Almost every drug in history has been a "finished product" — we synthesize the drug molecule in a factory and put it into the body. mRNA flips that logic on its head: instead of delivering the drug itself, we deliver the "instructions" (a set of code) and let the patient's own cells make the therapeutic protein — the same technology as the COVID vaccine the whole world got. This chapter walks through how it works at the cellular level, why it's called the "software of biology," why these companies' revenue crashed from tens of billions to a few billion after COVID, and why the next big bet is on individualized cancer vaccines.
Contains
Theme index· base 100 · USD total return
No index history for this theme yet.
Why is mRNA Platforms moving?
Latest
▲2▼2
mRNA platform expands into cancer and new RNA drugs, but valuation and patent risks bite
▲
mRNA cancer vaccine clears Phase 3 in melanoma Moderna and Merck's personalized mRNA cancer vaccine met its main goal in a Phase 3 melanoma trial, the first late-stage proof mRNA can fight cancer. This opens a large new market and strengthens the platform's long-term promise, though the exact size of that market is still debated.
It is the biggest new clinical validation of the mRNA platform this period.
▲
Novartis pays up to $7.2B for Abogen mRNA drug Abogen licensed an mRNA-encoded T-cell engager for autoimmune diseases to Novartis for $575 million upfront and up to $7.2 billion in milestones. Big Pharma paying up shows mRNA is moving beyond vaccines into new disease areas, widening the platform's uses and attracting capital.
It shows a new, large commercial use for mRNA beyond vaccines.
▼
Citi downgrade warns Moderna valuation is stretched Citigroup cut Moderna to Sell, saying its 222% rally prices in unrealistic cancer sales, and the stock fell 6%. This is a real counterweight: the platform's science is advancing, but the market may have already paid too much for it, which can weigh on the whole group.
It is the main new negative force on the theme's valuation.
▼
Patent lawsuits against mRNA makers move forward A Delaware judge refused to dismiss Monsanto's patent suits against Pfizer, BioNTech and Moderna over mRNA technology used in COVID vaccines. The legal fight could bring royalties or damages, adding a cost and uncertainty layer across the platform.
It is a new legal risk affecting several major mRNA players.
Q3 2026
▲3▼1
mRNA sector wins approvals and deals, but safety and valuation risks bite
▲
Moderna and Merck's mRNA cancer vaccine succeeds in Phase 3 melanoma trial Moderna and Merck's personalized mRNA cancer vaccine succeeded in a first Phase 3 melanoma trial, a major validation for mRNA in cancer. This opens a large new market beyond infectious diseases.
This is a new, major clinical win that drives the sector's growth story.
▲
Moderna's mRNA flu vaccine wins FDA approval Moderna's mRNA flu vaccine won FDA approval, the first for an mRNA flu shot. This expands the company's commercial products and validates the platform for seasonal viruses.
A new regulatory approval that directly boosts mRNA platform credibility and revenue potential.
▲
Sector gains backing from China, UAE, and Novartis-Abogen deal China's 2030 drug plan, UAE investment talks, and Novartis's up-to-$7.2B Abogen deal show global backing. Moderna also raised $2 billion, strengthening sector capital.
These new capital and policy supports are key external drivers for the sector.
▼
BioNTech cancer vaccine fails and safety halt; Moderna downgraded BioNTech's colorectal cancer vaccine failed and a second trial halted on safety. Moderna gave back ~20% on valuation doubts and was downgraded to Sell by Citi. Competition and patent lawsuits add pressure.
These are new negative events that create a real counterweight to the positive drivers.
News & notes movingmRNA Platforms
United StatesChinaDenmarkFrance
mRNA Platforms▼
Sanofi, Novartis and Novo Nordisk Lead Week of Multi-Billion-Dollar Healthcare Deals
A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech and Moderna to dismiss lawsuits filed by Bayer's Monsanto unit over their use of US Patent No. 7,741,118, a patent related to mRNA technology, with Judge William Bryson saying the companies failed to prove the patent was invalid or not infringed by their COVID-19 vaccines. Sanofi agreed to a deal worth up to $8B, including $1B upfront, with Regeneron to jointly develop four long-acting immunology therapies, led by the clinical-stage IL-13 monoclonal antibody REGN20423. China's Abogen Biosciences signed a licensing and option agreement with Novartis worth up to $7.8B, comprising a $575 million upfront payment and up to approximately $7.2 billion in potential milestone payments if all options on all programs are exercised, covering an exclusive worldwide license to Abogen's lead asset ABO2203. Jiangsu Hengrui Pharmaceuticals agreed to license global rights to its experimental obesity drug HRS-1596 to Novo Nordisk in a deal worth up to $2.6B, with $300M upfront and the transaction expected to close in Q4 2026. Meanwhile, the S&P 500 Health Care Sector Index slipped 2.66% for the week, with Incyte down 6.93% and Regeneron down 6.71% among the top decliners, while McKesson rose 4.11% and Cardinal Health gained 3.67%.
HSBC Upgrades Target, Citi Downgrades Moderna in Week of Analyst Calls
Wall Street analysts issued a slew of rating changes this week, led by HSBC's upgrade of Target to Buy from Hold with a price target raised to $190 from $125, citing a turnaround "gaining momentum." Citi downgraded Moderna to Sell from Neutral, calling the valuation "unjustifiable" after the biotech rallied more than 222% since a Phase 3 win for its personalized cancer shot intismeran autogene, and cut its price target to $60 from $80. Deutsche Bank downgraded PepsiCo to Hold from Buy, while Goldman Sachs upgraded Occidental Petroleum to Buy from Neutral with a $69 price target, up from $63, and double-downgraded Tourmaline Oil to Sell from Buy with a C$49 target, cut from C$59. Wells Fargo upgraded Consolidated Edison to Overweight from Equal Weight with a $118 target and BP to Overweight from Equal Weight with a $57 target, while downgrading ExxonMobil to Equal Weight from Overweight with an unchanged $182 target. Morgan Stanley reinstated Nvidia as its top pick in the semiconductor space.
Nasdaq 100 to Add Moderna, Replacing Warner Bros. Discovery, Effective Oct. 9
Nasdaq announced yesterday that shares of Moderna, the vaccine maker, will replace Warner Bros. Discovery in the Nasdaq 100 index, effective Oct. 9. The change follows a more than sixfold surge in Moderna's share price this year, giving the company a market value of about 75 billion dollars. Conversely, Warner Bros. Discovery will also be removed from the indexes of major index providers MSCI and S&P, as its merger with Paramount Skydance is expected to be completed on Oct. 6, after the process was delayed for many months.
Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › RNA Therapeutics ▲Capital
MRNA · Capital · Positive Moderna will be added to the Nasdaq 100 index, effective Oct. 9, following a sixfold share-price surge.
WBD · Capital · Negative Warner Bros. Discovery will be removed from the Nasdaq 100, MSCI, and S&P indexes as its merger with Paramount Skydance nears completion.
PSKY · Capital · Neutral Paramount Skydance's merger with Warner Bros. Discovery is expected to complete Oct. 6, but the article does not state the impact on Paramount.
Novartis inks up to $7.8B RNA therapeutics deal with Abogen
Novartis has entered into a licensing and option agreement with China's Abogen Biosciences to advance RNA-encoded therapeutics, according to a statement on Friday. Abogen will receive an upfront payment of $575 million, and, if all options on all programs are exercised, Abogen is eligible to receive up to approximately $7.2 billion in potential milestone payments, plus potential royalties on future product sales. The agreement includes an exclusive worldwide license to Abogen's lead asset, ABO2203, a novel mRNA-encoded CD19xCD3 T-cell engager designed to reset B cells by directing endogenous production of T-cell engagers in vivo, with the potential to transform treatment for patients with autoimmune diseases. The Swiss drugmaker also holds the exclusive option to license a number of next-generation therapeutic assets developed on Abogen's proprietary RNA platform.
Biotech & Genomic Medicine › RNA Therapeutics ▲Capital
Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Capital
NOVN.SW · Capital · Positive Novartis signs up to $7.8B licensing/option deal with Abogen for RNA-encoded therapeutics, expanding its pipeline via M&A/licensing.
Abogen Biosciences · Capital · Positive Abogen receives $575M upfront and up to ~$7.2B in milestones plus royalties under the Novartis licensing deal.
Moderna to Join Nasdaq-100, Replacing Warner Bros. Discovery
Nasdaq said Thursday that Moderna will become a component of the Nasdaq-100 Index, replacing Warner Bros. Discovery before market open on Friday, October 9. The vaccine maker's shares have jumped more than sixfold this year to a valuation of roughly $75B. Warner Bros. Discovery is also set to be removed from major indexes, including those tracked by MSCI and S&P, as its merger with Paramount Skydance is expected to close on October 6 following a months-long delay.
Biotech & Genomic Medicine › mRNA Platforms ▲Capital
Biotech & Genomic Medicine › RNA Therapeutics ▲Capital
MRNA · Capital · Positive Moderna will join the Nasdaq-100 Index, replacing Warner Bros. Discovery, an index-inclusion event.
WBD · Capital · Negative Warner Bros. Discovery is being removed from the Nasdaq-100 and other major indexes ahead of its merger with Paramount Skydance.
Moderna Falls 6% After Citigroup Downgrade to Sell
Moderna shares fell 6% in the morning session after Citigroup downgraded the biotechnology company to Sell from Neutral, warning that a 222% rally had pushed its valuation to unsustainable levels. Analyst Meacham wrote in a note to clients that the stock's surge since mid-August's Phase 3 INTerpath-001 melanoma readout reflects aggressive sales forecasts and unrealistic probability-of-success assumptions, according to Tipranks. Reaching a near-$200 share price would require roughly $13 billion in annual oncology revenue attributable to Moderna, nearly seven times Citigroup's model, a hurdle Meacham characterized as unrealistic. The run-up expanded Moderna's market capitalization to roughly $80 billion, rivaling Regeneron despite materially lower expected revenue and earnings, and Meacham added that even under a theoretical 100% probability of success across lead cancer programs, Citigroup's pipeline valuation model justifies only about $100 per share. Moderna is up 520% since the beginning of the year and at $191.35 per share is trading close to its 52-week high of $203.46 from September 2026.
Citi downgraded Moderna to Sell from Neutral, sending shares down 6.88% in premarket trading, with analyst Geoff Meacham calling the valuation "unjustifiable" after a Phase 3 win for the personalized cancer shot intismeran autogene developed with Merck. Workday said it is cutting 2.5% of its workforce, mainly in its Product and Technology team, according to a Form 8-K filed with the U.S. Securities and Exchange Commission, and shares slipped 1.23% in early trading. Conagra Brands reported fiscal first-quarter adjusted earnings of $0.41 per share, topping the $0.28 consensus estimate, on revenue of $2.60 billion, roughly in line with the $2.59 billion expected, and shares rose about 3% in premarket trading. SpaceX shares slipped 0.09% in early trading after Anthropic agreed to pay the company up to $84.5 billion to use its computing capacity through 2029, according to Reuters, which viewed a confidential initial public offering prospectus, a figure far larger than the agreement that surfaced in May.
Judge Rejects Pfizer, BioNTech, Moderna Bids to Dismiss Monsanto mRNA Patent Suits
A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech, and Moderna to dismiss lawsuits filed against them by Bayer's Monsanto unit over their use of a patent related to mRNA technology. The patent at issue, US Patent No. 7,741,118, covers bolstering mRNA in crops to boost expression of a pest-resistant protein, and Monsanto argued in its suit that the companies used it in their COVID-19 mRNA vaccines to eliminate problem coding sequences in the building blocks of cells to improve mRNA stability and the amount or quality of protein produced. Judge William Bryson said the companies failed to prove that the '118 patent was invalid or not infringed by their vaccines, according to Reuters. Moderna had argued that the patent covers an unpatentable law of nature. Monsanto also has a lawsuit in a New Jersey federal court against Johnson & Johnson involving the same patent.
BAYN.XETRA · Regulation · Positive Bayer's Monsanto unit won the ruling allowing its mRNA patent infringement suits against Pfizer, BioNTech and Moderna to proceed.
Moderna and Merck's Melanoma Vaccine Meets Phase 3 Endpoint
Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Demand
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
MRNA · Technology · Positive Moderna's personalized cancer vaccine intismeran autogene met the Phase 3 primary endpoint in melanoma, validating its mRNA oncology platform.
MRNA · Regulation · Positive Moderna recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, expanding its non-seasonal respiratory portfolio.
MRNA · Capital · Neutral Moderna is in talks with Middle East partners about potential investment and manufacturing cooperation.
MRK · Technology · Positive Merck's Keytruda combined with Moderna's intismeran autogene met the Phase 3 primary endpoint in melanoma, a positive clinical readout for its oncology franchise.
BioNTech Wins Health Canada Approval for XFG-Adapted COMIRNATY as Gotistobart Nearly Doubles Survival in Phase 3 Lung Cancer Trial
Pfizer Canada and BioNTech announced Health Canada's approval of the Omicron XFG-adapted COMIRNATY vaccine for individuals aged 6 months and older, aligning with 2026-2027 public health recommendations. A few days earlier, BioNTech and OncoC4 reported that the investigational CTLA-4 antibody gotistobart nearly doubled median overall survival versus chemotherapy in a Phase 3 lung cancer trial stage. The Health Canada authorization, following earlier US and EU XFG approvals in 2026, shows the COVID-19 franchise still contributes regulated, seasonal revenue while BioNTech leans into oncology. BioNTech's narrative projects €2.2 billion revenue and €390.1 million earnings by 2029, implying a 6.0% yearly revenue decline and an earnings increase of about €2.1 billion from -€1.7 billion today, with a $118.06 fair value and 20% upside to its current price. Bullish analysts assume revenue climbs to about €3.0 billion and earnings to €313.1 million by 2029, though the new gotistobart data and oncology execution risks could shift how those upbeat assumptions are weighed against more cautious views.
Moderna Enters High-Level Investment Talks With UAE Government
Moderna has entered high-level investment talks with the UAE government covering advanced pharmaceutical manufacturing and research and development collaboration. The discussions focus on expanded research capabilities, potential local production, and broader access to Middle Eastern healthcare markets. Management framed the UAE engagement as part of a wider push to build out Moderna's international footprint beyond existing Western partnerships. The company, a large US biotech group with a market cap of about $79.4b, focuses on messenger RNA based medicines and has a history of working closely with public sector buyers. Investors will watch whether the talks turn into concrete agreements, such as a defined R&D center, a manufacturing investment figure, or a multi year vaccine procurement deal, and any link to the INTerpath-001 melanoma program or the mRNA respiratory portfolio.
Biotech & Genomic Medicine › mRNA Platforms ▲Capital
MRNA · Demand · Positive Moderna is in high-level talks with the UAE government on pharma manufacturing, R&D collaboration, and broader Middle East market access, potentially expanding its international footprint.
Moderna Shares Hit Four-Year High on UAE Investment Talks
Moderna Chairman Noubar Afeyan met UAE Minister of State Saeed bin Mubarak Al Hajeri, who also chairs the Emirates Drug Establishments, to discuss investment and cooperation in advanced pharmaceutical industries. The talks covered research and development collaboration, exchange of expertise, and strengthening the UAE's pharmaceutical manufacturing capabilities, building on the strategic partnership between the United States and the UAE. Moderna shares climbed to a record intra-day high of $195.71 before closing up 6.98 percent at $194.82 apiece. Investors are also awaiting an updated readout on the INTerpath-001 trial of intismeran autogene in combination with Merck's Keytruda, to be presented at the European Society for Medical Oncology Congress 2026 in Madrid from October 23 to 27, 2026. The phase 3 trial previously met its primary endpoint of recurrence-free survival and key secondary target of distant metastasis-free survival, marking the first positive phase 3 readout for a combination of individualized neoantigen therapy and mRNA-based cancer therapy. In the second quarter, 49 hedge funds held positions in Moderna, down from 52 in the first quarter, but their combined holdings rose 10 percent to $1.5 billion from $1.4 billion quarter-on-quarter.
FDA Approves Pfizer and BioNTech's COMIRNATY XFG COVID-19 Vaccine Formula
Pfizer Inc. and BioNTech SE announced on August 27 that the U.S. FDA has approved the supplemental Biologics License Application for their 2026–2027 COVID-19 vaccine formula, COMIRNATY XFG. The updated formula targets the XFG variant and is authorized for adults aged 65 and older, as well as individuals aged 5 to 64 with high-risk underlying conditions. The approval, based on clinical, real-world, and manufacturing data showing strong immune responses against circulating strains, aligns with FDA strain guidance for fall 2026. For Pfizer, the clearance protects a recurring seasonal revenue stream that supports margins and cash flow while the company funds its non-COVID pipeline and manages upcoming loss-of-exclusivity events. For BioNTech, it validates the execution power of its proprietary mRNA platform and preserves its balance sheet, which carries minimal debt and substantial cash reserves to fund late-stage oncology trials without dilutive financing. Both companies still face long-term market contraction as COVID-19 booster demand has normalized well below pandemic peaks, leaving Pfizer's earnings less predictable against elevated debt and exposing BioNTech's heavy operating losses as vaccine revenues fall short of its massive R&D expenses.
Biotech & Genomic Medicine › mRNA Platforms ▲Regulation
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) Competition
22UA.XETRA · Regulation · Positive FDA approved BioNTech's COMIRNATY XFG formula, validating its mRNA platform and preserving its balance sheet.
PFE · Regulation · Positive FDA approved Pfizer's supplemental BLA for the 2026-2027 COMIRNATY XFG formula, protecting a recurring seasonal revenue stream.
Arcturus Reports Positive Interim Phase 2 Results for ARCT-810 in OTC Deficiency
Arcturus Therapeutics said interim phase 2 results for ARCT-810 showed the candidate reduced and/or maintained first morning fasting ammonia within the normal range in patients with ornithine transcarbamylase deficiency, and also reduced glutamine, with some individuals reaching the normal range. Based on those results and a June meeting with the US FDA, the company aims to begin dosing of ARCT-2601 close to the end of the year in participants 12 years and older under an amended phase 2 protocol that integrates ARCT-2601 into the current ARCT-810 phase 2 study. Both ARCT-810 and ARCT-2601 are mRNA therapeutics for OTC deficiency, but ARCT-810 uses the LUNAR platform while ARCT-2601 uses the next-generation LUNAR 2.0 platform, which Arcturus says produces greater than 30-fold higher protein expression and could allow for lower or less frequent dosing. OTC deficiency is a rare genetic disorder in which the body stops breaking down and removing nitrogen, leading to dangerous ammonia levels in the blood. Arcturus is also acquiring AI discovery company myNeo, with which it has worked since 2024, and the deal is expected to close in October.
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Rare Disease ▲Demand
Biotech & Genomic Medicine › AI Drug Discovery Technology
ARCT · Technology · Positive Interim Phase 2 results show ARCT-810 reduced/maintained normal fasting ammonia and glutamine in OTC deficiency, supporting advancement to ARCT-2601 dosing.
ARCT · Capital · Positive Arcturus is acquiring AI discovery company myNeo, with the deal expected to close in October.
myNeo · Capital · Positive myNeo is being acquired by Arcturus, with the deal expected to close in October.
Moderna to Present Detailed INTerpath-001 Melanoma Data at ESMO
Moderna will present detailed data from the phase III INTerpath-001 study of intismeran autogene, its personalized mRNA cancer therapy developed with Merck, at the European Society for Medical Oncology Congress next month. The findings will be presented on Oct. 24 in a Presidential Symposium, a session highlighting cutting-edge and potentially practice-changing clinical research, and are expected to provide investors with detailed data beyond the top-line results Moderna reported last month. Last month, Moderna and Merck reported positive results from INTerpath-001, which evaluated intismeran in combination with Merck's Keytruda in patients with high-risk Stage IIB-IV melanoma whose tumors had been surgically removed; the study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, though the companies did not report numerical data, stating only that the improvements were statistically significant and clinically meaningful. The companies are advancing 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, and a commercial launch of the therapy is targeted as early as next year. Moderna shares rose 12% yesterday, climbing to a new 52-week high of $176.86, and have skyrocketed nearly 500% year-to-date, significantly outperforming the industry's 6% growth.
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Demand
MRNA · Technology · Positive Moderna will present detailed phase III INTerpath-001 melanoma data for its personalized mRNA cancer therapy intismeran at ESMO.
MRK · Technology · Positive Detailed phase III INTerpath-001 data for intismeran plus Keytruda in melanoma to be presented at ESMO, advancing the partnered cancer therapy.
BMO Downgrades BioNTech to Market Perform, Cuts Price Target to $105
BMO Capital Markets downgraded BioNTech SE from outperform to market perform on Sept. 8, 2026, and lowered its 12-month price target for the biotech stock from $128 to $105. The downgrade followed BioNTech's Aug. 28, 2026 announcement that it was canceling a Phase 2 clinical trial of the personalized mRNA cancer vaccine BNT122-01 in colorectal cancer after the therapy failed to show statistically significant efficacy, with no safety concerns cited. BioNTech lowered its full-year revenue guidance to €1.6 billion to €1.9 billion from a previous forecast of €2 billion to €2.3 billion. The company still has more than 25 Phase 2 and Phase 3 clinical studies of experimental cancer therapies underway, and recently reported that gotistobart nearly doubled median overall survival versus standard-of-care chemotherapy in previously treated patients with squamous non-small cell lung cancer. BioNTech expects data from 11 other late-stage studies by the end of 2029, with results from three due before the end of this year, while its market cap sits near $24 billion and its cash, cash equivalents, and security investments totaled roughly €16.6 billion, or around $19 billion, as of June 30, 2026.
Biotech & Genomic Medicine › mRNA Platforms ▼Technology
Biotech & Genomic Medicine › Oncology Therapeutics Technology
22UA.XETRA · Capital · Negative BMO downgraded BioNTech to market perform and cut its price target to $105 from $128.
22UA.XETRA · Technology · Negative BioNTech canceled its Phase 2 BNT122-01 colorectal cancer vaccine trial after it failed to show statistically significant efficacy.
22UA.XETRA · Demand · Negative BioNTech lowered full-year revenue guidance to €1.6-1.9 billion from €2-2.3 billion.
Moderna Jumps 9% as Phase 3 Melanoma Study Wins ESMO Presidential Symposium Slot
Moderna shares surged 9% to $167.90 after the company said its Phase 3 adjuvant melanoma study of intismeran autogene was selected for a Presidential Symposium slot at the European Society for Medical Oncology congress in Madrid on October 24. The Phase 3 INTerpath-001 trial tests intismeran autogene plus pembrolizumab against pembrolizumab alone in patients whose melanoma had been surgically removed, and Moderna will host a live investor webcast the same day. No new efficacy data was released Monday; the melanoma result was first reported in August, and the announcement adds only the venue and a fixed date, with the Presidential Symposium being the congress's highest-profile placement, typically reserved for datasets organizers expect to shape clinical practice. Merck, the pharma partner on intismeran autogene and supplier of pembrolizumab, rose just 1% to $148.95, while BioNTech, which runs its own late-stage individualized messenger RNA cancer immunotherapy programs, gained 2% to $97.71, signaling the market views the move as a Moderna-specific re-rating rather than broad validation of messenger RNA oncology. The iShares Biotechnology ETF rose 1% to $207.28 and the SPDR S&P 500 ETF Trust rose 1.16% to $770.54, with Moderna's advance running several times either fund's move.
Biotech & Genomic Medicine › mRNA Platforms ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint Competition
MRNA · Technology · Positive Moderna's Phase 3 adjuvant melanoma study of intismeran autogene was selected for an ESMO Presidential Symposium slot, a high-profile validation of its mRNA cancer program.
MRK · · Neutral Merck is the pharma partner and pembrolizumab supplier, but the news is only a congress slot for Moderna's trial; Merck rose just 1%.
China Sets 2030 Goal to Develop 25% of Global First-in-Class Drugs
Beijing has unveiled a five-year plan aimed at making China a global leader in drug innovation, with a target of developing 25% of the world's first-in-class drugs by 2030. The plan, issued in a joint notice from multiple government ministries, lays out 25 priority tasks spanning innovation capacity, research and technology, including expanded R&D, the use of AI and quantum computing in drug discovery, and the building of pharmaceutical ecosystems beyond pipelines. The government aims for the industry to reach 3.5tn yuan, or $520bn, in annual revenue by 2030, with 50 companies exceeding $1.5bn in annual revenue, and at least five Chinese drugs achieving global annual sales above $1bn. The notice singled out next-generation therapies including antibody-drug conjugates, cell and gene therapies, and CAR-T, along with vaccines and newer platforms such as mRNA, and included a section on industrialising traditional Chinese medicine. Citi analysts said the plan signals a shift from scale-driven growth toward innovation-driven, quality-oriented development, with a broad whole-value-chain policy push covering innovative drugs, medical devices, AI-driven drug discovery, and CDMO/CRO. The biomedical plan was released alongside counterparts for other strategic sectors, including integrated circuits, aerospace, the low-altitude economy, new energy storage and intelligent robotics.
Arcturus Therapeutics to Present ARCT-810 Phase 2 OTC Deficiency Data on September 23
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.
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Rare Disease ▲Demand
ARCT · Technology · Positive Arcturus will present ARCT-810 Phase 2 OTC deficiency data and its mRNA liver therapeutics platform, a pipeline/R&D development.
BioNTech Lung Cancer Data Shows Gotistobart Nearly Doubled Survival
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.
BioNTech's gotistobart nearly doubles lung cancer survival in Phase 3 trial
BioNTech SE reported that its investigational lung-cancer drug gotistobart produced a clinically meaningful overall-survival benefit in the Phase 3 PRESERVE-003 trial in patients with metastatic squamous non-small cell lung cancer whose disease had progressed after prior immunotherapy and chemotherapy. Reuters said gotistobart nearly doubled survival compared with standard-of-care chemotherapy, strengthening the case for the drug as a potential chemotherapy-free treatment in a population with significant unmet need. The result builds on earlier Stage 1 data, where gotistobart reduced the risk of death by 54% versus docetaxel, with a hazard ratio of 0.46; median overall survival was not yet reached for gotistobart versus 9.95 months for docetaxel, while the 12-month progression-free survival rate was 25.2% versus 0%. BioNTech is now awaiting the pivotal Stage 2 readout, which remains the critical test for registration and broader investor confidence, and the company says it has 14 ongoing pivotal trials and more than 10 novel combination programs, with its lung-cancer strategy spanning more than 16 ongoing clinical trials and five Phase 3 programs. BioNTech had €16.6 billion in cash, cash equivalents, and securities at June 30, 2026, despite spending €1.0 billion on adjusted R&D during the first half, while first-half 2026 revenue fell to €223.7 million from €443.6 million a year earlier and the company expects 2026 revenue of only €1.6 billion to €1.9 billion.
GSK to Close Dresden Vaccine Plant, Cutting 641 Jobs by 2027
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.
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▼Supply
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
GSK.LSE · Supply · Negative GSK is closing its Dresden vaccine plant and cutting 641 jobs to consolidate flu vaccine production in Canada amid excess capacity from falling egg-based flu vaccine demand.
GSK.LSE · Technology · Positive GSK is advancing an mRNA-based seasonal flu vaccine into Phase III after Phase II results showed stronger immune responses than standard and high-dose vaccines.
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.
Biotech & Genomic Medicine › mRNA Platforms ▲Supply
605507.CG · Regulation · Positive Its subsidiary's pegylated dimyristoyl glycerol excipient passed CDE joint review and approval, changing registration status to A and enabling commercial production and supply.
Merck's Keytruda Franchise Drives $8.4 Billion as Cramer Calls It a Fantasy Defense Pick
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 Advances mRNA Flu Vaccine to Late-Stage After Strong Mid-Stage Results
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 Subsidiary Receives Drug Registration Certificate for Third-Generation COVID-19 mRNA Vaccine
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.
Biotech & Genomic Medicine › mRNA Platforms ▲Regulation
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) Competition
300142.CS · Technology · Positive Wholly owned subsidiary Yuxi Walvax received the Drug Registration Certificate for its third-generation COVID-19 mRNA vaccine, an R&D/product approval milestone.
Moderna's Cancer Vaccine Trial Success Drives Stock Surge
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.
BioNTech Ends Colorectal Cancer Vaccine Trial After Survival Imbalance
BioNTech SE is ending a mid-stage study of its personalized mRNA cancer vaccine, autogene cevumeran, in colorectal cancer after an independent monitoring committee concluded that continuing the trial was unlikely to demonstrate effectiveness. The committee also identified a numerical imbalance in overall survival between study groups, though the magnitude and cause were not disclosed. This setback raises questions about BioNTech's broader mRNA cancer vaccine strategy, particularly in "cold" tumors like colorectal and pancreatic cancer that have historically responded poorly to immunotherapy. The company said the decision will not affect its separate pancreatic cancer trial, which combines the vaccine with Roche's Tecentriq and has data expected in 2031. BioNTech's shares fell 7.5% following the announcement, contrasting with a recent 20% gain after Merck and Moderna reported positive melanoma results for their personalized mRNA vaccine. The company is also developing BNT113 for head and neck cancer, with interim data expected later this year, and is shifting toward antibody-drug conjugates and bispecific therapies like pumitamig.
Hualan Vaccine's novel influenza mRNA vaccine receives clinical trial approval, first in China
Hualan Biological Bacterin announced that its novel influenza virus mRNA vaccine has received clinical trial approval from the National Medical Products Administration, with a registration classification of preventive biological product 1.2, allowing clinical trials for the prevention of influenza caused by influenza viruses. The company stated that the product uses an mRNA technology platform, featuring flexible antigen design and a short production cycle, with potential in addressing influenza virus antigenic variation. As of the announcement date, no influenza mRNA vaccine has been approved for marketing in China, making Hualan Vaccine the first domestic company to obtain implied clinical trial approval for this type of product. Overseas, Moderna's influenza mRNA vaccine was approved by the U.S. FDA in August 2026. The company cautioned that vaccine development is difficult and lengthy, requiring subsequent clinical trials and marketing application procedures, and that product approval and market promotion remain uncertain.
Biotech & Genomic Medicine › mRNA Platforms Technology
301207.CS · Technology · Positive Hualan's novel influenza mRNA vaccine received clinical trial approval from China's NMPA, making it the first domestic company with such approval.
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 and Moderna Report First Positive Phase 3 mRNA Cancer Trial
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.
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
MRK · Technology · Positive Phase 3 INTerpath-001 trial of intismeran autogene plus KEYTRUDA met primary and key secondary endpoints in resected melanoma, reinforcing Merck's oncology pipeline.
MRNA · Technology · Positive First positive Phase 3 for an mRNA-based individualized neoantigen cancer therapy, validating Moderna's mRNA cancer platform.
Merck-Moderna Cancer Vaccine Breakthrough Spurs Healthcare ETF Interest
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 and software stocks lead S&P 500 in August
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 mRNA Flu Shot Shows Superior Immune Response, Phase 3 Trial Set for September
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 Soars 156% in August on Melanoma Trial and FDA Approval
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.
BioNTech Halts Colorectal Cancer Study, Stock Falls 8.4%
BioNTech has discontinued its phase II BNT122-01 study evaluating autogene cevumeran for high-risk stage II or stage III colorectal cancer, leading to an 8.4% drop in its stock on Friday. The study, initiated in 2021, tested the individualized mRNA cancer immunotherapy as a monotherapy against watchful waiting in patients with ctDNA-positive, completely resected tumors. After a futility boundary was crossed in October 2025, the data safety monitoring board later observed a numerical imbalance in overall survival and recommended termination, which BioNTech and Genentech, a Roche subsidiary, accepted. The discontinuation does not affect the separate IMCODE003 study in pancreatic cancer, which continues as planned with completion estimated for January 2031. Year to date, BioNTech shares have gained 7.2% compared with the industry's 8.8% growth.
Moderna and Merck Cancer Trial Drives Healthcare's Best Week Since June
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 Gets FDA Approvals for Updated COVID and First mRNA Flu Shots
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.
BioNTech halts cancer vaccine trial, Arcturus and Moderna fall
Messenger RNA drug developers Arcturus Therapeutics and Moderna traded lower on Friday after BioNTech halted a mid-stage trial for its mRNA-based cancer vaccine BNT122, developed with Roche, due to efficacy concerns. Arcturus lost more than 7%, while Moderna fell for a third consecutive session, weighed down by the trial setback and a new $2.6B convertible note offering. Last week, Moderna shares had climbed to a post-pandemic peak after a late-stage trial win for its own mRNA cancer shot, Intismeran, developed with Merck. BioNTech's BNT122-01 study enrolled patients with surgically removed colorectal cancers, whereas Moderna's Phase 3 INTerpath-001 trial targeted resected melanoma. BioNTech said it discontinued the trial after a data safety monitoring board noted a numerical imbalance in overall survival between treatment arms, determining the trial was unlikely to reach its efficacy outcome. Scotiabank analyst Louise Chen argued the decision bodes well for Merck, while BMO Capital Markets analyst Evan David Seigerman called it a clear setback but noted the negative read-through is not necessarily one-to-one across indications.