Pharmaceutical-grade cannabidiol oral solution made by INSYS Therapeutics was generally well-tolerated-even at high doses-as an investigational treatment for refractory pediatric epilepsy, according to new clinical data from a long-term safety study presented yesterday at the American Epilepsy Society 2018 annual meeting. “The results of this study support the promising safety profile of CBD oral solution from INSYS in the context of treating pediatric patients with intractable seizures due to epilepsy,” said James W. Wheless, M.D., professor and chief of pediatric neurology at the University of Tennessee Health Science Center in Memphis, where he directs the Neuroscience Institute & Le Bonheur Comprehensive Epilepsy at Le Bonheur Children’s Hospital and holds the Le Bonheur Chair in Pediatric Neurology. “In addition, these long-term safety data are consistent with those from other studies of CBD in refractory pediatric epilepsy.”
Tuesday, December 4, 2018
Veeva initiated at Leerink
Veeva initiated with an Outperform at Leerink. Leerink initiated Veeva with an Outperform and $120 price target.
Foamix remains ‘substantially undervalued,’ says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Foamix Pharmaceuticals to $12 from $11 citing the positive top-line results from two pivotal Phase 3 clinical trials of FMX103 for the treatment of moderate-to-severe papulopustular rosacea. The analyst believes the high level of statistical significance underscores the degree of efficacy observed. He reiterates a Buy rating on Foamix and says the stock remains “substantially undervalued.”
Cantor sees value in Vanda despite 26% rally, upgrades to Overweight
Cantor Fitzgerald analyst Charles Duncan upgraded Vanda Pharmaceuticals to Overweight from Neutral and raised his price target for the shares to $43 from $26. The analyst is “impressed” with the effect size magnitude for tradipitant in the Phase 2 study in patients with idiopathic and diabetic gastroparesis. This points to a clinically meaningful increase in nausea-free days, indicating a clear improvement in patient quality of life, Duncan tells investors in a research note. The analyst sees value in the shares despite yesterday’s 26% rally.
Anthem price target raised to $330 from $305 at Cantor Fitzgerald
Cantor Fitzgerald analyst Steven Halper raised his price target for Anthem to $330 after management said in investor meetings that it will use $3.2B from its pharmacy benefit manager savings beginning in 2020 and 2021 to drive membership growth in subsequent years. Accordingly, the analyst increased his top-line growth assumptions. He expects membership and revenue to grow faster without sacrificing margins and keeps an Overweight rating on Anthem.
TG Therapeutics presents data from ublituximab trial at ASH
TG Therapeutics announced updated clinical data from its Phase I/Ib trial of ublituximab, the company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with umbralisib, the company’s oral, next generation PI3K delta inhibitor, and bendamustine, in patients with Diffuse Large B-cell Lymphoma, or DLBCL, and Follicular Lymphoma, or FL. Data from this trial was presented yesterday evening during a poster session at the American Society of Hematology, or ASH. This poster presentation includes data from patients with relapsed or refractory DLBCL or FL treated with the triple combination of umbralisib, ublituximab and bendamustine. Thirty-nine patients were evaluable for safety of which 38 were evaluable for efficacy. Twenty-two patients were refractory to prior treatment. Overall, the triple combination was well tolerated and highly active in patients with advanced indolent and aggressive NHL, including those not eligible for HD/SCT or CD19 CART therapy.
Gilead receives China NMPA approval for Descovy for the treatment of HIV-1
Gilead Sciences announced that the China National Medical Products Administration has approved Descovy, a fixed-dose combination for the treatment of HIV. In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 in adults and adolescents. In the United States, Descovy has a boxed warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, TAF demonstrated improved renal and bone laboratory safety parameters compared to TDF. In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003. The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies in which the F/TAF-based regimen met its primary objective of non-inferiority compared to an F/TDF-based regimen among treatment naive adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen. The approval also is supported by a Phase 3 study evaluating the F/TAF-based regimen among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naive adolescents. Descovy received marketing approval from the U.S. Food and Drug Administration and the European Commission in 2016. In the U.S., only the emtricitabine 200 mg/tenofovir alafenamide 25 mg dosage form is approved. Descovy does not cure HIV infection or AIDS.
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