Tuesday, October 2, 2018
Intersect ENT strength attributed to Sinuva appearance on Anthem drug list
Intersect ENT’s (XENT) Sinuva nasal implant appears on Anthem’s (ANTM) national drug list, which is being pointed to as the reason for the stock’s early strength, according to contacts. Intersect ENT shares are up about 5% to $30.08 in early trading.
https://thefly.com/landingPageNews.php?id=2798559
Bausch unit announces publication of Phase 3 data on Bryhali Lotion
Ortho Dermatologics and its parent company, Bausch Health Companies, announced that the Journal of Drugs in Dermatology has published results of two Phase 3 randomized controlled trials examining the safety and efficacy of BRYHALITM Lotion, 0.01%, an investigational potent to superpotent** corticosteroid, in the treatment of moderate-to-severe plaque psoriasis. BRYHALI Lotion has a Prescription Drug User Fee Act action date of October 5, 2018. In the studies, BRYHALI Lotion was consistently more effective than vehicle in achieving treatment success, which was defined as at least a two-grade improvement from baseline in an Investigator Global Assessment score, and ‘clear’ or ‘almost clear’ skin. By week eight, 36.5% and 38.4% of BRYHALI Lotion patients had achieved treatment success, compared to 8.1% and 12% of patients receiving vehicle. At four weeks post treatment, no rebound of symptoms was observed in patients using BRYHALI Lotion. BRYHALI Lotion was also found to be well-tolerated, with a similar number of patients in the BRYHALI Lotion and vehicle groups reporting adverse events (21.5% and 23.9%, respectively). The most common adverse reactions were upper respiratory tract infection, application site dermatitis and hyperglycemia. The U.S. Food and Drug Administration has accepted the New Drug Application for BRYHALI Lotion with a Prescription Drug User Fee Act action date of October 5, 2018.
Pacira price target raised to $49 from $45 at Canaccord
Canaccord analyst Dewey Steadman maintained a Hold rating on Pacira Pharmaceuticals (PCRX) and raised his price target to $49 from $45. Recently reported IQVIA monthly data for August show a major acceleration of volume and revenue growth vs. a year ago as well as substantial alignment in growth trends with Symphony Health data, Steadman tells investors in a research note. Longer term, however, he remains concerned about the potential advent of competition from Heron’s (HRTX) HTX-011 with what some consider to be a superior clinical data set to Exparel, and expects Pacira shares could be rangebound for the near future following strong recent performance.
Assembly Biosciences to present on Phase 1 study at liver disease confab
Assembly Biosciences announced that the company will have an oral presentation of the full data set from the Phase 1b study of ABI-H0731 at the upcoming American Association for the Study of Liver Diseases, or AASLD. The oral presentation at AASLD will review final results of the Phase 1b study in patients with chronic hepatitis B, or HBV infection, including safety, tolerability and pharmacokinetics of ABI-H0731, as well as quantitative changes in HBV DNA, RNA and viral antigens. ABI-H0731 was safe and well tolerated, with dose dependent antiviral effects at doses ranging from 100 to 400 mg given orally once daily, and RNA declines paralleled the observed DNA declines. The company presented interim results of the study at the Annual Meeting of the European Association for the Study of the Liver, or EASL.
Bio-Techne price target raised to $230 from $210 at Argus
Argus analyst David Toung raised his price target on Bio-Techne to $230 and kept his Buy rating, saying the company appears to be on track for ongoing “solid” revenue growth thanks to the domestic and international demand for its products. The analyst is also positive on Bio-Techne’s continued expansion through acquisitions such as its recent purchase of Quad Technologies, producing advanced reagents for clinical and research use, and Exosome Diagnostics, marketing a noninvasive liquid biopsy diagnostic test for prostate cancer. Tough further cites the company’s internal development, including its “recent initiative to advance cell and gene therapy research and ex vivo cell processing”.
Jefferies sees Intercept moving higher after ‘mixed’ Gilead data
Jefferies analyst Michael Yee views Gilead Sciences’ (GILD) new six-month nonalcoholic steatohepatitis data as “mixed and undifferentiated.” As such, he thinks shares of Intercept Pharmaceuticals (ICPT) probably continue to move higher. The stock is likely to retrace back up into year-end and the first half of 2019 as Street realizes Intercept’s Phase III will be positive and de-risked, Yee tells investors in a research note. He says the company has had various competitor Farnesoid X receptor data in Phase I/II read out over the past year or and that these have ended up not too differentiated. This has removed some of the competitive overhang on Intercept, the analyst contends. Yee keeps a Buy rating on the shares with a $135 price target.
Arena reports ‘positive’ Phase 2 data for hypertension med ralinepag
Arena Pharmaceuticals announced positive data from a planned interim analysis of the ongoing open-label extension of the Phase 2 trial of its investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension. Patients who continued on ralinepag in the open-label extension had a median treatment duration of 1.8 years at the time of right heart catheterization. In these patients, sustained improvements from baseline in the original study were observed for PVR and 6MWD. Patients switching from placebo to active drug had a median ralinepag treatment duration of 1.4 years at the time of RHC. In these patients, a similar magnitude of improvement was observed for PVR. In both groups, these long-term changes in PVR and 6MWD were observed in a population where the majority of patients were already receiving dual combination PAH background therapy. Adverse events observed in this extension study were consistent with the known profile of prostacyclin therapies for the management of PAH, with headache and nausea being the most commonly reported. Among patients who continued ralinepag in the open-label extension, the incidence rate of AEs was lower relative to the randomized Phase 2 study, suggesting that AEs related to tolerability are reduced after initial drug titration.
https://thefly.com/landingPageNews.php?id=2798353
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