Gilead Sciences, Inc. GILD has announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in phase III TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
Gilead has submitted a supplemental biologics license application (sBLA) to the FDA for the same.
Shares gained 5% following the announcement. Gilead’s stock has lost 8.8% so far in the year compared with the industry's decline of 16.7%.
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Concurrently, the company announced an agreement with Everest Medicines to acquire the remaining worldwide rights to breast cancer drug Trodelvy (sacituzumab govitecan).
Everest Medicines and Immunomedics entered into an agreement in April 2019 granting the former an exclusive license to develop and commercialize Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia, excluding Japan. Thereafter, in October 2020, Gilead acquired Immunomedics.
Per the new agreement, Gilead will assume responsibility for clinical development and commercialization in Greater China and South Korea, among other Asian markets. Gilead will make a $280 million upfront payment to Everest. Additionally, Everest is eligible to receive up to $175 million in potential additional payments upon achievement of certain regulatory and commercial milestones. Gilead will also be able to recruit Everest employees working directly on the Trodelvy program. The transaction is expected to close later this year.
Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The drug is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Gilead is making efforts to develop its oncology business to diversify its revenue base as competition is stiff in the HIV business from the likes of GSK plc GSK.
Also, the loss of exclusivity for Truvada has hurt the company’s business.
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products Dovato, Cabenuva, Rukobia, Juluca and Apretude and a favorable U.S. pricing mix.
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Alkermes ALKS and Dynavax DVAX. Both 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%.
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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