Key Developments: Raptor Pharmaceutical Corp (RPTP.W)
7.83USD
18 Jun 2013
$0.26 (+3.43%)
$7.57
$7.61
$7.86
$7.61
1,500
1,939
$8.00
$4.35
Latest Key Developments (Source: Significant Developments)
Raptor Pharmaceutical Corp's PROCYSBI Receives FDA Approval For Treatment Of Nephropathic Cystinosis
Raptor Pharmaceutical Corp announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death. Full Article
The Law Firm Of Levi & Korsinsky, LLP Launches An Investigation Into Possible Breaches Of Fiduciary Duty By The Board Of Directors Of Raptor Pharmaceuticals Corp
Levi & Korsinsky, LLP announced that it is investigating on Raptor Pharmaceuticals Corp. and its Board of Directors, in connection with possible breaches of fiduciary duty. Full Article
Faruqi & Faruqi, LLP Is Investigating Raptor Pharmaceutical Corp On Behalf Of Shareholders
Faruqi & Faruqi, LLP, a national law firm concentrating on investor rights, consumer rights and the enforcement of federal antitrust laws, is investigating potential claims against the Board of Directors of Raptor Pharmaceutical Corporation concerning possible breaches of fiduciary duty and other violations of law related to the Company's compensation packages for executive officers. The investigation focuses on the approval and awarding of certain stock options to executives that may have violated the Company's compensation plans. Full Article
The Law Firm of Levi & Korsinsky, LLP Launches Investigation Into Possible Breaches Of Fiduciary Duty By Board Of Directors Of Raptor Pharmaceuticals Corp. In Connection With Executive Compensation
Levi & Korsinsky, LLP announced that it is investigating Raptor Pharmaceuticals Corp., and its Board of Directors, in connection with the compensation provided to certain of its executive officers. Full Article
Raptor Pharmaceutical Corp Signs $50 Million Loan Agreement With HealthCare Royalty Partners
Raptor Pharmaceutical Corp announced that it has signed a $50 million loan agreement with HealthCare Royalty Partners (HC Royalty) to help fund the commercialization of PROCYSBI, the branded name of RP103 for the potential treatment of nephropathic cystinosis, and advance the Company's development programs. Under the terms of the agreement, Raptor will receive $25 million (the First Tranche Loan) at closing and an additional $25 million (the Second Tranche Loan) upon U.S. Food and Drug Administration approval of PROCYSBI. The First Tranche and Second Tranche Loans, which mature on December 31, 2019, bear interest at an annual fixed rate of 10.75% and a Synthetic Royalty variable rate, tiered down, based on a percentage of future PROCYSBI sales. The loan is interest-only for the first two years. Full Article
Raptor Pharmaceutical Corp Announces FDA Acceptance Of New Drug Application For RP103 For Potential Treatment Of Nephropathic Cystinosis
Raptor Pharmaceutical Corp announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. The FDA has granted Standard Review designation for RP103. Previously, Raptor announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for RP103 for the potential treatment of nephropathic cystinosis. Raptor's MAA is under review by the EMA, and the Company expects a decision in the first half of 2013. The NDA submission for marketing approval includes previously announced data from Raptor's Phase 3 cystinosis clinical trial of RP103. As reported, RP103 met the clinical trial's sole primary endpoint and there were no unexpected serious safety concerns attributable to RP103 experienced by patients in the trial. The clinical trial was conducted at three clinical sites in the U.S. and five clinical sites in Europe. Full Article
Raptor Pharmaceutical Corp Announces At-The-Market Common Stock Sales Program
Raptor Pharmaceutical Corp announced that it has entered into an At-the-Market (ATM) Sales Agreement, dated April 30, 2012, with Cowen and Company, LLC under which Raptor may, at its discretion, sell its common stock with a sales value of up to a maximum of $40 million through ATM sales on the NASDAQ Stock Market. Cowen will act as sole sales agent for any sales made under the ATM. The common stock will be sold at prevailing market prices at the time of the sale of common stock, and, as a result, prices may vary. The ATM places no restrictions on Raptor's ability to enter into and consummate other equity and debt financing transactions. Raptor intends to use proceeds from any sales from the ATM program to support general corporate purposes, including the commercial launch of RP103, Raptor's delayed release cysteamine bitartrate formulation, for the potential treatment of nephropathic cystinosis, and continued clinical development for this same compound in non-alcoholic steatohepatitis (NASH) and Huntington's Disease. This ATM will provide Raptor with additional strategic leverage and financial flexibility as the Company prepares for the commercial launch of RP103. Full Article
Raptor Pharmaceutical Corp Submits New Drug Application For RP103 For Potential Treatment Of Nephropathic Cystinosis
Raptor Pharmaceutical Corp announced that it submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. In its application, Raptor has requested Priority Review of the NDA, which, if granted, could lead to a decision for marketing approval from the FDA of RP103 for the potential treatment of nephropathic cystinosis in the fourth calendar quarter of 2012. Earlier on March 26, Raptor announced European Medicines Agency validation of its Marketing Authorization Application for RP103 for the potential treatment of nephropathic cystinosis. Full Article
Raptor Pharmaceutical Corp Provides Program Update On RP103 (DR Cysteamine) For Nephropathic Cystinosis
Raptor Pharmaceutical Corp announced a program update for its lead investigational compound, RP103 for potential treatment of nephropathic cystinosis. RP103 is Raptor's enteric-coated, microbead delayed-release oral formulation of cysteamine bitartrate designed to potentially reduce dosing frequency and reduce gastrointestinal side effects associated with approved immediate-release cysteamine bitartrate. the Company has been conducting a planned voluntary extension study to monitor white blood cell cystine levels and collect long-term safety and quality of life data. Of the 40 patients who entered the safety study after completing the Phase 3 clinical trial, 38 are still enrolled. All of these 38 patients have been taking RP103 in extension study for at least six months, with some patients having been in extension study for as long as 15 months. Raptor intends to include at least six months of safety data for all Phase 3 completers who remain in extension study. Based on the positive results of Raptor's Phase 3 clinical trial and on the findings of its bioequivalence study, which demonstrated similar drug exposure whether administered in whole capsule or sprinkled onto applesauce, US and European regulatory agencies approved the Company's expanded enrollment in extension study to include patients who did not qualify for Phase 3 clinical trial. Full Article
Raptor Pharmaceutical Corp Signs Collaborative Research And Development Agreement With NIDDK On Phase 2b Clinical Trial Of RP104 (DR Cysteamine Tablets) In Non-Alcoholic Steatohepatitis
Raptor Pharmaceutical Corp announced signing of a cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) part of the National Institutes of Health (NIH) to conduct a Phase 2b clinical trial. The clinical trial will evaluate the safety and potential efficacy of RP104, Raptor's delayed-release tablet formulation of cysteamine bitartrate, as a potential treatment of non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease (NAFLD), in children. This planned CyNCh trial follows positive results of an open-label Phase 2a clinical trial which was conducted under a collaboration agreement between Raptor and UC San Diego at UC San Diego's General Clinical Research Center. The Phase 2 a clinical trial involved children with biopsy-confirmed diagnosis of moderate to severe NAFLD and baseline ALT and AST measurements at least twice that of normal levels. These patients received a prototype formulation of RP104 twice daily for six months, followed by a six-month post-treatment monitoring period. The reductions in ALT and AST were largely sustained during the six month post-treatment phase. Other important liver function markers showed positive trends with cytokeratin levels decreasing by an average of 45% and adiponectin increasing by 35% during the treatment period. Full Article
FDA approves Raptor's drug for nephropathic cystinosis
WASHINGTON - The Food and Drug Administration has approved an experimental drug from Raptor Pharmaceutical Corp to treat a rare genetic disorder that can cause irreversible tissue damage, organ failure and premature death.
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