We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
MRK/MRNA's Personalized Cancer Therapy Delivers First Phase III Win
Read MoreHide Full Article
Key Takeaways
MRK and MRNA's personalized melanoma therapy combo met both primary & secondary endpoints in phase III study.
Merck and Moderna saw shares jump 12.6% and 177%, respectively, after the phase III results.
MRK and MRNA plan to engage global regulators on a potential filing for intismeran with Keytruda.
Shares of both Merck (MRK - Free Report) and its partner Moderna (MRNA - Free Report) jumped to a 52-week high yesterday after the companies announced positive top-line data from a phase III study, which evaluated their personalized cancer therapy combo in certain patients with high-risk melanoma, a serious form of skin cancer.
The phase III INTerpath-001 study evaluated Moderna’s investigational mRNA-based individualized neoantigen therapy (“INT”), intismeran autogene (mRNA-4157 or V940), in combination with Merck’s blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), as an adjuvant treatment for patients with completely resected stage IIB-IV melanoma.
The INTerpath-001 study met its primary endpoint of recurrence-free survival (“RFS”) and key secondary endpoint of distant metastasis-free survival (“DMFS”).
The companies noted that this is the first combination regimen to show statistically significant and clinically meaningful improvements in both RFS and DMFS versus Keytruda alone, a standard-of-care immunotherapy in the adjuvant melanoma setting.
The safety profile of the combination therapy was similar to that seen in previously reported studies, with no new safety concerns observed. The study will continue to assess additional secondary endpoints, including overall survival.
Shares of Merck were up 12.6% while Moderna stock jumped a staggering 177% yesterday following the announcement of the news.
MRK & MRNA Price Performance
Year to date, shares of Merck have rallied 46.7%, while Moderna stock has skyrocketed 491.3% compared with the industry’s increase of 21.3%.
Image Source: Zacks Investment Research
More on MRK & MRNA’s Personalized Cancer Therapy
Intismeran autogene is an experimental, personalized mRNA-based cancer therapy that is designed using the unique genetic mutations found in a patient’s tumor and can target up to 34 tumor-specific antigens.
Merck and Moderna plan to present detailed data from the INTerpath-001 study at an upcoming international medical conference and engage with regulatory authorities regarding a potential filing seeking approval for intismeran in combination with Keytruda for the given indication.
The latest results build on positive phase IIb data from the KEYNOTE-942/mRNA-4157-P201 study. Five-year follow-up data presented at the 2026 ASCO annual meeting showed that the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% versus Keytruda alone.
Merck and Moderna are evaluating intismeran across the broader INTerpath clinical development program, which currently includes nine phase II and phase III studies across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. The program is evaluating intismeran in combination with Keytruda and other anticancer therapies, as well as a monotherapy.
Our Take on the Results
The latest positive phase III readout from the INTerpath-001 study marks an important milestone for both companies as they seek to advance personalized mRNA-based cancer treatment for long-term growth. For Merck, intismeran could strengthen Keytruda’s lifecycle and broaden its reach across other cancer indications, while Moderna could establish oncology as a key growth driver beyond vaccines. The broader INTerpath program offers additional upside across multiple tumor types.
MRK & MRNA Zacks Rank & Stocks to Consider
Both Merck and Moderna currently carry a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 7.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 121.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
View the Zacks #1 Rank List
Image: Bigstock
MRK/MRNA's Personalized Cancer Therapy Delivers First Phase III Win
Key Takeaways
Shares of both Merck (MRK - Free Report) and its partner Moderna (MRNA - Free Report) jumped to a 52-week high yesterday after the companies announced positive top-line data from a phase III study, which evaluated their personalized cancer therapy combo in certain patients with high-risk melanoma, a serious form of skin cancer.
The phase III INTerpath-001 study evaluated Moderna’s investigational mRNA-based individualized neoantigen therapy (“INT”), intismeran autogene (mRNA-4157 or V940), in combination with Merck’s blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), as an adjuvant treatment for patients with completely resected stage IIB-IV melanoma.
The INTerpath-001 study met its primary endpoint of recurrence-free survival (“RFS”) and key secondary endpoint of distant metastasis-free survival (“DMFS”).
The companies noted that this is the first combination regimen to show statistically significant and clinically meaningful improvements in both RFS and DMFS versus Keytruda alone, a standard-of-care immunotherapy in the adjuvant melanoma setting.
The safety profile of the combination therapy was similar to that seen in previously reported studies, with no new safety concerns observed. The study will continue to assess additional secondary endpoints, including overall survival.
Shares of Merck were up 12.6% while Moderna stock jumped a staggering 177% yesterday following the announcement of the news.
MRK & MRNA Price Performance
Year to date, shares of Merck have rallied 46.7%, while Moderna stock has skyrocketed 491.3% compared with the industry’s increase of 21.3%.
Image Source: Zacks Investment Research
More on MRK & MRNA’s Personalized Cancer Therapy
Intismeran autogene is an experimental, personalized mRNA-based cancer therapy that is designed using the unique genetic mutations found in a patient’s tumor and can target up to 34 tumor-specific antigens.
Merck and Moderna plan to present detailed data from the INTerpath-001 study at an upcoming international medical conference and engage with regulatory authorities regarding a potential filing seeking approval for intismeran in combination with Keytruda for the given indication.
The latest results build on positive phase IIb data from the KEYNOTE-942/mRNA-4157-P201 study. Five-year follow-up data presented at the 2026 ASCO annual meeting showed that the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% versus Keytruda alone.
Merck and Moderna are evaluating intismeran across the broader INTerpath clinical development program, which currently includes nine phase II and phase III studies across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. The program is evaluating intismeran in combination with Keytruda and other anticancer therapies, as well as a monotherapy.
Our Take on the Results
The latest positive phase III readout from the INTerpath-001 study marks an important milestone for both companies as they seek to advance personalized mRNA-based cancer treatment for long-term growth. For Merck, intismeran could strengthen Keytruda’s lifecycle and broaden its reach across other cancer indications, while Moderna could establish oncology as a key growth driver beyond vaccines. The broader INTerpath program offers additional upside across multiple tumor types.
MRK & MRNA Zacks Rank & Stocks to Consider
Both Merck and Moderna currently carry a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 7.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 121.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.