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3 Biotech and Pharma Stocks with FDA Catalysts this January
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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 (NVS - Free Report) Kymriah and Gilead Sciences’s (GILD - Free Report) 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 (RHHBY - Free Report) multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s (SNY - Free Report) 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.
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.
Image: Bigstock
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 (NVS - Free Report) Kymriah and Gilead Sciences’s (GILD - Free Report) 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 (RHHBY - Free Report) multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s (SNY - Free Report) 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 >>