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$ENTA expects to initiate two clinical studies by the end of 2017: a Phase 2 clinical study of EDP-305 in patients with primary biliary cholangitis and a Phase 1 study of respiratory syncytial virus development in healthy volunteers. A Phase 2 clinical study of EDP-305 in patients with NASH is also expected to begin in early 2018.
Biotech company $ENTA swung to 4Q17 profit on higher revenue, driven by milestone payments totaling $65MM received following $ABBV's U.S. approval of MAVYRET and EU approval of MAVIRET. Net income was $36.5MM or $1.86 per share in the quarter compared to a net loss of $1.8MM, or $0.09 loss per share a year earlier. Revenue jumped to $75.9MM.
$ENTA said that Japanese Ministry of Health, Labour and Welfare approved AbbVie’s MAVIRET, a ribavirin-free treatment for adults with chronic hepatitis C virus infection across all major genotypes (GT1-6). Enanta expects a $15MM milestone payment from AbbVie in the quarter ending Dec 31, 2017, upon price reimbursement approval of MAVIRET in Japan.
Pharmaceuticals company $ENTA has appointed Kristine Peterson to its BoD, raising the total number of directors to seven. Peterson had served as CEO of Valeritas Inc from 2009 to 2016. Earlier, she held marketing and commercial positions at Johnson & Johnson, most recently as Company Group Chair of the biotech division.
$ENTA said that regarding AASLD, the company has got different datasets together. $ENTA is also doing a larger study with full dose ranging in both patient populations; healthy volunteers and presumed NAFLD. Therefore, this is a bigger trial than the normal Phase 1, which has close to 150 subjects data.
At 2Q17 end, $ENTA's cash, cash equivalents and short-term and long-term marketable securities totaled $240.9MM. Enanta expects that its current cash, cash equivalents and marketable securities will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.
Total revenue of $ENTA slid 31% to $9.0MM in 2Q17, as the pharma company's net loss more than tripled to $5.4MM from last year's $1.6MM. Losses widened to $0.28 per diluted share from $0.09 a share, as R&D expenses hiked 43% to $13.0MM for the quarter.
$ENTA announced that priority review has been granted by the Japanese Ministry of Health, Labour and Welfare to $ABBV for its investigational, pan-genotypic, ribavirin-free combination of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus infection.
$ENTA said the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s New Drug Application (NDA) for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) being evaluated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV), and has granted the NDA priority review.
$ENTA said $ABBV submitted New Drug Application to the U.S. Food and Drug Administration for investigational, pan-genotypic, fixed-dose combination of glecaprevir and pibrentasvir, being evaluated for treatment of chronic hepatitis C Virus (HCV). $ABBV is on track to submit marketing authorization application in the European Union in early 2017.
$ENTA said it has demonstrated the efficiency of EDP-305, its lead FXR agonist under development to treat patients with non-alcoholic steatohepatitis. $ENTA is pursuing research in other classes of FXR agonist also. "Our work has resulted in an emerging intellectual property estate of over a dozen patent applications related to FXR agonist."
$ENTA expects to incur $50-60MM of R&D expense for FY17. $ENTA started phase 1 trials of EDP-305, its lead FXR agonist, which will treat silent liver disease or nonalcoholic steatohepatitis (NASH) as well as EDP-494, novel cyclophilin inhibitor. Also, $ENTA advanced promising leads in respiratory syncytial virus and hepatitis B virus.
$ENTA's research and development expenses for 4Q16 grew to $11.5MM from $7MM a year ago. This was due to increased clinical costs from progression of R&D programs in hepatitis C virus (HCV) cyclophilin, non-alcoholic steatohepatitis (NASH), respiratory syncytial virus (RSV) and hepatitis B virus (HBV).
Biotechnology company $ENTA slipped to a 4Q16 loss from a profit last year, due to higher research and development expenses. Net loss was $1.8Bil or $0.09 per share compared to a profit of $5.81MM or $0.29 per share a year ago. Revenue fell to $12.84MM from $14.42MM.
$ENTA said the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for $ABBV's investigational chronic hepatitis C virus (HCV) regimen. The BTD is granted based on phase 2 Magellan-1 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs).
$ENTA begins Phase 1 clinical study of EDP-305, its lead farnesoid X receptor (FXR) agonist under development to treat patients with non-alcoholic steatohepatitis (NASH) or fatty liver disease. The first subjects dosed in study that will evaluate EDP-305 in healthy subjects and subjects with presumptive non-alcoholic fatty liver disease (NAFLD).