This section highlights FDA-related milestones and regulatory updates for drugs developed by Gilead Sciences (GILD).
Over the past two years, Gilead Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bixlenvo, Trodelvy, seladelpar, BIC/LEN, ARTISTRY-1, Yescarta, and Trodelvy. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Bixlenvo FDA Regulatory Events
Bixlenvo is a drug developed by Gilead Sciences for the following indication: treatment of HIV in adults who are virologically suppressed.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bixlenvo
- Announced Date:
- August 27, 2026
- Indication:
- treatment of HIV in adults who are virologically suppressed.
Announcement
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.
Read Announcement
Trodelvy (sacituzumab govitecan-hziy) FDA Regulatory Timeline and Events
Trodelvy (sacituzumab govitecan-hziy) is a drug developed by Gilead Sciences for the following indication: Metastatic urothelial cancer (UC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- August 24, 2026
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- July 24, 2026
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).
AI Summary
Gilead Sciences said the European Medicines Agency’s CHMP has issued a positive opinion for Trodelvy (sacituzumab govitecan-hziy) used with Keytruda (pembrolizumab). The recommendation is for adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not had prior systemic treatment for metastatic disease and whose tumors are PD-L1 positive, with a combined positive score of at least 10.
The company said this move could help make Trodelvy a key first-line treatment option in the European Union for this harder-to-treat breast cancer type. The recommendation follows results from the ASCENT-04/KEYNOTE-D19 study, which showed a strong and clinically meaningful drop in the risk of disease progression or death.
If the European Commission gives final approval, the combination would add another treatment choice for patients whose cancer has a higher PD-L1 level and who need therapy early in the metastatic setting.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- June 23, 2026
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.
AI Summary
Gilead Sciences said the European Commission has approved Trodelvy (sacituzumab govitecan-hziy) as a single treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who have not had treatment for metastatic disease and cannot take PD-1 or PD-L1 inhibitor therapy. This makes Trodelvy the first antibody-drug conjugate and the first new treatment option in Europe in 20 years for some patients with first-line metastatic TNBC.
The approval was based on the ASCENT-03 study, where Trodelvy showed a highly significant and clinically meaningful improvement in progression-free survival compared with chemotherapy in patients who were not eligible for PD-(L)1 inhibitor treatment. Gilead said the decision is important because many people with metastatic TNBC may only get one chance at treatment, making early and effective therapy especially critical.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- May 22, 2026
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. nnounced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.
AI Summary
Gilead Sciences said the European Medicines Agency’s Committee for Medicinal Products for Human Use has given a positive opinion for Trodelvy, recommending approval in the European Union as a single treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer. This applies to patients who have not yet received treatment for metastatic disease and who are not eligible for PD-1 or PD-L1 inhibitor therapy.
The recommendation is based on the ASCENT-03 study, which showed a highly statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy in patients who could not receive PD-(L)1 inhibitors. Gilead said the decision is an important step toward bringing a first-line treatment option to people with metastatic TNBC, a fast-growing cancer with poor survival rates.
If approved, Trodelvy could offer an earlier treatment choice for patients who may only have one line of therapy and need the most effective option upfront.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- November 10, 2025
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. announced the Phase 3 ASCENT-07 study investigating Trodelvy® (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1 criteria.
AI Summary
Gilead announced that the Phase 3 ASCENT-07 trial comparing Trodelvy (sacituzumab govitecan-hziy) to physician’s choice chemotherapy as the first treatment after endocrine therapy in HR+/HER2‑negative metastatic breast cancer did not meet its primary endpoint. Progression‑free survival (PFS), assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 criteria, showed no statistically significant improvement with Trodelvy versus chemotherapy. The global, open‑label study enrolled 654 patients randomized 2:1 to receive Trodelvy or single‑agent chemotherapy options (for example capecitabine, paclitaxel or nab‑paclitaxel).
Overall survival (OS), a key secondary endpoint, was not mature at the primary analysis but showed an early trend favoring Trodelvy; the study will continue to follow patients to further assess OS. Safety findings were consistent with prior Trodelvy studies and no new safety signals were identified. Gilead plans to present full ASCENT‑07 data at a future medical conference. Trodelvy’s use in this first‑line post‑endocrine setting remains investigational.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- October 19, 2025
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc today shared positive data from the Phase 3 ASCENT-03 study demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Trodelvy® (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors.
AI Summary
Gilead Sciences shared results from the Phase 3 ASCENT-03 study showing that Trodelvy® (sacituzumab govitecan-hziy) significantly improved progression-free survival (PFS) versus chemotherapy as first-line treatment in metastatic triple-negative breast cancer (TNBC) patients not eligible for PD-1/PD-L1 inhibitors. The findings were published in The New England Journal of Medicine and presented in a late-breaking session at ESMO 2025.
Trodelvy reduced the risk of disease progression or death by 38% compared to chemotherapy (hazard ratio 0.62; p<0.0001). Median PFS was 9.7 months with Trodelvy versus 6.9 months with standard chemotherapy. Benefits were consistent across prespecified subgroups, including high-risk patients.
The objective response rate was 48% for Trodelvy and 46% for chemotherapy, while the median duration of response was longer with Trodelvy (12.2 vs. 7.2 months). These durable responses highlight its clinical value.
These practice-changing results support Trodelvy as a potential new backbone standard of care for first-line metastatic TNBC patients who cannot receive immunotherapy.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- October 13, 2025
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc and Kite, a Gilead Company, will demonstrate progress in our commitment to transform how cancer is treated with new data at the European Society for Medical Oncology (ESMO) 2025 Congress October 17 – 21.
AI Summary
Gilead Sciences, Inc. and Kite, a Gilead Company, will present new data at the European Society for Medical Oncology (ESMO) 2025 Congress, held October 17–21. This showcase highlights their commitment to transforming cancer treatment with cutting-edge research.
A late-breaking presentation will reveal full Phase 3 ASCENT-03 results for Trodelvy® (sacituzumab govitecan-hziy) as a first-line therapy in metastatic triple-negative breast cancer (TNBC) patients who can’t receive PD-1/PD-L1 inhibitors. In the study, Trodelvy significantly improved progression-free survival compared to standard chemotherapy.
In another session, Gilead and Arcus Biosciences will share overall survival data from the Phase 2 EDGE-Gastric trial. This study evaluated domvanalimab (anti-TIGIT) plus zimberelimab (anti-PD-1) with chemotherapy in advanced gastric or esophageal cancer. Half of the treated patients lived more than two years, with a median overall survival of 26.7 months.
These findings underscore Gilead’s strategy to advance innovative therapies into earlier treatment lines and address some of the most challenging cancer types.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- May 31, 2025
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. announced Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) reduced the risk of disease progression or death by 35% (HR: 0.65) versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC).
AI Summary
Gilead Sciences announced that a combination of Trodelvy® (sacituzumab govitecan-hziy) and Keytruda® (pembrolizumab) reduced the risk of disease progression or death by 35% (HR: 0.65) compared to standard treatment in patients with PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). In the Phase 3 ASCENT-04/KEYNOTE-D19 trial, patients receiving the combination had a median progression-free survival of 11.2 months versus 7.8 months for those on Keytruda plus chemotherapy. These promising results suggest significant improvements in treatment outcomes for this aggressive cancer type with few first-line options. Early overall survival trends add further support to the combination’s potential to become a new standard of care. These findings mark a key step forward in breast cancer care and underscore the importance of innovative treatment approaches in improving patient outcomes.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- April 21, 2025
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc. announced positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10).
AI Summary
Gilead Sciences announced positive topline results from the Phase 3 ASCENT‐04/KEYNOTE-D19 study. The trial showed that combining Trodelvy (sacituzumab govitecan-hziy) with Keytruda (pembrolizumab) significantly improved progression-free survival compared to the standard treatment of Keytruda plus chemotherapy. This study focused on patients with inoperable or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 with a CPS of 10 or higher.
The results indicate that the new combination can delay disease progression in this challenging patient population, possibly offering a more effective treatment option. The safety profile of the combination was consistent with what is already known for each drug, and no new safety concerns were identified. These encouraging findings mark an important step in expanding potential treatments for patients battling this aggressive type of breast cancer.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- December 17, 2024
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.
AI Summary
Gilead Sciences, Inc. announced that the FDA has granted Breakthrough Therapy Designation to its cancer drug Trodelvy® (sacituzumab govitecan-hziy) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy. This designation is based on encouraging results from the global Phase 2 TROPiCS-03 study, which showed promising antitumor activity when Trodelvy was used as a second-line treatment in patients with both platinum-resistant and platinum-sensitive disease. The positive trial data have provided hope for enhancing the treatment options available for this aggressive cancer, where few effective therapies currently exist. Building on these findings, Gilead plans to move forward with a Phase 3 clinical trial to further evaluate Trodelvy’s effectiveness in improving outcomes for patients with ES-SCLC.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- September 13, 2024
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
- Marengo Therapeutics, Inc announced that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. to study the combination of STAR0602 (Invikafusp alfa) with Trodelvy® (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate (ADC), as a potential treatment for adult patients with metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and metastatic triple-negative breast cancer (TNBC).
Read Announcement
Seladelpar FDA Regulatory Timeline and Events
Seladelpar is a drug developed by Gilead Sciences for the following indication: For the Treatment of Primary Biliary Cholangitis Including Pruritus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- seladelpar
- Announced Date:
- June 2, 2026
- Indication:
- For the Treatment of Primary Biliary Cholangitis Including Pruritus
Announcement
Gilead Sciences, Inc. announced positive results from a Phase 3 study in people with primary biliary cholangitis (PBC), showing that treatment with Livdelzi® (seladelpar) led to significantly more patients achieving normalization of alkaline phosphatase (ALP), a key liver marker of disease progression, compared with placebo after 52 weeks.
AI Summary
Gilead Sciences said its Phase 3 IDEAL study showed strong results for Livdelzi® (seladelpar) in people with primary biliary cholangitis (PBC), a chronic liver disease. After 52 weeks, many more patients taking Livdelzi reached normal alkaline phosphatase (ALP) levels than those taking placebo. ALP is an important blood marker used to track liver damage and disease activity in PBC.
The study focused on patients whose disease was not well controlled, including those with elevated ALP levels who did not fully respond to or could not take ursodeoxycholic acid (UDCA). Gilead said the results support ALP normalization as a realistic treatment goal in PBC. The company also reported that Livdelzi was generally well tolerated, with no new safety concerns seen in the study.
Read Announcement- Drug:
- seladelpar
- Announced Date:
- May 13, 2026
- Indication:
- For the Treatment of Primary Biliary Cholangitis Including Pruritus
Announcement
Gilead Sciences, Inc will present findings from 29 abstracts, including late-breaking presentations at the European Association for the Study of the Liver (EASL) Congress, May 27-30, 2026, Barcelona. These presentations advance understanding of primary biliary cholangitis (PBC) and viral hepatitis.
Read Announcement- Drug:
- seladelpar
- Announced Date:
- October 21, 2025
- Indication:
- For the Treatment of Primary Biliary Cholangitis Including Pruritus
Announcement
Gilead Sciences, Inc announced that Health Canada has approved LYVDELZI (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA alone, or as monotherapy in patients unable to tolerate UDCA..
AI Summary
Gilead Sciences announced that Health Canada granted conditional approval for LYVDELZI (seladelpar) to treat primary biliary cholangitis (PBC) in adults who respond inadequately to ursodeoxycholic acid (UDCA) or can’t tolerate it. PBC is a rare autoimmune liver disease that damages bile ducts, causing itching, fatigue and progressing to cirrhosis or liver failure. LYVDELZI is the only therapy showing significant, lasting improvements in both pruritus and cholestatic markers in a Phase 3 trial.
In the RESPONSE study, 62% of patients on LYVDELZI met key biochemical targets versus 20% on placebo, and 25% achieved alkaline phosphatase normalization compared to none on placebo. The treatment also significantly reduced itching. Common side effects included headache, abdominal pain, nausea, swelling and dizziness. This approval expands Gilead’s commitment to liver disease and offers a new option for Canadians living with PBC.
Read Announcement- Drug:
- seladelpar
- Announced Date:
- February 20, 2025
- Indication:
- For the Treatment of Primary Biliary Cholangitis Including Pruritus
Announcement
Gilead Sciences, Inc announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
AI Summary
Gilead Sciences, Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar in the treatment of primary biliary cholangitis (PBC). This new approval allows seladelpar to be used in combination with ursodeoxycholic acid (UDCA) for adults who do not respond well to UDCA alone, or as a single treatment for those who cannot tolerate UDCA. Seladelpar is notable for being the first treatment to show statistically significant improvements in biochemical response, normalization of alkaline phosphatase levels, and reduction in pruritus compared to a placebo. This breakthrough offers an important new option for patients in the European Economic Area who are currently underserved by existing therapies. Gilead is now collaborating with European health authorities to ensure that eligible patients have rapid access to this promising treatment option.
Read Announcement
BIC/LEN FDA Regulatory Events
BIC/LEN is a drug developed by Gilead Sciences for the following indication: treatment of HIV.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BIC/LEN
- Announced Date:
- April 29, 2026
- Target Action Date:
- August 27, 2026
- Indication:
- treatment of HIV
Announcement
Gilead Sciences, Inc announced that The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.
AI Summary
Gilead Sciences announced that the U.S. Food and Drug Administration has granted priority review for its new application pairing bictegravir with lenacapavir, and set a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026. Priority review signals the FDA will aim for a faster review timeline than standard review, with a target decision by the assigned PDUFA date.
The investigational single-tablet combination pairs bictegravir, a guideline-recommended integrase inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor designed to support sustained viral suppression. If approved, it would be the smallest single-tablet regimen (STR) for HIV treatment and the first STR studied in adults who are virologically suppressed on complex multi-tablet regimens. The combination is investigational and not approved; its safety and effectiveness have not been established, and there is currently no cure for HIV or AIDS.Read Announcement
- Drug:
- BIC/LEN
- Announced Date:
- April 29, 2026
- Indication:
- treatment of HIV
Announcement
Gilead Sciences, Inc announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed.
AI Summary
Gilead Sciences announced the U.S. Food and Drug Administration accepted its New Drug Application for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), an investigational once-daily single-tablet regimen for the treatment of HIV in adults who are virologically suppressed.
The combination pairs bictegravir — a guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance — with lenacapavir, a first-in-class capsid inhibitor designed to provide sustained virologic suppression. It acts at multiple stages of the viral lifecycle and has no known cross‑resistance to other antiretroviral classes. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment and the first STR studied as a switch option for adults suppressed on complex multi-tablet regimens.
BIC/LEN is investigational and not approved anywhere; its safety and efficacy have not been established. Gilead’s submission is now under FDA review.
Read Announcement
ARTISTRY-1 FDA Regulatory Events
ARTISTRY-1 is a drug developed by Gilead Sciences for the following indication: Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARTISTRY-1
- Announced Date:
- February 25, 2026
- Indication:
- Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment
Announcement
Gilead Sciences, Inc announced the presentation of new Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data at CROI 2026 showing a treatment switch to an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was effective in people living with HIV with virological suppression, including those switching from complex multi-tablet regimens or a global guideline-recommended single-tablet regimen.
AI Summary
Gilead presented Phase 3 ARTISTRY-1 and ARTISTRY-2 data at CROI 2026 showing that switching to an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) kept viral suppression in adults with HIV. The switch was effective for people moving from complex multi-tablet regimens and from a guideline-recommended single-tablet regimen (Biktarvy), demonstrating comparable efficacy to both prior regimens.
Safety results were generally favorable. In ARTISTRY-1, drug-related adverse events occurred in 14.3% of participants switching to BIC/LEN versus 1.6% who stayed on complex regimens; serious drug-related events were rare (0.3% vs 0%), and discontinuations were uncommon (1.6% vs 0.5%). In ARTISTRY-2, drug-related events were similar between BIC/LEN and Biktarvy (10.4% vs 12.0%), with no serious drug-related events and low discontinuation rates (1.6% each).
Bictegravir is a guideline-recommended INSTI and lenacapavir is a first-in-class capsid inhibitor. The combination is investigational, not approved, and these results will inform regulatory filings and may broaden treatment options for people with suppressed HIV.
Read Announcement- Drug:
- ARTISTRY-1
- Announced Date:
- November 13, 2025
- Indication:
- Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment
Announcement
Gilead Sciences, Inc announced positive topline results from the Phase 3 ARTISTRY-1 trial.
AI Summary
Gilead announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label study tested a once-daily single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in adults with HIV who were virologically suppressed and switched from multi-tablet regimens. BIC/LEN met the trial’s primary goal, showing efficacy that was statistically non-inferior to participants’ previous multi-tablet therapies.
In Phase 3, participants were randomized 2:1 to receive the fixed-dose BIC/LEN or continue their complex baseline regimen. The main endpoint measured the percentage of people with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA snapshot algorithm. Secondary endpoints included rates of virologic suppression (<50 copies/mL), CD4 count changes, and treatment-emergent adverse events.
BIC/LEN was generally well tolerated with no new or significant safety concerns reported. At baseline, participants took 2–11 pills daily and about 40% dosed more than once a day, so the single-tablet option could reduce pill burden. Gilead plans to file the Phase 3 data with regulators and share full results at a future scientific congress.
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Yescarta (Axicabtagene Ciloleucel) FDA Regulatory Timeline and Events
Yescarta (Axicabtagene Ciloleucel) is a drug developed by Gilead Sciences for the following indication: Relapsed or Refractory Follicular Lymphoma (FL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- February 6, 2026
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Kite, a Gilead Company announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
AI Summary
Kite, a Gilead company, announced that the U.S. Food and Drug Administration approved an update to the Yescarta (axicabtagene ciloleucel) prescribing information removing previous Limitations of Use for patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The change reflects that Yescarta may now be considered for this rare and aggressive form of non‑Hodgkin lymphoma.
The approval was supported by positive results from a Phase 1 investigator‑sponsored study led by Dana‑Farber Cancer Institute. The safety trial enrolled 18 patients (13 with PCNSL, 5 with secondary CNS lymphoma), with the first six monitored for treatment‑limiting toxicities. The primary endpoint was safety (treatment‑limiting toxicities and Grade ≥3 adverse events); secondary endpoints included objective and complete response rates, duration of response, progression‑free survival, and overall survival. The study reported a manageable safety profile with no new safety signals identified.
Yescarta is a CD19‑directed, genetically modified autologous T‑cell immunotherapy used to treat certain B‑cell lymphomas.Read Announcement
- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- December 7, 2025
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Kite, a Gilead Company presented a new analysis today demonstrating that second-line Yescarta® (axicabtagene ciloleucel) therapy offers consistent benefits in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL), even among those ineligible for the previous standard of care, high-dose chemotherapy followed by an autologous stem cell transplant (ASCT).
AI Summary
Kite, a Gilead company, reported a combined analysis showing that second-line Yescarta (axicabtagene ciloleucel) provides consistent benefits for patients with relapsed/refractory large B‑cell lymphoma (R/R LBCL), including those ineligible for high‑dose chemotherapy and autologous stem cell transplant (ASCT). The analysis pooled four‑year data from ZUMA‑7 and two‑year data from ALYCANTE, including 178 and 69 patients respectively.
Key two‑year outcomes in the pooled group were overall survival 64.9%, event‑free survival 45.2%, and progression‑free survival 47.4%. At three months, 55.6% achieved a complete metabolic response. One‑year overall response rate was 46.6%, and 12‑month duration of response was 61.0%. Results were broadly similar between the transplant‑eligible and transplant‑ineligible groups.
Safety findings were comparable across studies, with grade ≥3 treatment‑emergent adverse events in about 90.5% of patients; pooled grade ≥3 neurologic events, neutropenias, and anemia were 19.8%, 64.7%, and 27.6%, respectively. Quality of life showed initial dips then meaningful improvements by months 3–6, sustained to month 24. The data support considering Yescarta earlier for a wider range of patients.
Read Announcement- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- June 1, 2025
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Kite, a Gilead Company announced real-world data evaluating the safety and effectiveness of Yescarta® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital.
AI Summary
Kite, a Gilead Company, recently shared real-world data comparing the safety and effectiveness of Yescarta® (axicabtagene ciloleucel) in patients with relapsed/refractory large B-cell lymphoma treated in outpatient versus inpatient settings. The study used data from the Center for International Blood and Marrow Transplant Research registry, examining 119 patients in each group. Results showed that patients who received Yescarta in an outpatient setting experienced safety and effectiveness outcomes similar to those treated in a hospital. Importantly, nearly 25% of outpatient-treated patients did not require hospital admission within 30 days, and half did not need hospitalization within three days, suggesting a potential benefit to healthcare systems through reduced hospital resource use and associated costs.
These findings support the growing evidence that administering Yescarta in outpatient settings may be a safe, cost-effective option for eligible patients with relapsed or refractory large B-cell lymphoma.
Read Announcement- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- December 9, 2024
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Gilead Company announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL) including follicular lymphoma (FL) or marginal zone lymphoma (MZL).
AI Summary
Gilead’s Kite announced promising five-year follow-up results from the ZUMA-5 study, a Phase 2 trial that evaluated Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory non-Hodgkin lymphomas, including follicular lymphoma (FL) and marginal zone lymphoma (MZL). The study showed a median progression-free survival of 62.2 months and a median duration of response of 60.4 months after more than five years of follow-up, indicating that the treatment can offer long-lasting benefits.
More than half of the patients were still alive without needing additional therapy at the time of the analysis. These results suggest that Yescarta may be capable of providing durable responses and even a curative effect in these difficult-to-treat blood cancers, giving new hope to patients and clinicians alike.
Read Announcement- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- December 8, 2024
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Gilead Company announced findings from three new analyses for Yescarta®(axicabtagene ciloleucel) that demonstrate improved outcomes for people living with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), which were presented at 66th American Society of Hematology (ASH) Annual Meeting & Exposition.
AI Summary
Gilead, through its Kite division, announced new findings on Yescarta® (axicabtagene ciloleucel) that were presented at the 66th American Society of Hematology Annual Meeting & Exposition. The analyses focused on patients with relapsed or refractory large B-cell lymphoma (LBCL) and demonstrated significant improvements in outcomes. One major study, the largest real-world analysis, showed that when Yescarta was used as a second-line treatment, patients achieved a 71% overall survival rate, confirming results seen in the earlier pivotal ZUMA-7 trial. In addition, further real-world evidence revealed a decreasing trend in the incidence and severity of cytokine release syndrome and related neurotoxicities in later treatment settings. Findings from the ALYCANTE study also indicated that patients experienced either stable or improved long-term quality of life after treatment with Yescarta.
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Trodelvy (sacituzumab govitecan-hziy) TNBC FDA Regulatory Events
Trodelvy (sacituzumab govitecan-hziy) TNBC is a drug developed by Gilead Sciences for the following indication: Relapsed or refractory metastatic triple-negative breast cancer (TNBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Trodelvy (sacituzumab govitecan-hziy) TNBC
- Announced Date:
- January 21, 2026
- Indication:
- Relapsed or refractory metastatic triple-negative breast cancer (TNBC)
Announcement
Gilead Sciences, Inc published the full results from the positive Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC).
AI Summary
The New England Journal of Medicine published full results from the Phase 3 ASCENT-04/KEYNOTE‑D19 trial testing Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) versus Keytruda plus chemotherapy in previously untreated, PD‑L1+ (CPS ≥10) metastatic triple‑negative breast cancer. The randomized study enrolled 443 patients and met its primary endpoint of progression‑free survival: the combination reduced the risk of disease progression or death by 35% (HR 0.65; p<0.001). Median PFS was 11.2 months with Trodelvy plus Keytruda versus 7.8 months with Keytruda plus chemotherapy.
Safety was consistent with known profiles and no new signals emerged. Grade ≥3 neutropenia occurred in 43% of patients on Trodelvy plus Keytruda versus 45% with Keytruda plus chemotherapy; grade ≥3 diarrhea was 10% with the Trodelvy combination. Fewer patients stopped treatment due to adverse events on the Trodelvy arm (12% vs. 31%). Investigators described the results as an important step toward a potentially new frontline option for PD‑L1+ metastatic TNBC.
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Biktarvy FDA Regulatory Events
Biktarvy is a drug developed by Gilead Sciences for the following indication: HIV-1 in Pediatric Populations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Biktarvy
- Announced Date:
- December 15, 2025
- Indication:
- HIV-1 in Pediatric Populations
Announcement
Gilead Sciences, Inc. announced positive topline results from the Phase 3 ARTISTRY-2 trial.
AI Summary
Gilead Sciences announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind study looked at adults with HIV who were virologically suppressed and switched from BIKTARVY to a once-daily single tablet of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN was found to be statistically non-inferior to BIKTARVY.
The primary endpoint measured the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA snapshot algorithm. The trial randomized participants 2:1 to switch to BIC/LEN or remain on BIKTARVY. BIC/LEN met the study’s primary success criterion and was generally well tolerated, with no new or significant safety concerns reported.
Bictegravir is a guideline-recommended integrase inhibitor with a high barrier to resistance, while lenacapavir is a first-in-class capsid inhibitor with no overlapping resistance to other classes. A single-tablet BIC/LEN could expand treatment options for people sustaining viral suppression.
Gilead intends to combine ARTISTRY-2 results with ARTISTRY-1 data for regulatory submissions and will present full findings at a future scientific congress.
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Livdelzi FDA Regulatory Events
Livdelzi is a drug developed by Gilead Sciences for the following indication: In people living with PBC and compensated cirrhosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Livdelzi
- Announced Date:
- October 23, 2025
- Indication:
- In people living with PBC and compensated cirrhosis
Announcement
Gilead Sciences, Inc will present new research that reinforces its commitment to advancing innovation for people living with liver disease at The Liver Meeting® 2025, hosted by the American Association for the Study of Liver Diseases (AASLD), November 7-11 in Washington, D.C.
Read Announcement- Drug:
- Livdelzi
- Announced Date:
- May 7, 2025
- Indication:
- In people living with PBC and compensated cirrhosis
Announcement
Gilead Sciences, Inc announced new data from multiple analyses which reinforce that Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history.
AI Summary
Gilead Sciences, Inc. announced new data from several analyses that reinforce Livdelzi® (seladelpar), known as Lyvdelzi® in the EU, is effective and generally well-tolerated for treating primary biliary cholangitis (PBC). The findings indicate that Livdelzi delivers a sustained biochemical response in adults with PBC, regardless of their previous treatment history. In an ongoing long-term study, 60% of participants with a history of fibrate or obeticholic acid use achieved a composite biochemical response, which is comparable to those without prior treatment. Additionally, the data demonstrate that Livdelzi provides clinically and statistically significant improvements in pruritus, a common and debilitating symptom of PBC. These positive results, presented at EASL Congress 2025, support Livdelzi’s role as a promising treatment option that addresses significant unmet needs in PBC care.
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Yeztugo FDA Regulatory Events
Yeztugo is a drug developed by Gilead Sciences for the following indication: For HIV Prevention.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Yeztugo
- Announced Date:
- October 19, 2025
- Indication:
- For HIV Prevention
Announcement
Gilead Sciences, Inc will present new findings from its antiviral research and development programs at IDWeek, taking place October 19-22 in Atlanta, GA. Data from 34 presentations across HIV, respiratory viruses, viral hepatitis, and viruses of pandemic potential including six oral presentations underscore Gilead's leadership in advancing antiviral science and its ongoing efforts to bring forward innovative solutions for people and communities most affected by infectious diseases.
AI Summary
Gilead Sciences, Inc. will present new findings from its antiviral research and development programs at IDWeek October 19–22 in Atlanta. Data from 34 presentations across HIV, respiratory viruses, viral hepatitis, and viruses of pandemic potential—including six oral presentations—underscore Gilead’s leadership in advancing antiviral science and its ongoing efforts to bring forward innovative solutions for people and communities most affected by infectious diseases.
Highlights include pivotal Phase 3 PURPOSE data reinforcing the safety of twice-yearly Yeztugo (lenacapavir) as an effective HIV prevention option across diverse populations, and new results showing higher treatment satisfaction among people who switched from injectable cabotegravir + rilpivirine to once-daily Biktarvy.
New analyses reaffirm Veklury (remdesivir) efficacy in high-risk COVID-19 patients and explore obeldesivir’s activity against emerging pathogens. These findings highlight Gilead’s broad antiviral portfolio across HIV, respiratory viruses, viral hepatitis, and pandemic potential viruses, underscoring its commitment to person-centered, transformational medicines.
Read Announcement- Drug:
- Yeztugo
- Announced Date:
- July 14, 2025
- Indication:
- For HIV Prevention
Announcement
Gilead Sciences, Inc announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo®) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions.
AI Summary
Gilead Sciences announced new Phase 3 PURPOSE trial data that will be presented at IAS 2025, showing that twice-yearly injections of lenacapavir (Yeztugo®) are effective and well tolerated for HIV prevention. The studies included a diverse group of people, demonstrating positive results among pregnant and lactating women, adolescents, and young people. The data also supports dosing recommendations for individuals in special situations, such as those taking medications for tuberculosis (TB) and other conditions. In addition to the strong safety and efficacy results, more than 75% of trial participants said they preferred the twice-yearly injectable option over daily oral PrEP. These findings underline Yeztugo’s potential to become a valuable tool in HIV prevention by meeting the needs of varied populations and offering a convenient alternative to daily medication.
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Lenacapavir FDA Regulatory Timeline and Events
Lenacapavir is a drug developed by Gilead Sciences for the following indication: For the treatment of HIV infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lenacapavir
- Announced Date:
- August 26, 2025
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc announced that the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company's twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg.
AI Summary
Gilead Sciences announced the European Commission granted marketing authorization for Yeytuo® (lenacapavir), its twice-yearly injectable HIV-1 capsid inhibitor. Yeytuo is the first PrEP option in the EU, Norway, Iceland, and Liechtenstein to offer six months of protection for adults and adolescents at risk of sexually acquired HIV-1 who weigh at least 35 kg.
The approval followed an accelerated review by the European Medicines Agency’s Committee for Medicinal Products for Human Use, which deemed Yeytuo a product of major public health interest. Gilead will receive an additional year of market protection in the EU after demonstrating significant clinical benefit over existing therapies.
Phase 3 trials showed Yeytuo prevented 100 percent of HIV infections in a study of cisgender women and 99.9 percent in a diverse group of men and gender-diverse people. Gilead is pursuing global regulatory filings and partnerships to expand access to twice-yearly lenacapavir in low- and middle-income countries.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- July 25, 2025
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
AI Summary
Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion under accelerated review for lenacapavir—an injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP). If approved by the European Commission later this year, lenacapavir will become the first twice-yearly PrEP option in the European Union, marketed under the name Yeytuo®, and earn an additional year of market exclusivity.
The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion. This streamlined assessment will support World Health Organization prequalification and help national regulators in low- and lower-middle-income countries consider lenacapavir more quickly.
Results from the Phase 3 PURPOSE trials showed exceptional protection. In PURPOSE 1, twice-yearly lenacapavir led to zero HIV infections among 2,134 cisgender women in sub-Saharan Africa. In PURPOSE 2, only two infections occurred among 2,179 participants, representing 99.9% prevention versus once-daily oral Truvada.
Experts say lenacapavir could broaden prevention choices and help Europe meet its goal of ending new HIV infections by 2030, especially for people facing barriers to care.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- June 18, 2025
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) approved Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people who need or want PrEP.
AI Summary
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This approval marks a significant breakthrough, as Yeztugo is the first and only twice-yearly PrEP option available in the United States. The decision was supported by strong data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials, where over 99.9% of participants remained HIV negative while receiving the twice-yearly injectable treatment.
Yeztugo is poised to transform HIV prevention by offering a convenient dosing schedule that could help overcome challenges such as daily adherence and stigma. This innovative treatment represents a historic step forward, expanding the options for individuals who need or wish to enhance their HIV protection.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- March 11, 2025
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc. today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company's injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP).
AI Summary
Gilead Sciences, Inc. recently presented the first results from its ongoing Phase 1 study evaluating two new once-yearly injectable formulations of lenacapavir. This innovative HIV-1 capsid inhibitor is being developed for use in HIV prevention as pre-exposure prophylaxis (PrEP). In the study, a single 5000mg intramuscular dose maintained lenacapavir plasma concentrations above the effective threshold for at least 56 weeks in 40 healthy adults. The safety profile was positive, with the most common side effect being mild injection site pain that typically resolved within a week.
Based on these promising results, Gilead plans to advance the development of once-yearly lenacapavir by launching a Phase 3 trial in the second half of 2025. If approved, this new formulation could offer a more convenient PrEP option, helping to overcome adherence challenges seen with daily oral medications.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- October 7, 2024
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc announced additional data from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752) providing an overview of the efficacy and safety of twice-yearly lenacapavir, the company's injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.
AI Summary
Gilead Sciences recently shared promising data from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752) for twice‐yearly lenacapavir, an injectable HIV‑1 capsid inhibitor developed for HIV prevention. The trial, which involved a broad and geographically diverse group of cisgender men and gender‑diverse people, demonstrated a 96% reduction in HIV infections compared to the background rate. Only 2 out of 2,179 participants on lenacapavir acquired HIV, outperforming both the background HIV incidence and once‐daily Truvada. The study also showed lenacapavir to be well‑tolerated with a favorable safety profile and minimal serious adverse events. Gilead’s design intentionally reflected the diversity of populations affected by HIV, ensuring robust data across different regions. The company plans to initiate regulatory filings for lenacapavir as a pre‑exposure prophylaxis (PrEP) option by the end of 2024, aiming to expand effective HIV prevention globally.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- September 12, 2024
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc. announced the results of an interim analysis from a second pivotal Phase 3 clinical trial investigating the use of the company's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir.
AI Summary
Gilead Sciences announced positive interim results from a pivotal Phase 3 trial for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. In the PURPOSE 2 study, carried out in several countries with cisgender men, transgender, and gender non-binary individuals, only two HIV infections were recorded among 2,180 participants using lenacapavir, meaning 99.9% remained HIV-free. The trial showed a 96% reduction in HIV infections compared to background incidence and demonstrated superiority over the once-daily oral treatment Truvada®. Based on these impressive results, the independent Data Monitoring Committee recommended ending the blinded phase and offering open-label lenacapavir to all participants. These findings support the potential of lenacapavir as a transformative, long-acting option for HIV prevention, offering a promising alternative to daily pills, and paving the way for upcoming regulatory filings and potential worldwide access if approved.
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Bulevirtide FDA Regulatory Events
Bulevirtide is a drug developed by Gilead Sciences for the following indication: Hepatitis delta virus (HDV).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bulevirtide
- Announced Date:
- May 7, 2025
- Indication:
- Hepatitis delta virus (HDV)
Announcement
Gilead Sciences Inc announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT).
AI Summary
Gilead Sciences Inc announced final results from the Phase 3 MYR301 study, showing that 36% of adults with chronic hepatitis delta virus (HDV) who received bulevirtide (at either a 2 mg or 10 mg dose) maintained virologic suppression for nearly two years after stopping treatment. These patients had achieved undetectable HDV RNA by the end of treatment (EOT). Notably, among those who stayed undetectable for one year after EOT, no relapses were seen in the following year. The study also found that sustained suppression was more common in participants who had longer periods of undetectable HDV RNA while on treatment. Specifically, 90% of subjects with at least 96 weeks of undetectability at EOT remained undetectable during the two-year follow-up period. These results highlight bulevirtide’s potential for providing a durable response in treating chronic HDV, even after therapy cessation.
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Tecartus (brexucabtagene autoleucel) FDA Regulatory Events
Tecartus (brexucabtagene autoleucel) is a drug developed by Gilead Sciences for the following indication: Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tecartus (brexucabtagene autoleucel)
- Announced Date:
- December 9, 2024
- Indication:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Announcement
Gilead Company announced results today from four analyses that continue to demonstrate the durability of response of Tecartus® (brexucabtagene autoleucel) in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
AI Summary
Gilead’s subsidiary Kite shared promising four analyses at the 66th American Society of Hematology Annual Meeting showing that Tecartus® (brexucabtagene autoleucel) provides long-lasting benefits for patients with relapsed/refractory mantle cell lymphoma (R/R MCL) and B-cell precursor acute lymphoblastic leukemia (R/R B-ALL). In one study, the ZUMA-2 cohort 3 analysis revealed a 91% overall response rate and a 73% complete response rate in BTK inhibitor–naïve R/R MCL patients. Additionally, five-year follow-up data showed that 39% of R/R MCL patients were still alive, marking Tecartus as the only CAR T therapy with such long-term data in this population. Furthermore, real-world evidence in R/R B-ALL confirmed the treatment’s high effectiveness and safety profile, supporting its robust and durable response across various patient groups.
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Veklury (Remdesivir) FDA Regulatory Events
Veklury (Remdesivir) is a drug developed by Gilead Sciences for the following indication: COVID-19 in non-hospitalized patients at high risk for disease progression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Veklury (Remdesivir)
- Announced Date:
- October 9, 2024
- Indication:
- COVID-19 in non-hospitalized patients at high risk for disease progression
Announcement
Gilead Sciences, Inc announced the upcoming presentation of new findings from its antiviral research and development programs at IDWeek 2024, taking place from October 16-19.
AI Summary
Gilead Sciences, Inc. announced that it will present new findings from its antiviral research and development programs at IDWeek 2024 from October 16-19. The company is set to share data from 31 presentations covering its work on HIV treatment and prevention, COVID-19, and viral hepatitis. This includes key results from pivotal Phase 3 PURPOSE 1 and PURPOSE 2 trials studied in HIV prevention using lenacapavir, a long-acting injectable capsid inhibitor. These presentations will serve to highlight the company’s commitment to advancing research in addressing difficult viral diseases and contributing to better treatment options worldwide.
By presenting at this major international conference, Gilead aims to keep the scientific community informed of its latest innovations. Their research continues to push the boundaries in developing therapies that can treat, prevent, and ultimately help curb the global impact of viral infections.
Read Announcement- Drug:
- Veklury (Remdesivir)
- Announced Date:
- September 23, 2024
- Indication:
- COVID-19 in non-hospitalized patients at high risk for disease progression
Announcement
Gilead Sciences, Inc announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation.
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