Merck & Co. (MRK) Company Report

FDA conditionally approves Exzolt Cattle-CA1 for prevention/treatment of New World screwworm and control of cattle fever tick in beef cattle (over 2 months) and replacement dairy heifers (<20 months), marking the first novel isoxazoline ectoparasiticide for cattle; full approval pending further data over five years and prescription availability in Q1 2026.
Product excludes breeding bulls, dairy calves, and veal calves, carries a 98-day meat withdrawal period to ensure food safety, and strictly prohibits off-label use.
Merck secured expedited FDA review under a priority zoonotic animal designation (CARES Act) and has also obtained market authorization in Mexico to combat the economic threat of screwworm infestations in cattle.

22 minutes ago

Morningstar

Merck issues 2031, 2032 and 2035 notes

MRK

Debt Issuance

Merck & Co. authorized issuance of 4.150% Notes due March 15, 2031 with $1.0 billion aggregate principal; proceeds equal to 99.557% of principal; interest payable semi-annually on March 15 and September 15.
Merck & Co. authorized issuance of 4.450% Notes due December 4, 2032 with $1.0 billion aggregate principal; proceeds equal to 99.542% of principal; interest payable semi-annually on June 4 and December 4.
Merck & Co. authorized issuance of 4.750% Notes due December 4, 2035 with $1.5 billion aggregate principal; proceeds equal to 99.235% of principal; interest payable semi-annually on June 4 and December 4.

2 hours ago

8-K

Merck outlines pipeline and commercial strategies at 2025 Citi Global Healthcare Conference

MRK

Product Launch

Merck detailed CD388 (Cidara influenza antiviral) with 76% efficacy, targeting prophylaxis for 110 million US candidates (85 million high-risk), projecting >$5 billion peak commercial opportunity by early 2030s.
Sotatercept for PAH shows consistent benefits across patient segments; planned auto-injector launch expected to improve convenience and uptake.
Oral PCSK9 inhibitor MK-0616 poised as a “game changer,” delivering ~60% LDL reduction with convenient dosing to broaden patient access.
Subcutaneous Keytruda (QLEX) launch off to a strong start; Merck expects 30–40% adoption in first 18–24 months among early-stage oncology patients.
Merck raised $700 million from Blackstone to fund TROP2 ADC development, trading R&D support for low- to mid-single-digit royalties post-approval to optimize resource allocation.

1 day ago

Transcript

Merck outlines broad pipeline updates at Citi Healthcare Conference

MRK

M&A

Product Launch

CD388, an oral antiviral for influenza, is expected to address 110 million U.S. candidates (85 million high-risk or immunocompromised; 25 million older adults) with a >$5 billion commercial opportunity by early 2030s.
Merck’s acquisition of Ohtuvayre from Verona aims to scale a non-steroidal COPD therapy using Merck’s commercial capabilities following strong initial U.S. feedback.
WINREVAIR (sotatercept) in PAH demonstrates durable efficacy and safety in triple- and dual-therapy settings; an auto-injector is expected to improve patient convenience and support further uptake.
MK-0616, an oral PCSK9 inhibitor, showed up to 60 % LDL reduction comparable to injectables, potentially broadening access and driving guideline evolution toward LDL-lowering targets.
Tulisokibart (TL1A) from the Prometheus deal will report ulcerative colitis induction data next year, with Phase II readouts in systemic sclerosis-associated ILD (Apr 2026) and hidradenitis suppurativa later that year.

1 day ago

Transcript

Merck presents pipeline and commercial updates at Citi Global Healthcare Conference 2025

MRK

M&A

CD388 influenza antiviral demonstrates 76% efficacy, targeting ~110 million US high-risk individuals and projecting a >$5 billion market by the early 2030s
Acquisition of Ohtuvayre for COPD to leverage Merck’s commercial engine and expand its respiratory portfolio
Sotatercept (Winrevair) showed clear PVR improvements in the Cadence left-heart disease proof-of-concept study; Phase 3 in pulmonary hypertension scheduled for 2026
Oral PCSK9 inhibitor MK-0616 achieved ~60% LDL-C reduction in AHA data, positioning it to broaden patient access beyond injectables
TL1A blocker (tulisokibart) first Phase 3 induction readouts in ulcerative colitis and Crohn’s are due next year, alongside multiple Phase 2 trials in fibrotic inflammatory diseases

1 day ago

Transcript

Merck outlines R&D and commercial priorities at HealthCONx Conference

MRK

Merck presented positive Phase II proof-of-concept results for its cadence program in HFpEF-associated pulmonary hypertension and plans to initiate Phase III in 2026.
The company will price its oral PCSK9 inhibitor (“Enlisted Tide”) for broad access, aiming to be the most powerful LDL-lowering oral therapy versus competitors.
Subcutaneous KEYTRUDA (QLX) received EU approval; Merck expects 30–40% adoption over 18–24 months, priced at parity with the IV formulation, and sees patent protection through November 2029 for KEYTRUDA IV and 2039 for QLX.
Merck’s TL1A inhibitor “Truly Soquibar” targets anti-inflammatory and antifibrotic pathways in IBD and HIV, representing a >$5 billion commercial opportunity.
The company remains disciplined on PD-1/VEGF bispecifics, awaiting definitive overall survival data before escalating development investments.

2 days ago

Transcript

Merck outlines pipeline strategy and key milestones at HealthCONx Conference

MRK

Product Launch

Merck plans to price its upcoming oral PCSK9 inhibitor for broad access without specifying gross or net price targets, emphasizing value-based pricing to drive rapid adoption.
The company’s TROP2 ADC program (sacituzumab govitecan with sac-TMT payload) is positioned as a differentiated workhorse in EGFR-mutant lung and HR-positive breast cancer, with multiple Phase III studies ongoing and interim analyses planned.
In ophthalmology, Merck is advancing MK-3000 (a WNT agonist) and Tispectus (bispecific TITU/VEGF) to address the ~40% of DME patients unresponsive to anti-VEGFs, with rapid enrollment in Phase II trials.
The HIV pipeline features Islatravir as a novel NRTTI anchor for both treatment and PrEP, with optimized dosing (from 0.75 mg qDAY to 0.25 mg qDAY; 20 mg qWEEK to 2 mg qWEEK) mitigating prior CD4 count concerns and supporting future combination regimens.
KEYTRUDA’s composition-of-matter patent expires December 2028, with potential extensions into 2029, while subcutaneous QLX adoption is expected to reach 30–40% over 18–24 months post-launch, extending exclusivity through 2039.

2 days ago

Transcript

Merck outlines pipeline and commercial strategies at Evercore HealthCONx

MRK

WINREVAIR in PAH: ~75% of severe PAH triple-therapy patients on treatment in U.S. with 500–600 new patient adds per month; U.S. launch expanding to Japan and EU access processes underway.
Obicetrapib oral PCSK9 shows 60% LDL-C, 50% non-HDL, 50% ApoB, 30% Lp(a) reductions with placebo-level AE profile; will be priced for broad access, details TBD.
Nembtu-Brutinib BTK inhibitor targeting frontline CLL vs. acalabrutinib/ibrutinib with a strategy to demonstrate non-inferiority then superiority and a high resistance-barrier profile; pivotal readout timing not specified.
Subcutaneous KEYTRUDA (QLX) adoption projected at 30–40% over 18–24 months post-launch, priced at parity with IV; key composition-of-matter patent expires Dec 2028, with additional patents extending to Nov 2029.

2 days ago

Transcript

Merck presents early Alzheimer’s drug data, FDA grants Fast Track for MK-2214

MRK

New Projects/Investments

Merck will present data on MK-2214 and MK-1167 at the Clinical Trials on Alzheimer’s Disease conference in 2025.
MK-2214, an antibody targeting abnormal tau accumulation, received FDA Fast Track Designation to expedite its development.
Phase 1 studies of MK-2214 demonstrated safety, tolerability, and pharmacokinetics, supporting an ongoing Phase 2 trial in early Alzheimer’s patients (NCT07033494).
MK-1167, an oral α7 nicotinic acetylcholine receptor modulator, showed promising glutamate metabolism effects in healthy volunteers and is currently in Phase 2 trials.

4 days ago

Morningstar

Merck & Co. Imfinzi receives FDA approval for early-stage gastric cancers

MRK

Product Launch

FDA approved Imfinzi as the first and only perioperative immunotherapy for adults with resectable early-stage and locally advanced gastric and gastroesophageal junction cancers.
Phase III MATTERHORN results showed a 29% reduction in risk of progression, recurrence, or death when Imfinzi was added to FLOT chemotherapy versus chemotherapy alone.
Imfinzi sales reached $4.32 billion in the first nine months of 2025, a 25% year-over-year increase.
Final overall survival analysis reported 69% of Imfinzi-treated patients alive at three years versus 62% with chemotherapy alone.

Nov 25, 2025, 7:39 PM

Morningstar

Earnings Transcripts

Quarterly earnings call transcripts for Merck & Co..

Ask Fintool AI Agent

Get instant answers from SEC filings, earnings calls & more

What did Robert M. Davis say about margins?What are Merck & Co.'s strategic priorities?How is Merck & Co. positioned vs competitors?How did Merck & Co. do last quarter?

Let Fintool AI Agent track Merck & Co.'s earnings for you

Get instant analysis when filings drop