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Acorda Down More Than 30% in the Past 3 Months: Here's Why
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Shares of Acorda Therapeutics, Inc. have witnessed a decline by a huge margin in the past three months. In fact, the biotech company’s stock has plunged 33.2%, wider than the industry’s decline of 13.6%.
The company’s lead multiple sclerosis (MS) drug Ampyra is facing generic competition in the United States while the FDA extended its lead Parkinson disease candidate Inbrija’s review timeline by three months. The above-mentioned reasons induced a sharp decline in the stock over the past three months.
Ampyra Facing Generic Competition
The drug generated sales of $137.8 million in the third quarter of 2018.Sales of Ampyra rose 4% year over year but decreased 8.3% sequentially due to severe competition from Mylan's authorized generic version. The latter launched its authorized generic product in September 2018.
In March 2017, the U.S. District Court for the District of Delaware invalidated four patents pertaining to Ampyra on the basis of obviousness. Originally, these patents were set to expire between 2025 and 2027. In July 2018, the Federal Circuit denied Acorda’s plea for a preliminary injunction to avoid at-risk launches prior to the Appeals Court decision.
In September 2018, the U.S. Court of Appeals for the Federal Circuit upheld the District Court's previous ruling by a 2-to-1 vote to invalidate four patents of Ampyra. This paved the way for the entry of a generic product.
Though Ampyra’s sales were better-than-expected in the third quarter due to additional six weeks of exclusivity, which led to an increase in full year guidance, sales are expected to decline in the future quarters.
The company remains heavily dependent on Ampyra to draw major part of its revenues and losing out on the same in the upcoming quarters will be a major blow to the company’s sales and cash flow.
Inbrija Approval Delayed
Acorda is focused on its late-stage Parkinson disease candidate, Inbrija. A regulatory application for Inbrija is under review in the United States as well as in the EU. A response from the regulatory body was expected on Oct 5, 2018. However, in September 2018, the FDA extended the review timeline by three months and has now set an action date of Jan 5, 2019.The verdict in the EU is awaited before the end of this year.
The FDA postponed the timeline after Acorda submitted additional information regarding chemistry, manufacturing and controls on the regulatory agency’s request. The FDA stated that these submissions deemed a major amendment to the NDA and will require more time to reassess.
Meanwhile, Inbrija will face competition from a similar product of small pharma company Sunovion, which also has a Prescription Drug User Fee Act (PDUFA) in January 2019. However, Acorda believes that Inbrija will hold the majority market share.
Acorda currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are Gilead Sciences, Inc. (GILD - Free Report) and Alexion Pharmaceuticals, Inc. , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead Sciences’ earnings estimates have been revised 4.4% upward for 2018 and 4.2% for 2019 over the past 60 days.
Alexion’s earnings estimates have moved 4.8% north for 2018 and 1.8% for 2019 over the past 60 days.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Acorda Down More Than 30% in the Past 3 Months: Here's Why
Shares of Acorda Therapeutics, Inc. have witnessed a decline by a huge margin in the past three months. In fact, the biotech company’s stock has plunged 33.2%, wider than the industry’s decline of 13.6%.
The company’s lead multiple sclerosis (MS) drug Ampyra is facing generic competition in the United States while the FDA extended its lead Parkinson disease candidate Inbrija’s review timeline by three months. The above-mentioned reasons induced a sharp decline in the stock over the past three months.
Ampyra Facing Generic Competition
The drug generated sales of $137.8 million in the third quarter of 2018.Sales of Ampyra rose 4% year over year but decreased 8.3% sequentially due to severe competition from Mylan's authorized generic version. The latter launched its authorized generic product in September 2018.
In March 2017, the U.S. District Court for the District of Delaware invalidated four patents pertaining to Ampyra on the basis of obviousness. Originally, these patents were set to expire between 2025 and 2027. In July 2018, the Federal Circuit denied Acorda’s plea for a preliminary injunction to avoid at-risk launches prior to the Appeals Court decision.
In September 2018, the U.S. Court of Appeals for the Federal Circuit upheld the District Court's previous ruling by a 2-to-1 vote to invalidate four patents of Ampyra. This paved the way for the entry of a generic product.
Though Ampyra’s sales were better-than-expected in the third quarter due to additional six weeks of exclusivity, which led to an increase in full year guidance, sales are expected to decline in the future quarters.
The company remains heavily dependent on Ampyra to draw major part of its revenues and losing out on the same in the upcoming quarters will be a major blow to the company’s sales and cash flow.
Inbrija Approval Delayed
Acorda is focused on its late-stage Parkinson disease candidate, Inbrija. A regulatory application for Inbrija is under review in the United States as well as in the EU. A response from the regulatory body was expected on Oct 5, 2018. However, in September 2018, the FDA extended the review timeline by three months and has now set an action date of Jan 5, 2019.The verdict in the EU is awaited before the end of this year.
The FDA postponed the timeline after Acorda submitted additional information regarding chemistry, manufacturing and controls on the regulatory agency’s request. The FDA stated that these submissions deemed a major amendment to the NDA and will require more time to reassess.
Meanwhile, Inbrija will face competition from a similar product of small pharma company Sunovion, which also has a Prescription Drug User Fee Act (PDUFA) in January 2019. However, Acorda believes that Inbrija will hold the majority market share.
Acorda Therapeutics, Inc. Price
Acorda Therapeutics, Inc. Price | Acorda Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Acorda currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are Gilead Sciences, Inc. (GILD - Free Report) and Alexion Pharmaceuticals, Inc. , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead Sciences’ earnings estimates have been revised 4.4% upward for 2018 and 4.2% for 2019 over the past 60 days.
Alexion’s earnings estimates have moved 4.8% north for 2018 and 1.8% for 2019 over the past 60 days.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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