Hyperion Therapeutics, Inc. (HPTX)

[ECole]

Earnings transcript Q3


http://www.earningsimpact.com/Transcript/84480/HPTX/Hyperion-Therapeutics%2c-Inc----Q3-2013-Earnings-Call

[stocktrader001]

[mlkrborn]

Hyperion Therapeutics confirms its RAVICTI (glycerol phenylbutyrate) liquid received FDA approval for treatment of urea cycle disorders (HPTX) 16.13 +0.50 : Co announced that the FDA has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013.

Separately, co announced it has received notification from the U.S. Patent & Trademark Office (USPTO) of the allowance of the claims of patent application number 13/417,137 entitled, METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS, which discloses optimal measurement timing and target levels for blood ammonia in UCD patients. The issued patent would have a term that expires in March 2032. After issuance, Hyperion plans to list this patent in FDA's Approved Drug Products with Therapeutic Equivalence, or Orange Book.

[Norm]

approval - link attached. got out of this way to early.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm337639.htm

[mlkrborn]

Trading halted @$12 then jumped to $14 despite delayed PDUFA. Hyperion notified that FDA will not meet the PDUFA action date for Ravicti (HPTX) 12.00 : Co said that the U.S. Food and Drug Administration (FDA) has advised it not to expect a final action by the Prescription Drug User Fee Act action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application for Ravicti (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders.

[Norm]

$heff invested bought in last Friday. Should help raise pps

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82290395

[Norm]

If I had more powder I would be back in today. Still have some time but the lowest we see b4 PDUFA date.

[PoemStone]

looking in. nice chart. B'marked.

[Norm]

Friday's volume was almost double the average.

http://www.nasdaq.com/symbol/hptx/historical

[Norm]

Analyst info and old sa article

08-03-12 SA artical
http://seekingalpha.com/article/780201-hyperion-therapeutics-one-stock-i-m-adding-post-ipo

Analyst links
http://www.nasdaq.com/symbol/hptx/analyst-research

http://thestockmarketwatch.com/stock-data.aspx?stock=HPTX&a=showAnalyst

http://www.streetinsider.com/rating_history.php?q=HPTX

http://quotes.wsj.com/HPTX/research-ratings

[Norm]

finances

The company reported cash and cash equivalents of $7.3 million as of June 30, 2012. Subsequent to the end of the quarter, on July 31, 2012, the company successfully closed its initial public offering and the underwriters exercised their over-allotment option in full raising proceeds, net of underwriter discounts, of $53.5 million. The company intends to use the proceeds primarily for the potential launch of its first drug, Ravicti™ (glycerol phenylbutyrate).

According to Chief Executive Officer, Donald J. Santel, "Having a completed IPO makes us well positioned for the potential approval and launch of Ravicti. We believe Ravicti offers meaningful benefits over the only product currently FDA-approved for the treatment of the most prevalent urea cycle disorders, or UCD. With the Prescription Drug User Fee Act (PDUFA) target action decision date on the New Drug Application for Ravicti now January 23, 2013, we are actively planning for launch, and are looking forward to bringing this important potential new drug to the UCD community."

[Norm]

PDUFA date has been pushed out to Jan 23, 2013

Hyperion Therapeutics Announces Extension of Action Date for Ravicti(TM) NDA to January 23, 2013
5:54p ET September 5, 2012 (Benzinga) Hyperion Therapeutics (NASDAQ: HPTX) announced today that it has received a communication from the U.S. Food and Drug Administration (FDA) extending the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for Ravicti™ (glycerol phenylbutyrate) by three months to January 23, 2013. The FDA extended the action date to provide time for a full review of the submission. Such extensions are standard and are provided for by regulation when additional information is submitted within three months of a PDUFA action date.

About Ravicti™ (glycerol phenylbutyrate)

Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL®, the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders. Ravicti holds orphan product designations in the US and Europe for the maintenance treatment of patients with urea cycle disorders and in the US for the intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.

About Hyperion Therapeutics

Hyperion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of