CAMBRIDGE, MA / ACCESS Newswire / October 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 6, 2025 to report its third quarter 2025 financial results, and provide a corporate update. ...

Company Performance - Moderna's stock closed at $26.25, reflecting a -1.83% change from the previous day, underperforming the S&P 500's daily loss of 0.16% [1] - Over the past month, Moderna's stock has increased by 11.98%, outperforming the Medical sector's gain of 1.54% and the S&P 500's gain of 1.14% [1] Earnings Forecast - The upcoming earnings report for Moderna is expected to show an EPS of -$1.99, representing a significant 6733.33% decline from the same quarter last year [2] - Revenue is forecasted to be $861.08 million, indicating a 53.76% decrease compared to the same quarter of the previous year [2] - For the full year, earnings are projected at -$9.62 per share and revenue at $1.88 billion, reflecting changes of -8.46% and -41.8% respectively from the prior year [3] Analyst Revisions - Recent revisions to analyst forecasts for Moderna are crucial as they reflect short-term business trends, with upward revisions indicating analyst optimism regarding the company's profitability [4] - The Zacks Rank system, which incorporates estimate changes, has a strong track record of outperforming, with stocks rated 1 producing an average annual return of +25% since 1988 [6] Industry Context - The Medical - Biomedical and Genetics industry, part of the Medical sector, currently holds a Zacks Industry Rank of 94, placing it in the top 39% of over 250 industries [7] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [7]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over five years of experience in biotech consulting and has prepared detailed reports on more than 1,000 companies [1]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over five years of experience in biotech consulting and has prepared detailed reports on more than 1,000 companies [1]

Core Insights - Moderna Inc. announced the presentation of clinical data for mRNA-4359 in combination with pembrolizumab for CPI-R/R melanoma at the 2025 European Society for Medical Oncology Congress [1] Group 1: Clinical Data - mRNA-4359 is an investigational cancer antigen therapy targeting immune escape pathways PD-L1 and IDO1, aiming to elicit T cell responses to kill tumor cells [2] - The study involved 29 participants receiving the combination therapy at doses of 400 µg (n=14) or 1,000 µg (n=15), administered every three weeks for up to nine doses [2] - The objective response rate (ORR) across evaluable patients was 24%, while the disease control rate (DCR) was 60% [2] Group 2: Efficacy in Specific Patient Population - Among patients with PD-L1+ tumors (TPS≥1%), the ORR was significantly higher at 67% (6 of 9 participants) [3] - The treatment induced peripheral antigen-specific T cell responses and novel T cell receptor clones, with the median duration of response (DOR) not yet reached [3] Group 3: Safety Profile - The combination of mRNA-4359 and pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events reported [4] - mRNA-4359 is also being evaluated in ongoing studies as a monotherapy and in combination with pembrolizumab for advanced melanoma and non-small cell lung cancer (NSCLC) [4] Group 4: Additional Developments - Moderna released preliminary immunogenicity data for the 2025-2026 mNEXSPIKE COVID-19 vaccine formula, showing over a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in specific age groups [5] - Following these announcements, MRNA stock rose by 3.54% to $27.78 [5]

Core Insights - Moderna, Inc. has advanced mRNA-4359 into the Phase 2 portion of its ongoing Phase 1/2 trial [1] - Clinical, safety, and translational data from the study will be presented at the 2025 ESMO Congress in Berlin [1] - mRNA-4359 is an investigational cancer antigen therapy targeting immune evasion pathways PD-L1 and IDO1 [1] Company Developments - The trial evaluates mRNA-4359 in combination with pembrolizumab for checkpoint inhibitor-resistant/refractory melanoma patients [1] - The therapy aims to elicit antigen-specific T cell responses to directly kill tumor cells and deplete tumor suppressor cells [1]

Core Viewpoint - Moderna's stock has shown significant performance, with a recent increase of 14.76% over the last month, outperforming both the Medical sector and the S&P 500 [1] Financial Performance - Moderna is projected to report earnings of -$1.95 per share, indicating a year-over-year decline of 6600% [2] - The consensus estimate for revenue is $925.77 million, reflecting a 50.28% decrease from the same quarter last year [2] - For the full year, analysts expect earnings of -$9.59 per share and revenue of $1.93 billion, marking changes of -8.12% and -40.37% respectively from the previous year [3] Analyst Estimates - Recent revisions to analyst estimates suggest a correlation with near-term business trends, indicating analysts' confidence in Moderna's performance [3] - The Zacks Consensus EPS estimate has increased by 1.15% over the last 30 days, with Moderna currently holding a Zacks Rank of 3 (Hold) [5] Industry Context - The Medical - Biomedical and Genetics industry, which includes Moderna, has a Zacks Industry Rank of 73, placing it in the top 30% of over 250 industries [6] - Research indicates that top-rated industries outperform lower-rated ones by a factor of 2 to 1 [6]

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Technical Analysis - Moderna (MRNA) has recently reached a key level of support and has overtaken the 50-day moving average, indicating a short-term bullish trend [1] - The 50-day simple moving average is considered an important marker for determining support or resistance levels [1] Performance Metrics - MRNA has rallied 14.8% over the past four weeks and currently holds a Zacks Rank of 3 (Hold) [2] - The combination of recent performance and ranking suggests MRNA may be on the verge of another upward movement [2] Earnings Estimates - There have been no downward revisions in earnings estimates for MRNA in the past two months, with 6 upward revisions noted [2] - The consensus earnings estimate for MRNA has also increased, reinforcing the positive outlook [2][3] Investment Outlook - Given the positive technical indicators and earnings estimate revisions, MRNA may present a potential investment opportunity for further gains in the near future [3]

Group 1 - The U.S. White House announced that the new tariff measures on pharmaceuticals will not apply to countries that have trade agreements with the U.S. [2][4] - The new tariffs include a 100% tariff on imported brand-name or patented drugs starting October 1, 2025, unless companies establish pharmaceutical manufacturing in the U.S. [4] - Pharmaceutical stocks showed mixed performance in the U.S. market, with Novavax rising by 2.52% and Moderna falling by 0.49% on the day of the announcement [1][2] Group 2 - The U.S. will maintain a 15% tariff cap on pharmaceuticals from trade partners like the EU and Japan, as per existing agreements [2][4] - The U.K. will face a 100% tariff on pharmaceuticals due to ongoing negotiations regarding their trade agreement with the U.S. [2][3] - Canadian steel and related manufacturing industries have seen significant declines in output and exports due to U.S. tariffs, with a 24.8% drop in production since March [5][6]