Syneos Health initiated with an Outperform at Evercore ISI. Evercore ISI initiated Syneos Health with an Outperform and $58 price target.
Thursday, October 4, 2018
SeaSpine price target raised to $22 from $16 at Cantor Fitzgerald
Cantor Fitzgerald analyst Craig Bijou raised his price target for SeaSpine to $22 and reiterates an Overweight rating on the shares after hosting a chat with the company’s CEO and CFO. The analyst now has more conviction that SeaSpine can consistently deliver growth in the high-single to low-double-digit range. He thinks the company is “finally starting to see the benefit of management’s hard work over the last three years.” Bijou views SeaSpine’s 2018 sales guidance as conservative and sees upside to 2019 consensus estimates.
Alnylam reports updated ‘positive’ results from Phase 1/2 study of lumasiran
Alnylam Pharmaceuticals announced updated positive results from its Phase 1/2 clinical study of lumasiran, an investigational, subcutaneously administered RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1. The company also announced the initiation of ILLUMINATE-A, a global Phase 3 pivotal trial of lumasiran in children and adults with PH1. The study will enroll approximately 30 patients and is designed in alignment with FDA with a primary endpoint based on reduction of urinary oxalate at six months. Alnylam expects to report topline results from ILLUMINATE-A in late 2019 and, if positive, submit filings for regulatory approval starting in early 2020. New results from the Phase 1/2 study were as of a data cut-off date of August 15, 2018. Lumasiran demonstrated a mean maximal reduction in urinary oxalate of 75 percent relative to baseline across cohorts dosed at 1 mg/kg monthly or 3 mg/kg monthly or quarterly. The mean reduction relative to baseline was 66 percent when measured 28 days post last dose. All patients achieved oxalate lowering to less than 1.5 times the upper limit of normal. Among patients receiving 3 mg/kg monthly or quarterly doses of lumasiran, 83 percent achieved urinary oxalate levels within the normal range. Furthermore, lumasiran-treated patients in all cohorts experienced a mean maximal decrease of 76 percent in the ratio of urinary oxalate to creatinine – a corroborative measure of oxalate reduction that addresses the variability that is inherent to 24 hour urine collections. The Phase 1/2 safety results in patients with PH1 were based on a median study duration of seven months since first dose. As of the data cut-off date, there were no discontinuations from study treatment. Serious adverse events were reported for one patient receiving placebo and five patients receiving lumasiran; none were related to study drug. The placebo patient experienced acute pyelonephritis and kidney stones. The lumasiran patients with SAEs included one patient with vomiting, one patient with abdominal pain, fever and vomiting, one patient with gastroenteritis, and two patients with kidney stones. Adverse events were reported in three patients during placebo dosing and 19 patients after lumasiran dosing. The majority of AEs were mild or moderate in severity and were assessed as unrelated to study drug. Injection site reactions were reported in three patients receiving lumasiran. ISRs were mild or moderate in severity and were self-limiting. Lumasiran was not associated with any clinically significant adverse laboratory findings. In patients receiving lumasiran, plasma glycolate levels increased consistent with the pharmacology of lumasiran and results from healthy volunteers in Part A of the Phase 1/2 study. This increase was not associated with any safety findings.
Zafgen to present data from studies at rare disease confab
Zafgen announced results from three nonclinical, investigational new drug, or IND, -enabling studies of ZGN-1258 to be presented at the Foundation for Prader-Willi Research, or FPWR. ZGN-1258 is Zafgen’s second-generation, novel investigational MetAP2 inhibitor for the treatment of rare metabolic disorders, including Prader-Willi syndrome, or PWS, designed to decrease hyperphagia, change the way the body metabolizes fat, and reduce fat mass. Together, these studies demonstrate nonclinical efficacy and safety for ZGN-1258 and support further development. In one poster, the effects of ZGN-1258 are characterized in mouse models of hyperphagia and obesity. In a second poster, in three mouse models that share features with PWS, ZGN-1258 demonstrates improvement in behavioral manifestations commonly observed in PWS, including low physical activity, anxiety and obsessive-compulsive behaviors. A third poster shows a comparison of the effects of ZGN-1258 and Zafgen’s first generation MetAP2 inhibitor on safety measures, including measures of thrombotic risk, demonstrating a highly differentiated profile for ZGN-1258 on endothelial cell effects.
Walgreens steps up beauty emphasis with Birchbox partnership, CNBC reports
Walgreens is stepping up its emphasis on beauty with a new partnership with Birchbox, CNBC reports. Walgreens, which will take a minority stake in the digital beauty subscription company, will start a pilot program with Birchbox in 11 Walgreens stores Chicago, Dallas, Los Angeles, Miami, Minneapolis and New York City, as well as an online partnership, with Walgreens adding a Birchbox section to its website, according to the report. “Beauty is a very important category for Walgreens, and we’ve been doing a huge amount of work to get ourselves ready for a partnership like this to take us to the next step,” said Lauren Brindley, Walgreens’ group vice president of beauty and personal care
Allergan’s CoolSculpting cleared by FDA to treat area below jawline
Allergan’s CoolSculpting cleared by FDA to treat area below jawline Allergan’s treatment received FDA clearance to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. This recent clearance makes CoolSculpting the first and only nonsurgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments.
Arrowhead gains on news of $3.7 billion license agreement with Janssen
Arrowhead Pharmaceutics Inc. stock ARWR, -8.89% surged 19% in premarket trade Thursday, after the company said it has entered a $3.7 billion license and cooperation agreement with Janssen Pharmaceuticals Inc. to develop and commercialize its ARO-HBV treatment for chronic hepatitis B. As part of the deal, Arrowhead will receive $175 million upon close and Janssen parent Johnson & Johnson Innovation JJDC Inc., a unit of Johnson & Johnson JNJ, -0.62% will buy a $75 million stake priced at $23 a share of Arrowhead common stock. Arrowhead will be eligible to receive up to $1.6 billion in milestone payments and another roughly $1.9 billion in option and milestone payments for reaching three additional targets. The company will also be eligible for tiered royalties on product sales. Janssen will have an exclusive license on the ARO-HBV program, a subcutaneously administered RNAi therapeutic candidate aimed at treating hepatitis B. The deal is expected to close in the fourth quarter. Arrowhead shares have gained 404% in 2018, while the S&P 500 SPX, -0.59% has gained 9%.
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