is compounding gains
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DVAX hitting a Magic Box buy signal here at 4.35
Raptor Pharmaceutical Corp. Reports Fiscal Year 2012 Financial Highlights and Program Updates
Nov 1, 2012 06:30:10 (ET)
NOVATO, Calif., Nov 1, 2012 (GlobeNewswire via COMTEX) -- Raptor Pharmaceutical Corp. ("Raptor" or the Company") (RPTP, Trade ) today announced its fiscal year 2012 ended August 31, 2012 financial highlights, and updates on its clinical programs including the ongoing extension study of PROCYSBI(TM) (cysteamine bitartrate) delayed-release capsules for the potential treatment of patients with nephropathic cystinosis ("cystinosis").
Financial Highlights
-- As of October 19, 2012, Raptor had approximately $41 million in cash,
cash equivalents and short-term investments, taking into account
approximately $13.4 million of net proceeds the Company raised under its
At--The-Market sales issuance agreement ("ATM").
-- Based on current financial projections, the Company believes that this
cash balance should provide the Company with sufficient capital to fund
operations into the third quarter of calendar 2013.
Cystinosis Updates
- Craig B. Langman, M.D., Head of Kidney Diseases, and the Isaac A. Abt, M.D., Professor of Kidney Diseases and Tenured Professor of Pediatrics, Northwestern University Feinberg School of Medicine, will present "Extended Treatment with RP103 (PROCYSBI) in Patients with Nephropathic Cystinosis" on Saturday, November 3rd at Kidney Week 2012, which is being held October 30-November 4, 2012 in San Diego, California. This presentation will provide new data on cystinosis patients treated with PROCYSBI for up to 24 months.
- In anticipation of potential launch, Raptor has hired sales and medical affairs field launch teams in the US.
- In Europe, the Company has hired Country Managers in key markets and staffed medical affairs and other commercial functions. In keeping with plans for a rolling European Union launch, Raptor is establishing necessary foundational legal and operational structures.
- Raptor recently launched RaptorCares(TM), ( www.raptorcares.com ), a dedicated education, access and support program for the cystinosis community. RaptorCares provides access to education and support materials developed in partnership with the cystinosis community.
- In the US, Raptor has partnered with Accredo Health Group, Inc., also an Express Scripts Company, as its specialty pharmacy and distributor. If PROCYSBI receives marketing approval, this dedicated specialty pharmacy will provide individualized caseworker support and counseling to each patient (or caregiver) as they transition to PROCYSBI.
- The final Process Validation batches of PROCYSBI necessary for approval have been initiated and the Company is ramping up production for potential launch upon drug approval.
Huntington's Disease ("HD")
Raptor announced enrollment completion in its Phase 2/3 study using delayed-release cysteamine (RP103) in 96 HD patients in June 2012. The Phase 2/3 clinical trial is being conducted under a previously announced collaboration agreement with The Centre Hospitalier Universitaire d'Angers ("CHU d'Angers") of Angers, France.
The Phase 2/3 clinical trial enrolled 96 patients in an 18-month, placebo-controlled study to be followed by an open-label extension study with all patients on the placebo capsules rolling onto RP103 and all other patients continuing on RP103 for up to an additional 18 months. The primary endpoint of the clinical trial is based upon the Unified Huntington's Disease Rating Scale ("UHDRS"). Under the collaboration agreement with CHU d'Angers, Raptor will supply RP103 and placebo capsules for the clinical trial and open-label extension study in exchange for commercial rights to the clinical trial results. Clinical expenses of the study are covered by a grant from the French government (PHRC 2004-03bis CYST-HD).
This Phase 2/3 clinical trial was contemplated based on encouraging preclinical results reported by Institut Curie, CNRS and INSERM scientists that cysteamine prevents death of neurons and increases levels of a brain growth factor called brain-derived neurotrophic factor ("BDNF") in HD preclinical models. Addressing reduced levels of BDNF in the brain have been widely reported to be an important factor in the development of therapeutics to treat HD.
Raptor holds exclusive worldwide licenses to intellectual property related to the potential treatment of HD from the Weizmann Institute of Science in Israel and Japan's Niigata University. In 2008, Raptor received FDA orphan drug designation for cysteamine formulations, including RP103, for the potential treatment of HD.
Non-Alcoholic Steatohepatitis ("NASH")
In June 2012, Raptor announced the initiation of its Phase 2b trial of RP103 for the potential treatment of NASH. The trial is being conducted within a cooperative research and development agreement ("CRADA") with the National Institutes of Diabetes and Digestive Disease ("NIDDK") for the potential treatment of non-alcoholic fatty liver disease in children, known as the CyNCh trial. The trial will eventually enroll a total of 160 pediatric participants at ten US centers in the NIDDK-sponsored NASH clinical research network. NIDDK and Raptor are sharing the costs to conduct the CyNCh clinical trial. Raptor will retain exclusive development and commercial rights to the clinical trial data. Complete enrollment is expected in the first quarter of calendar 2013 and the data report from the clinical trial is anticipated to be released in the first half of calendar 2014. The CyNCh clinical trial follows previously reported positive results of an open-label Phase 2a clinical trial conducted at the University of California, San Diego ("UCSD").
The primary objective of this randomized, multicenter, double-blind, placebo-controlled Phase 2b CyNCh clinical trial is to evaluate whether 52 weeks of treatment with RP103 in children reverses damage caused by NASH as measured by changes in NAFLD Activity Score ("NAS"), a histological rating scale of disease activity. Secondary endpoints include blood markers for liver health including alanine transaminase ("ALT") and aspartate transaminase ("AST"), as well as safety and tolerability.
About Cystinosis, RP103 and PROCYSBI(TM)
Cystinosis is a rare, life-threatening metabolic disorder that causes systemic toxic cystine accumulation. Toxic cystine accumulation causes progressive and irreversible tissue damage and multi-organ failure including renal failure, blindness, CNS damage, respiratory deficiencies, muscle wasting, and premature death. Cystinosis is usually diagnosed in the first years of life and requires lifelong therapy. Left untreated, the disease is fatal by the end of the first decade of life. Renal transplantation and cystine reduction are the primary treatment strategies for cystinosis.
RP103 is an oral, delayed and extended-release medication containing enteric-coated spheronized micro-beads of cysteamine bitartrate. PROCYSBI is the branded name of RP103 for the potential treatment of cystinosis. RP103 is in clinical development for the potential treatment of HD and NASH. In cystinosis patients, PROCYSBI may reduce the cellular toxicity by continuously removing cystine from the lysosome. PROCYSBI, which can also cross the blood-brain barrier, was engineered specifically to allow release of cysteamine bitartrate micro-spheres in the duodenum for optimal absorption while simultaneously enabling administration every 12-hours for the potential treatment of cystinosis.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. ("Raptor") (RPTP, Trade ) seeks to research, develop, and provide access to medicines that improve life for patients with severe and rare disorders. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, Non-alcoholic Steatohepatitis, Huntington's Disease, and aldehyde dehydrogenase deficiency.
Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein and related proteins that are designed to target cancer and infectious diseases.
For additional information, please visit www.raptorpharma.com .
The Raptor Pharmaceutical Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7180
Both TEAR and PATH look good today
That's what I figured. Laughter is great medicine
No how about you?
lol...a little levity was in order
I'm heterosexual
Confused why you're posting on this one....you looking to add at a particular spot?
yeah it helped me too...because we always see manipulation and a bear attack on many of these bio-techs..but with DVAX..it was an amazing amount of volume slamming the bid the last two days so I was surprised...after seeing this..made more sense to me
Right...it just lists the sale of 6 million shares today so obviously he dumped 3 million yesterday and 3 today
I see on Finviz that Director Mark Kessel sold 6 million shares the last two days on DVAX at an average of 4.73. That would explain the super high volume as I didn't know where the volume was coming from. He made 28.3 million on the sale. He has 3 million shares left that he holds. I think I'm reading it right. Tired and just glanced at it.
RPTP now in a Red Ready (that's a good thing - puts you in front of a move and telegraphs it) and about to confirm a Magic Box (very bullish)
I have seen the light
I wouldn't touch a penny with my mother in law's money
Thank you Tina!! Good morning to you and to everyone
Strongly accumulating this one. Has a high ceiling here and not much downside
Agreed. You are correct sir. 3.04 is a huge technical break
Oh and good morning
DO NOT POST ANY PENNY STOCKS ON THE BOARD HERE PLEASE. IF YOU POST A PENNY PLAY IT WILL BE CONSIDERED OFF TOPIC AND INSTANTLY DELETED.
THANK YOU FOR YOUR COOPERATION
RPTP key 5.70 technical break. Now going to test 6.15 short term. Period. Buckle up and enjoy
RPTP what a close. wow wow wow
I agree RPTP looks fantastic. SRPT also putting in a very very strong day
RPTP at the high of the day today on increasing volume. Beautiful reversal candle today on the daily. Heads up. Next move breaks 5.70 and heads over 6 imo
Brings new meaning to the idea of double entendre doesn't it? Stock market is a very crooked place and it is disgusting to see personal agendas for personal greed enacted as article and tweets show a purpose in my opinion. Disgusting but is what it is and not the first time either