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 : Shares of clinical stage biotechnology Moderna, Inc., ( Moderna Surges on Shipping Vaccine Against Coronavirus MRNA Quick Quote MRNA - Free Report) 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 Incyte Announces Positive Data on Dermatitis Drug INCY 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.
: Shares of Heron Therapeutics Heron Therapeutics Down on Pipeline Setback HRTX 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 NGM Biopharmaceuticals Reports Positive Data NGM 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.
The Nasdaq Biotechnology index lost 0.08% in the last four trading sessions. Among the biotech giants, Incyte gained 4.15% during this period. Over the past six months, shares of Biogen have gained 43.01%. (See the last biotech stock roundup here:
Biotech Stock Roundup: INCY's Solid Q4 Results, EPZM & SGEN's Pipeline Updates).
What's Next in Biotech?
Stay tuned for more pipeline updates.
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