For Immediate Release
Chicago, IL –August 22, 2019 – 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: Celgene (CELG - Free Report) , Gilead (GILD - Free Report) , Vertex (VRTX - Free Report) , Sarepta (SRPT - Free Report) and Regeneron (REGN - Free Report) .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Celgene’s FDA Nod, SRPT’s Setback & More
It was a busy week for the sector with updates from quite a few big biotechs. While Celgene won the FDA approval for its bone marrow cancer drug, Gilead’s marketing authorization application (MAA) for filgotinib for rheumatoid arthritis and Vertex’s new drug application (NDA) for the triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor have been accepted by the European Medicines Agency (EMA) and the FDA, respectively. Meanwhile, Sarepta plummeted as the FDA rejected its muscular dystrophy treatment.
Recap of the Week’s Most Important Stories:
Celgene Gets FDA Approval for Bone Marrow Cancer Drug: Celgene Corporation announced that the FDA has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The drug provides a new, once-daily oral option to patients affected by rare bone marrow cancer. Between 16,000 and 18,500 patients are estimated to be living with myelofibrosis and 1.5 of every 100,000 people are expected to be diagnosed with the same annually. The approval was based on positive results from the JAKARTA2 study. The results of the study showed that 37% of patients treated with Inrebic 400 mg experienced a 35% or more reduction in spleen volume compared to just 1% (1 of 96) of patients who received placebo. However, Inrebic, an oral kinase inhibitor with activity against wild type and mutationally-activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3), carries a boxed warning for serious and fatal encephalopathy, including Wernicke’s.
Vertex NDA for Triple Combination CF Treatment Accepted: Vertex Pharmaceuticals announced that the FDA has accepted its NDA for the triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor for the treatment of cystic fibrosis (CF). The agency has also granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Mar 19, 2020. The NDA was supported by positive data from two global phase III studies in CF patients. Both studies showed statistically significant improvements in lung function, which was the primary endpoint, and in all key secondary endpoints.
Vertex currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead's Application for RA Drug Accepted in Europe: Gilead Sciences and partner Galapagos announced that the EMA has accepted the MAA for JAK inhibitor candidate, filgotinib. The MAA is seeking approval of the drug as a treatment for rheumatoid arthritis (RA) in Europe. The MAA includes data from the phase III clinical program, FINCH, which comprises three studies. Data from the studies have shown that once-daily treatment with filgotinib improved clinical signs and symptoms, and achieved low disease activity and remission. The candidate also inhibited structural damage in different sub-populations of RA patients.
Regeneron Presents Data on Cholesterol Drug: Regeneron announced positive pivotal phase III results for evinacumab, an experimental angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia (HoFH). On average, patients entered the trial with LDL cholesterol levels of 255 mg/dL despite treatment with other lipid-lowering therapies. The study met its primary endpoint, showing that the addition of evinacumab to other lipid-lowering therapies decreased LDL cholesterol by 49% on average compared to lipid-lowering therapies. The FDA granted the Breakthrough Therapy designation to evinacumab for the treatment of hypercholesterolemia in patients with HoFH in 2017. Data will be submitted to regulatory authorities, starting with the FDA in 2020.
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index lost 0.53% in the last five trading sessions. Among the biotech giants, Vertex gained 2.3% in the period. Over the past six months, shares of Amgen have gained 10.4%, whereas Biogen stock has declined 31%. (See the last biotech stock roundup here: Biotech Stock Roundup: Amgen’s Enbrel Patent Win, AMRN’s Setback & More)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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