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The Zacks Analyst Blog Highlights: Moderna, Incyte, Heron Therapeutics and NGM Biopharmaceuticals
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For Immediate Release
Chicago, IL – February 27, 2020 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna, Inc., (MRNA - Free Report) , Incyte (INCY - Free Report) , Heron Therapeutics (HRTX - Free Report) and NGM Biopharmaceuticals .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Pipeline Updates and More
As the earnings season comes to an end, the focus is back on pipeline updates from biotech players. While the bigwigs did not come out with much updates, pipeline and regulatory updates took centerstage.
Recap of the Week’s Most Important Stories:
Moderna Surges on Shipping Vaccine Against Coronavirus: Shares of clinical stage biotechnology Moderna, Inc., surged after it announced the release of the first batch of mRNA-1273, a vaccine against the novel coronavirus. Moderna shipped vials of mRNA-1273 to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to be used in the planned phase I study in the United States.
mRNA-1273 is an mRNA vaccine against the novel coronavirus, encoding for a prefusion stabilized form of the Spike (S) protein. The candidate was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
Incyte Announces Positive Data on Dermatitis Drug: Incyte announced that the second randomized, vehicle-controlled, pivotal phase III study from the TRuE-AD clinical trial program has met its primary endpoint. The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥ 12 years) with mild-to-moderate atopic dermatitis (AD).
Both primary and secondary endpoints were met in TRuE-AD1 and TRuE-AD2 studies. The long-term safety portion of both studies will continue as planned.
Heron Therapeutics Down on Pipeline Setback: Shares of Heron Therapeutics depreciated after the company announced that the FDA has extended the review period for the New Drug Application (NDA) for pipeline candidate HTX-011 by up to three months. The new PDUFA goal date is Jun 26, 2020.
HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine, with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. The FDA had earlier issued a Complete Response Letter (CRL) regarding the NDA for HTX-011 on Apr 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information.
NGM Biopharmaceuticals Reports Positive Data: NGM Biopharmaceuticals announced positive preliminary topline results from a mid-stage study on aldafermin. The 24-week double-blind, randomized, placebo-controlled cohort (Cohort 4) of an adaptive phase II study evaluating the efficacy, safety and tolerability of 1 mg aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2-F3).
Aldafermin is an engineered variant of the human hormone FGF19 being developed as a once-daily treatment for patients with NASH. 22% of aldafermin-treated patients versus 0% placebo achieved composite endpoint of both fibrosis improvement and resolution of NASH. The data showed clinically-meaningful response rates of 38% of patients treated with aldafermin having liver fibrosis improvement of ≥1 stage and 24% of patients achieving resolution of NASH at 24 weeks.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: Moderna, Incyte, Heron Therapeutics and NGM Biopharmaceuticals
For Immediate Release
Chicago, IL – February 27, 2020 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna, Inc., (MRNA - Free Report) , Incyte (INCY - Free Report) , Heron Therapeutics (HRTX - Free Report) and NGM Biopharmaceuticals .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Pipeline Updates and More
As the earnings season comes to an end, the focus is back on pipeline updates from biotech players. While the bigwigs did not come out with much updates, pipeline and regulatory updates took centerstage.
Recap of the Week’s Most Important Stories:
Moderna Surges on Shipping Vaccine Against Coronavirus: Shares of clinical stage biotechnology Moderna, Inc., surged after it announced the release of the first batch of mRNA-1273, a vaccine against the novel coronavirus. Moderna shipped vials of mRNA-1273 to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to be used in the planned phase I study in the United States.
mRNA-1273 is an mRNA vaccine against the novel coronavirus, encoding for a prefusion stabilized form of the Spike (S) protein. The candidate was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
Incyte Announces Positive Data on Dermatitis Drug: Incyte announced that the second randomized, vehicle-controlled, pivotal phase III study from the TRuE-AD clinical trial program has met its primary endpoint. The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥ 12 years) with mild-to-moderate atopic dermatitis (AD).
Both primary and secondary endpoints were met in TRuE-AD1 and TRuE-AD2 studies. The long-term safety portion of both studies will continue as planned.
Heron Therapeutics Down on Pipeline Setback: Shares of Heron Therapeutics depreciated after the company announced that the FDA has extended the review period for the New Drug Application (NDA) for pipeline candidate HTX-011 by up to three months. The new PDUFA goal date is Jun 26, 2020.
HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine, with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. The FDA had earlier issued a Complete Response Letter (CRL) regarding the NDA for HTX-011 on Apr 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information.
Heron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
NGM Biopharmaceuticals Reports Positive Data: NGM Biopharmaceuticals announced positive preliminary topline results from a mid-stage study on aldafermin. The 24-week double-blind, randomized, placebo-controlled cohort (Cohort 4) of an adaptive phase II study evaluating the efficacy, safety and tolerability of 1 mg aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2-F3).
Aldafermin is an engineered variant of the human hormone FGF19 being developed as a once-daily treatment for patients with NASH. 22% of aldafermin-treated patients versus 0% placebo achieved composite endpoint of both fibrosis improvement and resolution of NASH. The data showed clinically-meaningful response rates of 38% of patients treated with aldafermin having liver fibrosis improvement of ≥1 stage and 24% of patients achieving resolution of NASH at 24 weeks.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.