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Achillion's Renal Disease Candidate Gets Orphan Drug Status
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Achillion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation to its lead factor D inhibitor candidate, ACH-4471, for the treatment of C3 Glomerulopathy (C3G), a serious renal disorder.
We note that the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. The status makes ACH-4471 eligible for seven years of marketing exclusivity in the United States, following an approval for C3G. The designation also makes the company eligible for certain other benefits, including tax credits related to clinical trial expenses, exemption from the FDA user fee and assistance from the FDA in clinical trial design.
Shares of Achillion have underperformed the industry so far this year. The stock has lost 31.7% in contrast to the industry’s gain of 3%.
Preliminary data announced last month from a phase II study evaluating ACH-4471 demonstrated potential in treating C3G by reducing proteinuria, excess proteins in urine, by 50% over the treatment duration of 14 days
Achillion also announced the initiation of a phase I bioavailability study that will evaluate extended release oral tablet formulationsof ACH-4471. The endpoint of the study is to achieve once or twice daily dosing regimens of ACH-4471 with interim results expected by mid-2018.
Apart from C3G, the company is also developing ACH-4471 in a phase II study in patients with paroxysmal nocturnal hemoglobinuria (“PNH”).The candidate also enjoys orphan drug status for this indication.
Achillion has plans to initiate a phase II study in the first half of 2018 to evaluate the long-term potential of ACH-4471 in combination with Alexion Pharmaceuticals, Inc.’s Soliris for treating PNH.
We remind investors that Achillion faced a major setback when Johnson & Johnson (JNJ - Free Report) sold its stake in Achillion last month, following the termination of the global license and collaboration agreement for developing hepatitis C treatments in September. With no approved products in its portfolio, Achillion has lost out on future revenues in the form of milestone payments.
Corcept’s earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The company’s stock is up 128% so far this year.
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.
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Achillion's Renal Disease Candidate Gets Orphan Drug Status
Achillion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation to its lead factor D inhibitor candidate, ACH-4471, for the treatment of C3 Glomerulopathy (C3G), a serious renal disorder.
We note that the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. The status makes ACH-4471 eligible for seven years of marketing exclusivity in the United States, following an approval for C3G. The designation also makes the company eligible for certain other benefits, including tax credits related to clinical trial expenses, exemption from the FDA user fee and assistance from the FDA in clinical trial design.
Shares of Achillion have underperformed the industry so far this year. The stock has lost 31.7% in contrast to the industry’s gain of 3%.
Preliminary data announced last month from a phase II study evaluating ACH-4471 demonstrated potential in treating C3G by reducing proteinuria, excess proteins in urine, by 50% over the treatment duration of 14 days
Achillion also announced the initiation of a phase I bioavailability study that will evaluate extended release oral tablet formulationsof ACH-4471. The endpoint of the study is to achieve once or twice daily dosing regimens of ACH-4471 with interim results expected by mid-2018.
Apart from C3G, the company is also developing ACH-4471 in a phase II study in patients with paroxysmal nocturnal hemoglobinuria (“PNH”).The candidate also enjoys orphan drug status for this indication.
Achillion has plans to initiate a phase II study in the first half of 2018 to evaluate the long-term potential of ACH-4471 in combination with Alexion Pharmaceuticals, Inc.’s Soliris for treating PNH.
We remind investors that Achillion faced a major setback when Johnson & Johnson (JNJ - Free Report) sold its stake in Achillion last month, following the termination of the global license and collaboration agreement for developing hepatitis C treatments in September. With no approved products in its portfolio, Achillion has lost out on future revenues in the form of milestone payments.
Achillion Pharmaceuticals, Inc. Price
Achillion Pharmaceuticals, Inc. Price | Achillion Pharmaceuticals, Inc. Quote
Zacks Rank & Another Stock to Consider
Achillion carries a Zacks Rank #2 (Buy).
Another stock that investors may consider is Corcept Therapeutics Incorporated (CORT - Free Report) . The stock carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Corcept’s earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The company’s stock is up 128% so far this year.
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 >>