We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alnylam Completes Enrollment in Phase III Study of Lumasiran
Read MoreHide Full Article
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has completed enrollment in its phase III study ILLUMINATE-A of lumasiran. Lumasiran is an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of adults and children with primary hyperoxaluria type 1 (PH1). The study enrolled patients across 16 sites in eight countries. The company expects to report top-line results from the study in late 2019. If positive, it expects to submit filings for global regulatory approvals starting early 2020.
Further, the company announced complete final positive results from its phase I/II study and reiterated positive results from its ongoing phase II open-label extension (OLE) study of lumasiran.
In the phase I/II study, lumasiran demonstrated a mean maximal reduction in urinary oxalate of 75% relative to baseline across all cohorts (1 mg/kg monthly, 3 mg/kg monthly, and 3 mg/kg quarterly; N=20). In the study, lumasiran-treated patients across all cohorts (N=20) experienced a mean maximal decrease of 77% in the ratio of urinary oxalate to creatinine, an additional measure of oxalate reduction that addresses the variability, which is inherent in 24-hour urine collections.
All patients (100%), who completed phase I/II, continue dosing in the ongoing phase II OLE phase of the study. As of February 2019, patients in the phase II OLE study have received lumasiran for four months. The drug’s dosing across all evaluable cohorts (N=9) resulted in mean maximal reduction in urinary oxalate of 72% relative to phase I/II baseline levels.
Shares of the company have lost 2.2% against the industry’s growth of 4.4%.
Alnylam also has other candidates in its pipeline. The company along with partner The Medicine Company is evaluating inclisiran in phase III ORION studies for hypercholesterolemia.
Alnylam and Regeneron Pharmaceuticals (REGN - Free Report) extended their collaboration agreement. Both the companies will work together to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.
Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
Image: Bigstock
Alnylam Completes Enrollment in Phase III Study of Lumasiran
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has completed enrollment in its phase III study ILLUMINATE-A of lumasiran. Lumasiran is an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of adults and children with primary hyperoxaluria type 1 (PH1). The study enrolled patients across 16 sites in eight countries. The company expects to report top-line results from the study in late 2019. If positive, it expects to submit filings for global regulatory approvals starting early 2020.
Further, the company announced complete final positive results from its phase I/II study and reiterated positive results from its ongoing phase II open-label extension (OLE) study of lumasiran.
In the phase I/II study, lumasiran demonstrated a mean maximal reduction in urinary oxalate of 75% relative to baseline across all cohorts (1 mg/kg monthly, 3 mg/kg monthly, and 3 mg/kg quarterly; N=20). In the study, lumasiran-treated patients across all cohorts (N=20) experienced a mean maximal decrease of 77% in the ratio of urinary oxalate to creatinine, an additional measure of oxalate reduction that addresses the variability, which is inherent in 24-hour urine collections.
All patients (100%), who completed phase I/II, continue dosing in the ongoing phase II OLE phase of the study. As of February 2019, patients in the phase II OLE study have received lumasiran for four months. The drug’s dosing across all evaluable cohorts (N=9) resulted in mean maximal reduction in urinary oxalate of 72% relative to phase I/II baseline levels.
Shares of the company have lost 2.2% against the industry’s growth of 4.4%.
Alnylam also has other candidates in its pipeline. The company along with partner The Medicine Company is evaluating inclisiran in phase III ORION studies for hypercholesterolemia.
Alnylam and Regeneron Pharmaceuticals (REGN - Free Report) extended their collaboration agreement. Both the companies will work together to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.
Alnylam Pharmaceuticals, Inc. Price
Alnylam Pharmaceuticals, Inc. price | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>