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The biotech sector has been in the spotlight in the past week on earnings releases. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Bristol Myers’ Q2 Results: Bristol Myers’ (BMY - Free Report) topped earnings and sales estimates in the second quarter. The company reported earnings of $1.93 per share, which beat the Zacks Consensus Estimate of $1.79. Total revenues of $11.9 billion also surpassed the Zacks Consensus Estimate of $11.5 billion and increased 2% from the year-ago period. The year-over-year growth was primarily driven by in-line products (blood thinner drug Eliquis and immuno-oncology drug Opdivo) and a new product portfolio (Abecma, Opdualag and Reblozyl). Eliquis drove growth for the company as sales increased 16% to $3.2 billion. Moreover, the decline in Revlimid sales due to generic competition was not as steep as expected.
Biogen’s Q2 Earnings: Biogen (BIIB - Free Report) beat on both sales and earnings in the second quarter. The company reported earnings per share (EPS) of $5.25, which significantly beat the Zacks Consensus Estimate of $4.10. Sales of $2.59 billion were down 7% from the year-ago quarter due to lower sales of Tecfidera and Spinraza. The top line, however, beat the Zacks Consensus Estimate of $2.47 billion.
Concurrently, the company upped its previously issued guidance for 2022. Total revenues are now expected in the range of $9.9-$10.1 billion for 2022, up from the earlier expectation of $9.7-$10.0 billion. Adjusted earnings are expected in the range of $15.25 to $16.75, up from the prior expectation of $14.25-$16.00.
Biogen also announced that the FDA has accepted a new drug application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The application has been granted priority review with a target action date of Jan 25, 2023.
Regulatory Updates From Gilead: Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Commission adopted a positive opinion for COVID-19 treatment Veklury. The treatment was initially granted conditional marketing authorization in July 2020 for the treatment of COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The opinion is based upon the fulfillment of the last specific obligation for Veklury, which included the review of virology data inclusive of in vitro data showing Veklury retains activity against variants of concern, including Alpha, Beta, Gamma, Delta and Omicron (BA.1 and BA.2).
Gilead’s wholly owned company Kite announced that the CHMP has issued a positive opinion for Chimeric Antigen Receptor (CAR) T-cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL).
Updates From Vertex: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) entered into an exclusive, four-year global research collaboration agreement with Verve Therapeutics, Inc (VERV - Free Report) . The agreement primarily focuses on discovering and developing an in vivo gene editing program for a single undisclosed liver disease. Per the terms, Verve will receive an upfront payment of $60 million, which includes a $35 million equity investment. Verve is also eligible to receive up to $66 million in success payments, up to $340 million in development and commercial milestones and tiered royalties on future net sales for any products that may result from this collaboration agreement. Shares of Verve surged on the same.
While Verve will advance the discovery, research and certain preclinical development of a novel in vivo gene editing program for the target of interest, Vertex will be responsible for subsequent development, manufacturing and commercialization of any program stemming from such research efforts.
Vertex also announced that it plans to advance the selective NaV1.8 inhibitor VX-548 into late-stage studies in the fourth quarter following the positive phase II results earlier this year. The company also reached an agreement on the design of the pivotal development program with the FDA. Vertex also intends to initiate a phase II dose-ranging study of VX-548 in neuropathic pain by the end of this year. In addition, the FDA has granted VX-548 Breakthrough Therapy Designation for treating moderate-to-severe acute pain.
Performance
The Nasdaq Biotechnology Index has lost 1.68% in the past five trading sessions. Among the biotech giants, Amgen has gained 1.54% during the period. Over the past six months, shares of Vertex have surged 27.2%. (See the last biotech stock roundup here: Biotech Stock Roundup: APLS, NVAX Gain on Updates, INCY’s Regulatory News & More)
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What's Next in Biotech?
Stay tuned for earnings and other updates.
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Biotech Stock Roundup: BMY, BIIB's Q2 Earnings, GILD's Updates & More
The biotech sector has been in the spotlight in the past week on earnings releases. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Bristol Myers’ Q2 Results: Bristol Myers’ (BMY - Free Report) topped earnings and sales estimates in the second quarter. The company reported earnings of $1.93 per share, which beat the Zacks Consensus Estimate of $1.79. Total revenues of $11.9 billion also surpassed the Zacks Consensus Estimate of $11.5 billion and increased 2% from the year-ago period. The year-over-year growth was primarily driven by in-line products (blood thinner drug Eliquis and immuno-oncology drug Opdivo) and a new product portfolio (Abecma, Opdualag and Reblozyl). Eliquis drove growth for the company as sales increased 16% to $3.2 billion. Moreover, the decline in Revlimid sales due to generic competition was not as steep as expected.
Biogen’s Q2 Earnings: Biogen (BIIB - Free Report) beat on both sales and earnings in the second quarter. The company reported earnings per share (EPS) of $5.25, which significantly beat the Zacks Consensus Estimate of $4.10. Sales of $2.59 billion were down 7% from the year-ago quarter due to lower sales of Tecfidera and Spinraza. The top line, however, beat the Zacks Consensus Estimate of $2.47 billion.
Concurrently, the company upped its previously issued guidance for 2022. Total revenues are now expected in the range of $9.9-$10.1 billion for 2022, up from the earlier expectation of $9.7-$10.0 billion. Adjusted earnings are expected in the range of $15.25 to $16.75, up from the prior expectation of $14.25-$16.00.
Biogen also announced that the FDA has accepted a new drug application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The application has been granted priority review with a target action date of Jan 25, 2023.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Updates From Gilead: Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Commission adopted a positive opinion for COVID-19 treatment Veklury. The treatment was initially granted conditional marketing authorization in July 2020 for the treatment of COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The opinion is based upon the fulfillment of the last specific obligation for Veklury, which included the review of virology data inclusive of in vitro data showing Veklury retains activity against variants of concern, including Alpha, Beta, Gamma, Delta and Omicron (BA.1 and BA.2).
Gilead’s wholly owned company Kite announced that the CHMP has issued a positive opinion for Chimeric Antigen Receptor (CAR) T-cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL).
Updates From Vertex: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) entered into an exclusive, four-year global research collaboration agreement with Verve Therapeutics, Inc (VERV - Free Report) . The agreement primarily focuses on discovering and developing an in vivo gene editing program for a single undisclosed liver disease. Per the terms, Verve will receive an upfront payment of $60 million, which includes a $35 million equity investment. Verve is also eligible to receive up to $66 million in success payments, up to $340 million in development and commercial milestones and tiered royalties on future net sales for any products that may result from this collaboration agreement. Shares of Verve surged on the same.
While Verve will advance the discovery, research and certain preclinical development of a novel in vivo gene editing program for the target of interest, Vertex will be responsible for subsequent development, manufacturing and commercialization of any program stemming from such research efforts.
Vertex also announced that it plans to advance the selective NaV1.8 inhibitor VX-548 into late-stage studies in the fourth quarter following the positive phase II results earlier this year. The company also reached an agreement on the design of the pivotal development program with the FDA. Vertex also intends to initiate a phase II dose-ranging study of VX-548 in neuropathic pain by the end of this year. In addition, the FDA has granted VX-548 Breakthrough Therapy Designation for treating moderate-to-severe acute pain.
Performance
The Nasdaq Biotechnology Index has lost 1.68% in the past five trading sessions. Among the biotech giants, Amgen has gained 1.54% during the period. Over the past six months, shares of Vertex have surged 27.2%. (See the last biotech stock roundup here: Biotech Stock Roundup: APLS, NVAX Gain on Updates, INCY’s Regulatory News & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for earnings and other updates.