Mon, Aug. 8, 4:24 PM
Mon, Jun. 20, 10:06 AM
- Enanta Pharmaceuticals (ENTA +2.5%) commences the proof-of-concept portion of its ongoing Phase 1 study evaluating EDP-494, a pan-genotypic cyclophilin inhibitor, in patients with hepatitis C virus (HCV) genotypes 1 or 3 infection. The double-blind, randomized phase will assess the safety, pharmacokinetics and anti-viral activity of two different oral doses of EDP-494 in treatment-naive HCV patients, administered once daily for 14 days.
- According to the company, there is increasing resistance to currently available direct-acting HCV antivirals (DAAs). EDP-494 avoids this problem via its unique mechanism of action, inhibiting a protein called cyclophilin which plays an essential role in HCV replication. EDP-494 is called a host-targeting antiviral which means that it targets the host proteins that are involved in the viral life cycle. Other HCV therapies are categorized as virus-targeting antivirals since they act directly on viral proteins. It says cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
- After the Phase 1 is completed, Enanta intends to develop EDP-494, in combination with one or more DAAs, for treatment-resistant HCV infection.
- HCV-related tickers: (GILD +1.6%)(JNJ +1.1%)(BMY +1%)(MRK +1%)(GSK +3.4%)(RGLS +0.7%)(ABBV +1.7%)
Mon, May 9, 4:10 PM
Fri, Apr. 15, 8:21 AM
- Results from the ongoing Phase 2 MAGELLAN-1 study evaluating AbbVie's (NYSE:ABBV) pan-genotypic regimen of ABT-493 (300 mg) and ABT-530 (120 mg) with ribavirin (RBV) in patients with genotype 1 and genotypes 4-6 chronic hepatitis C virus (HCV) infection who failed previous therapy with direct-acting antivirals (DAAs) showed a 91% cure rate (SVR12) in the intent-to-treat population (n=20/22). In addition, 86% (n=19/22) of HCV-1 patients who received the regimen without ribavirin achieved SVR12. The data are being presented today at The International Liver Congress 2016 in Barcelona, Spain.
- In a modified intent-to-treat analysis which excluded patients who did not achieve SVR for reasons other than virologic failure, 95% were cured (with or without ribavirin).
- There were no discontinuations due to adverse events (AEs). Two patients experienced virologic failure, one from each arm (with/without ribavirin). The most common AEs reported were headache (30%), fatigue (27%) and nausea (20%).
- ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, are currently in Phase 3 development. ABT-493 was discovered under the company's collaboration with Enanta Pharmaceuticals (NASDAQ:ENTA).
- Read now Purchase AbbVie: Doctor's Orders
Tue, Feb. 9, 12:48 PM
Mon, Feb. 8, 4:04 PM
- Enanta Pharma (NASDAQ:ENTA): FQ1 EPS of $1.36 beats by $0.23.
- Revenue of $48.4M (-37.5% Y/Y) beats by $1.35M.
Nov. 24, 2015, 7:28 AM
- Enanta Pharmaceuticals (ENTA +1.5%) FQ4 results: Revenues: $14.4M (+453.8%); R&D Expense: $7M (+34.6%); SG&A: $3.7M (+32.1%); Operating Income: $3.7M (+169.8%); Net Income: $5.8M (+216.0%); EPS: $0.29 (+207.4%); Quick Assets: $145.2M (+59.9%).
- FY2015 results: Revenues: $160.9M (+237.3%); R&D Expense: $23.2M (+24.1%); SG&A: $13.5M (+35.0%); Operating Income: $124.1M (+553.2%); Net Income: $79M (+129.7%); EPS: $4.09 (+127.2%); Quick Assets: $145.2M (+59.9%).
- No guidance given.
Nov. 23, 2015, 4:05 PM
- Enanta Pharma (NASDAQ:ENTA): FQ4 EPS of $0.29 beats by $0.14.
- Revenue of $14.42M (+446.2% Y/Y) misses by $2.02M.
Nov. 22, 2015, 5:35 PM
Nov. 20, 2015, 9:31 AM
- In a regulatory filing, Enanta Pharmaceuticals (NASDAQ:ENTA) discloses that it earned a $30M milestone payment from development partner AbbVie (NYSE:ABBV) triggered by the establishment of reimbursement for VIEKIRAX in Japan. The Japanese Ministry of Health, Labour and Welfare cleared it for sale in September.
Nov. 16, 2015, 10:07 AM
- Data from two mid-stage clinical trials, SURVEYOR-I and SURVEYOR-II, show AbbVie's (ABBV +1.3%) investigational HCV regimen, ABT-493 and ABT-530, produced cure rates as high as 100% after 12 weeks of treatment. The results are being presented at The Liver Meeting in San Francisco.
- Results from the two ongoing studies include genotypes 1, 2 and 3. Data from genotypes 4 - 6 will be presented at future meetings.
- SURVEYOR-I is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adult HCV-1 patients and non-cirrhotic HCV-4,-5 and -6 treatment-naive or treatment-resistant adults. The cure rates range from 97 - 100% in HCV-1.
- SURVEYOR-II is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adults with HCV-2 or -3 who were new to therapy or had failed earlier treatment with interferon/ribavirin. The cure rates range from 96 - 100% in HCV-2 and 83 - 94% in HCV-3.
- ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, are being developed for the pan-genotypic (genotypes 1-6) treatment of HCV infection. ABT-493 was discovered under the company's collaboration with Enanta Pharmaceuticals (ENTA -1.2%). A Phase 3 trial in genotypes 1-6 was initiated this month.
- Related tickers: (MRK +0.4%)(GILD +0.1%)(BMY +0.2%)(JNJ +0.8%)
Nov. 16, 2015, 7:42 AM
- Preliminary results from a Phase 2a clinical trial, OSIRIS, showed HCV-4 patients treated with Janssen's (NYSE:JNJ) OLYSIO (simeprevir) and Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) for 12 weeks achieved cure rates as high as 100%. The data were presented at The Liver Meeting in San Francisco.
- OSIRIS assessed the regimen of simeprevir 150 mg and sofosbuvir 400 mg in 63 HCV-4 patients, both treatment-naive and treatment-experienced, with and without cirrhosis. Patients without cirrhosis were randomized to receive either eight or 12 weeks of therapy while patients with cirrhosis received 12 weeks of treatment.
- Results showed a 100% cure rate (SVR12) in patients treated for 12 weeks (n=43) and 75% (n=20) in patients treated for eight weeks. Five patients in the eight-week group relapsed, all were genotype IL28B non-CC and non-responders to other therapies.
- HCV-4 is the most common type of HCV infection in the Middle East. As many as 10% of Egyptians are HCV-positive, almost all genotype 4.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:MRK)
Nov. 16, 2015, 7:05 AM
- Pharco Pharmaceuticals, Egypt's largest drug firm, announces results from a Phase 3 clinical trial assessing the combination of Gilead Sciences' (NASDAQ:GILD) sofosbuvir (different formulation than Sovaldi) plus privately held Presidio Pharmaceuticals' pan-genotypic NS5A inhibitor ravidasvir in patients with HCV genotype 4 infection. The data will presented today at The Liver Meeting in San Francisco.
- Results from the 300-subject study showed that treating HCV-4 patients with sofosbuvir 400 mg and ravidasvir 200 mg once daily for 12 weeks resulted in cure rates (SVR12) of 98% overall (n=255/261) and 100% (n=163/163) in non-cirrhotic patients, suggesting that ribavirin in unnecessary for these patients even if they failed to respond to treatment with interferon. No relapses were observed.
- According to Sovaldi's package insert, its HCV-4 cure rate is 96% (n=27/28) when combined with interferon and ribavirin per results from the NEUTRINO study.
- HCV-4 is the most common type of HCV infection in the Middle East.
- Pharco licensed ravidasvir hydrochloride in Egypt from Presidio Pharma in August 2014.
- Related tickers: (NYSE:ABBV) (NYSE:MRK) (NASDAQ:ENTA)
Oct. 23, 2015, 7:27 AM
- Diplomat Pharmacy (DPLO +2.3%) initiated with Buy rating and $35 (44% upside) price target by UBS.
- Enanta (ENTA -1.2%) upgraded to Outperform from Market Perform by JMP Securities. Price target is $32 (36% upside).
- ZS Pharma (ZSPH +3.2%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $76 (15% upside) from $67.
- Pfizer (PFE +1.3%) upgraded to Outperform from Market Perform by Cowen and Company. Price target raised to $43 (27% upside) from $35.
- Valeant Pharmaceuticals (VRX +9.1%) downgraded to Market Perform from Outperform by BMO Capital. Price target lowered to $141 (28% upside).
- Mead Johnson (MJN +0.8%) downgraded to Neutral from Outperform by Credit Suisse. Price target is $86 (8% upside).
- Community Health Systems (CYH +6.7%) downgraded to Neutral from Buy by BofA Merrill Lynch. Price target lowered to $42 (50% upside) from $64.
Aug. 7, 2015, 5:40 PM
Aug. 6, 2015, 5:08 PM
- Enanta Pharma (NASDAQ:ENTA): FQ3 EPS of $0.13 misses by $0.06.
- Revenue of $11.6M (-72.4% Y/Y) misses by $4.58M.