Gilead $GILD to initiate Trials of filgotinib in Crohn’s and Ulcerative colitis with Galapagos- Galapagos N.V. $GLPG announced that it has successfully concluded negotiations with the both the American and European regulatory authorities that paves the way to initiate Phase 3 study, DIVERSITY, evaluating filgotinib for the treatment of Crohn’s disease and a Phase 2 b/3, SELECTION, in ulcerative colitis. Both studies will enroll about 1,300 participants at sites spread across the world. Gilead Sciences $GILB, a collaborative partner will lead the effort.
Alnylam Terminates revusiran development-Alnylam $ALNY shares nosedived in afterhours trading on Wednesday amid heavy volume trading in response to news that it has decided to terminate development of revusiran, an RNAi therapeutic for the potential treatment of hereditary ATTR amyloidosis (hATTR) with cardiomyopathy, an Orphan Drug Designation. The company also communicated its decision to regulatory authorities, study sites, and investigators.
Global Blood Falls Sharply ahead of Key sickle cell conference in London-Global Blood Therapeutics fell more than 10% on Wednesday amid four-fold increase in trading volume as investors remained anxious ahead of a key sickle cell meeting. The 2016 Sickle Cell Thalassemia Conference (ASCAT) got underway in London on Wednesday. Investors are edgy about the company’s lead product candidate, GBT440, in mid-stage development for sickle cell disease (SCD), particularly, a possibility that the efficacy period will be extended from 28 days to six months. At a Cowen panel today, doctors were unconvinced about GBT440's mechanism of action, adding to the bearish sentiment.GBT440 is an oral, once-daily SCD therapy that works by increasing hemoglobin's affinity for oxygen.
RedHill BioPharma Commences Mid-Stage Trial with YELIVA-RedHill BioPharma $RDHL announced that it has begun a Phase 2 clinical trial assessing YELIVA (ABC294640) in patients with advanced hepatocellular carcinoma (HCC). The study will be conducted at the Medical University of South Carolina Hollings Center, including several clinical centers in the U.S. It is supported by a $1.8mn grant from the National Cancer Institute. Enrollment for the study would commence soon. The trial will evaluate YELIVA as second-line monotherapy in up to 39 participants with advanced HCC who have experienced tumor progression following treatment with first line single agent sorafenib (Bayer’s Nexavar).
FDA cautions of risk of HBV reactivation in patients taking HCV meds-The FDA notified that it now requires a black box warning in the labels of at least nine brand name direct acting antiviral drugs for the treatment of hepatitis C virus (HCV) infection due to the risk of reactivation of hepatitis B in patients who previously had the disease. The authority said that it has observed 24 cases of such reactivation from November 22, 2013 to July 18, 2016. The revised labeling applies to Gilead Sciences $GILD Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), AbbVie's $ABBV Viekira Pak (ombitasvir/paritaprevir/ritonavir, dasabuvir) and Merck's $MRK Zepatier (elbasvir and grazoprevir).
Hurricane Matthew Might Spread Zika Virus-Officials in Florida have warned that hurricane Matthew could make controlling Zika a difficult task by interrupting mosquito-spraying efforts and boosting numbers of the biting bugs that spread the virus. The warnings come just after the authorities revealed six new suspected non-travel Zika cases in Miami Beach and Miami-Dade County, adding the number of cases where local mosquitoes are believed to have caused infections to 139. Zika treatment related tickers are: $SNY, $ABT, $INO, $AEMD, $XON, $CEMI, $BCRX, $TMO, $OSUR.