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Biotech Stock Roundup: BIIB & BMY's Q3 Earnings, TCDA Down on Study Update
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Earnings results, along with important regulatory and pipeline updates, continue to keep the biotech sector in focus.
Recap of the Week’s Most Important Stories:
Q3 Earnings From BMY, BIIB: Biogen (BIIB - Free Report) reported earnings per share (EPS) of $4.77 in the third quarter of 2022, which beat the Zacks Consensus Estimate of $4.13. Sales of $2.51 billion were down 10% on a reported basis from the year-ago quarter due to lower sales of Tecfidera but beat the Zacks Consensus Estimate of $2.47 billion. Nevertheless, Biogen upped its previously issued total revenues and adjusted earnings guidance for 2022. Total revenues are now expected in the range of $10-$10.15 billion for 2022, up from $9.9-$10.1 billion expected previously. Adjusted earnings are expected in the range of $16.50 to $17.50, up from the prior expectation of $15.25-$16.75.
Bristol-Myers Squibb Company (BMY - Free Report) reported mixed results for the third quarter of 2022 as earnings beat estimates but sales lagged the same. Earnings of $1.99 per share beat the Zacks Consensus Estimate of $1.83 and increased from $1.93 reported in the year-ago quarter. Total revenues of $11.2 billion surpassed the Zacks Consensus Estimate of $11 billion but decreased 2% from the year-ago period due to generic competition for multiple myeloma (MM) drug Revlimid and foreign exchange impacts, partially offset by in-line products (primarily Eliquis and Opdivo) and new product portfolio (primarily Opdualag, Abecma and Reblozyl).
Regeneron’s Eylea Update: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has granted pediatric exclusivity for the ophthalmology drug Eylea (aflibercept). Consequently, this extends the period of market exclusivity for Eylea in the United States by an additional six months through May 17, 2024.
The pediatric exclusivity determination is based on data from two phase III trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of Eylea as a treatment for retinopathy of prematurity (ROP) in preterm infants. The two Phase III trials also formed the basis of a supplemental Biologics License Application for Eylea in ROP that was recently accepted for Priority Review by the FDA.
Tricida Tanks on Study Update: Shares of Tricida, Inc. plunged after the company announced that the VALOR-CKD renal outcomes clinical trial failed. The study was designed to evaluate veverimer’s ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease (CKD). The study did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease (ESRD), or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR), also known as DD40. Consequently, the prespecified hierarchical analysis did not permit statistical testing of the secondary endpoints. Tricida is evaluating the next further steps given its cash runaway.
Performance
The Nasdaq Biotechnology Index gained 1.19% in the past five trading sessions. Among the biotech giants, Gilead has gained 4.08% during the period. Over the past six months, shares of Biogen have soared 27.51%. (See the last biotech stock roundup here: Biotech Stock Roundup: NERV, RLMD Down on Updates, MRNA, NVAX’s News & More)
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What's Next in Biotech?
Stay tuned for other updates.
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Biotech Stock Roundup: BIIB & BMY's Q3 Earnings, TCDA Down on Study Update
Earnings results, along with important regulatory and pipeline updates, continue to keep the biotech sector in focus.
Recap of the Week’s Most Important Stories:
Q3 Earnings From BMY, BIIB: Biogen (BIIB - Free Report) reported earnings per share (EPS) of $4.77 in the third quarter of 2022, which beat the Zacks Consensus Estimate of $4.13. Sales of $2.51 billion were down 10% on a reported basis from the year-ago quarter due to lower sales of Tecfidera but beat the Zacks Consensus Estimate of $2.47 billion. Nevertheless, Biogen upped its previously issued total revenues and adjusted earnings guidance for 2022. Total revenues are now expected in the range of $10-$10.15 billion for 2022, up from $9.9-$10.1 billion expected previously. Adjusted earnings are expected in the range of $16.50 to $17.50, up from the prior expectation of $15.25-$16.75.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers Squibb Company (BMY - Free Report) reported mixed results for the third quarter of 2022 as earnings beat estimates but sales lagged the same. Earnings of $1.99 per share beat the Zacks Consensus Estimate of $1.83 and increased from $1.93 reported in the year-ago quarter. Total revenues of $11.2 billion surpassed the Zacks Consensus Estimate of $11 billion but decreased 2% from the year-ago period due to generic competition for multiple myeloma (MM) drug Revlimid and foreign exchange impacts, partially offset by in-line products (primarily Eliquis and Opdivo) and new product portfolio (primarily Opdualag, Abecma and Reblozyl).
Regeneron’s Eylea Update: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has granted pediatric exclusivity for the ophthalmology drug Eylea (aflibercept). Consequently, this extends the period of market exclusivity for Eylea in the United States by an additional six months through May 17, 2024.
The pediatric exclusivity determination is based on data from two phase III trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of Eylea as a treatment for retinopathy of prematurity (ROP) in preterm infants. The two Phase III trials also formed the basis of a supplemental Biologics License Application for Eylea in ROP that was recently accepted for Priority Review by the FDA.
Tricida Tanks on Study Update: Shares of Tricida, Inc. plunged after the company announced that the VALOR-CKD renal outcomes clinical trial failed. The study was designed to evaluate veverimer’s ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease (CKD). The study did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease (ESRD), or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR), also known as DD40. Consequently, the prespecified hierarchical analysis did not permit statistical testing of the secondary endpoints. Tricida is evaluating the next further steps given its cash runaway.
Performance
The Nasdaq Biotechnology Index gained 1.19% in the past five trading sessions. Among the biotech giants, Gilead has gained 4.08% during the period. Over the past six months, shares of Biogen have soared 27.51%. (See the last biotech stock roundup here: Biotech Stock Roundup: NERV, RLMD Down on Updates, MRNA, NVAX’s News & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.