Gilead Sciences Inc - GILD STOCK NEWS

Kite, a Gilead Company (GILD), received a positive opinion from the European Medicines Agency (EMA) for Tecartus (brexucabtagene autoleucel) to treat adults over 26 with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This CAR T-cell therapy could address the significant unmet need in this patient population, where median overall survival is approximately eight months. The European Commission will review the opinion, with a decision expected soon. In clinical trials, Tecartus showed a 71% complete remission rate and a median overall survival of over two years for treated patients.

Gilead Sciences (GILD) announced that the European Commission's Committee for Medicinal Products for Human Use (CHMP) has recommended granting full Marketing Authorization for Veklury (remdesivir) in the EU. Initially authorized in July 2020 for COVID-19 treatment in hospitalized patients, the approval expands its use to non-hospitalized adults at risk for severe COVID-19. Veklury remains the only direct-acting antiviral with this full authorization in the EU. The decision is based on robust data confirming Veklury's efficacy against SARS-CoV-2 variants.

Gilead Sciences (NASDAQ: GILD) announced its participation in the 24th International AIDS Conference (AIDS 2022), held from July 29-August 2, 2022, in Montreal, Canada. The company aims to share updates on innovative initiatives and scientific findings regarding HIV treatment and prevention. Notable presentations include results from Phase 3 trials of Biktarvy and new data on investigational compounds like lenacapavir and vesatolimod. Gilead emphasizes collaboration with the global HIV community to improve health outcomes and drive towards ending the epidemic.

Gilead Sciences (NASDAQ: GILD) announced an $85 million contribution to the Gilead Foundation to bolster health equity and community support. This funding enhances previous commitments to promote educational equity for underserved adolescents, aligning with the foundation's mission. The foundation also recently funded STEM programs in local schools and supports a culture of employee giving. Gilead continues to be a leading philanthropic supporter of HIV programs globally, reflecting its dedication to advancing healthcare equity.

Gilead Sciences announced a new joint procurement agreement (JPA) with the European Commission to ensure equitable access to Veklury (remdesivir) for COVID-19 patients across the EU and EEA. This agreement, effective for 12 months with a possible 6-month extension, follows the expiration of the original JPA. Veklury is crucial as it is the only antiviral licensed in this region for treating COVID-19 patients requiring supplemental oxygen. Positive results from clinical trials have increased its indications, reinforcing its role as a key treatment in combating COVID-19.

Gilead Sciences (Nasdaq: GILD) will release its Q2 2022 financial results on August 2, after market close. A webcast discussing the results will be held at 4:30 p.m. Eastern Time that same day. Gilead is a biopharmaceutical company focused on developing innovative medicines for life-threatening diseases, including HIV, viral hepatitis, and cancer. With over three decades of breakthroughs, Gilead operates in more than 35 countries, headquartered in Foster City, California.

Gilead Sciences (GILD) announced the retirement of Brett Pletcher, Executive Vice President, Corporate Affairs, after 17 years. Deborah Telman will succeed him as Executive Vice President and General Counsel, effective August 1, 2022. Telman, who joins from Organon, brings over 25 years of legal experience and will oversee legal and corporate affairs. CEO Daniel O'Day praised Telman's leadership and commitment to health equity. Pletcher's tenure included significant contributions to Gilead's global expansion and health policy strategy.

Kite, a Gilead Company (Nasdaq: GILD), announces European Commission approval for Yescarta (axicabtagene ciloleucel) to treat adults with relapsed or refractory follicular lymphoma after three or more lines of therapy. The pivotal ZUMA-5 study demonstrated a 91% overall response rate and a 77% complete response rate among patients treated. Follicular lymphoma, the second most common lymphoma type, has limited treatment options, making this approval significant. Kite aims to improve access to innovative cancer therapies across Europe.

Gilead Sciences has resubmitted the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 treatment for heavily treatment-experienced patients with multi-drug resistant infections. This follows the FDA's Complete Response Letter issued in February 2022 concerning vial compatibility issues. The resubmission includes comprehensive data on compatibility with a new vial type. If approved, lenacapavir would be the only HIV-1 treatment option administered biannually. The FDA will establish a new PDUFA date upon acceptance of this NDA.