Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) has announced its acquisition of MiroBio, a UK-based biotechnology company, for approximately $405 million in cash. This strategic move provides Gilead with MiroBio's proprietary discovery platform and its pipeline of immune checkpoint agonists aimed at treating autoimmune diseases. Notably, MiroBio's lead investigational antibody, MB272, which targets immune inhibitory receptors, has entered Phase 1 clinical trials. The acquisition is expected to reduce Gilead's 2022 EPS by $0.30-$0.35.

Gilead Sciences reported a strong Q2 2022, with total revenue rising 1% to $6.3 billion. Noteworthy product sales include Biktarvy, which surged 28% year-over-year to $2.6 billion, and oncology sales, which grew 71% to $527 million. However, diluted EPS decreased to $0.91 from $1.21 due to higher IPR&D expenses from an upfront payment of $300 million. Gilead's updated full-year guidance anticipates total product sales between $24.5 billion and $25.0 billion, and non-GAAP EPS between $6.35 and $6.75.

Gilead Sciences (GILD) has announced positive interim results from the ALLIANCE trial, showing that Biktarvy is effective for HIV patients with HBV coinfection. The trial demonstrated superior suppression of HBV DNA with Biktarvy compared to an alternative regimen. Additionally, data from five years of two Phase 3 studies revealed no treatment failures due to resistance. Overall, 99% of participants maintained an undetectable viral load. These findings highlight Biktarvy's potential as a long-term treatment option for individuals with HIV.

AlloVir (ALVR) announced a registered direct offering to sell 27,458,095 shares at $4.61 each, raising approximately $126.6 million, expected to close around July 28, 2022. The proceeds will fund ongoing Phase 3 trials for posoleucel, aimed at treating severe infections in immunocompromised patients. AlloVir plans to use the funds for trial completion, regulatory submissions, and R&D. As of June 30, 2022, the company had $172.7 million in cash. The offering is made without an underwriter and involves participation from new and existing investors, including Kite (GILD).

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.