mRNA Platforms

Arcturus Therapeutics Holdings Inc. announced it will host a virtual presentation on Wednesday, September 23, 2026, at 4:30 p.m. ET covering the ARCT-810 Phase 2 clinical program for Ornithine transcarbamylase deficiency and the company's mRNA liver therapeutics platform. The company will issue a press release summarizing the presentation prior to the call. Marshall Summar, M.D., a founding member and Executive Committee member of the NIH UCD Consortium and a recognized expert in rare diseases and OTC deficiency, will participate in the presentation. ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency, and it holds Orphan Medicinal Product Designation and an approved pediatric investigation plan from the European Medicines Agency, plus Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. In Europe and the U.S., approximately 10,000 people have OTC deficiency.

BioNTech reported detailed Phase 3 data showing its investigational lung cancer therapy gotistobart nearly doubled median overall survival compared with standard chemotherapy. The shares traded around US$96.69, with a 30 day share price return of 3.87% and a 90 day share price return of 4.85%, while the 1 year total shareholder return declined 2.59% and the 5 year total shareholder return fell 71.40%. BioNTech now trades at roughly a 22% discount to analyst targets, with the most followed fair value view at $120.62 against the last close of $96.69. The company's pipeline includes multiple late stage Phase II and III trials for BNT327 and mRNA cancer immunotherapies in lung and breast cancers, supported by the planned CureVac acquisition. Risks to the bullish case include late stage oncology trial failures and prolonged COVID-19 vaccine demand weakness and related litigation.

Moderna and Merck reported positive results from the late-stage INTerpath-001 study of intismeran autogene (V940/mRNA-4157) in combination with Keytruda in patients with high-risk Stage IIB-IV melanoma whose tumors had been removed through surgery. The study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with the companies stating the improvements were statistically significant and clinically meaningful, though no numerical data were disclosed. INTerpath-001 marks the first positive phase III readout for an individualized neoantigen therapy and an mRNA-based cancer therapy, and five-year follow-up from the phase IIb KEYNOTE-942 study showed the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% versus Keytruda alone. Moderna and Merck are evaluating intismeran across nine phase II and phase III studies spanning multiple tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, while Moderna's broader pipeline includes separate mRNA-based cancer antigen therapies, a T-cell engager and a cell-therapy enhancer. Moderna shares have skyrocketed nearly 400% year to date, outperforming the industry's 7% growth, and the stock trades at 23.44 times forward 12-month sales versus the industry average of 1.90 times.

GSK plc plans to close its vaccine manufacturing facility in Dresden, Germany, by summer 2027, putting 641 jobs at risk. The company reviewed its Dresden and Ste-Foy, Canada, flu vaccine sites and chose to consolidate production in Canada, which it says can meet anticipated demand more sustainably and competitively, as falling demand for traditional egg-based flu vaccines has left GSK with more manufacturing capacity than it needs. The closure comes as GSK advances an mRNA-based seasonal flu vaccine into Phase III after Phase II results showed stronger immune responses than standard-dose vaccines in younger adults and high-dose vaccines in older adults. GSK's vaccine business remains a significant earnings contributor, with second-quarter 2026 vaccine sales rising 8% to £2.3 billion, meningitis vaccines up 21%, Arexvy sales increasing by more than 100%, and Shingrix generating £0.9 billion. The company faces execution risk, as the mRNA flu candidate has only reached Phase III and opposition from the German union and works council could make the closure process more complicated or expensive.

Guobang Pharma announced that the pharmaceutical excipient "pegylated dimyristoyl glycerol (for injection)" produced by its wholly-owned subsidiary Zhejiang Guobang Pharmaceutical has passed the joint review and approval with the formulation by the Center for Drug Evaluation of the National Medical Products Administration, and its registration status has been changed to A. This product is a key functional excipient for mRNA vaccines and pharmaceutical formulations. This approval enables the product to meet the conditions for commercial production and supply to downstream customers, and the company expects it will have a positive impact on the market expansion of its pharmaceutical excipient business.

Merck & Co. reported second-quarter worldwide sales of $16.6 billion, with its oncology franchise led by intravenous Keytruda and the subcutaneous formulation Keytruda QLEX generating $8.4 billion in quarterly revenue. The pulmonary arterial hypertension treatment Winrevair surged 75% to reach $588 million, and management raised its full-year 2026 sales guidance to a range between $66.3 billion and $67.3 billion. The company faces the loss of exclusivity for Keytruda toward the end of 2028, pushing it to fund and acquire new pipeline assets, including a personalized mRNA cancer vaccine collaboration with Moderna. According to Insider Monkey's database, 101 hedge funds held a stake in the company during the second quarter, up from 98 in the prior quarter, while short interest sits at just 0.99% of the float. Fisher Asset Management maintained the top position with 38.5 million shares, increasing its holdings by 46%.

GSK plc is advancing its experimental seasonal influenza vaccine into late-stage development after encouraging mid-stage results in both younger and older adults. The mRNA-based candidate generated stronger immune responses than currently approved standard-dose flu vaccines in younger adults and approved high-dose vaccines in older adults, according to GSK. Its design also targets two important surface proteins on the influenza virus, haemagglutinin and neuraminidase, rather than focusing on one. GSK said the late-stage study will be the first for an mRNA seasonal flu vaccine designed to target both proteins, and the company believes this approach could improve protection and reduce transmission. GSK intends to begin the late-stage trial in September 2026, part of a wider effort to accelerate its pipeline that, following a portfolio review by CEO Luke Miels, includes plans to initiate more than 20 late-stage studies by the end of 2026 as the company prepares for approaching patent expirations.

Walvax Biotechnology announced on the evening of September 10 that its wholly owned subsidiary, Yuxi Walvax Biotechnology, received the Drug Registration Certificate for the COVID-19 mRNA Vaccine approved and issued by the National Medical Products Administration that day. The vaccine is the company's third-generation COVID-19 mRNA vaccine iteratively developed on its mRNA platform technology, with the antigen sequence designed based on the S protein of the Omicron JN.1 strain, for use in people aged 18 and above to prevent disease caused by SARS-CoV-2 infection. The announcement showed that the company's previously developed first-generation COVID-19 variant vaccine with an S protein chimera and the second-generation iterative vaccine targeting the Omicron XBB.1.5 variant jointly validated the mRNA platform technology. Following the approval of this vaccine, research and development and drug registration work related to the first- and second-generation vaccines concluded simultaneously. Citing data, the announcement said global sales of mRNA COVID-19 vaccines exceeded 6 billion US dollars in 2025, and the company stated that the approval of this vaccine is not expected to have a significant impact on this year's performance.

Moderna's stock surged as much as 160% after the company announced positive Phase 3 trial results for its mRNA-based personalized cancer vaccine, which significantly reduced the risk of melanoma recurrence in over 1,100 patients when combined with Merck's Keytruda. The trial was stopped early because the efficacy was so high that standard medical ethics required allowing control-group patients access to the treatment. Despite the jump, shares remain below previous highs, and analysts caution that scaling and pricing questions remain. Meanwhile, Target reported a 5.3% sales increase and a 100% jump in earnings per share, though much of that came from a one-time $994 million tariff refund. The company's digital sales grew 8.7%, and same-day deliveries rose 25%, but analysts question whether the turnaround can sustain the stock's 60% year-to-date gain. In AI news, OpenAI's 18% quarterly growth disappointed investors, while Anthropic more than doubled revenue, and both companies are racing toward IPOs.

Moderna has initiated a Phase 3 trial of its mRNA-based bird flu vaccine, advancing the program into late-stage testing with support from a major international partnership focused on pandemic preparedness. The company has committed to equitable global access, including reserved manufacturing capacity for low- and middle-income countries. This trial is part of Moderna's broader strategy to apply its mRNA platform beyond COVID-19, targeting emerging infectious diseases. The program is backed by CEPI's US$54 million support, and Moderna has pledged to allocate 20% of manufacturing to low- and middle-income countries. Investors should watch for tangible government or multilateral purchase commitments that may follow, as the company's market value stands at about $59.4 billion.

GSK plc announced it will advance its mRNA-based seasonal influenza vaccine candidate into Phase III development, following positive Phase II results showing higher immune responses compared with standard-dose and high-dose flu vaccines in younger and older adults, respectively. The company plans to start the Phase III efficacy study in September 2026, which will be the first study of an mRNA flu vaccine designed to target both haemagglutinin and neuraminidase, potentially improving protection against illness and transmission. The FDA has granted Fast Track designation for the candidate. Year to date, GSK stock has risen 6.1%, while rival Moderna's shares jumped nearly 10% on the news, as investors viewed it as platform validation rather than a threat to its recently approved mRNA flu vaccine, mFlusiva.

Merck & Co., Inc. and Moderna, Inc. announced that their Phase 3 INTerpath-001 trial of individualized mRNA therapy intismeran autogene plus KEYTRUDA in completely resected stage IIB–IV melanoma met its primary and key secondary endpoints, improving recurrence-free and distant metastasis-free survival versus KEYTRUDA alone with no new safety issues identified. This marks the first positive Phase 3 outcome for both an individualized neoantigen therapy and an mRNA-based cancer therapy, potentially opening a new treatment class across multiple tumor types within the broader INTerpath clinical program. The success reinforces Merck's oncology leadership and could strengthen the short-term catalyst around pipeline conversion, while the biggest risk remains concentration in Keytruda and whether new launches can realistically fill that future revenue gap. Merck's raised 2026 sales guidance to US$66.3 billion to US$67.3 billion highlights how management already expected growth from multiple new products before factoring in this Phase 3 mRNA melanoma readout. Merck's narrative projects $74.9 billion revenue and $22.0 billion earnings by 2029, requiring 4.0% yearly revenue growth and a roughly $18.8 billion earnings increase from $3.2 billion today, with forecasts yielding a $136.85 fair value, a 9% downside to its current price.

Merck and Moderna announced a significant breakthrough in melanoma treatment, as their jointly developed mRNA cancer vaccine met the primary goal in its first Phase 3 trial, significantly extending the period patients lived without melanoma recurrence when combined with Merck's Keytruda compared to Keytruda alone. Following the announcement on Aug. 19, Moderna's shares surged nearly 177%, while Merck rose 12.60%. The global melanoma therapeutics market, estimated at $5.83 billion in 2024, is projected to reach $10.27 billion by 2030, with immunotherapy as the fastest-growing segment. Barclays analysts estimate the vaccine could generate up to $3 billion in annual melanoma-related sales by 2035. Investors seeking exposure may consider healthcare ETFs holding these stocks, such as the iShares Genomics Immunology and Healthcare ETF, where Moderna holds an 8.85% weight, and the VanEck Pharmaceutical ETF, where Merck holds a 10.94% weight.

Moderna led the S&P 500 in August after reporting promising results from a late-stage trial of a personalized mRNA cancer vaccine co-developed with Merck, according to CNBC. The data challenged years of skepticism about the company's mRNA technology following the decline of its Covid-19 vaccine business. Enterprise software stocks accounted for many of the index's other top performers, including Palantir, Veeva Systems, Salesforce, and ServiceNow, which had been under selling pressure due to AI concerns and large short positions held by the leveraged hedge fund Situational Awareness. When the fund was forced to unwind its trades in late July, those shorts became a tailwind for the stocks. Situational Awareness, run by Leopold Aschenbrenner, peaked at $45 billion in assets and lost roughly $35 billion after margin calls from prime brokers Bank of America, Goldman Sachs, and JPMorgan Chase forced a distressed sale to Ken Griffin's Citadel. Salesforce bounced back after better-than-expected quarterly results, while ServiceNow gained on AI integration, and Veeva Systems climbed as the anticipated AI threat failed to materialize. Outside software, Newmont benefited from gold price recovery, Coinbase rose with cryptocurrencies, and Super Micro Computer and Sandisk surged on AI memory demand. Moderna also raised $2 billion through convertible senior notes due 2032, earmarked for its cancer vaccine business, after its stock surged 177% on Aug. 19, adding $44.5 billion to its market capitalization in a single session.

GSK plc plans to launch a Phase 3 clinical trial in September for its experimental mRNA seasonal influenza vaccine after mid-stage data showed superior immune responses compared to licensed vaccines. The candidate, FLUm3HA.b-3NA, targets both haemagglutinin and neuraminidase surface antigens, a first for an mRNA flu vaccine. In the Flu-028 trial involving 971 adults, the vaccine generated higher immune responses against every tested strain than standard and high-dose inactivated vaccines, with acceptable safety. The U.S. Food and Drug Administration granted Fast Track designation in July 2026. GSK shares rose 0.46% to $50.48 in premarket trading.

Moderna Inc. saw its share price soar 156 percent in August, making it the highest-gaining stock for the month, driven primarily by strong clinical trial results for its melanoma therapy candidate and supported by a recent regulatory approval for its updated COVID-19 vaccines. The company, in partnership with Merck, is developing a treatment for melanoma combining mRNA-4157 with Keytruda; the phase 3 trial met its primary endpoint of recurrence-free survival and the key secondary target of distant metastasis-free survival, marking the first positive readout from a phase 3 trial for a combination of individualized neoantigen therapy and mRNA-based cancer therapy, and the first to show a clinically meaningful improvement over Keytruda alone. The US alone is expected to see 112,000 new melanoma cases this year, with 8,500 deaths, and globally 330,000 cases were diagnosed in 2022. The rally was also supported by the FDA's approval of Moderna's biologics license application for the 2026-2027 formulas of Spikevax and mNEXSPIKE vaccines, with Spikevax approved for individuals aged 6 months to 64 with at least one underlying condition and all adults 65 and older, and mNEXSPIKE approved for those 12 to 64 with high-risk conditions and all adults 65 and older. Hedge fund conviction strengthened in the second quarter, with 49 funds holding positions, down from 52, but their combined holdings increased 10 percent to $1.5 billion from $1.4 billion quarter-on-quarter.

The health-care sector was on track for its strongest week since June 26, with the Health Care index rising more than 4% in the five trading days leading up to August 21, compared to a 7.9% increase in late June. The spark was a single piece of clinical trial news: Moderna and Merck announced on August 19 that their tailored mRNA cancer treatment was successful in a late-stage trial, significantly improving recurrence-free survival and distant metastasis-free survival compared with Keytruda alone in a study of over 1,100 patients. The Phase 3 trial, dubbed INTerpath-001, tested an individualized cancer vaccine called intismeran autogene in combination with Merck's blockbuster immunotherapy Keytruda in patients with completely resected stage IIB-IV melanoma. The trial achieved both its primary goals, recurrence-free survival, and a critical secondary target, distant metastasis-free survival, when compared to Keytruda alone. The companies stated that no new safety signals arose throughout the trial, and that the results expanded on previous Phase 2b data showing that the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared to Keytruda alone. Personalized neoantigen vaccines have been considered as a cancer treatment concept for many years, but this is the first randomized Phase 3 experiment to definitely confirm their effectiveness. Moderna shares rose around 177% on the day of the news, adding approximately $45 billion to the company's market capitalization, while Merck posted a more modest but still significant 12% single-day rise. More broadly, roughly two-thirds of health-care stocks in a broad screen of over 100 names were higher on the week, with pharmaceutical and life-sciences names such as IQVIA, Danaher, and Thermo Fisher among the sector's other leaders, indicating that the rally is the result of renewed enthusiasm for the industry instead of a single-stock event.

Moderna received FDA approval for updated Spikevax and mNEXSPIKE COVID-19 vaccines tailored to the latest SARS-CoV-2 subvariant, as well as mFlusiva, its first mRNA-based influenza vaccine for adults aged 50 and over. These approvals expand Moderna's respiratory vaccine portfolio and mark the first FDA-authorized mRNA flu shot for older adults. The company, a US-based biotechnology firm developing messenger RNA medicines, sees these approvals as reinforcing its regulatory momentum and diversifying its respiratory offerings against competitors like Pfizer and Novavax in COVID and Sanofi and GSK in flu. However, analysts note that respiratory shots still depend on annual uptake, pricing, and pharmacy stocking, so the key question is how far these launches reduce reliance on a narrow set of seasonal products.

Pfizer and BioNTech have received U.S. FDA approval for their updated mRNA COVID-19 vaccine, COMIRNATY XFG, for the 2026-27 season. The shot targets the XFG variant and is indicated for individuals aged five to 64 with at least one underlying condition that puts them at high risk for severe outcomes from the virus, as well as for all adults aged 65 and older.

Moderna plans to raise $2 billion by selling convertible senior notes due 2032, with proceeds earmarked for its cancer vaccine business and debt repayment, the company said Thursday. The Cambridge, Massachusetts-based biotechnology company structured the offering to include an option for purchasers to acquire up to $300 million more in notes. Moderna stock fell 5% in premarket trading in New York after the announcement. The offering follows a 177% rally in Moderna's stock on Aug. 19, which added $44.5 billion to its market capitalization in a single session, after the company reported encouraging data from a late-stage study of a personalized mRNA cancer vaccine co-developed with Merck & Co. Because Moderna's stock remains elevated near last week's multi-year peak, the company is able to negotiate a higher conversion price on the notes, which translates to a smaller number of shares entering circulation should the notes convert, helping protect existing stockholders from dilution.

Merck shares reached a fresh 52-week high yesterday, driven by investor confidence in its long-term growth prospects, pipeline progress, regulatory approvals, and recent acquisitions. The rally follows positive top-line data from the phase III INTerpath-001 study, which evaluated Merck and Moderna's personalized cancer therapy combo in high-risk melanoma patients, meeting its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival. Merck's biggest revenue driver, Keytruda, recorded sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, with its subcutaneous formulation Keytruda Qlex contributing $590 million. The company's newer products, including Winrevair, Capvaxive, and Welireg, have shown encouraging growth, and recent approvals include the RSV antibody Enflonsia, Idvynso, and Lipfendra. Merck also strengthened its pipeline through the 2025 acquisition of Verona Pharma and the 2026 buyouts of Cidara Therapeutics and Terns Pharmaceuticals, and it expects more than $70 billion of potential non-risk-adjusted commercial opportunity from its current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028. Year to date, Merck shares have rallied 50.9%, outperforming the industry's 19.9% rise, though the stock trades at a premium with a forward P/E of 21.33 versus the industry's 19.44.

Overnight in the US market, mRNA vaccine maker Moderna saw its share price jump 14.36 percent, lifting vaccine sectors in both A-shares and Hong Kong stocks. On August 26, A-share CanSino Biologics hit the daily limit up, Wantai Biological Pharmacy also hit the daily limit up, while Zhifei Biological Products and Walvax Biotechnology rose more than 6 percent. In Hong Kong, CanSino Biologics surged more than 20 percent. Earlier, Moderna and Merck jointly announced that their personalised mRNA cancer vaccine met the primary endpoint in a Phase III clinical trial, making it the world's first personalised neoantigen therapy to deliver a positive result. Chinese companies such as CanSino Biologics have already announced plans to develop personalised mRNA tumour vaccines. However, the vaccine currently targets only melanoma, and its production cost is relatively high, so it is still some distance from being widely available to ordinary patients. Industry insiders estimate that its cost is lower than cell therapy but higher than ordinary antibody drugs, and China's mRNA cancer vaccine development remains in the early clinical stage.

On the morning of August 26, CanSino Biologics hit its 20 percent daily price limit just 48 seconds after the market opened, boosting activity across the pharmaceutical and biotech sector. After the close on the previous day, CanSino announced that its subsidiary CanSino Shanghai had signed a strategic cooperation framework agreement with Dephios Bio to co-develop a personalized therapeutic mRNA cancer vaccine. The two sides will combine their respective strengths in mRNA vaccine technology and tumor neoantigen discovery and design to jointly advance the vaccine's development and commercialization. The collaboration is global in scope and focuses on gastrointestinal solid tumors and rare tumor treatment. A representative from CanSino's securities department said the vaccine is still in the early research stage and commercialization will take a long time. A research note from Sinolink Securities pointed out that China's mRNA industry landscape has taken shape, but therapeutic mRNA products overall remain in early clinical stages.

On the morning of August 26, China's three major A-share indexes were mixed, while the pharmaceutical and biotech sector was active, with CanSino Biologics surging by the 20 percent daily limit. In terms of news, CanSino Biologics announced that its subsidiary CanSino Shanghai and Depushi Hangzhou Biotechnology Company Limited signed a strategic cooperation framework agreement for the joint development of mRNA personalized therapeutic cancer vaccines. The two sides will jointly advance the research, development, and commercialization of mRNA personalized therapeutic cancer vaccines, focusing on gastrointestinal solid tumors and rare tumor treatment areas. In addition, Hansen Pharmaceutical rose by the daily limit for the sixth consecutive day, while Qianjin Pharmaceutical, Yibai Pharmaceutical, and Wantai Biological Pharmacy also hit their daily limits. In the Hong Kong market, stocks fluctuated higher, with the Hang Seng Tech Index rising more than 1 percent, and XPeng, NIO, and Alibaba among the top gainers.

Moderna shares climbed nearly 13% on Tuesday after Wolfe Research upgraded its view on the biotechnology company and BofA Securities lifted its price target to $170. The move followed encouraging results from Moderna's Phase 3 INTerpath-001 study with Merck, which tested intismeran autogene, an individualized mRNA-based vaccine, together with Keytruda in patients with surgically treated high-risk melanoma. Results released Aug. 19 showed the study achieved its main measure of recurrence-free survival and met a secondary goal involving the time before melanoma spread to other parts of the body. The data could help reinforce Moderna's efforts to build a broader pipeline beyond its established vaccine business.

Merck & Co., Inc. jumped 12.6% to a record $152.20 on August 19 after a pivotal melanoma trial validated intismeran autogene, the individualized mRNA cancer therapy developed with Moderna. In the 1,137-patient Phase 3 INTerpath-001 study, intismeran plus Keytruda produced statistically significant and clinically meaningful improvements in recurrence-free survival and distant-metastasis-free survival compared with Keytruda alone, with no new safety concerns. The result strengthens the case that Keytruda, which generated $31.68 billion in 2025 sales, can remain commercially relevant after its primary compound patent expires in December 2028. However, Merck and Moderna share development costs and profits equally, and the companies have not disclosed Phase 3 effect sizes or overall-survival data, leaving approval, pricing, and reimbursement unresolved.

Merck and Moderna announced positive topline Phase 3 results for their individualized cancer vaccine intismeran autogene in resected melanoma, beating Keytruda alone on recurrence-free survival, though no specific efficacy numbers have been released yet. The news lifted several biotech names, with BioNTech surging 21.6% on read-across excitement and Illumina rising 15.6% to $223.22 because its NovaSeq X sequencers are required for every individualized neoantigen dose manufactured. Pacific Biosciences gained 5.8% to $1.28, Repligen traded at $181.62 after reporting second-quarter revenue of $204 million with 13% organic growth, and Danaher saw mid-teens bioprocessing order growth in the second quarter. Leerink Partners analyst Daina Graybosch called the market reaction overly optimistic but still raised her 2032 intismeran forecast to $1.4 billion, while Morningstar projects $16.8 billion by 2035.

Moderna shares rose 2.9% in pre-market trading, recovering some ground after several sessions of declines that followed a dramatic rally triggered by positive Phase 3 results for its personalised mRNA cancer vaccine, intismeran autogene. Barclays analyst Eliana Merle increased the firm's price target on Moderna to $125 from $48 while maintaining an Equal Weight rating, and Wolfe Research had previously upgraded Moderna from Underperform to Peerperform, estimating potential unadjusted peak sales of $9.2 billion across four indications. The shares have gained approximately 392% year to date following the successful Phase III melanoma trial, though they remain below their 52-week high of $176.66. Broader market gains also supported the rebound, with the Nasdaq Composite advancing 1.0% and the S&P 500 gaining 0.5%.

CancerVax welcomed positive Phase 3 results from Moderna and Merck's INTerpath-001 trial of a personalized mRNA cancer vaccine for melanoma, saying the data de-risk the LNP-mRNA technology used in its own off-the-shelf cancer vaccines. The trial met its primary endpoint of recurrence-free survival in completely resected stage IIB–IV melanoma, marking the first positive late-stage result for an mRNA cancer therapy. CancerVax is developing a universal cancer vaccine that disguises cancer as familiar viral infections to activate existing immunity, avoiding the expensive individualized manufacturing loop required for personalized vaccines. The company's chief scientific officer said the results strengthen the scientific rationale for using mRNA to direct immune responses against cancer.

Moderna and Merck announced that their individualized mRNA neoantigen therapy paired with Keytruda hit its primary endpoint in the Phase 3 INTerpath-001 melanoma trial, triggering a nearly 177% rally in Moderna, a gain of over 12% for Merck, and a jump of more than 4% in the SPDR S&P Biotech ETF to its highest level since February 2021. The trial win lifted gene-editing and AI drug discovery names broadly, with Prime Medicine, Intellia, CRISPR Therapeutics, Editas Medicine, and Beam Therapeutics rallying alongside the sector, and the iShares Genomics Immunology and Healthcare ETF jumping 13.53% in a single session on 2.8 times average volume. Analysts have turned more constructive on biotech ETFs, citing valuation, technical momentum, and M&A potential, with Bank of America's Research Investment Committee noting biotech has generated returns of roughly 10% or more since June and is being flagged as a diversification play away from crowded technology positioning. Potential targets for M&A include Revolution Medicines, IDEAYA Biosciences, Arcus Biosciences, and Iovance Biotherapeutics, while risks include macro shocks and the structural volatility of small-cap clinical-stage names.

Moderna and Merck announced that their personalized mRNA cancer therapy intismeran autogene, combined with Keytruda, met its primary endpoint of recurrence-free survival in a late-stage melanoma study. The INTerpath-001 trial also met the secondary goal of distant metastasis-free survival in patients with high-risk Stage IIB-IV melanoma after surgery. The companies are testing intismeran in nine additional phase II and III studies across lung, bladder, and kidney cancers. Moderna sees the result as validation of its mRNA platform beyond infectious-disease vaccines, though it still faces competition from BioNTech and others, and its stock trades at a premium with a Zacks Rank of 3, or Hold.

In the US market, the flow of funds from AI-related stocks to pharmaceutical stocks has strengthened, and shares of biopharmaceutical maker Moderna, which announced positive clinical trial results for a skin cancer vaccine, surged 2.3 times compared with the previous weekend. Merck, a major pharmaceutical company co-developing the cancer vaccine with Moderna, also rose 12.3 percent, with pharmaceutical stocks taking over the market's lead from AI stocks. Last week, stock prices fell sharply, led by AI stocks, due to concerns over rising global long-term interest rates and massive corporate bond issuance by AI companies. This week, Nvidia's earnings are scheduled for the 27th, and Federal Reserve Chair Warsh's speech at the Jackson Hole conference is scheduled for the 28th. Nvidia is expected to post rapid growth in both revenue and profit for the May-July 2026 quarter, nearly doubling year over year, but its stock price has continued to fall after earnings releases due to concerns over circular transactions involving massive loans to customers.

Moderna nearly doubled in value on Wednesday after its messenger-RNA-based cancer vaccine, developed with Merck, succeeded in a late-stage trial for melanoma patients. The Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival and a secondary endpoint of distant metastasis-free survival versus Merck's Keytruda alone. William Blair upgraded Moderna to Outperform from Market Perform, and CEO Stephane Bancel said the personalized shot could be approved as early as 2027. Separately, Aurora Cannabis confirmed Curaleaf Holdings has commenced an unsolicited takeover bid for all outstanding shares at implied consideration of $4 per share, comprising 0.3463 Curaleaf shares and $0.75 in cash. Eli Lilly also inked a collaboration with privately held Amplitude Therapeutics to develop trans-amplifying RNA vaccine candidates for infectious diseases, while Twist Bioscience jumped more than 15% after Anthropic selected it as an independent evaluator for AI-designed protein binders.

Tempus AI shares jumped 39.5% after phase 3 INTerpath-001 trial results showed a customized mRNA-based melanoma treatment improved recurrence-free survival, alongside its pending US$1.50 billion acquisition of Personalis Inc. The trial success and acquisition plan highlight how Tempus AI is tying advanced mRNA oncology research to its broader precision medicine and data-driven cancer testing ambitions. The Personalis deal would deepen Tempus AI's role in cancer genomics at the same time customized mRNA oncology approaches show clinical success, potentially strengthening the case that its data assets, assays, and AI tools are becoming more embedded in cutting edge oncology programs. Tempus AI's narrative projects $2.6 billion revenue and $13.4 million earnings by 2029, requiring 22.0% yearly revenue growth and roughly a $268 million earnings increase from -$254.4 million today. Some of the most optimistic analysts were already assuming revenue could reach about US$2.7 billion and earnings turn positive by 2029, and this new oncology trial result might eventually push those views even further apart.

The Phillip World Innovation Fund, or PWIN, and the Phillip World Innovation Retirement Mutual Fund, or PWINRMF, have received a positive boost from the global rise in healthcare stocks, one of the three core investment themes the funds emphasize, alongside information technology, semiconductors, AI and data centers, and clean energy infrastructure. The S&P 500 Healthcare Index has risen 10.8% since the outbreak of conflict in the Middle East, calculated from the closing price on March 2, 2026, compared with the closing price on August 19, 2026, according to Bloomberg data. A specific positive factor came from late-stage trial results in patients with melanoma skin cancer, indicating that the use of Moderna's mRNA vaccine in combination with Merck's Keytruda produced positive outcomes. This sent Moderna's share price soaring by as much as 176% and lifted Merck's shares by 12% on August 19 alone. Other healthcare stocks such as Eli Lilly, Novartis, and Pfizer also saw significant gains.