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Pharma Stock Roundup: FDA Nod for 2nd COVID Booster, New Approvals for AZN, GSK, NVS
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This week, the FDA authorized a second booster dose of Pfizer (PFE - Free Report) and Moderna’s mRNA-based COVID-19 vaccines for older adults. Novartis’ (NVS - Free Report) eye drug Beovu was approved for a new indication while AstraZeneca’s (AZN - Free Report) cocktail antibody, Evusheld was authorized for COVID-19 prevention in the European Union. The FDA approved Glaxo’s (GSK - Free Report) Triumeq PD, a dispersible single-tablet regimen containing dolutegravir, for HIV treatment. Roche’s (RHHBY - Free Report) late-stage study on anti-TIGIT immunotherapy, tiragolumab, for a hard-to-treat lung cancer, failed.
Recap of the Week’s Most Important Stories
FDA Authorizes Second COVID Jab Booster: The FDA authorized a second booster dose of COVID-19 vaccines made by Pfizer/BioNTech and Moderna for older adults and some immunocompromised individuals. The second booster dose of Pfizer/BioNTech and Moderna’s vaccine can be given to people 50 years of age and older at least four months after they have taken the first booster dose of any authorized or approved COVID-19 vaccine. Additionally, the FDA also authorized a second booster dose of Pfizer/BioNTech’s vaccine for certain immunocompromised individuals 12 years and older and Moderna’s vaccine for individuals 18 years of age and older with the same certain kinds of immunocompromise.
Roche’s Tiragolumab SCLC Study Fails: Roche’s phase III SKYSCRAPER-02 study on investigational anti-TIGIT immunotherapy tiragolumab in extensive-stage small cell lung cancer (ES-SCLC) failed to meet the co-primary endpoint of progression-free survival. The study also failed to meet the other primary endpoint of overall survival (OS) at interim analysis. The study is unlikely to reach statistical significance for OS at the planned final analysis. Roche continues to evaluate tiragolumab in non-small cell lung cancer (NSCLC) as well as other cancer types.
Pfizer’s 2nd Ulcerative Colitis Study on Etrasimod Meets Goals: Pfizer announced positive top-line data from its year-long phase III study evaluating pipeline candidate, etrasimod, for the treatment of moderately to severely active ulcerative colitis (UC). The ELEVATE UC 52 study met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints. ELEVATE UC 52 is the second phase III study on etrasimod for UC to have met primary and key secondary endpoints. Positive 12-week data from the first study ELEVATE 12 study were announced last week. Data from ELEVATE 12 and ELEVATE 52 studies and their long-term extension studies will now form the basis of the regulatory submissions expected later this year
AstraZeneca’s Evusheld Gets Authorization for COVID Prevention in Europe: AstraZeneca’s cocktail antibody medicine for COVD-19 Evusheld has been granted marketing authorization in the European Union (EU) for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population. It is authorized for use in all adults and adolescents aged 12 years and older weighing at least 40 kg. In the United States, Evusheld is authorized for pre-exposure prophylaxis of COVID-19 in only certain specified individuals. The authorization in Europe was based on results from the Evusheld studies, including data from the PROVENT phase III pre-exposure prophylaxis study. Also, data from some in vitro and in vivo (animal model) studies have shown that Evusheld retained potent neutralizing activity against BA.2 subvariant of Omicron, which currently accounts for over 60% of COVID-19 infections in Europe.
EU Approval for Novartis’ Beovu for a New Eye Disease: Novartis’s eye drug Beovu was approved by the European Commission for a second indication, diabetic macular edema, which is a leading cause of blindness in adults in developed countries. The approval for the indication was based on one-year data from the phase III KESTREL and KITE studies, which demonstrated non-inferiority of Beovu to Regeneron’s Eylea (aflibercept) in change in best-corrected visual acuity (BCVA), the study’s primary endpoint, from baseline.
Beovu is presently approved for the treatment of wet age-related macular degeneration (AMD) in several countries including the EU.
FDA Approves Glaxo’s Triumeq Expanded Use in Pediatric HIV: The FDA approved a new dispersible tablet formulation of Glaxo’s HIV medicine Triumeq, which is a fixed-dose combination of abacavir, dolutegravir and lamivudine, for children (weighing 10kgs to <25 kgs) with HIV. In addition, the FDA also approved the expanded use of Triumeq for pediatric patients weighing 25 kgs and above. At present, Triumeq is approved for treating HIV-1 infection in pediatric patients weighing at least 40 kg apart from being approved for use in adults.
The NYSE ARCA Pharmaceutical Index rose 0.5% 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
In the last five trading sessions, Merck rose the most (3.8%) while Pfizer declined the most (1.6%).
In the past six months, AbbVie has recorded the maximum gain (52.5%) while Merck recorded the least gain (0.6%).
Image: Bigstock
Pharma Stock Roundup: FDA Nod for 2nd COVID Booster, New Approvals for AZN, GSK, NVS
This week, the FDA authorized a second booster dose of Pfizer (PFE - Free Report) and Moderna’s mRNA-based COVID-19 vaccines for older adults. Novartis’ (NVS - Free Report) eye drug Beovu was approved for a new indication while AstraZeneca’s (AZN - Free Report) cocktail antibody, Evusheld was authorized for COVID-19 prevention in the European Union. The FDA approved Glaxo’s (GSK - Free Report) Triumeq PD, a dispersible single-tablet regimen containing dolutegravir, for HIV treatment. Roche’s (RHHBY - Free Report) late-stage study on anti-TIGIT immunotherapy, tiragolumab, for a hard-to-treat lung cancer, failed.
Recap of the Week’s Most Important Stories
FDA Authorizes Second COVID Jab Booster: The FDA authorized a second booster dose of COVID-19 vaccines made by Pfizer/BioNTech and Moderna for older adults and some immunocompromised individuals. The second booster dose of Pfizer/BioNTech and Moderna’s vaccine can be given to people 50 years of age and older at least four months after they have taken the first booster dose of any authorized or approved COVID-19 vaccine. Additionally, the FDA also authorized a second booster dose of Pfizer/BioNTech’s vaccine for certain immunocompromised individuals 12 years and older and Moderna’s vaccine for individuals 18 years of age and older with the same certain kinds of immunocompromise.
Roche’s Tiragolumab SCLC Study Fails: Roche’s phase III SKYSCRAPER-02 study on investigational anti-TIGIT immunotherapy tiragolumab in extensive-stage small cell lung cancer (ES-SCLC) failed to meet the co-primary endpoint of progression-free survival. The study also failed to meet the other primary endpoint of overall survival (OS) at interim analysis. The study is unlikely to reach statistical significance for OS at the planned final analysis. Roche continues to evaluate tiragolumab in non-small cell lung cancer (NSCLC) as well as other cancer types.
Pfizer’s 2nd Ulcerative Colitis Study on Etrasimod Meets Goals: Pfizer announced positive top-line data from its year-long phase III study evaluating pipeline candidate, etrasimod, for the treatment of moderately to severely active ulcerative colitis (UC). The ELEVATE UC 52 study met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints. ELEVATE UC 52 is the second phase III study on etrasimod for UC to have met primary and key secondary endpoints. Positive 12-week data from the first study ELEVATE 12 study were announced last week. Data from ELEVATE 12 and ELEVATE 52 studies and their long-term extension studies will now form the basis of the regulatory submissions expected later this year
AstraZeneca’s Evusheld Gets Authorization for COVID Prevention in Europe: AstraZeneca’s cocktail antibody medicine for COVD-19 Evusheld has been granted marketing authorization in the European Union (EU) for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population. It is authorized for use in all adults and adolescents aged 12 years and older weighing at least 40 kg. In the United States, Evusheld is authorized for pre-exposure prophylaxis of COVID-19 in only certain specified individuals. The authorization in Europe was based on results from the Evusheld studies, including data from the PROVENT phase III pre-exposure prophylaxis study. Also, data from some in vitro and in vivo (animal model) studies have shown that Evusheld retained potent neutralizing activity against BA.2 subvariant of Omicron, which currently accounts for over 60% of COVID-19 infections in Europe.
EU Approval for Novartis’ Beovu for a New Eye Disease: Novartis’s eye drug Beovu was approved by the European Commission for a second indication, diabetic macular edema, which is a leading cause of blindness in adults in developed countries. The approval for the indication was based on one-year data from the phase III KESTREL and KITE studies, which demonstrated non-inferiority of Beovu to Regeneron’s Eylea (aflibercept) in change in best-corrected visual acuity (BCVA), the study’s primary endpoint, from baseline.
Beovu is presently approved for the treatment of wet age-related macular degeneration (AMD) in several countries including the EU.
FDA Approves Glaxo’s Triumeq Expanded Use in Pediatric HIV: The FDA approved a new dispersible tablet formulation of Glaxo’s HIV medicine Triumeq, which is a fixed-dose combination of abacavir, dolutegravir and lamivudine, for children (weighing 10kgs to <25 kgs) with HIV. In addition, the FDA also approved the expanded use of Triumeq for pediatric patients weighing 25 kgs and above. At present, Triumeq is approved for treating HIV-1 infection in pediatric patients weighing at least 40 kg apart from being approved for use in adults.
The NYSE ARCA Pharmaceutical Index rose 0.5% 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
In the last five trading sessions, Merck rose the most (3.8%) while Pfizer declined the most (1.6%).
In the past six months, AbbVie has recorded the maximum gain (52.5%) while Merck recorded the least gain (0.6%).
(See the last pharma stock roundup here: NVS, MRK Get FDA Nod, PFE Ulcerative Colitis Study Succeeds)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.