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June 25, 2014
16:08 EDTHPTXHyperion says EMA to review of marketing authorization application for RAVICTI
Hyperion Therapeutics announced that the European Medicines Agency has completed technical and content validation and accepted the filing of the Marketing Authorisation Application for RAVICTI Oral Liquid for the treatment of urea cycle disorders. Acceptance of the MAA confirms that the submission is complete so as to permit a substantive review by the Rapporteurs and the Committee for Medicinal Products for Human Use. "We are very pleased to receive MAA acceptance for review of RAVICTI and anticipate a CHMP opinion in the third quarter of 2015," said Hyperion CEO Donald Santel.
News For HPTX From The Last 14 Days
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February 27, 2015
07:20 EDTHPTXHyperion Therapeutics could be a takeout target, says Brean Capital
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February 26, 2015
16:38 EDTHPTXHyperion Therapeutics sees 2015 revenue $120M-$128M, consensus $119.3M
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16:38 EDTHPTXHyperion Therapeutics reports Q4 adjusted EPS 47c
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February 17, 2015
05:28 EDTHPTXHyperion enters into agreement with CBI, Yeda regarding DiaPep277
Hyperion Therapeutics announced that it has amicably resolved its disputes, and entered into a completion of phase III clinical trial, option and mutual release agreement with Clal Biotechnology Industries, or CBI, and Yeda Research and Development regarding DiaPep277, a product candidate developed by Andromeda Biotech, a company which Hyperion acquired from CBI in June 2014. As announced in its September 8, 2014 press release, Hyperion will complete the ongoing DIA-AID 2 phase 3 clinical trial of DiaPep277 to treat new onset Type 1 diabetes and will not take DiaPep277 forward beyond completion of the DIA-AID 2 trial. Hyperion's estimated budget for completion of the DIA-AID 2 trial remains unchanged at $10.5M. CBI will have an option to acquire Andromeda, which option expires September 30. CBI will pay a nonrefundable option payment of $2.5M at signing, payable in shares of Hyperion stock currently held by CBI. Subject to agreed restrictions, a steering committee consisting of representatives from CBI, Yeda and Hyperion, will oversee and direct the completion of the trial, the analysis of its results, and interactions with regulatory authorities. Hyperion intends to use the option payment to offset any potential increases to the DIA-AID2 trial budget incurred at the steering committee's direction. Any increases to this budget beyond $2.25M , if incurred at the steering committee's direction, will be reimbursed by CBI. CBI exercises the option, CBI will pay an option exercise price of $3.5M, payable in shares of Hyperion stock currently held by CBI. In addition, if the option is exercised, then Andromeda will be obligated to pay Hyperion future contingent payments if and to the extent it or its shareholders receive revenues or certain other proceeds, which are capped at $36.5M. This amount, together with the option exercise price that Hyperion may receive, approximates the total amount Hyperion will have invested in Andromeda by the option exercise date. If CBI does not exercise the option, the Agreement provides for DiaPep277 intellectual property rights to revert to Yeda.

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