Key Developments: Hyperion Therapeutics Inc (HPTX.W)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Hyperion Therapeutics Inc Receives Orphan Drug Exclusivity From FDA
Hyperion Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) notified the Company that RAVICTI (glycerol phenylbutyrate) Liquid has qualified for orphan drug exclusivity. The orphan exclusivity is for seven years from the date of the approval on February 1, 2013. RAVICTI Indications, Usage and Safety Information RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ two years of age with UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements). The metabolite of RAVICTI, PAA, is associated with neurotoxicity at levels ≥ 500 μg/mL. If symptoms of vomiting, nausea, headache, drowsiness, or confusion are present in the absence of high ammonia or other intercurrent illnesses, reduce the RAVICTI dosage. Pancreatic insufficiency or intestinal malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely in these patients. Most common adverse reactions in 10% or more of patients are: diarrhea, flatulence, headache, nausea, vomiting, fatigue, decreased appetite, HA, dizziness, headache, upper abdominal (stomach) pain and rash. Full Article
Hyperion Therapeutics Inc Announces Pricing Of Follow-On Offering
Hyperion Therapeutics Inc announced that the pricing of its follow-on offering of 2,875,000 shares of its common stock at $20.75 per share, before underwriting discounts and commissions. All of the common stock is being offered by Hyperion. In addition, the underwriters have a 30-day option to purchase up to an additional 431,250 shares of common stock from Hyperion to cover over-allotments, if any. The offering is expected to close on March 13, 2013, subject to customary closing conditions. Leerink Swann LLC and Cowen and Company, LLC are serving as joint book-running managers for the proposed offering. Needham & Company, LLC and JMP Securities LLC are acting as co-managers for the proposed offering. Full Article
Hyperion Therapeutics Inc Completes Initial Public Offering And Announces Exercise Of Underwriters’ Over-Allotment Option
Hyperion Therapeutics Inc announced the completion of its Initial Public Offering (IPO) of 5,000,000 shares of common stock. In addition, the underwriters of its initial public offering exercised their over-allotment option in full and purchased an additional 750,000 shares of common stock. All of such shares were sold by Hyperion Therapeutics at the initial public offering price of $10.00 per share. Leerink Swann LLC and Cowen and Company, LLC acted as joint book-running managers for the proposed offering, and Needham & Company, LLC acted as co-manager of the offering. Full Article
Hyperion Therapeutics Inc Files Registration Statement For Proposed Initial Public Offering
Hyperion Therapeutics Inc announced that it has filed a registration statement with the Securities and Exchange Commission for a proposed Initial Public Offering of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined. Leerink Swann LLC and Cowen and Company, LLC are serving as joint book-running managers for the proposed offering. Needham & Company, LLC is acting as a co-manager for the proposed offering. The offering will be made only by means of a prospectus. Full Article
FDA OKs Hyperion drug for serious genetic disorder
- U.S. health regulators on Friday approved a drug from Hyperion Therapeutics Inc designed to remove ammonia buildup from the blood of patients with enzyme deficiencies known as urea cycle disorders.
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