BeiGene announced that the National Medical Products Administration of China has accepted the new drug application for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma.
Friday, August 31, 2018
AstraZeneca reports Phase 3 anifrolumab trial did not meet primary endpoint
AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus, or SLE. The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 at 12 months. A full evaluation of the data will be conducted when TULIP 2 data are available later this year. TULIP 1 data will be presented at a future medical meeting. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “SLE is a debilitating autoimmune disease with significant unmet need among patients who struggle to achieve meaningful disease control. The result of this trial is disappointing for patients and the lupus community.”
Cooper Companies earnings pullback a buying opportunity, says KeyBanc
KeyBanc analyst Matthew Mishan views the post-earnings pulback in shares of Cooper Companies as an opportunity. Bigger picture, the company’s revenue growth momentum appears sustainable, Mishan tells investors in a research note. Cooper’s sales beat with revenue growth inflecting sequentially, ahd the pull-though to earnings was understandably offset by current and elevated investment, the analyst contends. He reiterates an Overweight rating on Cooper Companies with a $298 price target.
Patterson Companies price target lowered to $20 from $23 at Barclays
Barclays analyst Steve Valiquette lowered his price target for Patterson Companies to $20 following yesterday morning’s “disappointing” earnings results. The analyst continues to model operating margin compression for Patterson’s dental segment each year during through fiscal 2021. He keeps an Underweight rating on the shares.
https://thefly.com/landingPageNews.php?id=2784469
WellCare price target raised to $360 from $265 at Argus
Argus analyst David Toung raised his price target on WellCare to $360 and kept his Buy rating, saying the company’s acquisition of Meridian is a reflection of its “expansion mode”. The analyst also raised his FY19 EPS view to $12.60 from $12.00, stating that WellCare’s growth opportunities from its M&A strategy justifies its premium valuation of 24.1-times his expected forward earnings – above the peer average of 19.0-times. Toung maintains that WellCare will continue to grow through acquisitions, increased Medicare Advantage coverage, and new contract awards
https://thefly.com/landingPageNews.php?id=2784485
Portola Pharmaceuticals announces Andexxa PAS submission to FDA
Portola Pharmaceuticals announced the submission of a prior approval supplement, or PAS, to the FDA for the large-scale generation 2 manufacturing process for Andexxa, inactivated-zhzo. If approved, the PAS will allow for broad commercial launch of Andexxa in the United States. Andexxa received both U.S. orphan drug and FDA breakthrough therapy designations, and was approved on May 3 under the FDA’s accelerated approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Based on FDA timelines, the company expects a final decision on the PAS in Q1 2019.
https://thefly.com/landingPageNews.php?id=2784529
MEI Pharma price target raised to $7.50 from $6 at Oppenheimer
MEI Pharma price target raised to $7.50 from $6 at Oppenheimer. Oppenheimer analyst Leah Rush raised her price target for MEI Pharma to $7.50 after adjusting her risk discount to reflect the planned registration study for ME-401. The analyst believes the clinical programs are advancing and keeps an Outperform rating on the shares. She anticipates MEI will commercialize its development-stage drug Pracinostat in acute myeloid leukemia and myeloid dysplastic syndromes, and ME-401 in chronic lymphocytic leukemia and follicular lymphoma, in 2022.
https://thefly.com/landingPageNews.php?id=2784543
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