Earnings took center stage for the biotech sector this week, with quite a few bigwigs like Gilead Sciences (GILD - Free Report) , Amgen (AMGN - Free Report) , Vertex Pharmaceuticals (VRTX - Free Report) and Celgene (CELG - Free Report) coming up with second-quarter results. Apart from these, regular pipeline updates and data read outs were the key highlights of the week.
Recap of the Week’s Most Important Stories:
Celgene, Vertex, Amgen Impress, Gilead’s CEO to Step Down: While Gilead Sciences’ second-quarter earnings beat estimates, the year-over-year decline was disappointing as the magnitude of decline in hepatitis C virus (HCV) sales continues to worsen. Moreover, the news of the company’s president and chief executive officer (CEO), John F. Milligan’s departure plan overshadowed the results.
Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
On the other hand, Vertex reported strong results for the second quarter, wherein both earnings and revenues beat estimates on the back of strong cystic fibrosis (CF) drug sales.
Both Amgen and Celgene fired from all cylinders as the results easily beat estimates. Celgene topped both revenue and earnings estimates in the second quarter on strong Revlimid sales. The company also upped its annual guidance. Amgen also beat on both earnings and sales and increased its outlook for the year. Alexion too beat both earnings and sales and lifted its guidance.
Amgen/Novartis Get Migraine drug Approval in EU: Amgen and partner Swiss pharma giant Novartis announced that the European Commission (EC) approved Aimovig (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month. The drug is already approved in the United States. Per the companies, Aimovig is the first and only approved migraine-prevention treatment designed specifically to block the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine. Data from trials shows that patients on Aimovig reported consistent and sustained migraine prevention, with many experiencing a 50% or more reduction in monthly migraine days; safety and tolerability were similar to placebo. We note that Novartis and Amgen have a commercialization agreement for Aimovig in the United States. Amgen has exclusive commercialization rights to the drug in Japan, and Novartis has exclusive rights to commercialize in the rest of the world.
Vertex Gets Positive CHMP Opinion For Symkevi: Vertex announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Symkevi (tezacaftor/ivacaftor) in a combination regimen with Kalydeco for the treatment of patients suffering from CF aging 12 and above. These patients either have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, or one copy of the F508del mutation and a copy of one of the following 14 mutations in which the CFTR protein shows residual activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. Upon approval, Symkevi will be Vertex’s third drug to treat the CFTR protein defect in CF patients. We note that the combination was approved by the FDA in February 2018 as Symdeko.
Biogen Announces Results on AD Candidate: Biogen Inc. (BIIB - Free Report) and partner Eisai Co., Ltd. announced detailed results from the phase III study (Study 201) on Alzheimer's disease (AD) candidate, BAN2401 an anti-amyloid beta (Aβ) protofibril antibody, at the Alzheimer’s Association International Conference (AAIC) 2018. The placebo-controlled, double-blind, parallel-group, randomized study was conducted among 856 patients with mild cognitive impairment (MCI) due to AD or mild Alzheimer's dementia (collectively known as early Alzheimer’s disease) with confirmed amyloid pathology in the brain. The study included five dose regimens. Data from the study demonstrated that treatment with BAN2401 for 18 months led to a dose-dependent statistically significant reduction in amyloid plaques, as measured by amyloid PET scan, at all doses. Meanwhile, after treatment for 18 months, the highest treatment dose (10 mg/kg biweekly) of BAN2401 demonstrated a statistically significant slowing of clinical decline of 30% on the key clinical endpoint (ADCOMS) compared to placebo. On Clinical Dementia Rating Sum of Boxes (CDR-SB) endpoint, the slowing of clinical decline at the highest dose was 26%, which was not statistically significant. On Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) endpoint, the slowing of clinical decline was 47% versus placebo. Investors weren’t much impressed with the results.
The NASDAQ Biotechnology Index lost 1.22% over the last five trading sessions. Among the major biotech stocks, Celgene has gained 3.35%. Over the past six months, Celgene has lost 10.94% while Alexion has gained 11.43%. (See the last biotech stock roundup here: Biotech Stock Roundup: Biogen Gains on Q2 Results, Agios Gets FDA Nod For Leukemia Drug)
What's Next in Biotech?
Stay tuned for more Q2 results along with other regulatory updates and pipeline development news.
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