The biotech sector saw updates from a few bigwigs last week. Both Regeneron (REGN - Free Report) and Biogen (BIIB - Free Report) obtained positive opinions on their drugs from the CHMP. Meanwhile, Amgen (AMGN - Free Report) reported positive data on its leukemia drug from late-stage studies.
Recap of the Week’s Most Important Stories:
Positive CHMP Opinion for Regeneron’s Dupixent: Regeneron and partner Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the label expansion of asthma drug, Dupixent, in a third indication. The CHMP recommended the approval of the drug as 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. The positive opinion of the committee was based on two pivotal phase III trials — the 24-week SINUS-24 and 52-week SINUS-52 — which evaluated Dupixent 300 mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.
Biogen's MS Drugs Get CHMP Nod for Use in Pregnancy: Biogen announced that the CHMP has given a positive opinion recommending the use of its interferon beta treatments, including Plegridy and Avonex, during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS). The committee has recommended removing pregnancy contraindications from labels of these drugs. The recommendation was based on data from real-world pregnancy outcomes, which showed that exposure to interferon beta, before conception and/or during the first trimester, did not lead to an increase in risk of major congenital anomalies.
Additionally, the company announced that it has initiated a phase II/III study on its spinal muscular atrophy (SMA) drug, Spinraza (nusinersen). The DEVOTE study will evaluate a higher dose of the drug to see whether it can provide greater efficacy for the treatment of SMA. Based on the long-term safety profile and proven efficacy of Spinraza, the DEVOTE study will also evaluate the safety and tolerability of the drug when administered at a higher dose. Moreover, long-term data from the SHINE study showed that treatment with Spinraza demonstrated improvements in or stabilization of motor function in patients as old as 21 years, who are treated for up to almost six years.
Amgen Announces Positive Results From Leukemia Studies: Amgen announced positive results from late-stage studies on Blincyto. The 20120215 study evaluated the efficacy, safety and tolerability of the drug compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia (ALL) at first relapse. The pre-specified interim analysis of the open-label phase III study showed that the primary endpoint of event-free survival was met. Based on a recommendation from the Independent Data Monitoring Committee (DMC), enrollment was terminated early due to encouraging efficacy in the Blincyto arm. Meanwhile, follow up will continue as prescribed per protocol.
Additionally, a randomized, phase III study (AALL1331) conducted by the Children's Oncology Group (COG), using Blincyto in pediatric B-cell ALL patients at first relapse, has closed to accrual for the high-risk and intermediate risk-arm based on the recommendation of the COG DMC. This study was also stopped early due to treatment benefit of Blincyto over chemotherapy.
Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zealand Jumps on Positive Results From Late-Stage Study: Shares of Zealand Pharma A/S (ZEAL - Free Report) jumped after it announced positive results in the pediatric phase III trial with dasiglucagon for severe hypoglycemia in diabetes. Dasiglucagon is a potential first-in-class soluble glucagon analog, which is being developed in the ready-to-use HypoPal rescue pen. The dasiglucagon HypoPal rescue pen is being developed as an easy-to-use, fast and effective rescue treatment for diabetes patients having a severe hypoglycemic event. The trial compared the glycemic response observed after induction of hypoglycemia and administration of dasiglucagon (0.6 mg) with that of placebo and GlucaGen (1 mg), a currently marketed glucagon in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as the first increase in plasma glucose of greater than equal to 20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. All primary and key secondary endpoints were met.
Clovis Gains Rights to Pre-Clinical Cancer Program: Clovis Oncology (CLVS - Free Report) entered a global licensing and collaboration agreement with privately-held, Germany-based biotech, 3B Pharmaceuticals GmbH. The deal grants Clovis the global rights (excluding Europe) to fibroblast activation protein alpha (FAP)-targeted radiopharmaceutical program. 3B Pharmaceuticals retains rights in Europe related to the FAP program.
The Nasdaq Biotechnology index lost 2.71% in the last five trading sessions. Among the biotech giants, Alexion lost 6.96% in the period. Over the past six months, shares of Celgene have gained 12.17%, whereas the Regeneron stock has slumped 26.66%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Halts AD Study, AMGN Posts Positive MM Drug Data & More)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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