Walgreens Boots Alliance price target lowered to $77 from $87 at Mizuho. Mizuho analyst Ann Hynes views Walgreens Boots Alliance’s sell-side event last week as “strange.” Management highlighted the company was focused on a new strategy for the stores, but would not share any details on the strategy for competitive reasons, Hynes tells investors in a research note. The analyst, however, keeps a Buy rating on the shares citing Walgreens’ current valuation, “strong” cash flow and likely limited downside risk to adjusted earnings estimates
Tuesday, May 29, 2018
Bayer, Loxo to get FDA priority review for cancer med
Bayer announced that the FDA has accepted the New Drug Application, or NDA, submitted by its collaboration partner Loxo Oncology and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase, or NTRK, gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act. NTRK gene fusions are genetic alterations that result in production of tropomyosin receptor kinase fusion proteins, and lead to the development of tumor growth. Bayer and Loxo Oncology are jointly developing larotrectinib, which is being studied globally for the treatment of patients across a wide range of cancers that harbor an NTRK gene fusion. Bayer plans to submit a Marketing Authorization Application, or MAA, in the European Union in 2018.
Foundation has new data on genomic profiling assays
Foundation Medicine announced that new data generated from its comprehensive genomic profiling assays will be presented at the American Society of Clinical Oncology Annual Meeting from June 1-5, 2018 in Chicago. The company and its collaborators will present a total of 28 studies, including two oral presentations. Highlights of these presentations include: studies demonstrating the importance of known and novel genomic biomarkers of immunotherapy response, including tumor mutational burden, microsatellite instability and PBRM1 alterations across a diverse range of cancer types that could inform more precise use of these treatments; new data from PURE-01, a phase II study evaluating neo-adjuvant pembrolizumab in urothelial bladder cancer demonstrates the ability of CGP to detect genomic biomarkers when combined with T-cell inflammation signatures to potentially predict response to immunotherapy; new data showing that high tissue TMB is associated with higher likelihood of response and longer duration of response to atezolizumab in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma; data from FoundationACT liquid biopsy assay, describing the landscape of kinase fusions and rearrangements from ctDNA in more than 9,000 clinical cases across multiple cancer types; and updated data from the precision oncology I-PREDICT clinical trial showing improvements in patient outcomes with integration of molecular tumor boards informed by CGP into treatment planning. These studies further underscore the importance of Foundation Medicine’s portfolio of CGP assays and molecular data services in supporting precision treatment approaches using tissue or blood samples.
Inspire Medical started at buy by Stifel
Inspire Medical initiated with a Buy at Stifel. Stifel analyst Jonathan Block started Inspire Medical Systems with a Buy rating and $42 price target, stating that his diligence with ENTs and Sleep Specialists identifies a significant opportunity for the company’s Upper Airway Stimulation procedure to gain market share from more invasive surgical procedures. Block also believes the company’s clinical data is likely robust enough to eventually win over commercial payors and sets a high hurdle for future competitors, he tells investors.
G1 started at buy by Wainwright
G1 Therapeutics initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Edward White started G1 Therapeutics with a Buy rating and $61 price target. The company’s trilaciclib could improve patient outcomes by maximizing the beneficial effects of chemotherapy, while minimizing myelosuppression and immunosuppression, White tells investors in a research note. He believes investors are missing the potential of trilaciclib, which he thinks become part of the standard of care for patients with CDK4/6-independent tumors, including small cell lung cancer and triple-negative breast cancer, that receive chemotherapy.
Acorda Parkinson’s med scheduled to get Europe review
Acorda Therapeutics announced that the European Medicines Agency, or EMA, has completed formal validation of Acorda’s Marketing Authorization Application, or MAA, for Inbrija. Inbrija is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The Inbrija MAA was submitted to the EMA on March 23. The EMA review of the MAA will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use, or CHMP, expected within 210 days. After the adoption of a CHMP opinion, a final decision regarding the MAA is carried out by the European Commission. The FDA is currently reviewing a new drug application for Inbrija and has set an action date of October 5 under the Prescription Drug User Fee Act.
Illumina target upped by Canaccord
Illumina price target raised to $290 from $270 at Canaccord. Canaccord analyst Mark Massaro raised his price target on Illumina to $290 from $270 and said it remains a “must-own” large cap stock. The company remains a top pick given its dominant leadership in the next-gen sequencing market. He sees room for raised guidance in 2018 given rising demand for NGS consumables and array consumables/services. Massaro reiterated his Buy rating on Illumina shares.
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