Gilead's Yescarta CAR-T Therapy Receives FDA Label Update
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3d ago
0mins
Should l Buy GILD?
Source: seekingalpha
- FDA Approval Update: Gilead's Kite unit announced that the FDA has approved a label update for its CAR-T therapy Yescarta, removing usage limitations for patients with relapsed or refractory primary central nervous system lymphoma, significantly broadening the therapy's applicability.
- First Unrestricted Therapy: Yescarta becomes the first CAR-T therapy for relapsed or refractory large B-cell lymphoma to have these restrictions lifted, which will help more patients access treatment and enhance the company's competitive position in this field.
- Clinical Data Support: The FDA's decision is backed by favorable safety data from a Phase 1 study that tested the autologous T cell immunotherapy in lymphoma patients, including those with relapsed or refractory primary central nervous system lymphoma, demonstrating good safety and efficacy.
- Market Potential Boost: This label update not only opens new market opportunities for Gilead but may also drive sales growth for Yescarta, further solidifying its leadership position in the CAR-T therapy market.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for GILD is 137.88 USD with a low forecast of 105.00 USD and a high forecast of 154.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 152.500
Low
105.00
Averages
137.88
High
154.00
Current: 152.500
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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- New Drug Potential: Gilead anticipates product sales of $28.6 billion for fiscal year 2025 at the midpoint, flat compared to 2024; however, if Yeztugo's market uptake exceeds expectations, it could significantly enhance financial performance and drive stock price appreciation.
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