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BriaCell's Bria-IMT™ Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer
GlobeNewswire News Room· 2025-07-11 11:30
Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Phase 2 study demonstrated that the median overall survival (OS) for triple-negative breast cancer (TNBC) patients treated with Bria-IMT plus CPI was 13.9 months, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4][5]. - For hormone receptor-positive (HR+) metastatic breast cancer patients, the median OS with Bria-IMT plus CPI was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [4][5]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [7]. Comparison with Established Treatments - Bria-IMT's performance in TNBC and HR+ patient subtypes outperformed established benchmarks, indicating a potential clinical impact of the novel immunotherapy [2][4]. - The survival rates at 6 months for TNBC patients were 78% for Bria-IMT plus CPI compared to 80% for Trodelvy and 56% for single-agent chemotherapy [3]. - For HR+ patients, the survival rates at 6 months were 90% for Bria-IMT plus CPI, compared to 83% for Trodelvy and 76% for single-agent chemotherapy [3]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2][6].
BriaCell’s Bria-IMT™ Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer
Globenewswire· 2025-07-11 11:30
Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Bria-IMT regimen demonstrated a median overall survival (OS) of 13.9 months in triple-negative breast cancer (TNBC) patients, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4]. - In hormone receptor-positive (HR+) metastatic breast cancer, the median OS for Bria-IMT was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [3][4]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [6]. Comparison with Established Treatments - Bria-IMT's performance outperformed established benchmarks like Trodelvy in both TNBC and HR+ patient subtypes, indicating its potential clinical impact [2][5]. - The median OS for Bria-IMT in TNBC patients is higher than that reported in the treatment arm of the ASCENT study for TNBC patients, and it is twice that reported in the physician's choice arm [5]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2].
Gilead Sciences Rallies 27.2% in Six Months: Buy or Sell the Stock?
ZACKS· 2025-07-08 14:56
Key Takeaways GILD stock has surged 27.2% in six months, outpacing its industry, sector, and the S&P 500 index. FDA approval of Yeztugo, the first twice-yearly PrEP, strengthens GILD's HIV portfolio and market edge. New liver drug Livdelzi and rising earnings estimates support GILD's growth and dividend sustainability.Shares of Gilead Sciences, Inc. (GILD) have gained 27.2% in the past six months against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 index in th ...
Gilead Sciences, Inc. (GILD) Presents at Goldman Sachs 46th Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-06-10 17:15
Core Insights - Gilead Sciences is focusing on executing its strategy across core franchises, particularly in HIV and oncology, while also diversifying into inflammation [2][3] - The company has developed a strategy over the past 5 to 6 years to maintain leadership in virology and expand into other therapeutic areas [3] - Gilead currently has three growing franchises: virology and HIV, oncology, and inflammation, with promising data from recent presentations at ASCO [4] Financial Position - Gilead has a strong balance sheet and robust cash flows, positioning the company well for future growth opportunities [4]
Gilead Sciences (GILD) FY Conference Transcript
2025-06-10 16:20
Summary of Gilead's Conference Call Company Overview - **Company**: Gilead Sciences - **Industry**: Biotechnology Key Points and Arguments Growth Strategy - Gilead is focusing on three core franchises: virology (HIV), oncology, and inflammation, with a strong emphasis on diversifying beyond virology [3][4] - The company has a robust balance sheet and cash flows, allowing for effective management of operating expenses and investment in growth opportunities [4][5] HIV and Lenacapavir Launch - The launch of lenacapavir for HIV PrEP is imminent, with a PDUFA date set for June 19 [7] - Gilead has been advocating for funding core HIV services, and discussions with the government have been positive regarding support for these programs [8] - Lenacapavir is reported to be 100% effective in preventing HIV, with high community awareness expected to drive uptake [9][10] - The target population for PrEP in the U.S. is approximately 1.2 million, with current users around 400,000, primarily men who have sex with men [13][14] - Gilead aims to improve compliance among current users and expand access to underserved communities [15][16] Reimbursement and Coverage - Gilead expects high insurance coverage for lenacapavir, similar to existing PrEP medications, with an anticipated 70-75% coverage within six months post-launch [22][23] - The company has various support systems in place for individuals with HIV, ensuring access to treatment [24][25] Pipeline and Innovation - Gilead has multiple long-acting HIV programs in development, including a once-a-year injection expected to be available by 2028 [27][28] - The company is also working on alternatives to its leading HIV treatment, Biktarvy, with several programs in various stages of development [32][34] Oncology Developments - Gilead presented significant data at ASCO for Trodelvy in treating triple-negative breast cancer, which could become the new standard of care [36][40] - The oncology business is currently generating over $3 billion annually, with Trodelvy contributing over $1 billion [44] - Gilead is expanding its oncology pipeline with ongoing trials in various cancer types, including lung cancer and multiple myeloma [45][46] Business Development and Future Outlook - Gilead plans to continue investing in late-stage research and development, with a focus on mid-stage acquisitions to complement its portfolio [55][57] - The company is committed to returning value to shareholders through dividends and share buybacks [58] Regulatory Environment - Gilead is actively engaging with the administration regarding potential policy changes, including the MFN executive order, emphasizing the need for a balanced approach to drug pricing [59][60] - The company believes it is less vulnerable to tariffs due to its significant U.S. presence and IP holdings [64][66] Additional Important Content - Gilead's long-term strategy includes exploring novel inflammation targets to complement its existing therapeutic areas [53] - The company is focused on maintaining a competitive edge in the biotechnology sector through innovation and strategic partnerships [54][66]
Royalty Pharma to Present at the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-06-04 20:15
NEW YORK, June 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2025 at 2:00 p.m. ET. The webcast will be accessible from Royalty Pharma’s “Events” page at https://www.royaltypharma.com/investors/events/. The webcast will also be archived for a minimum of thirty days. About Royalty Pharma Founded in 1996, Royalty Pharma is the largest buyer of biopharm ...
Gilead Sciences (GILD) 2025 Conference Transcript
2025-06-04 16:07
Gilead Sciences (GILD) 2025 Conference June 04, 2025 11:05 AM ET Speaker0 Good morning everyone. Welcome to our next panel discussion with Gilead Sciences. We have a couple of important members of the executive team from Gilead here up with us. To my left, Dietmar Berger, who's the new CMO, and I like to say running the hot seat of R and D in front of Wall Street to talk about obviously everything going on in the pipeline. As well as Cindy Paretti. She's Executive Vice President of Kite and runs everything ...
Gilead Sciences (GILD) Conference Transcript
2025-06-04 16:05
Gilead Sciences (GILD) Conference June 04, 2025 11:05 AM ET Speaker0 Good morning everyone. Welcome to our next panel discussion with Gilead Sciences. We have a couple of important members of the executive team from Gilead here up with us. To my left, Dietmar Berger, who's the new CMO, and I like to say running the hot seat of R and D in front of Wall Street to talk about obviously everything going on in the pipeline. As well as Cindy Paretti. She's Executive Vice President of Kite and runs everything at Ce ...
Protara Therapeutics Announces Appointment of William Conkling as Chief Commercial Officer
Globenewswire· 2025-06-02 20:04
NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the appointment of William “Bill” Conkling as Chief Commercial Officer. He brings more than two decades of experience developing and commercializing novel cancer and rare disease therapeutics to Protara. “It is a pleasure to welcome Bill, a deeply experienced and proven commercial leader,” said Jesse ...
Gilead Sciences Stock Gains 21% YTD: Buy, Sell or Hold?
ZACKS· 2025-05-30 16:10
Core Viewpoint - Gilead Sciences, Inc. has demonstrated strong performance in a volatile market, with shares up 21.1% year-to-date, significantly outperforming the industry and the S&P 500 Index, which declined by 4.7% [1][8]. Group 1: HIV Market Leadership - Gilead is a dominant player in the HIV market, with its flagship drug Biktarvy accounting for over 51% of the treatment market share in the U.S. [4] - The company’s Descovy for pre-exposure prophylaxis (PrEP) maintains over 40% market share in the U.S. [5] - The FDA has accepted new drug applications for lenacapavir for HIV prevention, with a target action date of June 19, 2025, which could enhance Gilead's HIV franchise [5][6]. Group 2: Liver Disease Portfolio - The FDA approval of seladelpar (Livdelzi) for primary biliary cholangitis (PBC) strengthens Gilead's liver disease portfolio and validates its CymaBay acquisition [7][9]. Group 3: Oncology Business Challenges - Gilead's oncology portfolio, including the Cell Therapy franchise and Trodelvy, faces competitive pressures, particularly in the U.S. and Europe, which are expected to continue into 2025 [10]. - Despite challenges, positive results from the phase III ASCENT-03 study on Trodelvy indicate potential for improvement in the oncology business [11]. Group 4: Financial Performance and Estimates - Gilead's shares trade at a price/earnings ratio of 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62x but higher than its historical mean of 10.53x [12]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.91 from $7.87, and the 2026 estimate improving to $8.39 from $8.31 [14]. Group 5: Strategic Positioning and Dividends - Gilead's strategic deals and acquisitions are aimed at diversifying its business, although Biktarvy sales may face pressure due to Medicare Part D redesign [17]. - The company has a strong cash position of $7.9 billion as of March 31, 2025, and has consistently increased dividends, declaring a quarterly dividend of $0.79 per share for Q2 2025, indicating a sustainable yield of 2.91% [18].