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Pharma Stock Roundup: PFE to Buy RSV Drugmaker, FDA Updates for NVS, MRK and RHHBY
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This week, Pfizer (PFE - Free Report) announced a deal to acquire private biotech ReViral, which will beef up its respiratory syncytial virus (RSV) antiviral portfolio. The FDA approved Novartis’ (NVS - Free Report) rare disorder drug, Vijoice (alpelisib), granted priority review to Roche’s (RHHBY - Free Report) application seeking expanded use of Actemra for COVID-19 and delayed decision on Merck’s (MRK - Free Report) application seeking approval for the use of its Vaxneuvance vaccine in children and infants. Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent, was approved for treating severe asthma in kids in Europe.
Recap of the Week’s Most Important Stories
Pfizer to Acquire Private RSV Antiviral Maker: Pfizer announced a definitive agreement to acquire a private biotech, ReViral, which is developing therapeutics for respiratory syncytial virus (RSV) for a total consideration of up to $525 million. The purchase consideration includes upfront and development milestones. The acquisition will strengthen Pfizer’s innovative anti-infective pipeline. ReViral has some promising RSV candidates in its portfolio, including sisunatovir, an oral therapy that has significantly reduced viral load in a phase II RSV human challenge study in healthy adults while also being evaluated in a phase II study in infants. Another candidate is in phase I study for inhibition of RSV replication targeting the viral N protein. Pfizer believes that if these RSV candidates are successfully developed, they have the potential to exceed $1.5 billion in annual revenues.
FDA Grants Approval to Novartis’ Ultra-Rare Disease Drug: The FDA granted accelerated approval to Novartis’ Vijoice (alpelisib) as the first treatment for severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS), a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies. The approval of Vijoice was based on real-world data from EPIK-P1 study, which showed that treatment with Vijoice resulted in a reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
The European Medicines Agency (“EMA”) accepted Novartis’ marketing authorization applications (MAAs) seeking approval of IgG4 anti-PD-1 monoclonal antibody tislelizumab in several non-small cell lung cancer and esophageal squamous cell carcinoma indications. The MAAs were based on data from multiple studies under the phase III RATIONALE program, which evaluated tislelizumab as a monotherapy and in combination with chemotherapy. Data from these studies demonstrated significant clinical benefits of tislelizumab versus chemotherapy in the above cancer types. Tislelizumab is already under review for esophageal cancer in the United States. Novartis has a collaboration with BeiGene for tislelizumab.
FDA Grants Priority Tag to Roche’s Actemra/RoActemra sBLA: The FDA accepted and granted priority review to Roche’s supplemental biologics license application (sBLA) seeking approval for its arthritis drug Actemra/RoActemra as an intravenous treatment of COVID-19 in hospitalized patients. The FDA’s decision is expected in the second half of the year. The FDA granted Emergency Use Authorization to Actemra/RoActemra in June last year for defined patients hospitalized with severe or critical COVID-19.
Actemra/RoActemra is already approved for treating COVID-19 in many territories, including the European Union
FDA Delays Decision on Merck’s Vaxneuvance sBLA: The FDA has delayed its decision by three months on Merck’s sBLA seeking approval for Vaxneuvance, its newly approved pneumococcal 15-valent conjugate vaccine, for use in children and infants. The FDA’s decision is now expected on Jul 1 this year. The FDA needs more time to analyze Merck’s data from the pediatric studies on Vaxneuvance, which has been cited as a reason for the delay. The FDA has not requested for any new studies to be conducted. The vaccine was approved in the United States in July and Europe in December last year for use in adults.
EU Approval to Sanofi’s Dupixent for Asthma in Kids: The European Commission approved Sanofi/Regeneron’s Dupixent for children aged 6 to 11 years with severe uncontrolled asthma with type II inflammation. The approval was based on data from a pivotal study that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children of this age group.
The FDA has accepted and granted priority review to a supplemental biologics license application (sBLA) seeking label expansion of Dupixent (dupilumab) for a new indication — eosinophilic esophagitis. The FDA’s decision is expected by Aug 3, 2022.
Dupixent is now approved in the United States, EU and some other countries for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis in different age populations.
The NYSE ARCA Pharmaceutical Index rose 5.8% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: PFE to Buy RSV Drugmaker, FDA Updates for NVS, MRK and RHHBY
This week, Pfizer (PFE - Free Report) announced a deal to acquire private biotech ReViral, which will beef up its respiratory syncytial virus (RSV) antiviral portfolio. The FDA approved Novartis’ (NVS - Free Report) rare disorder drug, Vijoice (alpelisib), granted priority review to Roche’s (RHHBY - Free Report) application seeking expanded use of Actemra for COVID-19 and delayed decision on Merck’s (MRK - Free Report) application seeking approval for the use of its Vaxneuvance vaccine in children and infants. Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent, was approved for treating severe asthma in kids in Europe.
Recap of the Week’s Most Important Stories
Pfizer to Acquire Private RSV Antiviral Maker: Pfizer announced a definitive agreement to acquire a private biotech, ReViral, which is developing therapeutics for respiratory syncytial virus (RSV) for a total consideration of up to $525 million. The purchase consideration includes upfront and development milestones. The acquisition will strengthen Pfizer’s innovative anti-infective pipeline. ReViral has some promising RSV candidates in its portfolio, including sisunatovir, an oral therapy that has significantly reduced viral load in a phase II RSV human challenge study in healthy adults while also being evaluated in a phase II study in infants. Another candidate is in phase I study for inhibition of RSV replication targeting the viral N protein. Pfizer believes that if these RSV candidates are successfully developed, they have the potential to exceed $1.5 billion in annual revenues.
FDA Grants Approval to Novartis’ Ultra-Rare Disease Drug: The FDA granted accelerated approval to Novartis’ Vijoice (alpelisib) as the first treatment for severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS), a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies. The approval of Vijoice was based on real-world data from EPIK-P1 study, which showed that treatment with Vijoice resulted in a reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
The European Medicines Agency (“EMA”) accepted Novartis’ marketing authorization applications (MAAs) seeking approval of IgG4 anti-PD-1 monoclonal antibody tislelizumab in several non-small cell lung cancer and esophageal squamous cell carcinoma indications. The MAAs were based on data from multiple studies under the phase III RATIONALE program, which evaluated tislelizumab as a monotherapy and in combination with chemotherapy. Data from these studies demonstrated significant clinical benefits of tislelizumab versus chemotherapy in the above cancer types. Tislelizumab is already under review for esophageal cancer in the United States. Novartis has a collaboration with BeiGene for tislelizumab.
FDA Grants Priority Tag to Roche’s Actemra/RoActemra sBLA: The FDA accepted and granted priority review to Roche’s supplemental biologics license application (sBLA) seeking approval for its arthritis drug Actemra/RoActemra as an intravenous treatment of COVID-19 in hospitalized patients. The FDA’s decision is expected in the second half of the year. The FDA granted Emergency Use Authorization to Actemra/RoActemra in June last year for defined patients hospitalized with severe or critical COVID-19.
Actemra/RoActemra is already approved for treating COVID-19 in many territories, including the European Union
FDA Delays Decision on Merck’s Vaxneuvance sBLA: The FDA has delayed its decision by three months on Merck’s sBLA seeking approval for Vaxneuvance, its newly approved pneumococcal 15-valent conjugate vaccine, for use in children and infants. The FDA’s decision is now expected on Jul 1 this year. The FDA needs more time to analyze Merck’s data from the pediatric studies on Vaxneuvance, which has been cited as a reason for the delay. The FDA has not requested for any new studies to be conducted. The vaccine was approved in the United States in July and Europe in December last year for use in adults.
EU Approval to Sanofi’s Dupixent for Asthma in Kids: The European Commission approved Sanofi/Regeneron’s Dupixent for children aged 6 to 11 years with severe uncontrolled asthma with type II inflammation. The approval was based on data from a pivotal study that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children of this age group.
The FDA has accepted and granted priority review to a supplemental biologics license application (sBLA) seeking label expansion of Dupixent (dupilumab) for a new indication — eosinophilic esophagitis. The FDA’s decision is expected by Aug 3, 2022.
Dupixent is now approved in the United States, EU and some other countries for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis in different age populations.
The NYSE ARCA Pharmaceutical Index rose 5.8% 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.
Image Source: Zacks Investment Research
In the last five trading sessions, Roche rose the most (7.8%) while J&J recorded the least gain (2.6%).
In the past six months, AbbVie has recorded the maximum gain (60.5%) while Merck recorded the least growth (0.6%).
(See the last pharma stock roundup here: FDA Nod for 2nd COVID Booster, New Approvals for AZN, GSK, NVS)
What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.