Raptor Pharmaceutical Corp. Is An Investment With Significant Upside IN 2015
Clinically Sound Investor • 12 Comments
Clinically Sound Investor • 12 Comments
Sep. 14, 2015, 9:14 AM
Sep. 14, 2015, 7:43 AM
- Raptor Pharmaceutical (NASDAQ:RPTP) reports that its product candidate for the treatment of nonalcoholic steatohepatitis (NASH) in adolescents aged 8 - 17, RP103 (cysteamine bitartrate), failed to achieve its primary endpoint of a two point decrease in NAFLD Activity Score (NAS) and no worsening of fibrosis compared to placebo (p=0.34) in a Phase 2b study.
- The trial, called CyNCh, assessed RP103 in 169 children. Subjects were randomized to receive either 600 mg/day, 750 mg/day, 900 mg/day of RP103 or placebo for 52 weeks.
- The results will be submitted for publication and presented at the American Association for the Study of Liver Diseases meeting in November in San Francisco, CA.
- Based on the results, the company will cease development of RP103 for NASH. Its development for Huntington's disease and mitochondrial diseases in ongoing.
- Shares are off 36% premarket on robust volume.
Aug. 20, 2015, 7:19 PM
- Raptor Pharmaceutical (NASDAQ:RPTP) acquires Quinsair (levofloxacin inhalation solution), the first inhaled fluoroquinolone approved for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis, from privately held Tripex Pharmaceuticals.
- Levofloxacin is a proven antimicrobial against a wide range of Gram-negative and Gram-positive bacteria. Two other promising orphan indications for Quinsair are bronchiectasis and nontuberculous mycobacteria lung infections.
- Quinsair was cleared for sale in the EU in March and in Canada in June. Raptor plans to launch it commercially in both territories in H1 2016. It also plans to discuss a regulatory path with the FDA for U.S. approval.
- Under the terms of the agreement, Raptor will pay $68.4M upfront (up to $34.2M in RPTP stock), milestones up to $350M and single-digit royalties on commercial sales. The deal should close this quarter.
- Separately, Raptor affirms its 2015 revenue guidance of $80M - 90M and non-GAAP operating expenses of $115M - 125M.
Aug. 17, 2015, 8:01 AM
- The FDA approves the use of Raptor Pharmaceutical's (NASDAQ:RPTP) PROCYSBI (cysteamine bitartrate) in younger children aged two to six with nephropathic cystinosis, a life-threatening metabolic lysosomal storage disorder that causes toxic accumulation of cystine in the body. It is typically diagnosed in infancy and requires lifelong therapy. It affects ~500 Americans and ~2,000 people globally.
- PROCYSBI is a cystine depleting agent that was formally cleared for use in children at least six years old.
Aug. 6, 2015, 4:37 PM
- Raptor Pharmaceutical (NASDAQ:RPTP): Q2 EPS of -$0.12 beats by $0.09.
- Revenue of $23.33M (+43.0% Y/Y) beats by $1.93M.
Jul. 15, 2015, 7:41 AM
- Raptor Pharmaceuticals (NASDAQ:RPTP) announces that Chief Business Officer Ted Daley will be leaving the company at the end of September to pursue other interests.
- Separately, the company appoints Ashely Gould, J.D., as SVP, General Counsel and Corporate Governance. She joins the firm from Hyperion Therapeutics where she was SVP, Governmental Affairs and Chief Legal and Compliance Officer.
Jul. 7, 2015, 10:50 AM
- Edwards Lifesciences (EW -0.8%) upgraded to Overweight from Equal Weight with a $168 (17% upside) price target (up from $135) by Morgan Stanley.
- HealthSouth (HLS -0.7%) upgraded to Market Outperform from Market Perform with a price target of $54 (15% upside) by JMP Securities.
- AstraZeneca (AZN -0.6%) upgraded to Buy from Hold with an $81 (25% upside) price target by Berenberg.
- Humana downgraded to Hold from Buy by Argus Research.
- Intuitive Surgical (ISRG -1.1%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $500 (6% upside) from $560.
- Aegerion Pharmaceuticals (AEGR -0.5%) downgraded to Sell from Neutral by Guggenheim Securities.
- Centene (CNC -3.3%) downgraded to Equal Weight from Overweight by Barclays. Price target lowered to $81 (20% upside) from $88.
- Raptor Pharmaceutical (RPTP -1.8%) downgraded to Underperform from Perform with an $8 (40% downside risk) price target by Oppenheimer.
- Aetna (AET -3.5%) downgraded to Market Perform from Outperform by FBR Capital Markets. Price target lowered to $120 (6% upside) from $130.
- Baxter International (BAX -2.3%) downgraded to Neutral from Buy by Bank of America. Price target lowered to $40 (8% upside) from $78.
Jul. 1, 2015, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Jun. 10, 2015, 5:38 PM
May 7, 2015, 4:17 PM
- Raptor Pharmaceutical (NASDAQ:RPTP): Q1 EPS of -$0.24 beats by $0.01.
- Revenue of $20.45M (+68.6% Y/Y) beats by $1.4M.
- Shares -0.06%.
Apr. 8, 2015, 12:25 PM
Apr. 2, 2015, 7:59 AM| Apr. 2, 2015, 7:59 AM | 1 Comment
Mar. 30, 2015, 4:24 PM
Mar. 24, 2015, 5:35 PM
Mar. 11, 2015, 10:56 AM
- Biotech investors, giddy over the robust demand for hepatitis C drugs like Gilead's (GILD +0.4%) Sovaldi and Harvoni, are eagerly anticipating the next wave of new therapies for non-alcoholic steatohepatitis (NASH) or "fatty liver disease." It resembles the alcoholic variety but affects people who drink little or no alcohol. According to the NIH, it affects 2 - 5% of Americans.
- Publicly-traded companies with NASH-related development programs include: Tobira Therapeutics (RGDO +2.3%), Islet Sciences (OTCQB:ISLT), Merck (MRK -0.5%), Intercept Pharmaceuticals (ICPT +3.4%), Gilead Sciences, Shire plc (SHPG -0.6%), Galectin Therapeutics (GALT), La Jolla Pharmaceutical (LJPC -1.5%), Conatus Pharmaceuticals (CNAT -1.2%), Raptor Pharmaceutical (RPTP -1.3%), Galmed Pharmaceuticals (GLMD +1.9%) and Genfit (OTCPK:GNFTF).
- TheStreet's Adam Feuerstein says that comparing clinical trial results between firms will require scrutiny because of differences in the designs of the studies, including efficacy criteria and treatment duration. In an article published today, he compares the ongoing trials of Genfit and Intercept. Genfit's efficacy endpoint of its mid-stage study is less stringent than Intercept's but it may make it more difficult to demonstrate a statistically significant benefit versus placebo. Results from Genfit's trial are expected later this month. If positive, it should rally NASH-related stocks.
Feb. 26, 2015, 4:08 PM
- Raptor Pharmaceutical (NASDAQ:RPTP): Q4 EPS of -$0.25 misses by $0.11.
- Revenue of $17.3M (+68.8% Y/Y) misses by $2.82M.
- Shares -1.1%.
Raptor Pharmaceutical Corp. is a biopharmaceutical company, which focuses on developing and commercializing life-altering therapeutics that treat debilitating and often fatal diseases. It has active development programs in cystinosis, a rare genetic disease, as well as other genetic and... More
Industry: Drug Manufacturers - Major
Country: United States
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