Gilead Sciences, Inc. (NASDAQ: GILD)*
As of 12 March 2025
Leadership & Strategy
Gilead is focused on three therapeutic areas: virology, oncology, and immunology
HIV/Virology Pipeline
Lenacapavir PrEP:
PDUFA date: June 19, 2025 (possibly June 18 due to holiday)
FDA interactions proceeding smoothly with no concerns
Company is prepared for launch with 75% site access expected within 6 months
Annual injection version in development with Phase III starting later this year
HIV Treatment:
Developing multiple dosing frequencies: daily, weekly, monthly, and 6-monthly options
Working on combination therapies including lenacapavir plus broadly neutralizing antibodies
Oncology
Anito-cel (BCMA CAR-T):
New data at EHA conference showing 97% overall response rate, 68% complete response rate
Superior safety profile vs. CARVYKTI (1% Grade 3+ CRS/ICANS)
Suitable for outpatient delivery
Filing planned for 2025, launch expected 2026
Kite has largest CAR-T footprint globally (550 centers)
Trodelvy:
Positive ASCENT-04 data in first-line triple-negative breast cancer
Potential new standard of care with roughly double the patient population vs. second-line
Additional studies ongoing in various cancer types
Yescarta/Tecartus:
Facing headwinds from competition but expected to be flat this year
Next-generation constructs showing promise (78% complete response rate)
Immunology
Earlier-stage portfolio including oral alpha4beta7 (Phase II), IRAK4 inhibitor/degrader, and STAT6 degrader
CAR-T for autoimmune diseases (lupus, myositis, scleroderma) moving forward
The company appears positioned for multiple near-term catalysts, particularly the lenacapavir PrEP approval and Trodelvy's expansion into first-line breast cancer.
Key Points on Anito-cel (BCMA CAR T)_for relapsed or refractory multiple myeloma (RRMM)
Impressive efficacy with 62% complete response rate and 97% overall response rate
Strong safety profile with 86% of patients experiencing only grade 1 or no CRS events
Low rate of ICANS and no observed long-term neurotoxicity
Differentiated by fast off-rate D-domain binder that provides effective killing with reduced immunotoxicity
Global manufacturing capabilities ensure consistent turnaround times
Launch expected in 2026 in the US with global expansion to follow
Current Business (Yescarta and Tecartus)
Facing competition from new indications and manufacturing improvements from competitors
Maintaining manufacturing reliability at 96% with 14-day US turnaround time (17 days outside US)
Some physicians trying competitor products but returning to Yescarta due to reliability and efficacy
Only CAR T with statistically significant overall survival data
Expanding Treatment Access
Working to bring community practices into CAR T delivery network
Developing modular FACT accreditation system for CAR T (piloting in 2025)
Working with payers to decouple CAR T reimbursement from traditional transplant center requirements
Focusing on outpatient delivery models to increase accessibility
Regulatory changes allowing patients to receive follow-up care at centers closer to home
Next-Generation Products
Developing bicistronic CAR T constructs combining CD19/CD28 with CD20/41BB
New constructs achieve efficacy with 1/10 to 1/20 of current doses
Data for these constructs to be presented throughout 2025
Moving into autoimmune diseases with construct 363 targeting lupus, lupus nephritis, myositis, scleroderma
Planning studies in MS and myasthenia gravis later in 2025
Business Outlook
Cell therapy viewed as long-term growth driver for Gilead
Lymphoma market projected to reach $10-12 billion by 2034
Multiple myeloma market estimated at $15-20 billion by 2034
Applying oncology learnings to autoimmune and solid tumor pipelines
Exploring allogeneic and in-vivo approaches alongside autologous CAR T