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Gilead Sciences, Inc. (GILD) Leerink Partners Global Biopharma Conference (Transcript)
2024-03-13 08:26
产品信息 - Anito-Cel是一种BCMA构造,研究显示在iMMagine-1研究中,63%的患者属于高风险群体[7] - Anito-Cel的转导效率达到70%,远高于同类产品的15%[10] - D-Domain的独特性使其在温度或pH变化时保持稳定,具有简单且优越的结合结构[17] 市场扩张和并购 - Kite拥有全球生产设施和超过420个授权治疗中心,为推广Anito-Cel提供了机会[11] - 目前CAR-T在美国的市场份额停滞在15%至17%,Kite正致力于提高市场份额[19] - 公司正在在社区建立授权治疗中心,以便更好地服务社区[23] 未来展望 - 预计在今年下半年公布iMMagine-1数据,并已与监管机构商讨进入更早期的治疗线[12] - 预计Anito-Cel将具有等效或更好的疗效,并具有差异化的安全性[14] - 到2026年,预计每年能生产24000名CAR-T患者的产品[58] 其他新策略和有价值的信息 - 公司正在在社区建立授权治疗中心,以便更好地服务社区[23] - 公司计划投资于多发性骨髓瘤和自身免疫疾病领域[59] - 公司的目标是随着规模扩大,继续提高盈利能力[61]
Gilead Sciences, Inc. (GILD) Leerink Partners Global Biopharma Conference (Transcript)
Seeking Alpha· 2024-03-13 08:26
Gilead Sciences, Inc.参加Leerink Partners Global Biopharma Conference - Anito-Cel的BCMA CAR-T疗法展示[5][6] Anito-Cel在iMMagine-1研究中表现出高效率和安全性 - 具有与竞争对手相媲美的疗效[7][8] Kite与Anito-Cel的合作 - 拥有全球生产设施和超过420个授权治疗中心,有望将Anito-Cel推广到全球更多患者[9] Kite计划在今年下半年分享iMMagine-1数据 - 已与监管机构讨论进入更早阶段的研究[10] Anito-Cel的D-Domain结构独特 - 具有高转导效率和低基础信号,使得剂量可以减半但依然保持高效的肿瘤细胞杀伤能力[8] Kite致力于提高CAR-T疗法的市场份额 - 通过在社区和学术中心推广CAR-T的使用,以及教育医生和患者,以增加CAR-T的接受率[15][16][17][18][19][20][21] Kite面临来自其他CAR-T产品和生物特异性产品的竞争 - 但认为提高CAR-T的使用率和教育意识是关键[22][23][24] Kite在社区推广CAR-T疗法的经验表明灵活性至关重要 - 但已经制定了一套可复制的操作方案,并与其他医院系统和社区实践进行合作[29][30] Kite认为CAR-T疗法与干细胞移植不同 - 社区实践不需要成为移植中心,因此CAR-T的推广路径将有所不同[31][32] Kite将重点放在大型社区实践的推广上 - 认为这些实践具有基础设施和患者资源,有望成为CAR-T的主要提供者[32][33] Kite认为随着BCMA社区的扩大 - 可能会对Yescarta和Tecartus产生短期负面影响,但他们正努力扩大CAR-T的使用范围,以弥补这种影响[35] Vanderbilt和HCA医院系统已经在提高门诊患者容量方面取得了成功 - [36] CAR-T治疗对于多发性骨髓瘤和自身免疫疾病的应用前景广阔 - [37] Kite正致力于扩大CAR-T治疗在社区医疗实践中的应用 - [39] Kite与Moffitt等医疗机构合作 - 探索在自身免疫疾病领域的合作机会[40] Kite正在与FDA讨论如何改进CAR-T治疗的安全性和监管 - [42] Kite计划在自身免疫疾病领域进行投资 - 以提高盈利能力[48] Kite的CAR-T治疗生产能力不断提升 - 预计到2026年每年可达到2.4万例[51] Kite将继续投资于多发性骨髓瘤和自身免疫疾病领域 - [52] Kite在研发领域探索新的CAR-T治疗构建 - 包括三天制造过程和双重/三重靶向[62] Kite在研发新的CAR-T治疗构建 - 如CD19与IL-18和IL-15的结合,以增强治疗效果[65] Kite正积极探索Allo疗法 - 以满足自身免疫疾病无法覆盖的需求[68] Allo今天的效力并不像自动构建那样有效 - [69] 对于高度侵袭性疾病的患者 - 仍然需要淋巴去除[70] 在骨髓瘤患者中 - 可能需要更好的过渡疗法[71]
Gilead Sciences Announces Expiration of Hart-Scott-Rodino Waiting Period for CymaBay Tender Offer
Businesswire· 2024-03-11 20:24
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) with respect to Gilead’s cash tender offer for CymaBay Therapeutics, Inc. expired at 11:59 p.m. on March 8, 2024. On February 22, 2024, Gilead and CymaBay filed the Premerger Notification and Report Forms required under the HSR Act with the Federal Trade Commission and the Antitrust Division of the U.S. Departmen ...
Why Gilead Sciences (GILD) Outpaced the Stock Market Today
Zacks Investment Research· 2024-03-08 07:55
In the latest trading session, Gilead Sciences (GILD) closed at $73.66, marking a +1.42% move from the previous day. The stock outpaced the S&P 500's daily gain of 1.03%. Meanwhile, the Dow gained 0.34%, and the Nasdaq, a tech-heavy index, added 1.51%.Prior to today's trading, shares of the HIV and hepatitis C drugmaker had lost 2.41% over the past month. This has lagged the Medical sector's gain of 2.1% and the S&P 500's gain of 3.21% in that time.Investors will be eagerly watching for the performance of G ...
Gilead (GILD) & MRK's HIV Oral Combo Shows Efficacy in Phase II
Zacks Investment Research· 2024-03-07 22:00
Gilead Sciences (GILD) and Merck (MRK) announced promising first data from a phase II study evaluating the combination of a once-weekly treatment regimen of Merck’s islatravir and Gilead’s lenacapavir.The data demonstrated the efficacy of this potential long-acting oral combination treatment option in maintaining viral suppression in individuals with HIV.At the 24-week mark, the combination of islatravir and lenacapavir showcased an impressive 94.2% rate of viral suppression (HIV-1 RNA <50 copies/mL), with ...
Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities
Businesswire· 2024-03-07 05:30
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three studies evaluating the efficacy and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for a broad range of people with HIV, including those with HIV/hepatitis B (HBV) coinfection and HIV/tuberculosis (TB) coinfection. These data and other studies supporting the important role of Biktarvy in the HIV treatment landscape were presented at ...
Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24
Businesswire· 2024-03-06 23:25
FOSTER CITY, Calif., & RAHWAY, N.J.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses ...
Here is What to Know Beyond Why Gilead Sciences, Inc. (GILD) is a Trending Stock
Zacks Investment Research· 2024-03-06 23:00
Gilead Sciences (GILD) has recently been on Zacks.com's list of the most searched stocks. Therefore, you might want to consider some of the key factors that could influence the stock's performance in the near future.Shares of this HIV and hepatitis C drugmaker have returned -6.1% over the past month versus the Zacks S&P 500 composite's +2.9% change. The Zacks Medical - Biomedical and Genetics industry, to which Gilead belongs, has gained 1% over this period. Now the key question is: Where could the stock be ...
New Real-World Data Further Support the Use of Veklury® (Remdesivir) for People Hospitalized With COVID-19
Businesswire· 2024-03-06 05:35
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI). One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19. In a separate study, Veklury use was associated with significantly reduced mortality among people who were immunocompromi ...
Gilead's Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health
Businesswire· 2024-03-06 05:30
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline. The latest results explore clinical outcomes from a study evaluating an investigational combination regimen of bictegravir and lenacapavir, new findings from a study evaluating the investigational combination of lenacapavir with broadly neutralizing antibodies (bNAbs), and new proof-of-concept data on GS-1720, a no ...