Gilead's Yescarta Label Update Approved by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 27 2025
0mins
Should l Buy GILD?
Gilead Sciences Inc's stock rose 4.01% as it reached a 52-week high, reflecting positive market conditions.
The FDA has approved an update to Yescarta's prescribing information, removing limitations for use in patients with relapsed or refractory primary central nervous system lymphoma. This significant advancement is based on positive results from a Phase 1 study conducted by Dana-Farber Cancer Institute, which emphasizes Yescarta's unique position in this therapeutic area. The approval addresses urgent clinical needs, potentially improving survival outcomes for patients with a five-year survival rate of only 30%.
This FDA approval not only enhances Gilead's product offerings but also reinforces its competitive position in the oncology market, likely boosting investor confidence and market interest in the company's future prospects.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to fall
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 154.980
Low
105.00
Averages
137.88
High
154.00
Current: 154.980
Low
105.00
Averages
137.88
High
154.00
About GILD
Gilead Sciences, Inc. is a biopharmaceutical company. It is engaged in advancing medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. It is focused on discovering, developing, and delivering medicines to address unmet medical needs in virology, oncology, and other therapeutic areas. Its portfolio of marketed products includes Biktarvy, Genvoya, Descovy, Complera/Eviplera, Symtuza, Truvada, Stribild, Sunlenca, Epclusa, Vemlidy, Harvoni, Viread, Livdelzi, Veklury, Yescarta, Tecartus, Trodelvy, AmBisome, and Letairis. Its product candidates include Bulevirtide, Lenacapavir, Axicabtagene ciloleucel, Sacituzumab govitecan-hziy, and others. It also develops the HB-400 program and the HB-500 program. It develops therapies that are intended to provide functional cures for hepatitis B virus and human immunodeficiency virus-1. It has a cancer program, namely TREX1. It operates in more than 35 countries worldwide.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
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- Milestone Payments: The agreement allows Genhouse to potentially receive up to $1.45 billion in milestone payments, which not only provides financial support to Genhouse but may also accelerate the development of GH31, enhancing its market competitiveness.
- Global Development Responsibility: Gilead will be responsible for the global development, regulatory submissions, and future commercialization of GH31, reflecting Gilead's confidence in the drug and potentially facilitating its rapid market introduction worldwide.
- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
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See More
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