This week,
J&J
JNJ
set in motion the first-quarter earnings season for the drug and biotech sector with mixed results. The FDA granted priority review status to
AstraZeneca
AZN
and Daiichi Sankyo’s regulatory application seeking approval of Enhertu in a lung cancer indication and also accepted
Glaxo
’s
GSK
filing for its pipeline candidate, daprodustat.
Recap of the Week’s Most Important Stories
J&J Begins Pharma Q1 Earnings:
J&J reported
mixed first-quarter results
as it beat estimates for earnings but missed the same for sales. Its Pharmaceuticals unit sales fell short of expectations. External supply constraints limited sales growth from the Consumer segment. Sales in the J&J’s MedTech segment improved, driven by a faster-than-expected market recovery, better commercial execution and product launches.
J&J lowered its earnings and sales expectations for 2022, citing the greater-than-expected negative impact from currency movements. The company suspended its previously issued sales guidance for its COVID-19 vaccine, citing surplus supply and demand uncertainty.
FDA’s Priority Tag to AstraZeneca’s Enhertu sBLA in Lung Cancer:
AstraZeneca announced that the FDA has accepted and granted priority review to its and Daiichi Sankyo’s supplemental biologics license application (sBLA) seeking approval for Enhertu for previously treated HER2-mutant metastatic non-small cell lung cancer (NSCLC). With the FDA granting priority review to the sBLA, a decision is expected during the third quarter of 2022. A similar application is also under review in Europe. The sBLA is based on data from the DESTINY-Lung01 phase III study. There are currently no HER2-directed therapies approved specifically for the treatment of HER2-mutant NSCLC. Enhertu has the potential to become the new standard-of-care medicine for this patient population.
Enhertu is presently approved for previously treated HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
FDA Accepts Glaxo’s NDA for Daprodustat:
The FDA accepted Glaxo’s new drug application (NDA) seeking approval of daprodustat for anemia associated with chronic renal disease. The FDA granted the NDA a standard review and hence a decision is expected on Feb 1, 2023. The NDA for daprodustat was based on data from the ASCEND phase III program comprising five studies. All the studies met their primary efficacy and safety endpoints.
Daprodustat is only approved in Japan as Duvroq for patients with renal anemia. An application seeking the approval of daprodustat for a similar indication is also under review in Europe.
The NYSE ARCA Pharmaceutical Index declined 1.9% 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, all stocks were in the red except J&J, which rose 1.9%. Roche declined the most (8.1%) in the last five trading sessions.
In the past six months, AbbVie has recorded the maximum gain (49%) while Roche declined the most (0.5%).
(See the last pharma stock roundup here:
PFE to Buy RSV Drugmaker, FDA Updates for NVS, MRK and RHHBY
)
What’s Next in the Pharma World?
Watch for first-quarter results of Merck, Lilly, AstraZeneca, Sanofi and other regular pipeline and regulatory updates next week.
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