J&J ( JNJ Quick Quote JNJ - Free Report) announced strong first-quarter results, beating estimates for both earnings and sales. Roche’s ( RHHBY Quick Quote RHHBY - Free Report) COVID-19 diagnostics tests sales boosted the top line, offsetting declines in its core drug business. The FDA granted approval to Glaxo’s ( GSK Quick Quote GSK - Free Report) endometrial cancer therapy, Jemperli (dostarlimab). Recap of the Week’s Most Important Stories J&J J&J Earnings & Sales Beat: beat first-quarter estimates for earnings as well as sales. Its Pharmaceuticals unit continued to perform above market levels while the recovery in the Medical Devices unit continued. However, unfavorable comparisons to the year-ago quarter due to COVID-19 pantry loading and demand surges experienced in 2020 hurt sales of the Consumer Health segment in the first quarter of 2021
The company reported $100 million in sales for its COVID-19 vaccine. J&J tightened its previously issued guidance range for earnings and sales for 2021 and announced a 5% increase in its quarterly dividend.
Meanwhile, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) confirmed that the
overall benefit-risk profile of J&J’s COVID-19 vaccine remains positive. The committee reviewed some cases of adverse events involving blood clots in combination with low platelet counts in some people one to three weeks after receiving J&J’s vaccine. J&J will update the label of the vaccine to include important information about diagnosis and management of the blood clot issues. Following the PRAC review, J&J will resume shipments of its vaccine in the European Union (EU), Norway and Iceland. Last week, the FDA and U.S. Centers for Disease Control and Prevention (“CDC”) jointly issued a statement to recommend a temporary pause in the use of J&J’s vaccine in the United States as they reviewed similar blood clot cases. Following the statement, J&J decided to delay the rollout of the vaccine in Europe.
Meanwhile, J&J announced that it will not pursue regulatory filing seeking approval of Erleada and Zytiga plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) based on data from the ACIS study. Though the study met its primary endpoint of radiographic progression-free survival (rPFS), the combination did not show significant benefit over the active control Zytiga plus prednisone in key secondary endpoints, including overall survival (OS).
Roche’s sales in the first quarter of 2021 declined 1% year over year. Sales in the Pharmaceuticals unit declined 9% as the coronavirus pandemic impacted overall demand. Biosimilars competition for legacy drugs like MabThera/Rituxan, Herceptin and Avastin also hurt sales of the Pharma unit. However, the Diagnostics division sales rose 55% in the quarter due to a surge in COVID-19 diagnostics tests Roche Reports Q1 Sales: The FDA granted approval to Glaxo’s PD-1 inhibitor, dostarlimab for treating women with dMMR recurrent or advanced endometrial cancer who progressed on or after a platinum-based regimen. The drug will be marketed by the trade name of Jemperli. The approval, which is on an accelerated basis, is based on results from the dMMR endometrial cancer cohort of the ongoing GARNET study, a large multi-center study evaluating an anti-PD-1 antibody as monotherapy treatment in women with endometrial cancer. FDA Approves Glaxo’s Endometrial Cancer Drug: Lilly Seeks Revocation of Bamlanivimab EUA: Lilly ( LLY Quick Quote LLY - Free Report) has requested the FDA to revoke the Emergency Use Authorization (EUA) granted to its antibody medicine for COVID-19, bamlanivimab as a monotherapy. Lilly will now focus only on supplying its antibody cocktail, bamlanivimab and etesevimab together, which were granted emergency approval by the FDA in February. Last week, Lilly modified the COVID-19 purchase agreement for bamlanivimab with the U.S. government to enable the supply of etesevimab to complement doses of bamlanivimab the government has already purchased. Lilly believes that the cocktail medicine can neutralize more of the emerging COVID-19 variants in the United States, including the rapidly growing B.1.427/B.1.429 California strain, than bamlanivimab alone. Lilly clarified that the request to revoke EUA for bamlanivimab was not due to any no safety concerns related to the drug. Lilly along with partner Amgen expects to manufacture sufficient supply of the cocktail therapy to meet global needs.
Lilly announced that BRAVE-AA1 phase III study evaluating once-daily Olumiant (baricitinib) 2-mg and 4-mg in adults with severe alopecia areata (AA) met the primary endpoint of hair regrowth. Both doses of baricitinib demonstrated a statistically significant improvement in scalp hair regrowth at week 36 compared to those randomized to placebo. There are currently no FDA-approved treatments for AA. In March, the first phase III study (BRAVE-AA2) evaluating baricitinib for AA also showed that baricitinib led to statistically significant improvement in scalp hair regrowth across both dosing groups
EU Approval for Second Indication of Sanofi’s Sarclisa : The European Commission granted approval to Sanofi’s ( SNY Quick Quote SNY - Free Report) Sarclisa for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least one prior therapy. The drug received the nod in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone (Kd) for treating adults with RRMM who have received one to three prior lines of therapy. The FDA approved Sarclisa for a similar indication in March 2021. The approval was based on encouraging data from the phase III IKEMA study, which showed that the Sarclisa combination reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies. In the EU, Sarclisa was approved in combination with pomalidomide and dexamethasone (pom-dex), for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor in June 2020. The European Commission exercised its option to Pfizer/BioNTech to Supply 100M More Doses of COVID-19 Vaccine to EU: purchase an additional 100 million doses of Pfizer ( PFE Quick Quote PFE - Free Report) and its German partner, BioNTech’s COVID-19 vaccine, Comirnaty. With this latest order, total doses ordered by the EU becomes 600 million. All doses are expected to be delivered in 2021, with 250 million expected to be delivered in the second quarter.
The NYSE ARCA Pharmaceutical Index rose 2% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks were in the green with
AstraZeneca ( AZN Quick Quote AZN - Free Report) recording the maximum gain (3.7%).
In the past six months, Lilly recorded the maximum gain (32%) while Merck declined the most (1.1%).
(See the last pharma stock roundup here:
JNJ’s COVID-19 Vaccine Woes, MRK Ends COVID-19 Drug Development) What's Next in the Pharma World?
Watch out for Merck, Lilly, AbbVie and others’ first-quarter results and regular pipeline and regulatory updates next week.
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