Raptor Pharmaceutical Corp. Is An Investment With Significant Upside IN 2015
Clinically Sound Investor • 12 Comments
Clinically Sound Investor • 12 Comments
Thu, May 5, 5:13 PM
Wed, May 4, 5:35 PM
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Mon, Apr. 11, 11:25 AM
- The European launch of Raptor Pharmaceutical's (RPTP -5%) QUINSAIR (levofloxacin inhalation solution) is underway with the first commercial sales in Denmark and Germany.
- The company acquired QUINSAIR, 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 last summer. Levofloxacin is a proven antimicrobial against a wide range of Gram-negative and Gram-positive bacteria. Two other promising orphan indications for the product are bronchiectasis and nontuberculous mycobacteria lung infections.
- Previously: Raptor Pharma acquires lung infection drug from Tripex for as much as $418M (Aug. 20, 2015)
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Wed, Apr. 6, 5:36 PM
Wed, Apr. 6, 1:45 PM
- Gilead Sciences' (GILD +2%) acquisition of Nimbus Therapeutics for as much as $1.2B appears to have investors in a lather over other developers of therapies to treat nonalcoholic steatohepatitis (NASH), especially Galmed Pharmaceuticals (GLMD +38.3%).
- NASH-related tickers: (MNOV +0.4%)(RGLS +4.8%)(ICPT +4.4%)(CNAT +10.9%)(VBLT +3%)(GALT +2%)(TBRA -0.1%)(OTCPK:ISLT)(SHPG +7.2%)(RPTP +3.6%)(OTCPK:GNFTF -0.9%)(CANF +11.8%)
- Read now NASH Drugs: A Comprehensive Review Of Current Clinical Trials
Thu, Feb. 25, 4:54 PM
Wed, Feb. 24, 5:35 PM
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Wed, Jan. 20, 5:39 PM
Dec. 10, 2015, 7:52 AM
- 36-month efficacy data from a Phase 2/3 clinical trial, CYST-HD, conducted in collaboration with the Centre Hospitalier Universitaire d'Angers in France showed a 25% treatment effect in Huntington's disease (HD) patients treated with Raptor Pharmaceuticals' (NASDAQ:RPTP) lead product candidate RP103 (cysteamine bitartrate). Specifically, patients treated with RP103 for the full 36 months experienced a 25% slower progression in the rate of change in the Total Motor Score (TMS) component of the Unified Huntington's Disease Rating Scale (UHDRS) at month 36 compared to those patients who delayed starting treatment with RP103 until month 18. The results fell short of statistical significance (p=0.18) but were considered clinically meaningful.
- The randomized, placebo-controlled study assessed the efficacy, safety and tolerability of RP103 for 36 months. Placebo subjects crossed over to open-label treatment at month 18 and continued through month 36. The primary efficacy endpoint was the change from baseline at month 18 in the TMS component of the UHDRS between the placebo/RP103 cohort and the cohort who received RP103 for the full 36 months. 88 subjects entered the open-label portion and 78 completed treatment. The full analyses included all randomized participants from month 0 through month 36.
- In a completers analysis, there was a 35% slower progression in the group that started with RP103 at month 0, but again, the results fell shy of statistical significance (p=0.06).
- The safety profile was consistent with previously reported results. The most common adverse events were nausea, vomiting, diarrhea, headache and breath odor. Three deaths from suicide occurred during the open-label period, but this was consistent with background rates in HD patients (5 - 7%).
- Based on discussions with the FDA and EMA, the company plans to conduct a pivotal Phase 3 study after the trial design is finalized.
- HD is a rare, progressive, inherited neurodegenerative disorder characterized by uncontrollable movements, mood swings and depression followed by dementia and premature death 15-20 years after diagnosis. It affects ~100K people worldwide.
- RP103 is a delayed and extended release formulation of PROCYSBI (cysteamine bitartrate), currently cleared in the U.S. for the treatment of nephropathic cystinosis.
- The company will host a conference call this morning at 8:00 am ET to discuss the data.
Nov. 16, 2015, 8:51 AM
- Raptor Pharmaceuticals (NASDAQ:RPTP) is down 15% premarket on light volume in response to its announcement of additional data from its CyNCh study assessing lead product candidate RP103 for the treatment of children with moderate-to-severe nonalcoholic fatty liver disease (NAFLD). The results will be presented today at The Liver Meeting in San Francisco.
- As previously reported on September 14, there was no statistically valid difference in response rate between the RP103 cohort and placebo (28% vs. 22%; p=0.34). No statistically significant difference was observed in the components of the NAS score or fibrosis, but an improvement in the number of subjects with lobular inflammation was seen (36% vs. 21%), although this also fell short of statistical significance when adjusted for multiple comparisons.
- A post-hoc analysis showed a statistically significant difference in the primary endpoint of improvement in liver histology versus placebo in patients weighing no more than 65 kg (p=0.01), about 28% of the study population. No improvement in liver histology was seen in subjects weighing more than 65 kg.
- Statistically significant improvements compared to placebo in the liver enzymes ALT, AST and GGT (p=0.02, p=0.008 and p=0.02, respectively) from baseline to week 52 were also seen.
- Raptor has yet to recover from its plunge in September in response to its initial report of results from CyNCh. Shares are still down over 60% from early summer.
Nov. 16, 2015, 8:21 AM
- The design of a pivotal Phase 3 clinical trial assessing GENFIT's (OTCPK:GNFTF) lead product candidate, Fast Track-tagged Elafibranor (GFT505), for the treatment of non-alcoholic steatohepatitis (NASH) has been finalized. The study is set to commence this quarter.
- The 1,800-subject, randomized, double-blind, placebo-controlled trial will be conducted across 200 centers worldwide. The study population will include NASH patients who have a NAFLD Activity Score (NAS) of at least 4, with F2 (light) or F3 (severe) fibrosis. Participants will receive 120 mg of Elafibranor or placebo once daily. An interim analysis will be performed on the first 900 patients after 72 weeks that will support initial regulatory approval. To support full approval, the trial will continue to conclusion to show the impact of Elafibranor on the prevention of cirrhosis and other liver-related outcomes on the full study population. A group of F1 fibrotic patients who have cardiometabolic co-morbidities will be enrolled as well. The study will continue post-marketing and will remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis or other liver-related events.
- The primary endpoint is the resolution of NASH without worsening of fibrosis.
- NASH-related tickers: (NASDAQ:TBRA)(NASDAQ:ICPT)(NASDAQ:DRRX)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:CNAT)(NASDAQ:VBLT)(NASDAQ:RPTP)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)
Nov. 5, 2015, 5:02 PM
- Raptor Pharmaceutical (NASDAQ:RPTP): Q3 EPS of -$0.14 beats by $0.04.
- Revenue of $25.8M (+8.6% Y/Y) beats by $1.55M.
Nov. 4, 2015, 5:35 PM
- AAOI, ABCO, ABTL, ACAD, ACET, ACHN, AEGR, AGO, AHS, AIRM, AL, ALEX, ALIM, AMBR, AMRS, AMTG, ANET, ARCW, ATHX, ATSG, BBG, BBRG, BCEI, BEBE, BLDR, BPI, BRKS, BRS, CALD, CBI, CERS, CLNE, CLVS, CMLS, CORT, CPST, CSOD, CTCT, CUBE, CYBR, CYTX, DATA, DIOD, DIS, DMD, DWA, EAC, EBS, ECOM, ECPG, ED, EFC, EGN, EGOV, ELON, EOG, ERII, EVC, EXAR, FICO, FNGN, FTEK, FXCM, GDOT, GERN, GLUU, GSAT, GSM, GST, GXP, HAIN, HBM, HE, HK, HNSN, HTGC, ICUI, INAP, INFI, INWK, IRG, JJSF, KHC, KTOS, LBTYA, LNT, MAIN, MASI, MDRX, MDVN, MED, MHK, MITK, MNST, MRC, MSCC, MTD, NEWR, NFG, NKTR, NVDA, OLED, ONTY, OREX, OUT, PCTY, PETX, PKI, PLT, PODD, PRAA, PRO, PXLW, QRVO, RATE, RBA, RLYP, RMAX, RPTP, RRMS, RRTS, SEMG, SHAK, SKUL, SLH, SNAK, SREV, SSRI, STMP, SWIR, SWKS, TCRD, TCX, TEAR, TNGO, TRIP, TRMR, TRQ, TRUE, TTWO, UBNT, UEPS, VRNS, VVC, WAGE, WG, WIFI, WTW, XOMA, YUME
Sep. 18, 2015, 10:11 AM
- Anthera Pharmaceuticals (ANTH +3.3%) initiated with Buy rating and $15 (56% upside) price target by Citi.
- Trovagene (TROV +4.2%) initiated with Buy rating and $10 (47% upside) price target by Cantor Fitzgerald.
- Bruker (BRKR -1.1%) initiated with Equal Weight rating and $21 (16% upside) price target by Morgan Stanley.
- Align Technology (ALGN -0.8%) initiated with Outperform rating and $70 (21% upside) price target by Leerink.
- WebMD (WBMD -0.8%) upgraded to Outperform from Market Perform by Cowen & Co. Price target raised to $53 (29% upside) from $42.
- Dentsply (XRAY -0.7%) upgraded to Outperform from Market Perform by Baird. Price target raised to $61 (15% upside) from $58.
- Dentsply (XRAY -0.7%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $70 (32% upside) from $56.
- Vertex Pharmaceuticals (VRTX -4.2%) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $150 (16% upside) from $120.
- Sirona Dental Systems (SIRO -0.8%) downgraded to Equal Weight by Morgan Stanley.
- Amicus Therapeutics (FOLD -0.1%) downgraded to Neutral from Buy by Chardan Capital Markets. Price target is $17.50 (0% upside).
- Raptor Pharmaceuticals (RPTP -0.7%) downgraded to Neutral from Buy by Citi. Price target lowered to $8 (16% upside) from $20.
- Alexion Pharmaceuticals (ALXN -0.7%) downgraded to Equal Weight from Overweight by Barclays. Price target lowered to $205 (23% upside) from $220.
Sep. 14, 2015, 12:45 PM
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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