Merck & Co. (MRK) Company Report

Merck sees visibility to $70 billion in commercial opportunity by the mid-2030s (up $20 billion year-over-year), targeting $50 billion by the early 2030s, with 80 Phase III studies underway and plans to clinically de-risk $35 billion of that by end-2026.
In 2025, Merck secured key approvals for QLEX (subcutaneous Keytruda in one-minute administration), clesrovimab (weight-independent infant RSV vaccine), and NUMELVI (next-generation JAK inhibitor for animal atopic dermatitis pending US approval in early 2026).
Upcoming clinical catalysts include Phase III readouts for diabetic macular edema agent MK3000 in September 2026, ulcerative colitis therapy tulisokibart in August 2026, and continued progress on oral PCSK9 inhibitor enlicitide and weekly HIV regimen islatravir/lenacapavir.
Management expects Keytruda’s 2029–2030 loss of exclusivity to be a “hill, not a cliff,” forecasting a shallow post-LOE earnings dip followed by renewed growth, bolstered by a diversified late-stage pipeline and an animal health business set to more than double from 2024 to the mid-2030s.

2 days ago

Transcript

Merck projects $70B mid-2030s opportunity with de-risking roadmap

MRK

Product Launch

M&A

Merck targets >$70 billion of mid-2030s commercial opportunity across 20+ growth drivers, planning to de-risk $35 billion by end-2026 and the full $70 billion by 2027
2025 approvals include subcutaneous QLEX for Keytruda, Clesrovimab infant RSV vaccine, and Numelvy animal health product in Europe, with a next-gen JAK inhibitor due in the U.S. early 2026
The company has 80 phase III studies ongoing, featuring oral PCSK9 Enlicitide with three positive readouts and an expected Islatravir/Doravirine HIV treatment launch in April 2026
Since 2021, Merck has invested >$60 billion in business development, acquiring Verona’s Ohtuvayre (COPD), Cidara’s MK1406 flu antiviral, and Hengrui’s oral Lp(a) program
QLEX launched in late 2025 with a goal of 30–40% adoption within 18–24 months, and Merck expects Keytruda LOE to resemble a “hill, not a cliff,” with a shallow dip and return to growth

2 days ago

Transcript

Merck outlines pipeline expansion and >$70B mid-2030s opportunity

MRK

New Projects/Investments

Product Launch

>20 new product launches in development alongside ~80 Phase 3 studies demonstrate robust pipeline momentum.
Mid-2030s commercial opportunity from potential new growth drivers increased to >$70 billion.
Launch product revenues accelerated from $70 million in Q2 2024 to $824 million in Q3 2025.
Achieved notable 2025 approvals in oncology (KEYTRUDA QLEX; early-stage KEYTRUDA), cardiometabolic (WINREVAIR PAH), infectious disease (ENFLONSIA), and animal health (BRAVECTO QUANTUM, NUMELVI).
Strong business development track record with >$60 billion invested since 2012 to augment pipeline and portfolio.

2 days ago

Presentation

Merck outlines pipeline and growth drivers at J.P. Morgan Healthcare Conference

MRK

Product Launch

New Projects/Investments

Merck has 80 phase III studies underway and sees visibility to > $70 billion of commercial opportunity by the mid-2030s, with plans to de-risk most of this by end-2027; animal health, excluded from the $70 billion, is expected to more than double from 2024 to mid-2030s.
Recent approvals and launches include QLEX (subcutaneous Keytruda), Clesrovimab infant RSV vaccine, animal health drug Numelvy, COPD therapy Ohtuvayre, and influenza antiviral MK1406, showcasing a diversified growth-driver portfolio.
Merck is confident in managing the post-Keytruda LOE period (2029–30) without meaningful earnings decline, supported by internal pipeline and animal health growth; business development added roughly $10 billion (half of the recent $20 billion increase) to the $70 billion target, with capacity for multi-tens of billions in future deals.
The oral PCSK9 inhibitor demonstrated biologic-level LDL-C reductions with near-100% compliance and safety comparable to placebo; Merck plans to file under CNPV with a potential launch in late 2026 or early 2027.

2 days ago

Transcript

Merck announces FDA acceptance of NDA for pimicotinib

MRK

Product Launch

The FDA has accepted Merck’s NDA for pimicotinib as a systemic treatment for tenosynovial giant cell tumor, based on the global Phase 3 MANEUVER study.
The MANEUVER trial demonstrated statistically significant objective response rate improvements and durable tumor responses, with a median 14.3-month follow-up.
Pimicotinib received approval in China in December 2025 for adult patients with symptomatic TGCT and holds breakthrough therapy and PRIME designations in the US and EU.
Merck holds worldwide commercialization rights for pimicotinib and is positioned to address a significant unmet need beyond surgery in TGCT treatment.

2 days ago

Press Release

Vibrant Therapeutics raises $61M and appoints co-CEO

MRK

Management Change

New Projects/Investments

Vibrant Therapeutics secured $61 million in new financing led by Pfizer Ventures and Apricot Capital, bringing total capital raised to $100 million.
Han Lee, Ph.D. was appointed co-CEO alongside Larry Wang to spearhead the company’s global expansion.
The FDA accepted the IND for VIB305, a logic-gated, dual-targeting masked T-cell engager for EGFR-positive solid tumors, enabling U.S. clinical trials.

3 days ago

Press Release

Merck in talks to acquire Revolution Medicines for up to $32B

MRK

M&A

Merck is reportedly negotiating to acquire Revolution Medicines in a $28–32 billion deal, potentially the largest pharma transaction since Pfizer’s $43 billion Seagen buy.
Revolution’s pipeline is led by pan-RAS candidate daraxonrasib, now in registration trials for pancreatic ductal adenocarcinoma and non-small cell lung cancer, with pivotal PDAC data expected this summer.
Other major drugmakers, including AbbVie, are said to be circling, indicating a potential bidding contest; no agreement has been finalized and talks could continue for weeks.
The acquisition would bolster Merck’s revenue ahead of Keytruda’s 2028 patent cliff but carries execution risk and a premium valuation.

6 days ago

Bloomberg

Merck completes acquisition of Cidara Therapeutics

MRK

M&A

Merck completed its cash tender offer to acquire all outstanding shares of Cidara at $221.50 per share, valid as of January 6, 2026.
27.15 million shares were tendered, representing 85.96% of Cidara’s issued and outstanding common stock.
Remaining shares will be cancelled and converted into the same cash consideration, and Cidara will be delisted from the Nasdaq Global Market upon merger close.
The deal will be accounted for as an asset acquisition, increasing 2026 R&D expenses by $9.0 billion (approximately $3.65 per share) and reducing GAAP and non-GAAP EPS by about $0.30 in the first 12 months.

8 days ago

Press Release

Basilea Pharmaceutica enters collaboration with Prokaryotics on broad-spectrum antifungal

MRK

New Projects/Investments

Basilea Pharmaceutica Ltd has signed an agreement with Prokaryotics Inc. to co-develop a first-in-class broad-spectrum antifungal targeting severe invasive infections caused by Candida, Aspergillus and rare molds.
Basilea will pay an undisclosed upfront fee plus near-term milestones; Prokaryotics is eligible to receive up to USD 48.5 million in development, regulatory and commercial milestones, plus tiered low single-digit royalties on global net sales.
After candidate selection, Basilea will be responsible for all clinical development and global commercialization under an exclusive license.
The partnership combines Prokaryotics’ expertise in anti-infective discovery with Basilea’s R&D and commercialization capabilities to address critical unmet medical needs.

8 days ago

Press Release

Merck & Co. achieves FDA IND clearance for BTK degrader APG-3288

MRK

New Projects/Investments

Ascentage Pharma’s next-generation BTK-targeted PROTAC degrader, APG-3288, has received IND clearance from the U.S. FDA, marking a major expansion of its global innovative pipeline.
The clearance enables a global, multicenter Phase I study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with relapsed/refractory B-cell malignancies.
APG-3288 utilizes proteolysis-targeting chimera (PROTAC) technology to induce proteasome-mediated degradation of both wild-type and mutation-driven BTK, aiming to overcome resistance to existing inhibitors.
In preclinical comparisons, APG-3288 demonstrated more potent BTK degradation, higher selectivity, and favorable pharmacokinetic properties versus other BTK degraders in development.