Investors of Merck & Co. (NYSE: MRK) and Moderna (Nasdaq: MRNA) were the most obvious—but not the only—beneficiaries when the companies announced what they said were the first-ever positive Phase III results for their mRNA-based cancer vaccine, the individualized neoantigen therapy (INT) intismeran autogene.
Merck and Moderna made both Wall Street and biotech news by trumpeting positive topline results from the Phase III INTerpath-001 trial (NCT05933577) showing that patients treated with intismeran plus Merck’s blockbuster cancer immunotherapy Keytruda® (pembrolizumab) showed greater improvement than patients treated with Keytruda alone. The cancer INT surpassed Keytruda on both the trial’s primary endpoint of recurrence-free survival (RFS) and the study’s key secondary endpoint of distant metastasis-free survival (DMFS).
While Merck and Moderna saw their shares jump far above normal increases, several sequencing companies caught the proverbial tailwind and surged as well. That happened because intismeran is a personalized cancer therapy made for each patient based on the individual genetic mutations of their tumors.
As a result, the Merck-Moderna surge extended to sequencing giants such as Illumina (Nasdaq: ILMN), Pacific Biosciences of California (Nasdaq: PACB), and, to a degree Oxford Nanopore Technologies (London Stock Exchange: ONT), though a strong first-half earnings report and other positive announcements propelled Oxford Nanopore’s climb.
Between Wednesday’s announcement and Friday, Illumina shares jumped 16%, from $188.29 to $219.40, while PacBio climbed 18%, from $1.14 to $1.35. Oxford Nanopore rocketed 39% from £122.20 ($166.68) to an even £170 ($231.97), for reasons that go beyond Merck-Moderna.
In addition to the cancer INT, those reasons include an announced 10.5% revenue jump from £105.6 million ($144 million) to £116.7 million ($159.2 million) during the first half of this year, a restated commitment by new CEO Francis Van Parys to grow annual revenue to £700 million+ ($955 million+) by 2030, plus an intellectual property cross-licensing agreement with an undisclosed diagnostics developer that agreed to pay Oxford Nanopore $20 million in fees to be included in H2 2026 results, plus $15 million in committed purchases in 2027–2028, and low- to mid-single digit royalties.
Data to be presented
Merck and Moderna saw their shares surge despite not sharing any specific data for either the intismeran-plus-Keytruda arm or the Keytruda-alone arm of their trial.
That data, the companies said, will be presented at an “upcoming international medical meeting”—which analysts speculated could be either the European Society for Medical Oncology (ESMO) or the Society for Immunotherapy of Cancer (SITC) conferences—and shared with regulators.
Yet the absence of specific data did not stop analysts from sharing mostly very positive vibes about Moderna, whose shares had already more than doubled, soaring 124% in the year preceding the cancer INT announcement, from $28.09 to $62.96. The announcement sent Moderna’s shares into the stratosphere, catapulting them 177% to $174.38 and adding $45 billion to the company’s market capitalization (share price times the number of outstanding shares).
Moderna shares tumbled nearly 24% the following day to $133.32 on a combination of profit-taking plus expectations of a longer Iran war that sank most of the markets. But Moderna’s stock resumed its upward climb Friday, jumping 9% to finish the week at $145.13 and a 130.5% three-day gain. That’s a far cry from the 10% rise Moderna saw in December 2023 when it joined Merck to report positive Phase IIb data in stage III/IV melanoma.
“We see [Wednes]day’s update as a clear positive for shares and Moderna’s fundamental business,” Myles R. Minter, PhD, a partner and biotechnology analyst with William Blair, declared in a research note.
“Watershed moment” and “landmark win”
Minter also upgraded Moderna shares from “Market Perform” to “Outperform.” He was one of two analysts who raised their ratings on the company’s shares. Alec Stranahan, PhD, BofA Securities vp, equity research covering U.S. small- to mid-cap biotechnology companies, upgraded his firm’s rating from “Underperform” to “Neutral” and set a 12-month price target of $170, calling the positive data announcement “a watershed moment for Moderna,” as reported by Forbes. At Needham & Co., senior analyst Joseph Stringer, PhD, declared the results a “landmark win,” according to Investors Business Daily.
Behind the upbeat assessments of analysts is a view, shared by a consensus, that the cancer INT will significantly broaden Moderna’s sales beyond its two marketed mRNA-based COVID-19 vaccines.
Spikevax® and mNexspike® accounted for 97% ($91 million) of the company’s $94 million in second-quarter net product sales, down 17.5% from $114 million in Q2 2025, all of that from Spikevax (mNexspike did not reach the market until the third quarter of last year). The remaining $3 million in Q2 2026 sales came from respiratory syncytial virus (RSV) vaccine mResvia®. A fourth FDA-approved vaccine, mCombriax®, is an influenza/COVID-19 combination jab that has yet to be commercialized.
“We believe Moderna has a clear line of sight to revenue diversification from the COVID-19 business,” Minter added.
Andrew Tsai, equity analyst with Jefferies, wrote in a research note that market watchers were “likely to ascribe multibillion peak sales pot’l to melanoma,” as well as to conclude that those strong sales will read across intismeran’s numerous Phase II and Phase III programs in various solid tumor indications.
As for what the positive data is likely to show, Tsai continued, “We can infer RFS (and DMFS) could imply at least an HR [hazard ratio of between] 0.5–0.8, which seems clinically meaningful, especially if OS [overall survival] trends are favorable. Tsai noted that an earlier Phase IIb trial of the cancer INT in Stage III/IV melanoma showed a durable HR=0.51 on RFS stretching as far as year 5 after treatment, including an HR of 0.561 (p=0.0266) on two years of follow-up data presented at the American Association for Cancer Research (AACR) Annual Meeting 2023.
The Merck-Moderna announcement led to gains for the stocks of two leading rivals in cancer INT vaccine development: BioNTech (Nasdaq: BNTX) is partnering with Roche (SIX Swiss: RO and ROP)-owned Genentech on an mRNA-based individualized cancer vaccine, autogene cevumeran (BNT122/ RO7198457), that is in Phase II trials for advanced colorectal cancer and adjuvant pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer.
BioNTech shares jumped 26% this week from $92.75 to $116.59, while Roche’s RO bearer shares rose 3.5%, from CHF 366.80 ($457.93) to CHF 379.60 ($473.91), while its ROP participation certificates increased 4% from CHF 360.90 ($450.57) to CHF 375.60 ($468.96).
“Overly optimistic”
Daina M. Graybosch, PhD, senior managing director, immuno-oncology, and a senior research analyst with Leerink Partners, took a more cautious view on the Merck-Moderna announcement: “While we were thrilled to see a positive market reaction for the definitive success of the therapeutic cancer vaccine intismeran autogene (INT), the reception was overly optimistic and creates expectations that we believe will be difficult to meet.”
Graybosch said her caution reflected her views that:
- There will be less read-across to other cancer indications since melanoma is a tumor that is most immune-sensitive and has the highest tumor mutational burden (TMB).
- Rosy multi-billion-dollar sales forecasts won’t materialize for the cancer INT since its per-patient manufacturing cost as a personalized therapy will result in a lower gross margin of ~50–75% compared with the ~90% of monoclonal antibodies.
- HR will be no worse than 0.76 to 0.79, and could be much better.
Despite those cautions, Graybosch and colleagues at Leerink raised their projected 2032 sales forecast for intismeran 17%, from $1.2 billion to $1.4 billion. Karen Andersen, a director with Morningstar, went much further, projecting $16.8 billion in sales by 2035, more than double its previous projection of $7.2 billion. Morningstar also doubled its “fair value” or long-term, intrinsic value estimates on Moderna shares from $79 to $163, and on Merck shares by 29%, from $111 to $143.
INTerpath-001 is one of nine Phase II and Phase III trials within the INTerpath clinical development program assessing intismeran as a monotherapy and in combination with Keytruda and other anti-cancer therapies. In addition to melanoma, intismeran is being studied in non-small cell lung cancer (NSCLC), bladder cancer, and renal cell carcinoma.
The cancer INT is also under study in the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial (NCT03897881) in adjuvant melanoma, and a Phase I study evaluating intismeran in adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma, and perioperative NSCLC.
In NSCLC, Merck and Moderna are studying intismeran in two Phase III trials, INTerpath-009 (NCT06623422) in patients with resectable Stage II to IIIB (N2) NSCLC; and INTerpath-014 (NCT07513376), in patients with completely resected high-risk Stage I NSCLC.
“Critical” read-across
“We see the read-across to other indications as critical, and even more important, to thinking about value from here” for Moderna stock, J.P. Morgan analyst Jessica Fye and four colleagues wrote in a research note.
While viewing a launch of intismeran in adjuvant melanoma as key to Moderna returning to profitability, Fye and colleagues said the positive results announced Wednesday were less a driver of value for Moderna shares than the other cancer indications since the cancer INT is a partnered product in a relatively small indication by immuno-oncology standards whose probability of success in adjuvant melanoma was pegged at 85% and already priced into the company’s shares before the announcement.
A day later, Fye and colleagues nearly doubled her firm’s price target on Moderna shares, raising it 92.5% from $40 per share as of December to $77 per share as of December 2027. The J.P. Morgan analysts also stopped risk-adjusting Moderna’s economic prospects in adjuvant melanoma. And they raised their probability of success forecasts for Moderna generating future profits in three other cancer indications—adjuvant lung cancer, adjuvant kidney cancer, and adjuvant bladder cancer—from 55% to 70%.
“While we have the most questions around whether this efficacy in adjuvant melanoma can read across to the metastatic setting, we are adding more heavily risk-adjusted credit for the possibility of activity in metastatic disease,” Fye and colleagues wrote.
As with Moderna, Merck enjoyed a mostly positive week that started with its shares jumping nearly 13% from $135.17 to $152.20 on Wednesday—an all-time high closing price and an unusual one-day double-digit leap for a pharma giant.
“These first Phase III findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment,” Dean Y. Li, MD, PhD, president, Merck Research Laboratories, said in a statement. “We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.”
Merck shares slid 2% Thursday to $148.99 before bouncing back 2% Friday, finishing the week at a new all-time high close of $152.52 and a 13% three-day gain.
Merck needs a new blockbuster to help it recoup sales it will lose when Keytruda loses exclusivity for key U.S. patents in 2028—the most successful drug facing the proverbial patent cliff over the remainder of this decade. Keytruda racked up $15.81 billion in Q1–Q2 2026 sales in addition to the $31.641 billion it generated last year. Keytruda Qlex, a subcutaneous injection form of Keytruda, generated $590 million in the first half of this year and $40 million in 2025, since Qlex didn’t win FDA approval till September of last year.
“We expect positive investor reaction that will help sustain momentum for MRK into the fall,” Graybosch wrote. “Whether INT will be a large contributor to Merck’s bottom line is still uncertain, as we await pricing, COGS [cost of goods sold], and whether this success in the most immune-sensitive tumor will translate to non-small cell lung cancer.”
Leaders and laggards
- Capricor Therapeutics (Nasdaq: CAPR) shares yo-yoed in recent days, soaring 77% over two days from $4.21 to $7.45 on August 17 after the company told analysts on its second quarter earnings call that the FDA had agreed to review an amendment to its Biologics License Application (BLA) with additional 24-month data showing improved upper limb function following treatment with its drug candidate deramiocel. Capricor shares rose further to $7.98 by Wednesday, then nosedived 21% over two days to $6.29 at Friday’s close, on speculation that the FDA will reject deramiocel a second time.
- Tenax Therapeutics (Nasdaq: TENX) shares cratered 90% from $13.44 to $1.38 on August 10 after the cardiopulmonary drug developer said its lead candidate TNX-103 (oral levosimendan), a first-in-class K-ATP channel activator/calcium sensitizer developed to treat pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), failed the Phase III LEVEL trial (NCT05983250). TNX-103 missed the study’s primary endpoint of improvement in the six-minute walk distance vs. placebo, and the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score. Tenax said it will request a Type C meeting with the FDA to present the complete LEVEL dataset together with the company’s recommendations and will seek scientific consultation from the European Medicines Agency. Tenax said it intends to enrich the study population of its ongoing Phase III LEVEL-2 trial (NCT07288398), citing subgroup data from LEVEL that identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population.
