Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.

BOULDER, Colo., June 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has priced its previously announced underwritten public offering of 8,394,737 shares of its common stock at a price to the public of $19.66 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 1,780,263 sha ...

BOULDER, Colo., June 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has commenced an underwritten public offering of $200 million of shares of its common stock and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase shares of Enliven's common stock. In addition, Enliven intends to grant the u ...

Key Takeaways PFE's non-COVID revenues are rising, fueled by new drugs, key in-line products and Seagen acquisition. The Seagen deal added four ADCs to PFE's oncology portfolio, boosting revenues in 2024 and early 2025. PFE shares trade at a forward P/E of 7.97, well below the industry average and its 5-year historical mean.With the end of the pandemic, sales of Pfizer’s (PFE) COVID products, Comirnaty and Paxlovid, have declined. Though COVID revenues are declining, Pfizer’s non-COVID operational revenue ...

ROCKVILLE, Md., June 12, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (“I-Mab” or the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that on June 11, 2025 it received notification from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it had regained compliance with Nasdaq’s $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the “Listing Rule”). The Company’s ...

WALTHAM, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced the appointment of Akintunde (Tunde) Bello, Ph.D., to the company’s board of directors. “Tunde is an accomplished leader with a strong track record of successfully developing novel therapies across a broad range of therapeutic areas, including several important cance ...

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]

Core Insights - Merck (MRK) has over six blockbuster drugs, with Keytruda being the primary revenue driver, accounting for approximately 50% of pharmaceutical sales [1][9] - Keytruda's sales are increasing due to its rapid adoption in early-stage non-small cell lung cancer (NSCLC) and continued strong performance in metastatic indications [2] - There are concerns regarding Merck's heavy reliance on Keytruda, especially with the impending loss of exclusivity in 2028, prompting the need for diversification [3] Sales and Growth - Keytruda generated sales of $7.21 billion in Q1 2025, reflecting a 6% year-over-year growth, with an estimated compound annual growth rate (CAGR) of 5.4% over the next three years [7][9] - Merck is exploring innovative strategies to sustain Keytruda's growth, including combinations with LAG3 and CTLA-4 inhibitors, and a partnership with Moderna for a personalized mRNA therapeutic cancer vaccine [5][9] Competitive Landscape - Competitive pressure for Keytruda may increase, particularly with Summit Therapeutics' ivonescimab showing promising results in a phase III study, which could challenge Keytruda's market position [4] Future Strategies - Merck is developing a subcutaneous formulation of Keytruda to potentially extend its patent life, with an FDA decision expected in September [6] - The company is also banking on the recently launched pulmonary arterial hypertension (PAH) drug Winrevair to support revenue after Keytruda's exclusivity ends [7] Valuation and Market Performance - Merck's shares have decreased by 19.6% this year, contrasting with a 0.3% increase in the industry [8] - From a valuation perspective, Merck's price/earnings ratio stands at 8.55, which is lower than the industry average of 15.12 and its own 5-year mean of 12.89 [10]

Core Points - OSE Immunotherapeutics has requested an extension for the Combined General Meeting scheduled for June 25, 2025, to ensure a regular and transparent process for shareholders [1][2][6] - The request is in response to shareholder concerns regarding the timely communication of resolutions aimed at changing the Board of Directors' composition [2][3] - The resolutions presented by a group of shareholders acting in concert have been renumbered from n°35 to 44 to A to K, with the content remaining unchanged [4] Company Information - OSE Immunotherapeutics is a biotech company focused on developing first-in-class assets in immuno-oncology and immuno-inflammation [8] - The company collaborates with leading academic institutions and biopharmaceutical companies to develop transformative medicines for serious diseases [8] - OSE Immunotherapeutics is based in Nantes and Paris and is listed on Euronext [8]

5 June 2025 | 12:27AM HKT Innovent Biologics (1801.HK): ASCO 2025 take: Encouraging survival benefit of IBI363; Better understanding of POC hinges on RCT data As noted in our previous ASCO2025 notes (preview, abstract takeaway), Innovent orally presented the updated ph1 data of IBI363 (PD-1/IL-2α-bias BsAb) in NSCLC, CRC, and melanoma, which we view as incrementally positive for ORR/PFS compared to abstract, with particular highlight on the encouraging survival benefit (OS data debut) in IO-treated squamous ...