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Merck and Daiichi Sankyo withdraw lung cancer drug application

Fri, 25 Sep 2026 16:30:42 -0400

Merck (NYSE: MRK) and Daiichi Sankyo have voluntarily withdrawn a Biologics License Application (BLA) seeking accelerated U.S. approval for ifinatamab deruxtecan (I-DXd) in adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after platinum-based chemotherapy.

The withdrawal followed discussions with the U.S. Food and Drug Administration, which indicated that data from the IDeate-Lung01 Phase 2 trial and other supporting data did not meet the requirements for accelerated approval of the proposed indication.

Patient enrollment continues in the IDeate-Lung02 Phase 3 trial, which is evaluating ifinatamab deruxtecan against physician's choice of chemotherapy — amrubicin, lurbinectedin, or topotecan —

Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn

Fri, 25 Sep 2026 16:30:00 -0400

RAHWAY, N.J.--(BUSINESS WIRE)-- The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy has been voluntarily withdrawn.

The decision to withdraw the BLA is based on discussions with the U.S. Food and Drug Administration (FDA) that data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy

Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn

Fri, 25 Sep 2026 16:30:00 -0400

FDA approves Merck and Eisai kidney cancer combination therapy

Fri, 25 Sep 2026 06:45:22 -0400

Merck (NYSE: MRK) and Eisai announced that the U.S. Food and Drug Administration has approved a combination of belzutifan (Welireg) and lenvatinib (Lenvima) for adult patients with advanced renal cell carcinoma with a clear cell component following treatment with a PD-1 or PD-L1 inhibitor.

The approval is based on data from the Phase 3 LITESPARK-011 trial, in which 747 patients were randomized to receive the combination or cabozantinib. A pre-specified interim analysis showed the combination reduced the risk of disease progression or death by 26% compared to cabozantinib (HR=0.74 [95% CI, 0.61-0.89]; p=0.001). Median progression-free survival was 14.6 months for the

U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC)

Fri, 25 Sep 2026 06:45:00 -0400

Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor

WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients

RAHWAY, N.J. & NUTLEY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced the U.S. Food and Drug Administration (FDA) has approved the dual oral regimen of WELIREG® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2

U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC)

Fri, 25 Sep 2026 06:45:00 -0400

WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients

Merck's remigromig meets primary endpoint in DME phase 2b/3 trial

Thu, 24 Sep 2026 06:45:23 -0400

Merck (NYSE: MRK) announced topline results from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig (MK-3000), an investigational tri-specific antibody, in adults with diabetic macular edema (DME).

At 52 weeks, both doses of remigromig — 0.5 mg and 0.8 mg — independently demonstrated non-inferiority to the active control, 0.5 mg ranibizumab, for mean change from baseline in best-corrected visual acuity (BCVA) in patients with DME. The trial enrolled 984 participants randomized 1:1:1 to receive low-dose remigromig, high-dose remigromig, or ranibizumab every four weeks during the first year.

Both doses of remigromig were described as generally well tolerated. However, higher rates of proliferative

Merck’s Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, Met Primary Endpoint in the Pivotal Phase 2b/3 BRUNELLO Study of Adults with Diabetic Macular Edema

Thu, 24 Sep 2026 06:45:00 -0400

Remigromig demonstrated non-inferiority to active control ranibizumab for mean change from baseline in best-corrected visual acuity (BCVA) at week 52

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal Phase 2b/3 BRUNELLO trial in adults with diabetic macular edema (DME). BRUNELLO is the first of two Phase 2b/3 trials evaluating the safety and efficacy of remigromig (MK-3000, formerly EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance

Merck’s Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, Met Primary Endpoint in the Pivotal Phase 2b/3 BRUNELLO Study of Adults with Diabetic Macular Edema

Thu, 24 Sep 2026 06:45:00 -0400

Remigromig demonstrated non-inferiority to active control ranibizumab for mean change from baseline in best-corrected visual acuity (BCVA) at week 52

Merck (MRK) Reiterated at Neutral by Cantor Fitzgerald

Tue, 22 Sep 2026 07:43:43 -0400

Cantor Fitzgerald analyst Carter Gould reiterated a Neutral rating and $120.00 price target on Merck (NYSE: MRK).

The analyst commented, "INTerpath-001 will be a main event at ESMO after the study in adjuvant melanoma was stopped early for overwhelming efficacy. Recall, MRK shares tacked on >$40bn in market cap (for half of the drug's economics), with meaningful credit ascribed to its efforts beyond melanoma. With this in mind, the RFS hazard ratio achieved will be a critical point of focus, with conversations largely centered on the 0.6-0.65 range."

For an analyst ratings summary and ratings history on Merck click here. For

FDA updates Merck's Winrevair label with early PAH trial data

Tue, 22 Sep 2026 06:45:20 -0400

The U.S. Food and Drug Administration has approved an update to the product label for Merck's (NYSE: MRK) Winrevair (sotatercept-csrk) to include data from the Phase 3 HYPERION trial, which studied adults recently diagnosed with pulmonary arterial hypertension (PAH).

The HYPERION trial enrolled 320 participants diagnosed with PAH within the previous 12 months who were at intermediate to high risk of disease progression. Participants were randomized equally to receive either Winrevair or placebo added to background therapy. Adding Winrevair to background therapy reduced the risk of clinical worsening events by 76% compared to placebo, with a hazard ratio of 0.24 (95%

U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH

Tue, 22 Sep 2026 06:45:00 -0400

In HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events compared to placebo, informing the use of WINREVAIR earlier in the treatment journey

Newly published European Respiratory Society (ERS) clinical guidelines provide updated evidence-based recommendations for the treatment of PAH

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg,

U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH

Tue, 22 Sep 2026 06:45:00 -0400

Newly published European Respiratory Society (ERS) clinical guidelines provide updated evidence-based recommendations for the treatment of PAH

Japan approves Merck's subcutaneous pembrolizumab for all Keytruda uses

Mon, 21 Sep 2026 06:45:33 -0400

Merck (NYSE: MRK) announced that Japan's Ministry of Health, Labor and Welfare has approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous use, covering all indications already approved in Japan for the intravenous form, Keytruda.

The product will be marketed in Japan under the trademark Keyject. It can be administered in one minute every three weeks or in two minutes every six weeks. Berahyaluronidase alfa, an enzyme that enables the drug to be delivered under the skin, was developed and manufactured by Alteogen Inc.

The approval is based on results from the Phase 3 MK-3475A-D77 trial, which enrolled 377 patients with treatment-naïve

Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for Subcutaneous Administration for All KEYTRUDA® (pembrolizumab) Indications Approved in Japan

Mon, 21 Sep 2026 06:45:00 -0400

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use for all indications approved in Japan for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. In Japan, KEYJECT®, for subcutaneous injection is the planned trademark for KEYTRUDA QLEX. KEYJECT can be administered in

Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for Subcutaneous Administration for All KEYTRUDA® (pembrolizumab) Indications Approved in Japan

Mon, 21 Sep 2026 06:45:00 -0400

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute

EU panel backs Merck's Keytruda plus Padcev for bladder cancer

Fri, 18 Sep 2026 06:55:19 -0400

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Merck's (NYSE: MRK) Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC), according to a company statement.

The recommendation covers use as neoadjuvant treatment followed by continued adjuvant treatment after radical cystectomy. It also includes Keytruda SC, known as Keytruda QLEX in the U.S. The opinion will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway. A final decision is expected by

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIB

Fri, 18 Sep 2026 06:55:00 -0400

Opinion granted based on positive results from the Phase 3 KEYNOTE-B15 trial, which demonstrated improvements in event-free survival, overall survival and pathologic complete response rate

If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for patients with MIBC regardless of cisplatin eligibility in the European Union

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIB

Fri, 18 Sep 2026 06:55:00 -0400

Opinion granted based on positive results from the Phase 3 KEYNOTE-B15 trial, which demonstrated improvements in event-free survival, overall survival and pathologic complete response rate

Merck Launches Your Hive of Whole Health to Support Whole Person Care for People Living With HIV

Fri, 18 Sep 2026 06:45:00 -0400

Debbie Allen, famed actress, director, producer and longtime HIV advocate, joins Merck to launch the initiative and honor the community

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today launched Your Hive of Whole Health, a multi-year educational program that helps people living with HIV build personalized networks of support to address their physical, mental, emotional, and social well-being. Unveiled at the 2026 U.S. Conference on HIV/AIDS (USCHA) in Anaheim, California, Sept. 17-20, 2026, the initiative aims to honor the strides made toward ending the epidemic while emphasizing that

Merck Launches Your Hive of Whole Health to Support Whole Person Care for People Living With HIV

Fri, 18 Sep 2026 06:45:00 -0400

Debbie Allen, famed actress, director, producer and longtime HIV advocate, joins Merck to launch the initiative and honor the community

Perspective Therapeutics and Merck to test cancer drug combination

Mon, 14 Sep 2026 06:16:16 -0400

Perspective Therapeutics, Inc. (NYSE American: CATX) announced a clinical trial collaboration and supply agreement with Merck (NYSE: MRK) to evaluate a combination of Perspective's targeted alpha-particle therapy [212Pb]PSV359 with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in patients with FAP-α positive solid tumors.

The combination will be assessed under an amendment to Perspective's ongoing Phase 1/2a study of [212Pb]PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha, or FAP-α. The study has completed enrollment in its first three monotherapy dose cohorts. Perspective is sponsoring the study, and Merck is providing pembrolizumab at

Perspective Therapeutics and Merck to test cancer drug combination

Mon, 14 Sep 2026 06:16:16 -0400

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda® (Pembrolizumab) in FAP-α Positive Solid Tumors

Mon, 14 Sep 2026 06:16:00 -0400

SEATTLE, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective,” the “Company,” “we,” “us,” and “our”) (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, today announced a clinical trial collaboration agreement with Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The agreement supports the evaluation of Perspective’s targeted alpha-particle therapy [²¹²Pb]PSV359 in combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. This combination will be evaluated under an amendment to the Company’s ongoing Phase 1/2a study of [²¹²Pb]PSV359 in patients with certain types

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda® (Pembrolizumab) in FAP-α Positive Solid Tumors

Mon, 14 Sep 2026 06:16:00 -0400