It was a busy week for the biotech sector with updates from most bigwigs. Alexion ALXN and Amgen AMGN both topped earnings estimates in the third quarter, while Gilead GILD reported mixed results. Meanwhile, the FDA advisory committee voted on AMAG’s Makena.
Recap of the Week’s Most Important Stories:
Alexion & Amgen Impress in Q3: Alexion’s earnings and sales beat estimates in the third quarter of 2019 on sustained growth of its blockbuster drug, Soliris, and solid uptake of Ultomiris.
Amgen too beat on earnings and sales in the third quarter. The company slightly raised its sales guidance, while increasing the earnings range significantly.
However, Gilead reported mixed results for the third quarter as earnings missed expectations but sales managed to marginally surpass the same.
Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead Collaborates With Glympse Bio: Gilead Sciences Inc announced that it had entered a collaboration with Glympse Bio for advancing its nonalcoholic steatohepatitis clinical development. The financial terms of the agreement were not disclosed. Glympse Bio’s proprietary synthetic biomarkers are bioengineered to identify the stage and progression of the disease as well as early detection of treatment response. Gilead will use these to determine clinical trial participants’ stage of disease at initial screening and their responses to study treatment.
AMAG’s Updates on FDA Committee Meeting for Makena: AMAG Pharmaceuticals announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has analyzed the data from the PROLONG trial on Makena. The drug is approved to reduce preterm birth in pregnant women, who have had a prior spontaneous preterm birth. Nine of 16 advisory committee members voted to recommend the FDA to pursue the withdrawal of Makena from the market, while the rest voted to keep the product in the market under accelerated approval and request a new confirmatory trial. The agency will consider the advisory committee's recommendation when making its decision but is not bound by the same.
Regeneron’s Dupixent Label Expansion in Europe: Regeneron Pharmaceuticals, Inc REGN and partner Sanofi SNY announced that the European Commission has approved a label expansion of asthma drug, Dupixent. The drug is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP), for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Hence, Dupixent now is approved in the EU for three type 2 inflammatory diseases — severe CRSwNP, severe asthma and moderate-to-severe atopic dermatitis.
Amgen to Make Repatha Available at a Lower List Price: Amgen announced that its PCSK9 inhibitor, Repatha, will be available at a 60% lower list price of $5,850 per year, effective Dec 31, 2019. The drug is approved for the treatment for patients with high cholesterol and cardiovascular disease to reduce heart attacks and strokes. In October 2018, Amgen slashed the U.S. list price of Repatha by 60%.
The Nasdaq Biotechnology index gained 2.06% in the last five trading sessions. Among the biotech giants, Alexion gained 8.3% in the period. Over the past six months, shares of Biogen have gained 29.7%, whereas Alexion stock has declined 20.5%. (See the last biotech stock roundup here: Biotech Stock Roundup: Biotech Stock Roundup: BIIB Up on AD Data, ALXN to Buy ACHN & Other Pipeline Updates)
What's Next in Biotech?
Stay tuned for quarterly results from most biotech bigwigs.
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