JMP Securities analyst Liisa Bayko noted that Sarepta’s gene therapy showed robust improvement in functional endpoints in the latest data from the program, which she sees “reinforcing the leapfrog this platform can offer” in Duchenne muscular dystrophy. The safety also still looks acceptable, added Bayko, who reiterates her Outperform rating and $270 price target on Sarepta shares.
Thursday, October 4, 2018
Ophthotech completes recruitment for Phase 2b of macular degeneration trial
Ophthotech announced completion of patient recruitment for its Phase 2b clinical trial of Zimura, the company’s complement factor C5 inhibitor, monotherapy in patients with geographic atrophy secondary to dry age-related macular degeneration, or AMD. Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. A total of 286 patients have been enrolled into this randomized, double-masked, sham controlled multi-center clinical trial. This clinical trial is designed to assess the safety and efficacy of various Zimura dosing regimens over 12 months. Patients will continue to be treated and monitored until month 18.
AMN Healthcare initiated at Berenberg
AMN Healthcare initiated with a Buy at Berenberg. Berenberg analyst Sam England initiated AMN Healthcare with a Buy and $70 price target. England believes the company’s transition into a full-service workforce solutions provider from a temporary staffing of nurses and doctors will lead to a stickier customer base, higher growth, and increased margins.
Vaxart to present new data from Phase 2 Challenge study of oral H1 Flu vaccine
Vaxart announced it will present new data from the Phase 2 Challenge Study of its H1 influenza oral tablet vaccine at IDWeek 2018 in San Francisco on Saturday, October 6, 2018. “These latest results show that our vaccine elicited a significant expansion of mucosal homing receptor alpha4beta7+ plasmablasts to approximately 60% of all activated B cells, while Fluzone only maintained baseline levels of 20%. We believe these beta7+ plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our oral recombinant vaccines,” said CSO Sean Tucker. “Further analysis of the data also confirm that, while our vaccine also generated protective hemagglutinin inhibition antibodies in serum like conventional injectable flu vaccines, it primarily protected through the mucosal mechanism, providing a robust 39% reduction in illness versus placebo overall. In contrast, Fluzone, the market-leading injectable quadrivalent influenza vaccine, only provided a 27% reduction in illness versus placebo, while protecting primarily through HAI antibodies.” Vaxart previously reported only 37% of study participants receiving the Vaxart vaccine developed influenza infection after challenge, compared to 44% of those receiving Fluzone and 71% of those receiving placebo. The new Phase 2 data to be presented at IDWeek 2018 showed that the Vaxart vaccine generated a strong increase in mucosal homing antibody secreting cells, or beta7+ plasmablasts. In protected study participants, the percentage of beta7+ plasmablasts in recipients of the Vaxart vaccine nearly doubled, whereas the percentage of beta7+ plasmablasts in Fluzone recipients remained unchanged. The Phase 2 study was completed with support from Biomedical Advanced Research and Development Authority. Vaxart received a $13.9M contract from BARDA in September 2015 to support the advanced development of more effective influenza vaccines to ultimately improve seasonal and pandemic influenza preparedness. The contract was increased to $15.7M in 2017.
https://thefly.com/landingPageNews.php?id=2799671
Amag Pharmaceuticals to present data on Intrarosa at NAMS
Amag Pharmaceutical and Endoceutics announced an oral presentation regarding the effect of time since menopause, age, and previous hormone therapy on treatment efficacy of intravaginal 6.5 mg prasterone at the Annual Meeting of The North American Menopause Society, or NAMS. David Archer and colleagues analyzed combined data obtained from two prospective, randomized, double-blind, placebo-controlled clinical trials to evaluate the effect of daily intravaginal 6.5 mg Intrarosa administered for 12 weeks to women who identified moderate to severe pain at sexual activity as their most bothersome symptom, or MBS, of vulvar and vaginal atrophy, or VVA. The goal of the analysis was to assess the potential influence of time since menopause, age and previous hormone therapy on the response to treatment. Overall, there were 406 women treated with 6.5 mg Intrarosa and 234 women who received placebo. Women were divided into subgroups based upon time since menopause, age and if they had ever taken hormone therapy. While age and prior hormone therapy did not influence the overall efficacy of Intrarosa, the greatest reduction of dyspareunia had a tendency to be observed in women who were 1-2 years post menopause, compared to 3-5 years and more than 6 years post menopause, although the difference did not reach statistical significance.
https://thefly.com/landingPageNews.php?id=2799681
Oramed enrolls first patient in clinical study for oral insulin in NASH
Oramed has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis, or NASH. The three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed’s oral insulin capsule has the potential to reduce inflammation of the liver.
https://thefly.com/landingPageNews.php?id=2799719
Becton Dickinson price target raised to $280 from $250 at Morgan Stanley
Morgan Stanley analyst David Lewis expects Becton Dickinson will guide FY19 revenue growth to 5%-6% during its upcoming Q4 earnings, which he believes “seems achievable if not conservative.” Management is also likely to introduce revenue synergy guidance which should be higher, Lewis predicted. However, he thinks Becton’s reported earnings guidance is likely to come in below the Street consensus. Lewis raised his price target on Becton Dickinson shares to $280 to reflect a roll forward to CY20 estimates and he keeps an Equal Weight rating on the stock.
https://thefly.com/landingPageNews.php?id=2799737
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