Stockwinners Market Radar for March 13, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:49 EDT WTW announces withdrawal from Russia - WTW, a global advisory, broking and solutions company, announced it will withdraw from all of its businesses in Russia. Carl Hess, WTW's CEO, said, "We continue to be dismayed by the crisis in Ukraine. WTW remains steadfast in our support for all our colleagues and their families in the region who have been affected. We wholeheartedly wish for a peaceful solution. WTW intends to transfer ownership of our Russian businesses to local management who will operate independently in the Russian market. While we strongly believe this is the right decision, it was not made in haste nor without consideration for our dedicated Russian colleagues."

18:32 EDT Ascendis Pharma announces Phase 3 PaTHway trial of TransCon PTH data - Ascendis Pharma announced that top-line data from the randomized, double-blind, placebo-controlled portion of its Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism demonstrated statistically significant improvement with TransCon PTH compared to control on the primary composite endpoint and all key secondary endpoints. The primary endpoint - defined as serum calcium levels in the normal range and independence from conventional therapy with no increase in prescribed study drug within the 4 weeks prior to the Week 26 visit - was achieved by 78.7% of TransCon PTH-treated patients, compared to 4.8% for patients in control group. The PaTHway Trial is a Phase 3 double-blind, placebo-controlled trial of 82 dosed adults with chronic hypoparathyroidism randomized 3:1. TransCon PTH was generally well tolerated, with no discontinuations related to study drug. Three patients discontinued during the treatment period - 2 from the placebo arm and 1 from the TransCon PTH arm. 82% of TransCon PTH patients and 100% of patients in control group reported treatment-emergent adverse events, the majority of which were Grade 1, 2 in severity. One serious related TEAE in the TransCon PTH arm was reported due to a dosing error. One death in the TransCon PTH arm was assessed as unrelated to study drug. TransCon PTH-treated patients showed a mean decrease in 24-hour urine calcium excretion into the normal range, from 390 mg/24 hours down to 220 mg/24 hours. Despite a higher mean serum calcium at Week 26, there was a significantly greater decrease in mean 24-hour urine calcium for TransCon PTH-treated patients compared to patients in control group. Following an initial blinded study period of 26 weeks, for which top-line data are reported here, all 79 patients completing the blinded period opted to receive treatment with TransCon PTH in the ongoing open-label extension portion of the study for up to 3 years. As of today, all 79 patients continue in the open label extension portion of the PaTHway Trial. Ascendis plans to submit a New Drug Application to the U.S. Food & Drug Administration for TransCon PTH for adults with hypoparathyroidism during the third quarter of 2022 and a Marketing Authorization Application to the European Medicines Agency during the fourth quarter of 2022. Top-line results for the Phase 3 PaTHway Japan Trial are expected in the third quarter of 2022. In addition, Ascendis plans to initiate a clinical trial of TransCon PTH in pediatric hypoparathyroidism during the fourth quarter of 2022.