Yahoo Finance J&J (JNJ) Seeks Expanded Use of HIV Drug in US and Europe
Johnson & Johnson JNJ announced that it has submitted a supplemental new drug application (sNDA) seeking expanded use of its HIV-1 therapy, Prezcobix, for younger kids in the United States.
Prezcobix is a two-drug fixed-dose combination tablet for treating HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescent patients weighing at least 40 kg. It combines darunavir, J&J’s HIV-1 protease inhibitor, and cobicistat, Gilead Sciences’ GILD CYP3A inhibitor. J&J markets darunavir as Prezista, as a single agent, in the United States and Gilead markets cobicistat by the name of Tybost.
So far this year, J&J’s shares have declined 5.7% against the industry’s 17.3% increase.
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The sNDA seeks approval of Prezcobix for treatment-naïve and treatment-experienced pediatric patients aged 6 and older weighing at least 25 kg who have no viral resistance mutations associated with darunavir. A similar label expansion application has also been submitted to the European Medicines Agency (EMA) for expanded use of Rezolsta for pediatric patients in Europe. Rezolsta is Prezcobix’s brand name in Europe.
Prezcobix/Rezolsta is also marketed under a collaboration between J&J and Gilead. The companies have developed a separate new combination tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) for younger kids.
Other than Prezista and Prezcobix/Rezolsta, J&J also markets a darunavir-based once-daily single-tablet regimen (STR) called Symtuza.
Other than J&J and Gilead, another key player in the HIV market is GSK plc GSK via its HIV subsidiary, ViiV Healthcare. GSK generates the majority of its HIV sales from its dolutegravir franchise, comprising three-drug regimens — Triumeq and Tivicay — and two-drug regimens — Dovato and Juluca. Some of its new long-acting medicines are Cabenuva and Apretude, which are also witnessing strong patient demand and contributing to sales growth. GSK’s HIV sales rose 13% at constant exchange rates in 2023. HIV sales are projected to grow in the high single-digit to low double-digit range in 2024.
Zacks Rank and Stock to Consider
J&J currently has a Zacks Rank #3 (Hold).
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
A top-ranked stock in the healthcare sector is Bioventus BVS, which has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 estimates for Bioventus have improved from 16 cents per share to 27 cents per share. For 2025, earnings estimates have improved from 40 cents to 43 cents per share in the past 60 days. So far this year, shares of BVS are up 27.1%.
Earnings of Bioventus beat estimates in three of the last four quarters while missing in one, delivering a four-quarter average earnings surprise of 151.67%.
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