AMGN, VRTX Q4 results, encouraging SAVA drug data and more

Some of the leading biotech companies released earnings reports this week. This sector has also come into the limelight with the development of antibodies and vaccines against the coronavirus, which are gaining importance with each passing day. Other pipeline and regulatory updates also came into focus.

A roundup of the week’s top stories: :

Amgen, Vertex report Q4 results: : Amgen AMGN reported better-than-expected fourth-quarter results as sales and earnings beat estimates. Higher sales of Repatha, Otezla and biosimilars were offset by the erosion of mature brands due to biosimilar/novel competition and the impact of Covid-19 on certain medicines. The outlook for 2021 was not optimistic.

Top VRTX, a leader in cystic fibrosis (CF) drugs, surpassed revenues but lost profits. Nevertheless, strong revenues from CF products led to year-on-year profit growth. Revenues increased year over year due to the rapid adoption of Trikafta, a triple combination regimen, in both the United States and Europe.

Vertex currently carries a Zacks Rank #3 (Hold). You can see see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cassava surges on positive AD drug data: Cassava Sciences, Inc. stock SAVA rose following positive results from an interim analysis of its lead drug candidate, simufilam, from an open-label study for the treatment of Alzheimer’s disease. Six months of simufilam treatment improved cognitive scores by 1.6 points on the ADAS-Cog11, representing an average improvement of 10% from baseline to month 6.

Patients’ cognitive and behavioral scores improved after six months of treatment with simufilam, without any safety issues. Furthermore, the safety profile of simufilam in the interim analysis was consistent with previous human studies.

Biogen’s BLA for AD drug is extended by FDA: : Biogen BIIB and partner Eisai Co., Ltd. announced that the FDA has extended the Biologics License Application (BLA) review period for aducanumab by three months. The BLA was submitted to the FDA in July 2020, which the agency accepted in August 2020 and granted priority review. Companies are seeking approval for a candidate to treat Alzheimer’s disease. The effective date of the new Prescription Drug User Fee Act (PDUFA) is June 7, 2021.

Biogen provided a response to the FDA’s request for information, including additional analyzes and clinical data as part of the ongoing review. The agency considered this a major change to the application that would require additional time to process.

Concert down on schizophrenia research results: Shares Concert pharmaceuticals CNCE’s value dropped significantly after the company announced disappointing Phase II trial data for CTP-692. The study evaluated its candidacy as an adjunctive drug in patients with schizophrenia. The primary endpoint of the study was the change from baseline in the Positive and Negative Symptom Scale (PANSS) total score at 12 weeks.

The study did not meet its primary or other secondary endpoints because CTP-692 did not show statistically significant improvement compared to placebo at either dose. Additionally, no significant improvement was observed in either the positive or negative symptom subscales of the PANSS at any of the CTP-692 doses assessed.

Viela Bio gains traction under the Horizon deal: Shares Bio Viel VIE rose after the announcement of the company’s acquisition by Horizon of Therapy. Pursuant to the agreement, Horizon will acquire all of the issued and outstanding common shares of Viela Bio, Inc. at a price of $53.00 per share in cash, representing 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 January 29 closing price of $34.68. The acquisition will add Uplizna, the first and only FDA-approved humanized B-cell-depleting monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), to the Horizon portfolio.

Novavax has increasing data on Covid-19 vaccines: Shares Novavax NVAX gained momentum after announcing that its protein-based Covid-19 vaccine, NVX-CoV2373, met its primary endpoint with 89.3% efficacy in a Phase 3 trial conducted in the United Kingdom (UK). Importantly, the study assessed effectiveness during a period of high transmission and the emergence and wide spread of the new UK variant strain of the virus.

The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group compared to 6 cases observed in the NVX-CoV2373 group, giving a point estimate of vaccine effectiveness of 89.3%. Preliminary analysis indicates that the increasingly common British strain was detected in over 50% of symptomatic cases confirmed by PCR. Additionally, Novavax also announced successful results from a Phase IIb trial conducted in South Africa.

Efficiency

Medicine – Biomedical and genetics industry 5-year % return

Medicine – Biomedical and genetics industry 5-year % return

The Nasdaq Biotechnology Index has lost 0.16% over the last five trading sessions. Among biotech giants, Vertex lost 8.5% during this period. Alexion shares are up 47.7% over the past six months. (See the latest biotech stock roundup here: Biotech Stock Overview: Corona Virus Updates from REGN, MRNA and Other Updates)

What’s next in biotechnology?

Stay tuned for more pipeline, regulatory and upcoming earnings updates.

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