Gilead Sciences (GILD)

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Gilead Sciences, Inc. (Nasdaq: GILD) today 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. Seladelpar (an orphan designated product) is now approved and will provide an important treatment option for people living with the rare liver disease in the European Economic Area (EEA).

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Board of Directors has declared an increase of 2.6% in the company’s quarterly cash dividend, beginning in the first quarter of 2025. The increase will result in a quarterly dividend of $0.79 per share of common stock. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 2025. Future dividends will be subject to Board approval.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2024 financial results and 2025 guidance will be released on Tuesday, February 11, 2025, after the market closes. At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s fourth quarter and full year 2024 financial results and provide a business update.

EQNX::TICKER_START (NASDAQONCY),(TSX:ONC),NYSE:GSKNYSEGSK)(NASDAQ:AZNNASDAQAZN,(NASDAQ:GILDNASDAQ),(NYSE:BMYBMY) EQNX::TICKER_END

PALM BEACH, Fla., Jan. 22, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The demand for effective pancreatic cancer treatments is and has been undeniably high. The growing number of diagnoses, with the aggressive nature of the disease, fuels the market. This demand is further amplified by rising awareness and a focus on personalized medicine, leading to potentially more targeted and effective therapies. Pancreatic cancer remains a formidable foe, with the American Cancer Society estimating over 66,000 new diagnoses and a staggering 51,750 deaths in the US alone for 2024. This translates to 3% of all cancers and a grim 7% of all cancer fatalities, highlighting the urgent need for improved treatment options. The pancreatic cancer treatment market is driven by several factors, including the rising prevalence of obesity, alcohol consumption, and smoking. These lifestyle factors, combined with the growing geriatric population, are expected to fuel market growth. Additionally, personal or family history of pancreatitis and BRCA2 mutation predisposes individuals to pancreatic cancer, further driving demand for effective treatments. A recent report from S&S Insider said that the Pancreatic Cancer Treatment Market size is expected to reach USD 10.53 billion by 2032 and grow at a CAGR of 15.85%. The report continued: “On the supply side, pharmaceutical companies are actively involved in research and development… Moreover, 322 studies were under clinical trial according to clinicaltrail.com in their 3, and 4 phases. Governments also play a crucial role with increased funding for research initiatives and streamlined regulatory processes can accelerate the development and approval of new treatments. Collaborations between public and private entities foster progress, with the shared goal of improving patient outcomes. The overall market for pancreatic cancer treatments is expected to experience significant growth due to the increasing prevalence of the disease and the ongoing search for effective therapies. The development of innovative approaches… offers hope for patients and presents opportunities for pharmaceutical companies and research institutions.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQONCY) (TSX: ONC), GSK plc NYSE: GSKNYSEGSK)(NASDAQ: AZNNASDAQAZN, Gilead Sciences, Inc. (NASDAQ: GILDNASDAQ), Bristol Myers Squibb (NYSE: BMYBMY).

Gilead Sciences, Inc. (Nasdaq: GILD) and LEO Pharma today announced a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conference:

Gilead Sciences, Inc. (Nasdaq: GILD) today 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.

Gilead Sciences, Inc. (Nasdaq: GILD) and Terray Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending 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. The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Dietmar Berger, MD, PhD, will join the company on January 2, 2025, as Chief Medical Officer and will become a member of Gilead’s senior leadership team. Dr. Berger succeeds Merdad Parsey, MD, PhD.

Kite, a Gilead Company (Nasdaq: GILD), today 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). The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. The data were shared in an oral presentation (Abstract #864) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

Kite, a Gilead Company (Nasdaq: GILD), 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.

Kite, a Gilead Company (Nasdaq: GILD), today 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.

Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis today announced that they have entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine (NEJM) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study, which showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi® (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression. Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function. These findings were unveiled as a late-breaker presentation at The Liver Meeting® 2024 hosted by the American Association for the Study of Liver Diseases (AASLD) in San Diego, California from November 15-19.

Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, today announced the pricing of senior unsecured notes in an aggregate principal amount of $3.5 billion, in an underwritten, registered public offering, consisting of $750 million of 4.80% senior notes maturing in 2029, $1 billion of 5.10% senior notes maturing in 2035, $1 billion of 5.50% senior notes maturing in 2054 and $750 million of 5.60% senior notes maturing in 2064. The offering is expected to close November 20, 2024, subject to customary closing conditions.

Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is studying 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. Newly presented results include data on adherence to and pharmacokinetics of lenacapavir among trial participants.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new research data from its innovative HIV treatment portfolio and pipeline, including a broad range of data on investigational and marketed agents with varied dosing frequencies and administration methods. The key findings presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024) reflect a transformative portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV treatment and help end the global epidemic.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences: