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News Breaks
March 18, 2014
17:16 EDTHPTX, PRXHyperion says Par filed ANDA with FDA for generic version of RAVICTI
In a filing, the company said, "On March 10, Hyperion Therapeutics (HPTX) disclosed that it had become aware that the FDA on March 6, posted on its website that FDA’s Office of Generic Drugs had received an Abbreviated New Drug Application, ANDA, containing a Paragraph IV patent certification with respect to RAVICTI, glycerol phenylbutyrate, oral liquid on November 19, but that the company had not received notification of the Paragraph IV certification with respect to this filing. On March 17, the company received notification of the Paragraph IV certification from Par Pharmaceutical (PRX) advising the company that it had filed an ANDA with the FDA for a generic version of 1.1 gm/ml RAVICTI oral liquid. The Paragraph IV certification alleges that the company’s U.S. Patent No. 8,404,215, titled “Methods of therapeutic monitoring of nitrogen scavenging drugs,” which expires in March 2032, and U.S. Patent No. 8,642,012, titled “Methods of treatment using ammonia scavenging drugs,” which expires in September 2030, are invalid and/or will not be infringed by Par’s manufacture, use or sale of the product for which the ANDA was submitted. Par did not challenge the validity, enforceablility, or infringement of the company’s U.S. Patent No. 5,968,979, titled “Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders,” which expires in February 2015. The company intends to vigorously enforce its intellectual property rights relating to RAVICTI. As noted in the Initial Form 8-K, the Paragraph IV certification does not challenge or affect RAVICTI’s orphan drug exclusivity, which extends to February 2020."
News For HPTX;PRX From The Last 14 Days
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September 10, 2014
07:54 EDTHPTXHyperion Therapeutics price target lowered to $38 from $43 at Cantor
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September 9, 2014
09:08 EDTHPTXHyperion Therapeutics weakness creates buying opportunity, says JMP Securities
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September 8, 2014
12:18 EDTHPTXOn The Fly: Midday Wrap
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10:49 EDTHPTXHyperion Therapeutics program end removes catalyst, says Leerink
Leerink says Hyperion Therapeutics' termination of its DiaPep277 program removes a near-term catalyst and potential upside driver. The firm reiterates an Outperform rating on the stock, however, noting the Ravicti base business remains strong.
10:40 EDTHPTXHyperion Therapeutics drops on termination of DiaPep277 program
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09:12 EDTHPTXOn The Fly: Pre-market Movers
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08:03 EDTHPTXHyperion terminates DiaPep277 program, finds misconduct by Andromeda Biotech
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08:01 EDTHPTXHyperion terminates DiaPep277 program, finds misconduct by Andromeda Biotech
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07:51 EDTHPTXHyperion Therapeutics trading halted, pending news
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