Associated tags: Medicine, Science, HIV, Cancer, Health, Biotechnology, Pharmaceutical, Hospitals, Pharmaceutical industry, Patient, Oncology, Clinical Trials, Gilead Sciences, Research, MD
Locations: UNITED STATES, NORTH AMERICA, CALIFORNIA
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Pharmaceutical industry Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.
Key Points:
- Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.
- Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.
- The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year.
- In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.”
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Pharmaceutical industry Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 18 abstracts during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 18 abstracts during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
- An updated analysis from the Phase 2 EDGE-Gastric study will be featured as a rapid oral presentation in partnership with Arcus Biosciences.
- These updated data will highlight the efficacy and safety of Yescarta in this patient population with important unmet need.
- Accepted abstracts at the 2024 ASCO Annual Meeting include:
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Eastern Time Zone Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:
BofA Securities Health Care Conference on Tuesday, May 14 at 11:20am Pacific Time
RBCCM Global Healthcare Conference on Wednesday, May 15 at 10:30am Eastern Time
Jefferies Global Healthcare Conference on Wednesday, June 5 at 11:00am Eastern Time
Goldman Sachs Annual Global Healthcare Conference on Wednesday, June 12 at 1:20pm Eastern Time
The live webcasts can be accessed at the company’s investors page at investors.gilead.com .
- The replays will be available for at least 30 days following the presentation.
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National Medical Association This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.
Key Points:
- This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.
- Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
- “This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
- “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.
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Pharmaceutical industry Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.
- Diluted (loss) earnings per share (“EPS”) was $(3.34) in the first quarter 2024, compared to $0.80 in the same period in 2023.
- Non-GAAP diluted (loss) EPS was $(1.32) in the first quarter 2024, compared to $1.37 in the same period in 2023.
- During the first quarter 2024, Gilead paid dividends of $990 million and repurchased $400 million of common stock.
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Pharmaceutical industry FOSTER CITY, Calif. and WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.
Key Points:
- -- Gilead Granted Exclusive License to Xilio’s Tumor-Activated IL-12 Program, Including XTX301, a Clinical-Stage IL-12 Molecule with Potential to Treat a Broad Range of Cancers --
FOSTER CITY, Calif. and WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.
- XTX301 is currently being evaluated in a Phase 1 dose escalation trial in patients with advanced solid tumors.
- Xilio will receive $43.5 million in upfront payments, including a cash payment of $30.0 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a premium.
- Xilio will be responsible for conducting clinical development of XTX301 in the ongoing Phase 1 clinical trial through dose expansion.
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2024 financial results and guidance will be released on Thursday, April 25, 2024, after the market closes.
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2024 financial results and guidance will be released on Thursday, April 25, 2024, 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 first quarter 2024 financial results and provide a business update.
- A live webcast will be available on the Investor Relations section of www.gilead.com and will be archived there for one year.
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Pharmaceutical industry Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.
- View the full release here: https://www.businesswire.com/news/home/20240328734624/en/
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies.
- Xilio will receive $43.5 million in upfront payments, including a cash payment of $30 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a premium.
- Xilio will be responsible for conducting clinical development of XTX301 in the ongoing Phase 1 clinical trial through dose expansion.
Vemlidy is a targeted prodrug of tenofovir that was approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease.
Key Points:
- Vemlidy is a targeted prodrug of tenofovir that was approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease.
- In 2022, the FDA approved Vemlidy for the treatment of chronic HBV infection in pediatric patients 12 years of age and older with compensated liver disease.
- “Chronic hepatitis B can have a significant and lasting impact on the health of children.
- VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.
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Itch,
Pharmaceutical industry Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value.
Key Points:
- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value.
- “The acquisition of CymaBay brings us a potential best in disease therapy that could transform the treatment landscape for people with primary biliary cholangitis,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
- “I want to thank the CymaBay team for their efforts and commitment to addressing this high unmet need.
- Pursuant to the merger agreement, Gilead and Purchaser commenced a tender offer on February 23, 2024, to acquire all outstanding shares of CymaBay at a price of $32.50 per share.
