This week, AstraZeneca AZN and Sanofi’s SNY RSV vaccine, nirsevimab and Sanofi and GSK’s GSK next-generation COVID vaccine booster vaccine were approved in Europe. Bayer BAYRY and AstraZeneca announced mixed third-quarter results.
Recap of the Week’s Most Important Stories
AZN Q3 Earnings Beat, Sales in Line: AstraZeneca’s third-quarter results were encouraging as it beat estimates for earnings while sales came in line. Product sales growth was driven by higher sales of key medicines across Oncology and CVRM units like Tagrisso and Farxiga, which offset lower sales of some key older medicines like Brilinta and Symbicort. Higher collaboration revenues also boosted the top line.
AstraZeneca maintained its sales growth guidance for 2022 while raising its earnings growth expectations
Bayer’s Mixed Q3 Results: Bayer missed estimates for earnings while beating the same for sales in the third quarter. Sales in its Crop Science unit rose 8.4% on a currency- and portfolio-adjusted basiswhile the Pharmaceuticals segment rose 2.9%. Sales of key ophthalmology drug Eylea, which Bayer markets in partnership with Regeneron, increased 4.3%. Regeneron records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. The Consumer Health sales segment increased 4.4% year over year.
GSK/Sanofi’s COVID Vaccine Gets Approval in Europe: The European Commission granted approval to Sanofi and GSK’s next-generation COVID-19 vaccine called VidPrevtyn Beta, which can be given as a booster for the prevention of COVID-19 in adults. This protein-based COVID-19 booster vaccine is based on the Beta variant antigen and has shown a strong immune response against multiple variants. GSK/SNY said they would be ready to ship the boosters for fall-winter COVID-19 vaccination campaigns in Europe.
AstraZeneca/Sanofi’s RSV Vaccine Gets Approval in Europe: The European Commission granted the first approval worldwide to AstraZeneca and Sanofi’s nirsevimab vaccine for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The vaccine will be marketed by the trade name of Beyfortus and is the first and only single-dose RSV preventative option approved for the broad newborn and infant population. The approval was based on MELODY phase III, MEDLEY phase II/III and phase IIb studies.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor of U.S. approval of AstraZeneca’s, PT027, a pressurized metered-dose inhaler (pMDI), as a rescue medicine for treating asthma in adults 18 years and older. PT027 is a fixed-dose combination of albuterol and budesonide. The committee voted 16-1 that the data supports a favorable benefit-risk assessment for treating asthma in adults 18 years and older. However, the Committee voted against the use of PT027 for the treatment of asthma in adolescents (aged 12 to 17 years) and children (aged 4 to 11 years). PT027 is under review with the FDA and a decision is expected in the first half of 2023.
GSK’s Multiple Myeloma Drug Fails in Phase III Study: GSK’s phase III study (DREAMM-3) on Blenrep in patients with relapsed or refractory multiple myeloma failed to meet its primary endpoint of progression-free survival (PFS). The head-to-head study evaluated Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low-dose dexamethasone (PomDex) in RRMM patients. In the study, the median progression-free survival was 11.2 months for belantamab mafodotin, which was longer than 7 months for PomDex. Secondary endpoints include overall response rate (ORR), duration of response (DOR) and overall survival (OS). ORR was 41% for belantamab mafodotin and 36% for PomDex. DOR rates at 12 months were 76.8% and 48.4% for belantamab mafodotin and PomDex, respectively. At the time of the primary analysis, the OS data had only achieved 37.5% overall maturity. The median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively,
Blenrep (belantamab mafatotin) was granted accelerated approval as a monotherapy for RRMM patients who have received at least four prior therapies in 2020 based on the results of the DREAMM-2 overall response rate. The final approval was contingent upon a confirmed clinical benefit from a randomized phase III study. GSK said additional trials within the DREAMM clinical trial program would continue. Data from DREAMM-7 and DREAMM-8 phase III studies are expected in 2023.
The NYSE ARCA Pharmaceutical Index rose 3.6% 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
All stocks rose in the last five trading sessions, with AstraZeneca rising the most (8.6%).
In the past six months, Lilly has gained the highest (26.4%), while Pfizer declined the most (5.9%).
(See the last pharma stock roundup here: NVS, MRK Reports Q3 Earnings JNJ’s Tecvayli Gets FDA Nod)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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