Workflow
mRNA therapy
icon
Search documents
Moderna, Inc. (MRNA) Shareholder/Analyst Call Transcript
Seeking Alpha· 2025-10-17 20:06
PresentationKyle Holen [Audio Gap] Some time with us. We're really excited about sharing with you some new data that we just shared earlier today on one of our assets, 4359 that's quickly becoming one of our newest late-stage assets similar to INT, which you've heard a lot about. I'm going to walk you through some of the INT data. And then we're just pleased to have some experts in the field that have joined us tonight to talk to you about melanoma and to talk to you about the data that was presented, the ...
Moderna (NasdaqGS:MRNA) FY Earnings Call Presentation
2025-09-25 14:30
mRNA-4157/V940 in combination with KEYTRUDA - At ~3 years of follow-up, the recurrence-free survival rate of mRNA-4157/V940 in combination with KEYTRUDA was 74.8%, compared to 55.6% for KEYTRUDA alone[12] - At a median planned follow-up of 34.9 months, mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 49%[14] - At ~3 years of follow-up, mRNA-4157/V940 in combination with KEYTRUDA demonstrated a 62% reduction in the risk of developing distant metastasis or death compared to KEYTRUDA alone[17] Safety and Tolerability of mRNA-4157/V940 - In the adjuvant melanoma trial, any treatment-related adverse event occurred in 100% of patients (n=104) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 25% of patients[18] - Serious adverse events occurred in 14.4% of patients (n=15) receiving mRNA-4157 (V940) + pembrolizumab[18] - Immune-related adverse events occurred in 37.5% of patients (n=39) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 10.6% of patients[18] - 94.2% of patients (n=98) experienced mRNA-4157 (V940)-related adverse events, with 33.7% Grade 1, 49% Grade 2, and 11.5% Grade 3[18] Development Programs - The Phase 3 study for adjuvant melanoma with mRNA-4157/V940 is fully enrolled[21, 22] - mRNA-4359 is ongoing in Phase 1/2 study; now enrolling Phase 2 with additional indications planned[27] - mRNA-2808 is in Phase 1 development[41] - mRNA-4203: IND open, in combination with Immatics' IMA203[49]
Why Vertex Pharmaceuticals Stock Is a Screaming Buy on the Dip
The Motley Fool· 2025-05-07 08:49
Core Viewpoint - Vertex Pharmaceuticals experienced a significant stock decline after missing Wall Street's revenue and earnings estimates for Q1, but this sell-off presents a buying opportunity for investors [1][2]. Financial Performance - Vertex reported Q1 revenue of $2.77 billion, a 3% increase year over year, but below the expected $2.83 billion [2]. - Adjusted earnings per share were $4.06, missing the consensus estimate of $4.29 [2]. Operational Updates - The company announced a temporary pause in the multiple ascending dose portion of its phase 1/2 study for mRNA therapy VX-522 due to a tolerability issue [3][5]. - Vertex attributed weaker-than-expected financial results partly to illegal copycat products in Russia, although it believes this issue is isolated to that market [3]. Guidance and Future Outlook - Vertex raised the lower end of its full-year revenue guidance for 2025 to between $11.85 billion and $12 billion, up from a previous lower end of $11.75 billion [4]. - The management remains optimistic about the investment thesis despite the setbacks with VX-522 [5]. Product Developments - Vertex's new cystic fibrosis therapy, Alyftrek, is receiving positive feedback from physicians and patients, with expectations for a switch from existing CF drugs [7]. - The company received a positive opinion from the CHMP for Alyftrek, aiming for European Commission approval in the second half of 2025 [8]. - Vertex's new non-opioid pain drug, Journavx, is expected to see increased sales volume in the coming months, despite minimal sales reported in Q1 [10]. Pipeline Prospects - Vertex plans to file for regulatory approvals for zimislecel in treating severe Type 1 diabetes next year, pending positive study results [11]. - The company may also seek U.S. accelerated approval for povetacicept in treating IgA nephropathy in the first half of 2026, contingent on favorable interim data [11]. Risk Management - Vertex's CFO indicated that the company has low exposure to tariffs due to its geographically diverse supply chain and manufacturing primarily in the U.S. [12]. Investment Sentiment - Despite the revenue and earnings miss, Vertex is viewed as a strong investment opportunity, with expectations for significant returns driven by the adoption of Alyftrek and the potential success of Journavx [13][14].