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
Bulevirtide, Lenacapavir, Livdelzi, seladelpar, Tecartus, Trodelvy, and Veklury. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Bulevirtide - FDA Regulatory Timeline and 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.
Read Announcement- Drug:
- Bulevirtide
- Announced Date:
- June 6, 2024
- Indication:
- Hepatitis delta virus (HDV)
Announcement
Gilead Sciences, Inc. announced data from the Phase 2b MYR204 open-label study assessing the efficacy and safety of the first-in-class entry inhibitor bulevirtide as monotherapy and in combination with pegylated interferon alfa-2a (PegIFN), in adults living with compensated chronic hepatitis delta virus (HDV) infection.
AI Summary
Gilead Sciences, Inc. shared new results from the Phase 2b MYR204 study that evaluated bulevirtide, a first-in-class entry inhibitor, both as a stand-alone treatment and in combination with pegylated interferon alfa-2a (PegIFN) in adults with chronic hepatitis delta virus (HDV) infection. The study, published in the New England Journal of Medicine and presented at EASL 2024, showed that the combination of bulevirtide 10 mg with PegIFN had a strong effect in reducing the virus. At Week 24 after treatment ended, 46% of patients had undetectable levels of HDV RNA, and similar rates were maintained through Week 48. These findings support the potential for a finite treatment course for chronic HDV using this combination, offering new hope for people battling this severe form of hepatitis.
Read Announcement
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:
- 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.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- July 24, 2024
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc announced full efficacy and safety results from its pivotal, Phase 3 PURPOSE 1 trial. Detailed data from the trial's interim analysis announced in June showed that lenacapavir, the company's twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women (women assigned female at birth).
AI Summary
Gilead Sciences, Inc. recently announced full efficacy and safety results from its pivotal Phase 3 PURPOSE 1 trial. The trial focused on lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, used for HIV prevention in cisgender women. Results from the interim analysis revealed zero HIV infections in the lenacapavir group, demonstrating 100% efficacy, and showing superiority over both background HIV incidence and once-daily oral Truvada. This breakthrough data highlights the potential of lenacapavir to address adherence challenges often seen with daily oral pre-exposure prophylaxis (PrEP), offering a more convenient and discreet option for those at risk of HIV. Gilead emphasized its commitment to swift access and efficient regulatory pathways to bring this innovative treatment to high-incidence, resource-limited regions, helping close critical gaps in HIV prevention globally.
Read Announcement- Drug:
- Lenacapavir
- Announced Date:
- June 20, 2024
- Indication:
- For the treatment of HIV infection
Announcement
Gilead Sciences, Inc announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.
AI Summary
Gilead Sciences, Inc. announced positive topline results from an interim analysis of its Phase 3 PURPOSE 1 trial. The study showed that twice-yearly injectable lenacapavir, an HIV-1 capsid inhibitor, achieved 100% efficacy for preventing HIV infection in cisgender women, with zero infections reported. These promising results led the independent Data Monitoring Committee to recommend stopping the blinded phase of the trial so that all participants could receive open-label lenacapavir. The trial compared the twice-yearly lenacapavir to once-daily oral treatments and background HIV incidence, and it met key endpoints for both comparisons. This breakthrough could offer a new, long-acting option for HIV pre-exposure prophylaxis (PrEP), potentially improving adherence and offering hope for more accessible HIV prevention strategies for women globally.
Read Announcement
Livdelzi - FDA Regulatory Timeline and 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:
- 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.
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:
- 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
Tecartus (brexucabtagene autoleucel) - FDA Regulatory Timeline and 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.
Read Announcement- Drug:
- Tecartus (brexucabtagene autoleucel)
- Announced Date:
- June 3, 2024
- Indication:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Announcement
Kite, a Gilead Company announced updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
AI Summary
Kite, a Gilead Company, presented updated four-year overall survival data from the pivotal ZUMA-3 study, which evaluated the CAR T-cell therapy Tecartus® in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The study showed a median overall survival (OS) of 25.6 months and a four-year OS rate of 40%, demonstrating significant improvement over historically low survival rates in this patient population.
The survival benefit was observed regardless of age, previous treatments, or whether patients underwent subsequent allogeneic stem cell transplant. Importantly, the safety profile remained consistent with earlier results, and no new adverse events were reported since the three-year analysis. These findings suggest that Tecartus offers an important treatment option for adult patients with R/R B-ALL, potentially extending their survival even when few treatment options are available.
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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:
- 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- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- June 25, 2024
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
IDEAYA Biosciences, Inc announced that it has dosed its first patient in the Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed ADC, in patients with MTAP-deletion bladder cancer.
AI Summary
IDEAYA Biosciences has dosed its first patient in a global Phase 1 clinical trial testing a new treatment for MTAP-deletion bladder cancer. The study combines IDE397, IDEAYA’s investigational MAT2A inhibitor, with Trodelvy®, Gilead’s Trop-2 directed antibody-drug conjugate, which is already approved in several countries for certain types of breast and urothelial cancers. The trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of efficacy while targeting two complementary cancer-driving pathways in patients, about 26% of whom have the MTAP deletion. Researchers hope that this first-of-its-kind combination can improve outcomes for bladder cancer patients facing limited treatment options and poor prognoses.
This approach represents a promising advance in precision medicine, focusing on targeted therapies that more effectively address the specific genetic changes present in aggressive bladder cancers.
Read Announcement- Drug:
- Trodelvy (sacituzumab govitecan-hziy)
- Announced Date:
- May 30, 2024
- Indication:
- Metastatic urothelial cancer (UC)
Announcement
Gilead Sciences, Inc announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians' choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy..
AI Summary
Gilead Sciences announced the topline results from the confirmatory Phase 3 TROPiCS‑04 study in patients with locally advanced or metastatic urothelial cancer who had previously received platinum-based chemotherapy and anti‑PD-(L)1 therapy. The study compared Trodelvy® (sacituzumab govitecan-hziy) with single‐agent chemotherapy chosen by the treating physician. Although the primary endpoint of overall survival was not met in the intention‑to‑treat population, a numerical improvement in overall survival was observed with Trodelvy. Additionally, trends toward improved progression‑free survival and overall response rate were seen in selected pre‑specified subgroups, though these analyses were not statistically controlled. The trial also noted a higher number of early deaths due to adverse events, mainly from neutropenic complications. Gilead plans to further investigate these findings and emphasizes the need for using granulocyte‑colony stimulating factor (G‑CSF) to help prevent complications.
Read Announcement
Veklury (Remdesivir) - FDA Regulatory Timeline and 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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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:
- 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.
Read Announcement- Drug:
- Yescarta (Axicabtagene Ciloleucel)
- Announced Date:
- June 14, 2024
- Indication:
- Relapsed or Refractory Follicular Lymphoma (FL)
Announcement
Kite, a Gilead Company announced results from three new analyses for Yescarta® (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid.
AI Summary
Kite, a Gilead Company, announced three new analyses for Yescarta® (axicabtagene ciloleucel) in patients with relapsed/refractory large B‑cell lymphoma. The data include both clinical research and real‐world evidence showing that when Yescarta is used in the second‐line setting, it has a higher manufacturing success rate and improved T‑cell performance compared to its use in later treatment lines. This improvement in manufacturing can reduce the time from leukapheresis to infusion, potentially leading to better patient outcomes. Additionally, preliminary results explore the feasibility and safety of administering Yescarta and Tecartus® (brexucabtagene autoleucel) in an outpatient setting. These findings will be further discussed at the upcoming 2024 European Hematology Association Annual Congress in Madrid from June 13–16, reinforcing the benefits of early intervention and streamlined cell manufacturing in managing LBCL.
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