Company

Merck

Pharmaceutical intelligence for Merck with 66 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 27
Catalysts: 39
Assets: 22

Recent signals(27)

RegulatoryJune 20, 2026

FDA Grants Priority Review for Welireg Supplement from Merck

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck.

RegulatoryJune 19, 2026

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

The FDA has approved an expanded indication for CAPVAXIVE to include children and adolescents aged 2-17 at increased risk for pneumococcal disease.

RegulatoryJune 18, 2026

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

The FDA has granted priority review for the supplemental application of KEYTRUDA QLEX, which includes pembrolizumab and berahyaluronidase alfa-PMPH.

RegulatoryJune 18, 2026

FDA Grants Priority Review for Welireg Supplement NDA215383

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck Sharp Dohme.

ClinicalJune 18, 2026

Phase III Trial Evaluates Pembrolizumab Timing in NSCLC Treatment

A phase III trial is comparing the efficacy of pembrolizumab alone versus in combination with chemotherapy as first-line treatment for stage IV non-squamous non-small cell lung cancer.

ClinicalJune 18, 2026

Phase III Trial of Pembrolizumab Plus Doxorubicin in Aggressive Sarcomas

A phase III trial is comparing immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) against chemotherapy alone in patients with metastatic or unresectable poorly differentiated sarcomas.

ClinicalJune 17, 2026

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

ClinicalJune 17, 2026

Zilovertamab Vedotin Shows Promise in rrDLBCL with Standard Care in Phase 2/3 Study

A Phase 2/3 study is evaluating zilovertamab vedotin in combination with standard care for rrDLBCL, with a protocol amendment discontinuing enrollment in one cohort.

ClinicalJune 17, 2026

Phase III Trial of Pembrolizumab with Chemotherapy in Non-small Cell Lung Cancer

The ALCHEMIST trial is evaluating the efficacy of adding pembrolizumab to standard chemotherapy in resected non-small cell lung cancer.

StrategyJune 17, 2026

Merck's Acquisition of Terns Pharmaceuticals Advances as HSR Waiting Period Expires

Merck's acquisition of Terns Pharmaceuticals progresses as the HSR waiting period has expired, allowing the tender offer to move forward.

RegulatoryJune 17, 2026

Merck's ENFLONSIA Approved in EU for RSV Prevention in Infants

The European Commission has approved ENFLONSIA (clesrovimab) as the first RSV preventive option for infants in the EU.

RegulatoryJune 17, 2026

FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment

The FDA has granted priority review for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for muscle-invasive bladder cancer.

RegulatoryJune 17, 2026

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.

ClinicalJune 17, 2026

Merck and Eisai's LITESPARK-012 Trial Fails to Meet Primary Endpoints in RCC

The Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival and overall survival for the evaluated combination therapies.

ClinicalJune 17, 2026

Calderasib and Pembrolizumab Study in KRAS G12C NSCLC Shows Promising Efficacy

The study evaluates calderasib combined with pembrolizumab as a first-line treatment for KRAS G12C mutant NSCLC.

ClinicalJune 17, 2026

NeoAdjuvant Therapy Trial for TNBC: Sacituzumab Govitecan + Pembrolizumab

The ADAPT-TN-IV trial will explore the efficacy of Sacituzumab Govitecan combined with Pembrolizumab in neoadjuvant therapy for TNBC.

StrategyJune 17, 2026

Merck Acquires Terns Pharmaceuticals, Enhancing Oncology Pipeline with TERN-701

Merck has completed the acquisition of Terns Pharmaceuticals, gaining TERN-701, a novel BCR::ABL1 inhibitor.

RegulatoryJune 17, 2026

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.

StrategyJune 16, 2026

Merck Acknowledges Daiichi Sankyo's ADC Manufacturing Update

Merck has acknowledged Daiichi Sankyo's update regarding its manufacturing and supply plan for ADC products.

CompetitiveJune 16, 2026

Merck Publishes Method for Scalable Synthesis of Oral PCSK9 Inhibitor Enlicitide Decanoate

Merck has published a method for the large-scale synthesis of enlicitide decanoate, an investigational oral PCSK9 inhibitor.

RegulatoryJune 16, 2026

FDA Grants Breakthrough Therapy Designation for Calderasib in KRAS G12C-Mutant NSCLC

Calderasib (MK-1084) received Breakthrough Therapy designation for first-line treatment of KRAS G12C-mutant NSCLC.

CompetitiveJune 16, 2026

Merck Reports Promising Long-Term Data for KEYTRUDA and Intismeran in Oncology at ASCO 2026

Five-year follow-up data from KEYNOTE-942 show the potential of intismeran autogene in combination with KEYTRUDA for high-risk melanoma. Additionally, KEYNOTE-522 results indicate a continued survival benefit for high-risk early-stage TNBC patients.

ClinicalJune 16, 2026

5-Year Data Shows Intismeran Autogene + KEYTRUDA Reduces Melanoma Recurrence Risk by 49%

Intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death in high-risk melanoma patients.

RegulatoryJune 16, 2026

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

ClinicalJune 16, 2026

Merck's Sacituzumab Tirumotecan Shows OS and PFS Improvement in Endometrial Cancer Phase 3 Trial

The TroFuse-005 trial demonstrated that sacituzumab tirumotecan significantly improved overall survival and progression-free survival compared to chemotherapy in patients with advanced or recurrent endometrial cancer.

ClinicalJune 16, 2026

Merck and Gilead Discontinue Phase 3 Study of Trodelvy and KEYTRUDA in NSCLC

The Phase 3 KEYNOTE-D46/EVOKE-03 study of Trodelvy and KEYTRUDA has been discontinued due to lack of statistically significant efficacy.

RegulatoryJune 13, 2026

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for adjuvant treatment in ccRCC patients, marking a significant advancement in therapy.

Upcoming catalysts(1)

Label Expansion

Merck — Keytruda

Further label stacking extends Keytruda lifecycle amid biosimilar horizon.

July 22, 2026 · Approved

Regulatory activity(11)

RegulatoryJune 20, 2026

FDA Grants Priority Review for Welireg Supplement from Merck

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck.

RegulatoryJune 19, 2026

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

The FDA has approved an expanded indication for CAPVAXIVE to include children and adolescents aged 2-17 at increased risk for pneumococcal disease.

RegulatoryJune 18, 2026

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

The FDA has granted priority review for the supplemental application of KEYTRUDA QLEX, which includes pembrolizumab and berahyaluronidase alfa-PMPH.

RegulatoryJune 18, 2026

FDA Grants Priority Review for Welireg Supplement NDA215383

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck Sharp Dohme.

RegulatoryJune 17, 2026

Merck's ENFLONSIA Approved in EU for RSV Prevention in Infants

The European Commission has approved ENFLONSIA (clesrovimab) as the first RSV preventive option for infants in the EU.

RegulatoryJune 17, 2026

FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment

The FDA has granted priority review for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for muscle-invasive bladder cancer.

RegulatoryJune 17, 2026

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.

RegulatoryJune 17, 2026

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.

RegulatoryJune 16, 2026

FDA Grants Breakthrough Therapy Designation for Calderasib in KRAS G12C-Mutant NSCLC

Calderasib (MK-1084) received Breakthrough Therapy designation for first-line treatment of KRAS G12C-mutant NSCLC.

RegulatoryJune 16, 2026

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

RegulatoryJune 13, 2026

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for adjuvant treatment in ccRCC patients, marking a significant advancement in therapy.

Clinical activity(11)

ClinicalJune 18, 2026

Phase III Trial Evaluates Pembrolizumab Timing in NSCLC Treatment

A phase III trial is comparing the efficacy of pembrolizumab alone versus in combination with chemotherapy as first-line treatment for stage IV non-squamous non-small cell lung cancer.

ClinicalJune 18, 2026

Phase III Trial of Pembrolizumab Plus Doxorubicin in Aggressive Sarcomas

A phase III trial is comparing immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) against chemotherapy alone in patients with metastatic or unresectable poorly differentiated sarcomas.

ClinicalJune 17, 2026

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

ClinicalJune 17, 2026

Zilovertamab Vedotin Shows Promise in rrDLBCL with Standard Care in Phase 2/3 Study

A Phase 2/3 study is evaluating zilovertamab vedotin in combination with standard care for rrDLBCL, with a protocol amendment discontinuing enrollment in one cohort.

ClinicalJune 17, 2026

Phase III Trial of Pembrolizumab with Chemotherapy in Non-small Cell Lung Cancer

The ALCHEMIST trial is evaluating the efficacy of adding pembrolizumab to standard chemotherapy in resected non-small cell lung cancer.

ClinicalJune 17, 2026

Merck and Eisai's LITESPARK-012 Trial Fails to Meet Primary Endpoints in RCC

The Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival and overall survival for the evaluated combination therapies.

ClinicalJune 17, 2026