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Pharma Stock Roundup: PFE COVID-19 Vaccine Final Analysis, FDA Updates & More
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This week, Pfizer (PFE - Free Report) announced its COVID-19 vaccine candidate is 95% effective at preventing the disease from the final analysis of its phase III study. The FDA approved Merck’s (MRK - Free Report) blockbuster drug Keytruda for the first time for a breast cancer indication. The regulatory agency also granted Emergency Use Authorization (EUA) to Lilly’s (LLY - Free Report) Olumiant for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients
Recap of the Week’s Most Important Stories
Pfizer’s COVID-19 Vaccine is 95% Effective: Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, proved to be 95% effective in final analysis, a week after interim results showed that the vaccine was more than 90% effective. 170 participants in the study were infected with COVID-19 with 162 in the placebo group and 8 in the BNT162b2 vaccinated group. The vaccine proved effective across all age and ethnic groups including older people who are the most at-risk population. Pfizer has now reached FDA’s safety milestone and expects to file for EUA soon and also submit the data to other global regulatory authorities.
FDA Grants EUA to 2nd Lilly Therapy for COVID-19: The FDA granted EUA to Lilly and Incyte’s oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study. This is the second EUA for a COVID-19 treatment for Lilly. Last week, the FDA had granted EUA to Lilly’s antibody candidate bamlanivimab as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. Lilly’s BLA for bamlanivimab was based on data from the phase II BLAZE-1 study.
FDA Approves Merck’s Keytruda in TNBC: The FDA approved Merck’s supplemental biologics license application (sBLA), seeking accelerated approval for Keytruda for an aggressive breast cancer indication. The latest approval is for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on KEYNOTE-355 study. This marks the first approval for Keytruda in the breast cancer setting.
FDA Updates for Sanofi: The FDA issued a complete response letter (CRL) to Sanofi’s (SNY - Free Report) regulatory application for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD), a serious, chronic, rare blood disorder. The reason for the CRL is the identification of certain deficiencies by the FDA during a pre-license inspection of a third-party manufacturing facility. The CRL does not mention any clinical or safety deficiencies in the BLA.
The FDA also granted priority review tag to Sanofi’s regulatory filing for its investigational enzyme replacement therapy (ERT), avalglucosidase alfa, for the treatment of Pompe disease. With the FDA granting a priority review, a decision is expected on May 18 next year.
The regulatory agency also gave Fast Track status to Sanofi’s investigational BTK inhibitor, rilzabrutinib, which the company had acquired from Principia Biopharma, to treat immune thrombocytopenia (ITP), a blood disorder that causes high risk for bleeding events.
Also, the European Commission granted approval to its quadrivalent recombinant influenza vaccine, Supemtek. The vaccine is already marketed in the United States.
FDA’s Breakthrough Tag for Glaxo’s HIV Candidate: The FDA granted Breakthrough Therapy designation to Glaxo’s (GSK - Free Report) long-acting injectable cabotegravir (CAB LA) for HIV prevention. The designation was based on data from the phase IIb/III HPTN 083 study and phase III HPTN 084 study, which showed that CAB LA was superior to daily oral pills in preventing HIV infection.
J&J Expands BARDA Deal for COVID-19 Vaccine Studies: J&J (JNJ - Free Report) expanded its agreement with BARDA, part of U.S. Department of Health and Human Services, to support its large pivotal phase III study, ENSEMBLE, on its coronavirus vaccine candidate, JNJ-78436735. Per the latest deal, J&J will commit approximately $604 million and BARDA is putting up approximately $454 million to support the ENSEMBLE study.
Novartis Buys Rights to ADRS Candidate: Novartis (NVS - Free Report) in-licensed worldwide rights to develop, commercialize and manufacture Australian company, Mesoblast’s investigational candidate remestemcel-L, a potential, therapy for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. At present, a phase III study is ongoing to study remestemcel-L for COVID-19-related ARDS while Novartis will begin a phase III study in non-COVID-19-related ARDS after the deal closure. For the deal, Novartis will make a $25 million upfront cash payment and also make investments worth $25 million in Mesoblast’s equity.
The NYSE ARCA Pharmaceutical Index rose 0.1% in the last five trading sessions.
Watch out for pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Pharma Stock Roundup: PFE COVID-19 Vaccine Final Analysis, FDA Updates & More
This week, Pfizer (PFE - Free Report) announced its COVID-19 vaccine candidate is 95% effective at preventing the disease from the final analysis of its phase III study. The FDA approved Merck’s (MRK - Free Report) blockbuster drug Keytruda for the first time for a breast cancer indication. The regulatory agency also granted Emergency Use Authorization (EUA) to Lilly’s (LLY - Free Report) Olumiant for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients
Recap of the Week’s Most Important Stories
Pfizer’s COVID-19 Vaccine is 95% Effective: Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, proved to be 95% effective in final analysis, a week after interim results showed that the vaccine was more than 90% effective. 170 participants in the study were infected with COVID-19 with 162 in the placebo group and 8 in the BNT162b2 vaccinated group. The vaccine proved effective across all age and ethnic groups including older people who are the most at-risk population. Pfizer has now reached FDA’s safety milestone and expects to file for EUA soon and also submit the data to other global regulatory authorities.
FDA Grants EUA to 2nd Lilly Therapy for COVID-19: The FDA granted EUA to Lilly and Incyte’s oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study. This is the second EUA for a COVID-19 treatment for Lilly. Last week, the FDA had granted EUA to Lilly’s antibody candidate bamlanivimab as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. Lilly’s BLA for bamlanivimab was based on data from the phase II BLAZE-1 study.
FDA Approves Merck’s Keytruda in TNBC: The FDA approved Merck’s supplemental biologics license application (sBLA), seeking accelerated approval for Keytruda for an aggressive breast cancer indication. The latest approval is for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on KEYNOTE-355 study. This marks the first approval for Keytruda in the breast cancer setting.
FDA Updates for Sanofi: The FDA issued a complete response letter (CRL) to Sanofi’s (SNY - Free Report) regulatory application for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD), a serious, chronic, rare blood disorder. The reason for the CRL is the identification of certain deficiencies by the FDA during a pre-license inspection of a third-party manufacturing facility. The CRL does not mention any clinical or safety deficiencies in the BLA.
The FDA also granted priority review tag to Sanofi’s regulatory filing for its investigational enzyme replacement therapy (ERT), avalglucosidase alfa, for the treatment of Pompe disease. With the FDA granting a priority review, a decision is expected on May 18 next year.
The regulatory agency also gave Fast Track status to Sanofi’s investigational BTK inhibitor, rilzabrutinib, which the company had acquired from Principia Biopharma, to treat immune thrombocytopenia (ITP), a blood disorder that causes high risk for bleeding events.
Also, the European Commission granted approval to its quadrivalent recombinant influenza vaccine, Supemtek. The vaccine is already marketed in the United States.
FDA’s Breakthrough Tag for Glaxo’s HIV Candidate: The FDA granted Breakthrough Therapy designation to Glaxo’s (GSK - Free Report) long-acting injectable cabotegravir (CAB LA) for HIV prevention. The designation was based on data from the phase IIb/III HPTN 083 study and phase III HPTN 084 study, which showed that CAB LA was superior to daily oral pills in preventing HIV infection.
J&J Expands BARDA Deal for COVID-19 Vaccine Studies: J&J (JNJ - Free Report) expanded its agreement with BARDA, part of U.S. Department of Health and Human Services, to support its large pivotal phase III study, ENSEMBLE, on its coronavirus vaccine candidate, JNJ-78436735. Per the latest deal, J&J will commit approximately $604 million and BARDA is putting up approximately $454 million to support the ENSEMBLE study.
Novartis Buys Rights to ADRS Candidate: Novartis (NVS - Free Report) in-licensed worldwide rights to develop, commercialize and manufacture Australian company, Mesoblast’s investigational candidate remestemcel-L, a potential, therapy for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. At present, a phase III study is ongoing to study remestemcel-L for COVID-19-related ARDS while Novartis will begin a phase III study in non-COVID-19-related ARDS after the deal closure. For the deal, Novartis will make a $25 million upfront cash payment and also make investments worth $25 million in Mesoblast’s equity.
The NYSE ARCA Pharmaceutical Index rose 0.1% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
While AbbVie recorded the maximum increase (2.1%), AstraZeneca declined the most (4.9%).
In the past six months, while AbbVie recorded the maximum increase (7.1%), Lilly declined the most (5.7%).
(See the last pharma stock roundup here: PFE Coronavirus Data, FDA Emergency Tag for LLY COVID-19 Drug)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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