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Pharma Stock Roundup: FDA Panel Nod for PFE, MRNA Young Kids' COVID Jabs & More
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This week, the FDA approved Lilly’s (LLY - Free Report) Olumiant for a new indication and accepted Merck’s (MRK - Free Report) regulatory application seeking approval of its blockbuster cancer drug Keytruda for an adjuvant early-stage lung cancer indication. Roche (RHHBY - Free Report) and partner AC Immune’s Alzheimer’s treatment did not demonstrate a statistically significant clinical benefit in a study. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended the emergency approval of Pfizer (PFE - Free Report) and BioNTech and Moderna’s (MRNA - Free Report) vaccines for young children.
Recap of the Week’s Most Important Stories
FDA Committee Recommends COVID Vaccines of Pfizer, Moderna for Under 5 Kids: The FDA VRBPAC committee unanimously recommended emergency approval of Pfizer and BioNTech and Moderna’s vaccines for young children, saying the benefits of the vaccines outweigh the risks. While Pfizer and BioNTech were seeking approval for their mRNA-based COVID-19 vaccine for children six months to under five years of age as a three-dose vaccine, Moderna filed for the emergency approval of two 25-µg doses of its mRNA-based vaccine in children six months to under six years of age
The FDA will now give its decision on whether to grant emergency use authorization to the vaccines. If the FDA approves both or either of Pfizer/BioNTech or Moderna’s vaccines and the Centers for Disease Control and Prevention recommends them, President Biden expects vaccinations to begin in kids under the age of 5 next week.
Roche Alzheimer’s Candidate Fails to Show Clinical Benefit: Roche announced data from an Alzheimer’s disease study on its pipeline candidate, crenezumab, conducted in Colombia. However, in the study, crenezumab failed to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation, which causes early-onset of Alzheimer’s disease. The study’s co-primary endpoints were assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index. However, the study did not show a statistically significant clinical benefit in either of its co-primary endpoints. Crenezumab was originally discovered by Roche’s partner AC Immune.
FDA Approves Lilly’s Olumiant for Alopecia Areata: The FDA approved Lilly and partner Incyte’s oral JAK inhibitor, Olumiant (baricitinib), for treating adults with severe alopecia areata, a disease that causes non-scarring hair loss. Until now, there were no FDA-approved systemic treatments for AA. Systemic treatments are treatments that target the entire body and not any specific area. Olumiant is the first-ever FDA-approved systemic treatment for alopecia areata patients. Olumiant will now be available for adults with AA as a 4-mg, 2-mg and 1-mg once-daily tablet. Olumiant’s approval for AA was based on data from two phase III studies, BRAVE-AA1 and BRAVE-AA2, which showed that Olumiant significantly improved hair regrowth.
Olumiant is approved to treat rheumatoid arthritis (RA) and COVID-19 in certain hospitalized adults requiring various degrees of oxygen support. Olumiant is also approved in Europe and Japan for atopic dermatitis while it is under review in the United States for the same indication.
FDA Accepts Merck’s Keytruda sBLA for Adjuvant Lung Cancer: The FDA accepted for review Merck’s supplemental biologics license application (sBLA) seeking approval of Keytruda for treating adjuvant stage IB-IIIA non-small cell lung cancer (NSCLC), following complete surgical resection. The FDA is expected to give its decision on Jan 29, 2023. The sBLA was based on data from the phase III KEYNOTE-091 study, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. KEYNOTE-091 was Merck’s seventh pivotal study on Keytruda in the earlier stages of cancer that met the primary endpoint.
Pfizer Stops Enrolment in Paxlovid Study in Standard-Risk Patients: Pfizer announced that it is stopping enrolment in a study evaluating its oral COVID-19 pill, Paxlovid in standard-risk patients. The decision was taken after data from the phase II/III EPIC-SR study showed that Paxlovid did not improve symptoms in the standard-risk patients. Paxlovid is presently authorized for emergency treatment of high-risk COVID-19 patients.
As previously reported last year, the EPIC-SR study had failed to achieve its primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days. An updated analysis of the data showed a 51% relative reduction in the key secondary endpoint of hospitalization or death in standard-risk patients, which Pfizer said was not statistically significant. Though the data from the EPIC-SR study is not at all statistically significant, Pfizer intends to submit the same along with the new drug application (NDA), which will seek the FDA’s approval to treat appropriate individuals who are at high risk of progression to severe illness. The NDA will be based on data from the phase II/III EPIC-HR study, which evaluated Paxlovid in high-risk patients for developing severe COVID-19 infection.
The European Medicines Agency (EMA) initiated the rolling review of Pfizer and BioNTech’s regulatory application for a variant-adapted version of their COVID-19 vaccine. Pfizer and BioNTech are also planning to file data supporting a potential variant-adapted vaccine to the FDA in the coming weeks.
The NYSE ARCA Pharmaceutical Index declined 4.94% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
All the stocks were in the red in the last five trading sessions. Pfizer declined the most (8.3%).
In the past six months, Merck rose the most (12.1%) while Roche declined the most (23.6%).
Image: Bigstock
Pharma Stock Roundup: FDA Panel Nod for PFE, MRNA Young Kids' COVID Jabs & More
This week, the FDA approved Lilly’s (LLY - Free Report) Olumiant for a new indication and accepted Merck’s (MRK - Free Report) regulatory application seeking approval of its blockbuster cancer drug Keytruda for an adjuvant early-stage lung cancer indication. Roche (RHHBY - Free Report) and partner AC Immune’s Alzheimer’s treatment did not demonstrate a statistically significant clinical benefit in a study. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended the emergency approval of Pfizer (PFE - Free Report) and BioNTech and Moderna’s (MRNA - Free Report) vaccines for young children.
Recap of the Week’s Most Important Stories
FDA Committee Recommends COVID Vaccines of Pfizer, Moderna for Under 5 Kids: The FDA VRBPAC committee unanimously recommended emergency approval of Pfizer and BioNTech and Moderna’s vaccines for young children, saying the benefits of the vaccines outweigh the risks. While Pfizer and BioNTech were seeking approval for their mRNA-based COVID-19 vaccine for children six months to under five years of age as a three-dose vaccine, Moderna filed for the emergency approval of two 25-µg doses of its mRNA-based vaccine in children six months to under six years of age
The FDA will now give its decision on whether to grant emergency use authorization to the vaccines. If the FDA approves both or either of Pfizer/BioNTech or Moderna’s vaccines and the Centers for Disease Control and Prevention recommends them, President Biden expects vaccinations to begin in kids under the age of 5 next week.
Roche Alzheimer’s Candidate Fails to Show Clinical Benefit: Roche announced data from an Alzheimer’s disease study on its pipeline candidate, crenezumab, conducted in Colombia. However, in the study, crenezumab failed to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation, which causes early-onset of Alzheimer’s disease. The study’s co-primary endpoints were assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index. However, the study did not show a statistically significant clinical benefit in either of its co-primary endpoints. Crenezumab was originally discovered by Roche’s partner AC Immune.
FDA Approves Lilly’s Olumiant for Alopecia Areata: The FDA approved Lilly and partner Incyte’s oral JAK inhibitor, Olumiant (baricitinib), for treating adults with severe alopecia areata, a disease that causes non-scarring hair loss. Until now, there were no FDA-approved systemic treatments for AA. Systemic treatments are treatments that target the entire body and not any specific area. Olumiant is the first-ever FDA-approved systemic treatment for alopecia areata patients. Olumiant will now be available for adults with AA as a 4-mg, 2-mg and 1-mg once-daily tablet. Olumiant’s approval for AA was based on data from two phase III studies, BRAVE-AA1 and BRAVE-AA2, which showed that Olumiant significantly improved hair regrowth.
Olumiant is approved to treat rheumatoid arthritis (RA) and COVID-19 in certain hospitalized adults requiring various degrees of oxygen support. Olumiant is also approved in Europe and Japan for atopic dermatitis while it is under review in the United States for the same indication.
FDA Accepts Merck’s Keytruda sBLA for Adjuvant Lung Cancer: The FDA accepted for review Merck’s supplemental biologics license application (sBLA) seeking approval of Keytruda for treating adjuvant stage IB-IIIA non-small cell lung cancer (NSCLC), following complete surgical resection. The FDA is expected to give its decision on Jan 29, 2023. The sBLA was based on data from the phase III KEYNOTE-091 study, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. KEYNOTE-091 was Merck’s seventh pivotal study on Keytruda in the earlier stages of cancer that met the primary endpoint.
Pfizer Stops Enrolment in Paxlovid Study in Standard-Risk Patients: Pfizer announced that it is stopping enrolment in a study evaluating its oral COVID-19 pill, Paxlovid in standard-risk patients. The decision was taken after data from the phase II/III EPIC-SR study showed that Paxlovid did not improve symptoms in the standard-risk patients. Paxlovid is presently authorized for emergency treatment of high-risk COVID-19 patients.
As previously reported last year, the EPIC-SR study had failed to achieve its primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days. An updated analysis of the data showed a 51% relative reduction in the key secondary endpoint of hospitalization or death in standard-risk patients, which Pfizer said was not statistically significant. Though the data from the EPIC-SR study is not at all statistically significant, Pfizer intends to submit the same along with the new drug application (NDA), which will seek the FDA’s approval to treat appropriate individuals who are at high risk of progression to severe illness. The NDA will be based on data from the phase II/III EPIC-HR study, which evaluated Paxlovid in high-risk patients for developing severe COVID-19 infection.
The European Medicines Agency (EMA) initiated the rolling review of Pfizer and BioNTech’s regulatory application for a variant-adapted version of their COVID-19 vaccine. Pfizer and BioNTech are also planning to file data supporting a potential variant-adapted vaccine to the FDA in the coming weeks.
The NYSE ARCA Pharmaceutical Index declined 4.94% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
All the stocks were in the red in the last five trading sessions. Pfizer declined the most (8.3%).
In the past six months, Merck rose the most (12.1%) while Roche declined the most (23.6%).
(See the last pharma stock roundup here: FDA Nod to GSK’s MMR Jab & SNY’s Dupixent Expanded Use)
What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.