FOSTER CITY, Calif. - Gilead Sciences Inc . (NASDAQ:GILD), a prominent biotechnology company with a market capitalization of $114.7 billion and annual revenue of $28.3 billion, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its drug Trodelvy for treating a specific form of lung cancer, the company announced today. According to InvestingPro analysis, Gilead's stock is currently trading near fair value, with a robust gross profit margin of 77.8%. The designation aims to speed up the development and review of drugs intended to treat serious conditions when preliminary evidence suggests substantial improvement over existing therapies.
The FDA's decision is based on positive results from the Phase 2 TROPiCS-03 study, which evaluated Trodelvy as a second-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) that has progressed after platinum-based chemotherapy. InvestingPro data reveals that Gilead maintains excellent financial health with a "GREAT" overall score, suggesting strong backing for its drug development programs. Investors can access detailed analysis and 10+ additional ProTips through InvestingPro's comprehensive research reports. The study findings, presented at the IASLC 2024 World Conference on Lung Cancer, demonstrated that Trodelvy showed promising antitumor activity in both platinum-resistant and platinum-sensitive diseases. The safety profile was in line with prior studies of the drug.
Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate, is currently approved in over 50 countries for certain patients with metastatic triple-negative breast cancer and in more than 40 countries for pre-treated HR+/HER2- metastatic breast cancer. The drug is also under investigation for various other types of tumors with high Trop-2 expression, including small cell lung cancer and metastatic non-small cell lung cancer.
Small cell lung cancer accounts for about 15% of lung cancer cases in the U.S. and is a leading cause of cancer-related deaths. The prognosis for patients with ES-SCLC, where the cancer has spread widely, is generally poor, especially when the disease does not respond to the current first-line standard of care.
Gilead plans to initiate a Phase 3 clinical trial to further investigate Trodelvy's efficacy in patients with ES-SCLC. This marks the second Breakthrough Therapy Designation for Trodelvy, reinforcing its potential in treating advanced cancer stages.
The press release also includes safety information for Trodelvy, highlighting severe or life-threatening neutropenia and diarrhea as potential risks, among other warnings and precautions. Trodelvy has a boxed warning for neutropenia and diarrhea, and its prescribing information contains detailed safety and drug interaction guidelines. The company's strong market position is reflected in its stock performance, trading near its 52-week high of $98.90, with a consistent dividend history spanning 10 consecutive years of increases.
The information in this article is based on a press release statement from Gilead Sciences, Inc. (NASDAQ:GILD)
In other recent news, Gilead Sciences has entered into a strategic collaboration with Terray Therapeutics to develop small molecule therapies. The partnership will leverage Terray's AI-driven tNova drug discovery platform to identify therapeutic candidates across multiple disease targets. Terray will receive an upfront payment from Gilead and is eligible for additional milestone payments based on the achievement of preclinical, clinical, and sales targets. Analysts at Bernstein SocGen Group and Deutsche Bank (ETR:DBKGn) maintained their Outperform and Hold ratings for Gilead, respectively.
Gilead also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for seladelpar, a treatment for primary biliary cholangitis. This follows a successful Phase 3 trial. Furthermore, Gilead has entered into an exclusive agreement with Tubulis to develop an antibody-drug conjugate for solid tumor treatment.
In other developments, Gilead's investigational HIV prevention drug, Lenacapavir, demonstrated a 96% reduction in HIV infections in a pivotal Phase 3 trial. Deutsche Bank highlighted the potential longevity of Gilead's HIV franchise, projecting its influence could extend into fiscal year 2035. These are recent developments in Gilead's ongoing commitment to HIV treatment and prevention, as well as its potential for growth and profitability.
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