We are a commercial biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan diseases. Our products, RAVICTI® (sodium phenylbutyrate) Tablets and Powder, are designed to lower ammonia in the blood. Ammonia is produced in the intestine after a person eats protein and is normally detoxified in the liver by conversion to urea. Elevated levels of ammonia are potentially toxic and can lead to severe medical complications which may include death. We have developed RAVICTI, which we launched during the first quarter of 2013, to treat most urea cycle disorders (“UCD”) including 7 of the 8 and the most prevalent UCD subtypes, and are developing glycerol phenylbutyrate (“GPB”), the active pharmaceutical ingredient in RAVICTI, to treat hepatic encephalopathy (“HE”). UCD and HE are diseases in which blood ammonia is elevated. UCD are inherited rare genetic diseases caused by a deficiency of one or more enzymes or transporters that constitute the urea cycle, which in a healthy individual removes ammonia through its conversion to urea. We estimate there are approximately 2,100 cases of UCD in the United States of which approximately 1,100 have been diagnosed. However, we estimate that only about 675 patients are currently treated with medication approved by the U.S. Food and Drug Administration (“FDA”). HE may develop in some patients with liver scarring, known as cirrhosis, or acute liver failure and is a chronic complication of cirrhosis which fluctuates in severity and may lead to serious neurological damage. On February 1, 2013, the FDA granted approval of RAVICTI for chronic management of UCD in adult and pediatric patients greater than two years of age who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Limitations of use include treatment of patients with acute hyperammonemia (“HA”) crises for whom urgent intervention is typically necessary, patients with N-acetylglutamate synthetase (“NAGS”) deficiency for whom the safety and efficacy of RAVICTI has not been established, and UCD patients under two months of age for whom RAVICTI is contraindicated due to uncertainty as to whether newborns, who may have immature pancreatic function, can effectively digest RAVICTI.
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Company profile
Ticker
HPTX
Exchange
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
SEC CIK
Corporate docs
IRS number
611512713
Latest filings (excl ownership)
CT ORDER
Confidential treatment order
1 Jun 15
15-12B
Securities registration termination
18 May 15
UPLOAD
Letter from SEC
14 May 15
25-NSE
Exchange delisting
7 May 15
8-K
Completion of Acquisition or Disposition of Assets
7 May 15
RW
Registration withdrawal request
7 May 15
S-8 POS
Registration of securities for employees (post-effective amendment)
7 May 15
S-8 POS
Registration of securities for employees (post-effective amendment)
7 May 15
S-8 POS
Registration of securities for employees (post-effective amendment)
7 May 15
S-8 POS
Registration of securities for employees (post-effective amendment)
7 May 15
Latest ownership filings
SC 13G/A
Hyperion Therapeutics Inc
11 Feb 16
SC 13D/A
Hyperion Therapeutics Inc
15 May 15
4
Change in insider ownership
11 May 15
4
M JAMES BARRETT
11 May 15
4
Jason Raleigh Nunn
11 May 15
4
FOREST BASKETT
11 May 15
4
PATRICK J KERINS
11 May 15
4
SCOTT D SANDELL
11 May 15
4
RYAN D DRANT
11 May 15
4
KRISHNA KITTU KOLLURI
11 May 15
Institutional ownership, Q3 2019
13F holders | Current |
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Total holders | 0 |
Opened positions | 0 |
Closed positions | 0 |
Increased positions | 0 |
Reduced positions | 0 |
13F shares | Current |
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Total value | 0.00 |
Total shares | 0.00 |
Total puts | 0.00 |
Total calls | 0.00 |
Total put/call ratio | – |
Largest owners | Shares | Value |
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