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Last year, there was a notable dip in FDA novel drug approvals with the agency giving its nod to 22 treatments, well below the 45 approvals in 2015 and 41 in 2014. So far in 2017, only one drug has gained approval -- Synergy Pharmaceuticals Inc.’s Trulance for the treatment of chronic idiopathic constipation (CIC) in adults (Read more: Synergy Trulance Wins FDA Approval for Constipation).
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 -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Here is a look at important regulatory events scheduled for the month of February.
First up is biotech major, Amgen Inc.’s (AMGN - Free Report) Parsabiv. Parsabiv, which gained EU approval in Nov 2016, got a complete response letter from the FDA in Aug 2016 for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis. Amgen’s resubmitted regulatory application is under review with a decision from the FDA expected on Feb 9. According to information provided by Amgen, sHPT, a chronic and serious condition, affects many of the approximately 2 million people across the world who are receiving dialysis, including 468,000 people in the U.S. Amgen, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company’s shares gaining 1.1% compared to the industry decline of 7.8%.
On Feb 16, 2017, the FDA is expected to issue a response regarding the approval status of Valeant Pharmaceuticals International, Inc.’s investigational psoriasis treatment, brodalumab. Approval would allow the company to schedule a launch in the second quarter in the psoriasis market which is estimated to be worth about $10 billion. Valeant has had a rough time finding itself in the midst of the drug pricing controversy -- over the last one year, the Zacks Rank #5 (Strong Sell) stock has underperformed the Zacks categorized Medical-Drugs industry with shares declining 86.1% during this period compared to the industry decline of 10.1%. Brodalumab’s approval would boost investor confidence in the company which is currently divesting non-core assets.
Celgene Corporation is looking to expand the label of its key revenue generator, blood cancer drug Revlimid, which is currently under review for use as maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM) after receiving an autologous stem-cell transplant (ASCT). A decision from the FDA is expected on Feb 24. Label expansion into this indication will be a significant driver of Revlimid sales. Revlimid brought in sales of $6.9 billion in 2016 and Celgene is guiding towards 2017 sales in the range of $8 - $8.3 billion. Celgene, a Zacks Rank #3 stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company’s shares gaining 12.3%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) also has a big day coming up with the FDA expected to decide on the approval status of telotristat ethyl for the treatment of carcinoid syndrome on Feb 28.
The FDA was earlier expected to respond on Nov 30, 2016 but the PDUFA date was extended by three months as the agency needed more time to review additional clinical data analyses that had been submitted at the agency’s request. With telotristat ethyl being its most advanced pipeline candidate, approval would be a major boost for Lexicon. We note that over the last one year, Lexicon has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company’s shares rising 33.2% during this period.
Zacks' Top 10 Stocks for 2017
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4 FDA Decisions to Watch Out for in Feb 2017
Last year, there was a notable dip in FDA novel drug approvals with the agency giving its nod to 22 treatments, well below the 45 approvals in 2015 and 41 in 2014. So far in 2017, only one drug has gained approval -- Synergy Pharmaceuticals Inc.’s Trulance for the treatment of chronic idiopathic constipation (CIC) in adults (Read more: Synergy Trulance Wins FDA Approval for Constipation).
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 -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Here is a look at important regulatory events scheduled for the month of February.
First up is biotech major, Amgen Inc.’s (AMGN - Free Report) Parsabiv. Parsabiv, which gained EU approval in Nov 2016, got a complete response letter from the FDA in Aug 2016 for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis. Amgen’s resubmitted regulatory application is under review with a decision from the FDA expected on Feb 9. According to information provided by Amgen, sHPT, a chronic and serious condition, affects many of the approximately 2 million people across the world who are receiving dialysis, including 468,000 people in the U.S. Amgen, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company’s shares gaining 1.1% compared to the industry decline of 7.8%.
On Feb 16, 2017, the FDA is expected to issue a response regarding the approval status of Valeant Pharmaceuticals International, Inc.’s investigational psoriasis treatment, brodalumab. Approval would allow the company to schedule a launch in the second quarter in the psoriasis market which is estimated to be worth about $10 billion. Valeant has had a rough time finding itself in the midst of the drug pricing controversy -- over the last one year, the Zacks Rank #5 (Strong Sell) stock has underperformed the Zacks categorized Medical-Drugs industry with shares declining 86.1% during this period compared to the industry decline of 10.1%. Brodalumab’s approval would boost investor confidence in the company which is currently divesting non-core assets.
Celgene Corporation is looking to expand the label of its key revenue generator, blood cancer drug Revlimid, which is currently under review for use as maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM) after receiving an autologous stem-cell transplant (ASCT). A decision from the FDA is expected on Feb 24. Label expansion into this indication will be a significant driver of Revlimid sales. Revlimid brought in sales of $6.9 billion in 2016 and Celgene is guiding towards 2017 sales in the range of $8 - $8.3 billion. Celgene, a Zacks Rank #3 stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company’s shares gaining 12.3%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) also has a big day coming up with the FDA expected to decide on the approval status of telotristat ethyl for the treatment of carcinoid syndrome on Feb 28.
The FDA was earlier expected to respond on Nov 30, 2016 but the PDUFA date was extended by three months as the agency needed more time to review additional clinical data analyses that had been submitted at the agency’s request. With telotristat ethyl being its most advanced pipeline candidate, approval would be a major boost for Lexicon. We note that over the last one year, Lexicon has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company’s shares rising 33.2% during this period.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>