Roche RHHBY recently announced that the FDA has approved a label expansion of its influenza drug for Xofluza (baloxavir marboxil).
The regulatory body approved a supplemental new drug application (sNDA) for Xofluza to treat acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
Per the company, the approval makes Xofluza the first single-dose oral influenza medicine approved in the United States for children in this age group.
Additionally, Xofluza was approved by the FDA for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with the disease.
The FDA approval was based on results from two phase III studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members in both adults and children.
We remind investors that the drug is already approved in the United States for the treatment of influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with the disease. It is also approved by the European Commission.
Xofluza is being further evaluated in a phase III development programme, including children under the age of one (NCT03653364), as well as to assess the potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212).
The Swiss pharma giant’s stock has lost 20.6% in the year so far compared with the industry’s decline 0.7%.
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Roche’s performance in the first half of the year was good. The pharmaceuticals business remained stable, and strong demand for new drugs, namely Hemlibra (hemophilia), Ocrevus (multiple sclerosis), Evrysdi (spinal muscular atrophy), Phesgo (cancer) and Tecentriq (cancer) drove growth for this division. This offset the decline in sales of legacy drugs like Avastin, MabThera/Rituxan and Herceptin.
However, demand for COVID-19 tests is expected to decline in the second half of the year. This will impact the Diagnostics division, which recorded solid growth last year due to the outbreak.
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the sector are Alkermes ALKS, BioMarin BMRN and Dynavax DVAX All three carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ALKS’ earnings estimates for 2022 reversed from a loss of 17 cents to earnings of 20 cents in the past 60 days. Alkermes surpassed earnings in all the trailing four quarters, the average being 325.48%.
BioMarin’s earnings estimates for 2022 have increased from $1.95 pr share to $2.01 over the past 60 days. Earnings of BioMarin beat estimates in all of the last four quarters. BMRN delivered an earnings surprise of 98.90%, on average.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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