Amgen – AMGN, VRTX Q4 Results, SAVA’s Encouraging Drug Data & More
Some of the leading biotechs came up with their earnings reports this week. The sector has also been in focus, thanks to the development of antibodies and vaccines for coronavirus gaining importance with each passing day. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Amgen, Vertex Report Q4 Results: Amgen AMGN reported better-than-expected results for the fourth quarter as sales and earnings topped estimates. Higher sales of Repatha, Otezla and biosimilar products were offset by the erosion of mature brands from biosimilar/new competition and COVID-19 related impact on some drugs.The outlook for 2021 was lackluster.
Vertex VRTX, a leader in cystic fibrosis (CF) drugs, beat on revenues but missed on earnings. Nevertheless, strong CF product revenues led to growth in year-over-year earnings. Revenues were up year over year driven by the rapid uptake of Trikafta, a triple combination regimen, in the United States as well in Europe.
Vertex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cassava Surges on Positive Data on AD Drug: Shares of Cassava Sciences, Inc. SAVA surged following positive results of an interim analysis on its lead drug candidate, simufilam, from an open-label study for the treatment of Alzheimer’s disease. Six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6.
Patients’ cognition and behavior scores both improved following six months of simufilam treatment, with no safety issues. Moreover, the safety profile of simufilam in the interim analysis was consistent with prior human studies.
Biogen’s BLA For AD Drug Gets FDA Extension: Biogen BIIB and partner Eisai Co., Ltd. announced that the FDA has extended the review period by three months for its Biologics License Application (BLA) for aducanumab. The BLA was submitted to the FDA in July 2020, which the agency accepted in August 2020 and granted Priority Review. The companies are seeking approval of the candidate for the treatment of Alzheimer’s disease. The new Prescription Drug User Fee Act (PDUFA) action date is Jun 7, 2021.
Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data as part of the ongoing review. The agency considered this a major amendment to the application that will require additional time for review.
Concert Down on Schizophrenia Study Results: Shares of Concert Pharmaceuticals CNCE plunged significantly after the company announced disappointing data from its phase II study on CTP-692. The study was evaluating the candidate as an adjunctive treatment in patients with schizophrenia. The primary endpoint of the trial was the change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline.
The study did not meet the primary endpoint or other secondary endpoints as CTP-692 did not show a statistically significant improvement over placebo at any of the doses. Additionally, no significant improvements were observed in either the positive or negative symptoms subscales of the PANSS scale at any of the CTP-692 doses evaluated.
Viela Bio Surges on Horizon Deal: Shares of Viela Bio VIE surged following the announcement of acquisition of the company by Horizon Therapeutics. Per the agreement, Horizon will acquire all of the issued and outstanding shares of Viela Bio, Inc. common stock for $53.00 per share in cash, which represents a fully diluted equity value of approximately $3.05 billion, or approximately $2.67 billion net of Viela’s cash and cash equivalents. The offer price represented a significant premium to Viela’s closing price of $34.68 on Jan 29. The acquisition will add Uplizna, the first and only FDA-approved B-cell-depleting humanized monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), to Horizon’s portfolio.
Novavax Surges on COVID-19 Vaccine Data: Shares of Novavax NVAX surged after it announced that its protein-based COVID-19 vaccine candidate, NVX-CoV2373, met the primary endpoint, with an efficacy of 89.3%, in a phase III study conducted in the United Kingdom (UK). Importantly, the study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely.
The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3%. The preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases. Moreover, Novavax also announced successful results of its phase IIb study conducted in South Africa.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 0.16% in the last five trading sessions. Among the biotech giants, Vertex lost 8.5% during this period. Over the past six months, shares of Alexion have rallied 47.7%. (See the last biotech stock roundup here: Biotech Stock Roundup: Coronavirus Updates From REGN, MRNA, & Other Updates)
What’s Next in Biotech?
Stay tuned for more pipeline, regulatory and upcoming earnings updates.
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Biogen Inc. (BIIB) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
Novavax, Inc. (NVAX) : Free Stock Analysis Report
Viela Bio, Inc. (VIE) : Free Stock Analysis Report
Cassava Sciences, Inc. (SAVA) : Free Stock Analysis Report
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