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The biotech sector has been in focus over the past week with earnings releases. Bigwig Gilead Sciences (GILD - Free Report) came out with fourth-quarter earnings. Also, pipeline and regulatory updates grabbed the spotlight in the sector.
Recap of the Week’s Most Important Stories:
Regulatory and Pipeline Updates From Regeneron: Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that they have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was taken after the companies failed to align with the FDA on certain post-marketing studies of the drug. Discussions with regulatory authorities outside of the United States are ongoing.
Regeneron and Sanofi also announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive opinion for a label expansion of asthma drug Dupixent. The CHMP recommended expanding Dupixent (dupilumab) label in the European Union to include add-on maintenance treatment for children aged six to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to give a final decision in the coming months.
Gilead’s Q4 Results, Other Updates: Gilead missed earnings estimates in the fourth quarter but beat on sales. It reported earnings of 69 cents per share, which missed the Zacks Consensus Estimate of $1.53 and declined from $2.19 in the year-ago quarter. The year-over-year decline was primarily due to the impact of $1.25 billion charge related to a legal settlement and a charge of $625 million pertaining to the Arcus collaboration opt-in.
Total revenues of $7.2 billion surpassed the Zacks Consensus Estimate of $6.6 billion but decreased 2% from the year-ago quarter due to reduced demand for Veklury (remdesivir 100 mg for injection) for the treatment of COVID-19. Excluding Veklury, product sales increased due to higher demand for flagship HIV therapy Biktarvy and favorable pricing dynamics in HIV as well as contributions from breast cancer drug Trodelvy (sacituzumab govitecan-hziy) and Cell Therapy.
Gilead also announced that the FDA has approved an update to the prescribing information for chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel) to include the use of prophylactic corticosteroids across all approved indications.
Moderna Gets Approval for COVID-19 Vaccine: Moderna (MRNA - Free Report) announced that the FDA has approved the biologics license application (BLA) for its mRNA-based COVID-19 vaccine, SPIKEVAX. The vaccine was approved to prevent COVID-19 in individuals 18 years of age and older.
The FDA approval was based on a comprehensive submission package by Modena, including efficacy and safety data approximately six months after the second dose. This included follow-up data from the phase III COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure.. The vaccine was available under Emergency Use Authorization (EUA) in the United States from Dec 18, 2020.
Biogen Sells Equity Stake: Biogen Inc. (BIIB - Free Report) announced that it has entered into an agreement with partner Samsung Biologics to sell its equity stake in their biosimilar joint venture. Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon the achievement of certain commercial milestones. The companies will, however, continue with their exclusive agreements for the commercialization of Flixabi, Benepali and Imraldi. Biogen will also keep commercial rights for Byooviz and SB15.
Biogen also announced that it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30 million one-time option fee to Roche’s Genentech for the same. Mosunetuzumab is an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic areas.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 5.90% in the past five trading sessions. Among the biotech giants, Moderna has gained 11.47% during the period. Over the past six months, shares of Vertex have soared 23.87%. (See the last biotech stock roundup here: Biotech Stock Roundup: VRTX Q4 Earnings, GILD, INCY’s Regulatory Updates & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates, along with earnings updates.
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Biotech Stock Roundup: GILD Q4 Earnings, REGN, MRNA's Regulatory Updates & More
The biotech sector has been in focus over the past week with earnings releases. Bigwig Gilead Sciences (GILD - Free Report) came out with fourth-quarter earnings. Also, pipeline and regulatory updates grabbed the spotlight in the sector.
Recap of the Week’s Most Important Stories:
Regulatory and Pipeline Updates From Regeneron: Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that they have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was taken after the companies failed to align with the FDA on certain post-marketing studies of the drug. Discussions with regulatory authorities outside of the United States are ongoing.
Regeneron and Sanofi also announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive opinion for a label expansion of asthma drug Dupixent. The CHMP recommended expanding Dupixent (dupilumab) label in the European Union to include add-on maintenance treatment for children aged six to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to give a final decision in the coming months.
Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead’s Q4 Results, Other Updates: Gilead missed earnings estimates in the fourth quarter but beat on sales. It reported earnings of 69 cents per share, which missed the Zacks Consensus Estimate of $1.53 and declined from $2.19 in the year-ago quarter. The year-over-year decline was primarily due to the impact of $1.25 billion charge related to a legal settlement and a charge of $625 million pertaining to the Arcus collaboration opt-in.
Total revenues of $7.2 billion surpassed the Zacks Consensus Estimate of $6.6 billion but decreased 2% from the year-ago quarter due to reduced demand for Veklury (remdesivir 100 mg for injection) for the treatment of COVID-19. Excluding Veklury, product sales increased due to higher demand for flagship HIV therapy Biktarvy and favorable pricing dynamics in HIV as well as contributions from breast cancer drug Trodelvy (sacituzumab govitecan-hziy) and Cell Therapy.
Gilead also announced that the FDA has approved an update to the prescribing information for chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel) to include the use of prophylactic corticosteroids across all approved indications.
Moderna Gets Approval for COVID-19 Vaccine: Moderna (MRNA - Free Report) announced that the FDA has approved the biologics license application (BLA) for its mRNA-based COVID-19 vaccine, SPIKEVAX. The vaccine was approved to prevent COVID-19 in individuals 18 years of age and older.
The FDA approval was based on a comprehensive submission package by Modena, including efficacy and safety data approximately six months after the second dose. This included follow-up data from the phase III COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure.. The vaccine was available under Emergency Use Authorization (EUA) in the United States from Dec 18, 2020.
Biogen Sells Equity Stake: Biogen Inc. (BIIB - Free Report) announced that it has entered into an agreement with partner Samsung Biologics to sell its equity stake in their biosimilar joint venture. Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon the achievement of certain commercial milestones. The companies will, however, continue with their exclusive agreements for the commercialization of Flixabi, Benepali and Imraldi. Biogen will also keep commercial rights for Byooviz and SB15.
Biogen also announced that it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30 million one-time option fee to Roche’s Genentech for the same. Mosunetuzumab is an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic areas.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 5.90% in the past five trading sessions. Among the biotech giants, Moderna has gained 11.47% during the period. Over the past six months, shares of Vertex have soared 23.87%. (See the last biotech stock roundup here: Biotech Stock Roundup: VRTX Q4 Earnings, GILD, INCY’s Regulatory Updates & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates, along with earnings updates.