical need for NCFBE with more than 150,000 people in the United States and over 200,000 people in Europe being affected by the severe, chronic and rare disease. The company expects that sales for the NCFBE indication could cross $500 million by 2021. Aradigm’s shares are up 318.7% over the last one year.
FDA to Decide on Pediatric Label Expansion for Sucampo’s Amitiza: Biopharma company, Sucampo Pharmaceuticals, Inc., is awaiting a decision from the FDA for the label expansion of its key marketed drug, Amitiza. The company is looking to get Amitiza approved for use in children aged 6 to 17 years with pediatric functional constipation. With the FDA granting Priority Review designation, a response is expected on Jan 28, 2018. Timely approval would make Amitiza the first branded product available for certain pediatric patients that suffer from pediatric functional constipation. We remind investors that Sucampo recently agreed to be acquired by Mallinckrodt in a deal valued at approximately $1.2 billion. The acquisition is expected to close in the first quarter of 2018 (Read more: Mallinckrodt to Buy Sucampo for $1.2B to Diversify Portfolio). Sucampo’s shares are up 32.5% over the last one year.
Sucampo is a Zacks Rank #2 (Buy) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Download it free >>
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1 Stock of the Day pick for free.
About Zacks Equity Research
Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.
Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.
Strong Stocks that Should Be in the News
Many are little publicized and fly under the Wall Street radar. They're virtually unknown to the general public. Yet today's 220 Zacks Rank #1 "Strong Buys" were generated by the stock-picking system that has nearly tripled the market from 1988 through 2015. Its average gain has been a stellar +26% per year.See these high-potential stocks free >>.
Follow us on Twitter: https://twitter.com/zacksresearch
Join us on Facebook: https://www.facebook.com/home.php#/pages/Zacks-Investment-Research/57553657748?ref=ts
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
Zacks Investment Research
800-767-3771 ext. 9339
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.