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Monday, April 1, 2019

Stryker price target raised to $219 from $214 at Wells Fargo

Wells Fargo analyst Larry Biegelsen raised his price target for Stryker to $219 from $214 following his monthly MAKO Surgeon Tracker, that analyzes trends in surgeon training. The analyst notes that surgeon training for Stryker’s MAKO Total Knee Application was up 1.2% in March month over month as compared to up 2.7% in February. There is typical quarter-to-quarter variation in surgeon training and Biegelsen expects normalized growth going forward versus the high-growth seen in the initial quarters post launch. The analyst continues to believe there is runway for growth as MAKO remains vastly underpenetrated both from a system placement and procedure volume standpoint, globally. He reiterates an Outperform rating on the shares.

Encompass Health to acquire Alacare Home Health & Hospice

Encompass Health announced it has entered into a definitive agreement to purchase substantially all of the assets of privately owned Alacare Home Health & Hospice. Birmingham, Alabama-based Alacare operates 23 home health locations and 23 hospice locations in Alabama and generated revenues of approximately $117M in 2018. The transaction is expected to close in the second quarter of 2019, subject to certain customary closing conditions and regulatory approvals. Encompass Health will fund the purchase with cash on hand and borrowings under its revolving credit facility.

Puma Biotechnology, Pierre Fabre enter into license agreement

Puma Biotechnology and Pierre have entered into an exclusive license agreement under which Pierre Fabre will develop and commercialize NERLYNX within Europe and part of Africa. In September 2018 the European Commission granted marketing authorization for NERLYNX for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy. Under the terms of the agreement, Puma will receive an upfront payment of $60M, as well as additional regulatory and commercial milestone payments totaling up to $345M. In addition, Puma will receive significant double-digit royalties on NERLYNX sales throughout the territory covered by the license agreement between Puma and Pierre Fabre.

Iovance Biotherapeutics presents data on T-cell diversity at AACR meeting

Iovance Biotherapeutics announced data from an investigation of the persistence and diversity of circulating T cells from metastatic melanoma patients from the innovaTIL-01 study receiving lifileucel TIL therapy. Results from an analysis of the persisting T cell clones circulating 42 days following infusion, as compared to the initial TIL product, demonstrated two phenomena: first, that TIL product from 100 percent of the evaluated patients in Cohort 2 of the innovaTIL-01 trial are persisting in circulation at 42 days post-infusion, and second, that each patient has a unique TIL product with almost no overlap between patients for expanding clones in the human body observed post-infusion. Furthermore, the small number of overlapping clones between a few patients were not associated with a clinical response. The uniqueness of the clonal profiles associated with response highlights the challenge of identifying a few T cell receptors as mediators of activity and supports using a polyclonal product such as the Iovance bulk TIL to treat high mutational load solid tumors.

Cowen ups AstraZeneca to Outperform after cancer partnership pullback

As previously reported, Cowen analyst Steve Scala upgraded AstraZeneca to Outperform from Market Perform, stating that the 5% stock decline on news of the company’s partnership with Daiichi Sankyo for trastuzumab deruxtecan, which he calls a “promising” breast cancer drug, offers a compelling entry point. Key opinion leading doctors he speaks with anticipate use of trastuzumab deruxtecan in many patients with metastatic HER2+ disease, while low HER2+ “shows promise but requires more data,” said Scala. Meanwhile, Imfinzi, Tagrisso and Lynparza all have “big potential” and Roxadustat “offers upside,” the analyst tells investors. He raised his price target on AstraZeneca shares to $48 from $42.

Fate Therapeutics presents data on clonal master engineered iPSC lines

Fate Therapeutics presented late-breaking preclinical data highlighting the company’s “unmatched ability to mass produce uniformly engineered chimeric antigen receptor T cells for off-the-shelf cancer immunotherapy” at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. New preclinical data presented at AACR for FT819, the company’s universal, off-the-shelf CAR19 T-cell product candidate being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., demonstrate the production of clonal master engineered iPSC lines having complete elimination of T-cell receptor expression and insertion of a novel 1XX CAR signaling domain into the T-cell receptor alpha locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic profile of CAR T cells.

PolarityTE enrolls patients in trials evaluating SkinTE

PolarityTE announced that patient enrollment has begun for two new randomized controlled trials evaluating SkinTE for the treatment of chronic wounds, specifically diabetic foot ulcers and venous leg ulcers. SkinTE is commercially available through a regional market release and is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement.