Baxter initiates U.S. clinical trial for on-demand PD solution generation system

Baxter International announced that the first patients have been enrolled in a U.S. clinical trial for the company’s on-demand peritoneal dialysis, or PD, solution generation system. The innovative system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The FDA has indicated that the company may proceed with the prospective, multi-center clinical trial.
https://thefly.com/landingPageNews.php?id=2844625

Gamida Cell expects to present additional data from NAM-NK study in 1H19

Gamida Cell expects to achieve the following milestones this year: Present additional data from the Phase 1 study of NAM-NK in first half of 2019. Report early data from the Phase 1/2 study of NiCord in patients with severe aplastic anemia data in the first half of 2019. Complete patient enrollment in the Phase 3 study of NiCord in patients with high-risk hematologic malignancies in the second half of 2019.
https://thefly.com/landingPageNews.php?id=2844639

Eli Lilly sees no change to dividend policy as a result of Loxo deal

Eli Lilly (LLY), on its conference call discussing its proposed $8B acquisition of Loxo Oncology (LOXO), said that it sees no change to dividend policy as a result of the deal, though it will limit share repurchases in 1H. The company said it expects modest downward pressure on margins in the near-term.
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Jefferies keeps $30 target on Amarin, says guidance conservative

Amarin Friday night reported “strong” Q4 Vascepa results, although stock is trading lower perhaps due to conservative guidance, Jefferies analyst Michael Yee tells investors in a research note. The analyst views the news “as a positive sign of what’s been going on recently.” Amarin does not even have a label expansion yet and it has been only two months since the mid-November data presentation, Yee writes. He expects trends to continue to grow monthly throughout the year, even before Amarin receives a formal label expansion. While the stock may be down today, “things look strong fundamentally,” Yee contends. He views the company’s sales guidance as conservative and keeps a Buy rating on Amarin with a $30 price target.
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Nevro sees Q4 revenue $107.6M-$108.1M, consensus $106.15M

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Ascendis Pharma reports oncology as second independent area of focus

Ascendis Pharma introduced Vision 3×3, the company’s strategic roadmap through 2025 to achieve sustainable growth, at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. As part of that vision, the company also announced oncology as its second independent therapeutic area of focus. The goal of Ascendis Pharma’s Vision 3×3 strategic roadmap through 2025 is to achieve sustainable growth through multiple approaches: Obtain regulatory approval for three endocrinology rare disease products: TransCon hGH for pediatric growth hormone deficiency, TransCon PTH for adult hypoparathyroidism (HP), and TransCon CNP for achondroplasia. Create further growth of the company’s endocrinology rare disease pipeline through: Label expansion programs with the goal of obtaining 9 indications in total; and Global clinical reach either directly or through partnerships. Build an integrated commercial business for the endocrinology rare disease franchise in North America and select European countries, and establish a global commercial presence with partners in other geographic areas. Create three independent therapeutic areas, each with a diversified pipeline built on TransCon technologies and the company’s unique algorithm for product innovation. The company has established oncology as the next independent therapeutic area. Ascendis also announced that it has established oncology as its second independent therapeutic area. To lead the oncology research and development programs, Ascendis recently appointed Juha Punnonen, MD, PhD, as Senior Vice President and Head of Oncology.
https://thefly.com/landingPageNews.php?id=2844671

Quorum Health to divest Big Springs, Texas hospital

Quorum Health announced that it has entered into a definitive agreement to divest the 146-bed Scenic Mountain Medical Center in Big Springs, Texas. The transaction is expected to be complete by the end of the first quarter of 2019, subject to customary approvals and conditions.
https://thefly.com/landingPageNews.php?id=2844681