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2 Attractive But Speculative Biotech Gems For Consideration
- Many of the names in the small cap biotech sector seem to be on the move recently posting some of the strongest performances since the biotech sell-off in March.
- Part of this could be due to fund managers picking up high beta names to catch up with their benchmarks by year end and/or abandoning other "risk on" sectors like energy.
- Below are profiled two attractive, but speculative biotech gems I hold within my "Shotgun Investing" portfolio that could have major upside if they deliver solid trial results.
Conatus Pharmaceuticals Down On Low Enthusiasm For High Risk
- While biotechs targeting liver diseases were hot earlier in 2014, they have been weakened considerably as investors have turned away from biotechs with risky and early-stage programs.
- The basic mechanism of action for emricasan makes sense, targeting the broad array of caspases that lead to inflammation and cell death in the liver.
- Even with longer timelines to peak revenue, I still believe Conatus shares can trade to more than $20 if the company's Phase II reports are positive.
Conatus Pharmaceuticals: Large Upside With Attractive Risk And Income Profiles
- Healthcare and Biotechnology will continue to produce strong results for the near to mid term.
- Conatus Pharmaceuticals is well poised to generate effective treatment in a spectrum of liver diseases.
- By using a covered-call strategy one can build a position with 100% upside potential coupled with an attractive risk profile and attractive income.
Conatus Pharmaceuticals: An Undervalued Biotech With Intriguing Long-Term Potential
- As a world leader in caspase protease inhibition, Conatus could change the way the medical world treats liver disease.
- After a successful carcinogenicity study regulated by the FDA, Conatus stands on the cusp of succeeding where others have failed.
- With more than 80% of outstanding shares held by reputable institutions, downside risk for retail investors is minimized.
- In possession of a versatile drug candidate with multiple market implications, Conatus could make a noteworthy impact on a multi-billion dollar market.
Conatus: An Undervalued Biotech With A Looming Short Squeeze
- Conatus' sell-off represents an opportunity for considerable near-term price appreciation as shorts begin covering before Thursday's earnings announcement.
- Roth Capital Analysts have a $23 CNAT price target that is almost triple the current price.
- Conatus shares are currently trading below IPO levels of almost 1 year ago, despite past positive phase 1 and 2 studies.
Fri, Nov. 21, 8:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of AbbVie's (NYSE:ABBV) Viekirax (a combination of ombitasvir, paritaprevir and ritonavir) plus Exviera (dasabuvir), with or without ribavirin, for patients with chronic HCV genotype 1 infection and Viekirax only, with ribavirin, for patients with HCV genotype 4 infection. A final decision by the European Commission usually takes about 60 days.
- The FDA tagged Viekirax a Breakthrough Therapy and granted priority review of AbbVie's NDA in June.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:CNAT) (NASDAQ:ACHN)
- Previously: Enanta declines HCV drug co-development option with AbbVie
- Previously: AbbVie presents HCV/HIV and liver transplant HCV data
Wed, Nov. 12, 4:04 PM
Tue, Nov. 11, 5:35 PM
Tue, Nov. 11, 11:03 AM
- At The Liver Meeting in Boston, Gilead Sciences (GILD +1.1%) presented results from several Phase 2 and Phase 3 trials evaluating Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic HCV infection in patients with limited or no treatment options, including decompensated cirrhosis, HCV recurrence following liver transplantation and patients refractory to other direct-acting antivirals.
- In a pooled analysis of Phase 2 and Phase 3 open-label studies involving more than 500 HCV-1 patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, 96% achieved SVR12.
- In a Phase 2 open-label study evaluating patients with decompensated cirrhosis and those with HCV recurrence after a liver transplant, 87% of those receiving Harvoni + RBV for 12 weeks achieved SVR12 compared to 89% of the treatment arm receiving a 24-week regimen (subgroup analysis of 108 HCV genotype 1 and 4 patients).
- In another subgroup analysis from the same Phase 2 trial, response rates for patients who developed HCV (genotypes 1 and 4) recurrence following liver transplantation who were treated with Harvoni + RBV were analyzed. SVR12 rates for non-cirrhotic patients were 96% and 98%, respectively, for the 12- and 24-week regimens. For patients with compensated cirrhosis, the SVR12 rate was 96% for both regimens. For patients with decompensated cirrhosis, the SVR12 rate was 81% for both regimens.
- In two studies of HCV patients who failed prior therapy, those receiving Harvoni + RBV for 12 weeks achieved SVR12 rates of 96% and 98%. Those receiving Harvoni alone for 24 weeks (Study GS-US-337-0121) achieved an SVR12 rate of 97%.
- HCV-related tickers: (BMY -0.1%)(MRK +1.4%)(ABBV +0.3%)(JNJ +0.2%)(ACHN -0.6%)(RGLS -2.7%)(CNAT -1.1%)(ENTA -0.4%)
Tue, Nov. 11, 10:07 AM
- At The Liver Meeting in Boston, AbbVie (ABBV -0.1%) presented results from studies in HCV patients co-infected with HIV and liver transplant recipients who received its all-oral, interferon-free investigational treatment combining three antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir)
- SVR12 rates for patients co-infected with HCV/HIV that received the company's investigational treatment plus ribavirin were 93.5% for the 12-week regimen and 90.6% for the 24-week regimen.
- In non-cirrhotic liver transplant recipients with recurrent HCV-1 new to treatment, SVR12 and SVR24 rates were each 97.1%.
- HCV-related tickers: (GILD +0.5%)(MRK +1%)(JNJ -0.1%)(BMY -0.2%)(ENTA +0.2%)(RGLS +0.2%)(CNAT -0.5%)(ACHN -1.7%)
Tue, Nov. 11, 9:37 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented data from a Phase 2 clinical trial evaluating the combination of the company's investigational NS3/4A inhibitor, grazoprevir, and its investigational NS5A inhibitor, elbasvir, with and without ribavirin, in treatment-naive and treatment-experienced HCV-1 patients. The length of treatment was either eight,12 or 18 weeks.
- SVR12 rates in treatment-naive non-cirrhotic patients were: 8-week regimen with RBV: 80%; 12-week regiment with and without RBV: 93% and 98%.
- SVR12 rates in treatment-naive patients with cirrhosis were: 12-week regimen with and without RBV: 90% and 97%; 18-week regimen with and without RBV: 97% and 94%.
- SVR12 rates for treatment-experienced patients with and without cirrhosis: 12-week regimen with and without RBV: 94% and 91%; 18-week regimen with and without RBV: 100% and 97%.
- SVR12 rates for HCV-1 patients co-infected with HIV: 12-week regimen with and without RBV: 97% and 87%.
- Results from a Phase 3 trial are expected in 1H 2015.
- Previously: Merck triple therapy HCV candidate fails as a four-week regimen
- HCV-related tickers: (GILD +0.4%)(JNJ -0.2%)(BMY -0.1%)(ABBV +0.3%)(ACHN +3%)(ENTA +0.4%)(CNAT)(LGND +0.5%)(RGLS)
Tue, Nov. 11, 9:05 AM
- At The Liver Meeting in Boston, Gilead Sciences (NASDAQ:GILD) presented data from three Phase 2 studies evaluating an all-oral pan-genotypic regimen, Sovaldi (sofosbuvir) + the company's investigational NS5A inhibitor GS-5816, for the treatment of HCV infection. The specific regimens were Sovaldi 400 mg plus GS-5816 25 mg or 100 mg, with and without ribavirin, for eight or 12 weeks.
- The first study, GS-US-342-0109, evaluated Sovaldi + GS5816 with and without ribavirin for 12 weeks in treatment-experienced HCV-1 and HCV-3 patients with and without cirrhosis. SVR12 rates: SOF + GS-5816 100 mg: 100% for GT1 with and without cirrhosis; 100% for GT3 without cirrhosis and 88% for GT3 with cirrhosis. SVR12 rates: SOF + GS-5816 + RBV: 100% for GT1 without cirrhosis and GT3 without cirrhosis; 90% in GT1 with cirrhosis and 96% in GT3 with cirrhosis.
- The second study, ELECTRON 2, evaluated the same regimen as the first study for eight weeks in non-cirrhotic treatment-naive genotype 3 patients. The SVR12 rate inclusive of ribavirin was 100% and 96% for the ribavirin-free approach.
- The third study, GS-US-342-0102, evaluated the same regimen as first study in non-cirrhotic treatment-naive patients. Results from Part A evaluating 12 weeks of treatment were presented at The International Liver Congress in April 2014. The results from Part B, presented this week, evaluated eight weeks of treatment in HCV-1 and HCV-2 patients. SVR12 rates were: G1: 81% and 90% with and without RBV; G2: 88% with and without RBV.
- HCV-related tickers: (NASDAQ:ACHN) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Mon, Nov. 10, 7:49 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented interim data on its triple-therapy regimen for HCV-1 infection. The investigational product combines the company's NS3/4A protease inhibitor, grazoprevir and its NS5A inhibitor, elbasvir, with Sovaldi (sofosbuvir).
- SVR4/8 for the 8-week regimen in treatment-naive cirrhotic patients was 94.7% (18 of 19). SVR4/8 values for other treatment groups, however, appear low. For the six-week regimen in treatment-naive cirrhotic patients, SVR4/8 was only 80% (16 of 20) with four relapses. For treatment-naive non-cirrhotic patients, the six-week regimen SVR4/8 was 86.7% (26/30) with four relapses while the four-week regimen failed to come anywhere close to efficacy at 38.7% (12/31) with 19 relapses.
- Of the 28 total relapses, 25 were genotype 1a and three were genotype 1b.
- The company plans to initiate Phase 2 clinical trials to assess the safety and efficacy of two short-duration triple therapy regimens: MK-3682 in combination with grazoprevir/elbasvir and MK-3682 in combination with grazoprevir and MK-8408 in non-cirrhotic HCV patients. MK-3682 is an investigational oral prodrug HCV nucleotide analogue NS5B polymerase inhibitor. MK-8408 is an investigational early-stage NS5A inhibitor.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 6:04 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its Phase 3 UNITY program investigating a 12-week all-oral TRIO regimen of daclatasvir (DCV) with asunaprevir and beclabuvir for the treatment of HCV-1 infection.
- In the UNITY-1 trial, a 12-week regimen of DCV-TRIO without ribavirin was evaluated in treatment-naive and treatment-experienced non-cirrhotic HCV patients. SVR12 was 91% overall, 92% for the treatment-naive group and 89% for the treatment-experienced group.
- In UNITY-2, a 12-week regimen of DCV-TRIO was evaluated in cirrhotic patients. SVR12 was 98% in the treatment-naive group and 93% in the treatment-experienced group with ribavirin and 93% and 87%, respectively, without ribavirin.
- In October, the company announced it would not pursue FDA approval for the dual regimen of asunaprevir and daclatasvir for the treatment of HCV-1b infection.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 5:37 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
- The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 5:06 PM
- At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
- In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
- The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
- According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:ENTA) (NYSE:MRK) (NASDAQ:LGND) (NASDAQ:CNAT)
Wed, Nov. 5, 5:10 PM
Thu, Aug. 14, 5:35 PM
Thu, Aug. 14, 12:47 PM
Thu, Aug. 14, 9:17 AM
Wed, Aug. 13, 5:36 PM
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