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The Zacks Analyst Blog Highlights: Biogen, Celgene, Incyte, Alexion and Vertex

Zacks Equity Research
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For Immediate Release

Chicago, IL – May 2, 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 Biogen BIIB, Celgene CELG, Incyte INCY, Alexion ALXN and Vertex VRTX.

Here are highlights from Wednesday’s Analyst Blog:

Biotech Stock Roundup: BIIB, CELG, INCY & More

The past week was busy for the biotech sector with earnings updates by most biotech bigwigs along with regulatory and other pipeline updates as well as collaborations. Most companies have delivered better-than-estimated top and the bottom-line numbers. Label expansion of existing drugs and other pipeline updates grabbed headlines.

Recap of the Week’s Top Stories:

Alexion, Celgene, Biogen Fire on All Cylinders: The going has been good so far for the biotech sector in first-quarter earnings season. Most bigwigs surpassed on both earnings and sales. For instance, Biogen emerged with flying colors, fueled mainly by a strong performance of its newest drug, Spinraza. Other biotechs like Celgene and Incyte too beat on both counts. Also, Alexion's earnings and sales topped the Zacks Consensus Estimate in the first quarter and therefore, the company upped its guidance. Additionally, Vertex’s earnings and sales exceeded expectations. 

Alexion currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex Gets FDA Nod for Label Expansion of Kalydeco: Vertex Pharmaceuticals announced the FDA approval of cystic fibrosis (CF) drug Kalydeco’s label expansion. The drug has been approved for use in children suffering cystic fibrosis aged from six to less than 12 months with at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on the clinical and/or in vitro assay data. Kalydeco is already approved in the United States, Canada and EU for the treatment of CF in patients aged 12 months and above. The regulatory agency’s approval was based on data from a 24-week phase III open-label safety cohort (ARRIVAL) of 11 children with CF, aged from six to less than 12 months.

Alexion’s Ultomiris Receives Positive CHMP Opinion: Alexion announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending marketing authorization for the long-acting C5 complement inhibitor, Ultomiris (ravulizumab). The committee has recommended the drug’s approval for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) with haemolysis involving clinical symptoms, indicative of a high disease activity. The drug has also been recommended for adult patients, who are clinically stable after being treated with Soliris for at least the past six months.

The European Commission will review the CHMP recommendation and a final decision is expected in two months. The FDA approved Ultomiris for adult patients with PNH last December.

Celgene, Acceleron Pharma Submit Luspatercept Application in Europe: Celgene announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept. The company along with partner Acceleron Pharma is seeking an approval of the drug for treating adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia, who have ring sideroblasts, require red blood cell (RBC) transfusions and have received or are not eligible for erythropoiesis-stimulating agents. The same is also sought for the treatment of adult subjects with beta-thalassemia-associated anemia, requiring RBC transfusions.

Concurrently, both companies announced that European Medicines Agency's (EMA) CHMP has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab). The CHMP recommended its conditional approval for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation.

Incyte Opts Out of Baricitinib Development Program: Incyte announced that it will no longer co-fund the development of baricitinib in order to reallocate capital for other promising internal projects. However, the company will continue to receive royalties on global net sales of Olumiant, pursuant to the terms of its agreement with Lilly. Lilly plans to share data from BREEZE-AD1 and BREEZE-AD2, the two phase III studies of baricitinib on patients with moderate-to-severe atopic dermatitis later this year, and also expects to provide top-line results from the other ongoing phase III programs for this indication later in 2019.

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