It has been a busy week for the biotech sector with third-quarter earnings and regulatory and pipeline updates. The development of coronavirus vaccines and subsequent progress also continue to be in the spotlight.
: Recap of the Week’s Most Important Stories : Bristol-Myers Q3 Earnings, Sales Beat Bristol-Myers ( BMY Quick Quote BMY - Free Report) reported better-than-expected results in the third quarter of 2021 driven by solid performance of Revlimid, Eliquis, and Opdivo. Incremental sales from newer drugs like Reblozyl also boosted the top line. Third-quarter earnings of $2 per share beat the Zacks Consensus Estimate of $1.91 and increased from the year-ago quarter’s $1.63. Total revenues of $11.6 billion surpassed the Zacks Consensus Estimate of $11.5 billion and increased 10% from the year-ago period. The company also upped the lower end of its annual earnings guidance. : Regulatory and Pipeline Updates on Regeneron’s Dupixent Regeneron Pharmaceuticals, Inc. ( REGN Quick Quote REGN - Free Report) and Sanofi ( SNY Quick Quote SNY - Free Report) announced positive results from a second phase III study evaluating the use of Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The study met its co-primary endpoints as Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from the first phase III study.
Earlier, both the companies
announced that the phase III study evaluating Dupixent in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions was successful. The study met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting.
The FDA also approved a label expansion of Dupixent as an add-on maintenance treatment of patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see
. the complete list of today’s Zacks #1 Rank stocks here : Gilead, Merck Initiate HIV Study Gilead Sciences, Inc. ( GILD Quick Quote GILD - Free Report) has initiated a phase II study in collaboration with pharma giant Merck ( MRK Quick Quote MRK - Free Report) among HIV patients who are virologically suppressed on antiretroviral therapy. The phase II study is designed to evaluate the safety and antiviral effect of an oral weekly regimen of Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, in combination with Gilead’s investigational capsid inhibitor, lenacapavir. The primary endpoint is the proportion of study participants with HIV-1 RNA viral load ≥ 50 c/mL at Week 24. Participants age 18 years and older will be enrolled in this study, which is being conducted at 25 sites in the United States. Both the companies had collaborated in March 2021. : Updates From Moderna Moderna ( MRNA Quick Quote MRNA - Free Report) announced that the Swissmedic has authorized a booster dose of its COVID-19 vaccine, Spikevax, at the 50 µg dose level in particularly vulnerable individuals 12 years of age and older, at least six months after completion of the primary series. The agency also approved a third dose of Spikevax at the 100 µg dose level for people with a weakened immune system at least 28 days after the second dose.
Earlier, the FDA authorized for emergency use a booster dose of its COVID-19 vaccine at the 50 µg dose level for people aged 65 and older, people aged 18 to 64 who are at high risk of severe COVID-19, and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The booster dose is to be administered at least six months after completion of the primary series.
Moderna also announced that the first participant has been dosed in the phase III registration study of mRNA-1647, its cytomegalovirus (CMV) vaccine candidate. This study is known as CMVictory. The study will evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women aged 16-40 years.
: Vertex Collaboration for Gene-Editing Therapies Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) announced a collaboration with Mammoth Biosciences to develop in vivo gene-editing therapies for two genetic diseases using Mammoth’s next-generation CRISPR systems. Per the terms, Mammoth Biosciences will receive upfront payments of $41 million, including an investment in the form of a convertible note, and is eligible to receive up to $650 million in potential milestone payments. Vertex will also pay tiered royalties on future net sales on any products that may result from this collaboration. Performance
The Nasdaq Biotechnology Index has gained 1.29% in the past five trading sessions. Among the biotech giants, Moderna has gained 3.64% during the period. Over the past six months, shares of Moderna have soared 94.66%. (See the last biotech stock roundup here:
). Biotech Stock Roundup: BIIB’s Q3 Results, REGN’s COVID-19 Cocktail Update & More Image Source: Zacks Investment Research What's Next in Biotech?
Stay tuned for more earnings, pipeline, and regulatory updates.