Enlicitide chloride

Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX) Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX) GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Charge of $3.62 per Share for the Acquisition of Cidara Presented New Data From Cardio-Pulmonary Pipeline at ACC.26, Including Positive Results From Phase 3 CORALreef AddOn Trial Received U.S. FDA Approval for IDVYNSO, a Once-Daily, Oral Treatment for Certain Adults With Virologically Suppressed HIV-1 Achieved Multiple Significant Regulatory and Clinical Milestones Across Oncology Pipeline Announced Agreement To Acquire Terns Pharmaceuticals, Inc. and Expand Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia; Transaction Expected To Close in May Full-Year 2026 Financial Outlook Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $65.8 Billion and $67.0 Billion Narrows and Raises Expected Non-GAAP EPS Range To Be Between $5.04 and $5.16 Outlook Does Not Reflect Any Impact From Proposed Acquisition of Terns Pharmaceuticals, Inc., Which Is Expected To Close in May and Result in a One-Time Charge of Approximately $5.8 Billion or Approximately $2.35 per Share RAHWAY, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2026. “We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,” said Robert M. Davis, chairman and chief executive officer. “During the first quarter, we continued to strengthen our pipeline with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on the promise of our pipeline for patients.” Financial Summary $ in millions, except EPS amounts First Quarter 2026 2025 Change Change Ex- Exchange Sales $16,286 $15,529 5% 3% GAAP net (loss) income 2 (4,240) 5,079 N/M N/M Non-GAAP net (loss) income that excludes certain items 2,3* (3,156) 5,611 N/M N/M GAAP EPS (1.72) 2.01 N/M N/M Non-GAAP EPS that excludes certain items 3* (1.28) 2.22 N/M N/M *Refer to table on page 7. N/M - Not meaningful. For the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share. Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. First-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. First Quarter $ in millions 2026 2025 Change Change Ex- Exchange Commentary Total Sales $16,286 $15,529 5% 3% Pharmaceutical 14,349 13,638 5% 2% Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases. KEYTRUDA/ KEYTRUDA QLEX 8,034 7,205 12% 8% Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million. GARDASIL/ GARDASIL 9 1,069 1,327 -19% -22% Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing. JANUVIA/JANUMET 574 796 -28% -29% Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition. PROQUAD, M-M-R II and VARIVAX 538 539 0% -2% Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period. WINREVAIR 525 280 88% 87% Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe. BRIDION 472 441 7% 7% Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition. Lynparza* 341 312 9% 6% Growth primarily due to higher demand in the U.S. and many international markets. PREVYMIS 272 208 31% 26% Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications. Lenvima* 256 258 -1% -2% Relatively flat compared with prior year. ROTATEQ 206 228 -10% -11% Decrease primarily driven by lower demand in China. VAXNEUVANCE 202 230 -12% -16% Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure. WELIREG 199 137 45% 43% Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets. CAPVAXIVE 142 107 33% 31% Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory. OHTUVAYRE 131 - - - Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma). LAGEVRIO 28 102 -73% -73% Decline largely due to lower demand in Japan and the U.S. Animal Health 1,791 1,588 13% 6% Growth attributable to performance in both Livestock and Companion Animal product portfolios. Livestock 1,064 924 15% 8% Growth primarily driven by higher demand for ruminant and poultry products as well as price. Companion Animal 727 664 9% 4% Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange. Other Revenues** 146 303 -52% 4% Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. In addition, Koselugo alliance revenue was $161 million for the first quarter of 2026 compared with $44 million for the first quarter of 2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure. First-Quarter Expense and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs 4 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP 3 First Quarter 2026 Cost of sales $4,195 $1,014 $237 $ - $2,944 Selling, general and administrative 2,700 32 - - 2,668 Research and development 12,592 - 34 - 12,558 Restructuring costs 195 - 195 - - Other (income) expense, net 138 - - (180) 318 First Quarter 2025 Cost of sales $3,419 $620 $36 $- $2,763 Selling, general and administrative 2,552 23 - - 2,529 Research and development 3,621 7 - - 3,614 Restructuring costs 69 - 69 - - Other (income) expense, net (35) (3) - (107) 75 GAAP Expense, EPS and Related Information Gross margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix. Selling, general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange. Research and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio). Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities. The income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded. GAAP loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due to the unfavorable impact of foreign exchange, partially offset by favorable product mix. Non-GAAP SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange. Non-GAAP R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBio. Non-GAAP other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense. The non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded. Non-GAAP loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara. A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows. First Quarter $ in millions, except EPS amounts 2026 2025 EPS GAAP EPS $(1.72) $2.01 Difference 0.44 0.21 Non-GAAP EPS that excludes items listed below 3 $(1.28) $2.22 Net (Loss) Income GAAP net (loss) income 2 $(4,240) $5,079 Difference 1,084 532 Non-GAAP net (loss) income that excludes items listed below 2,3 $(3,156) $5,611 Excluded Items: Acquisition- and divestiture-related costs 4 $1,046 $647 Restructuring costs 466 105 Income from investments in equity securities (180) (107) Increase to net loss / decrease to net income before taxes 1,332 645 Estimated income tax benefit 5 (248) (113) Increase to net loss / decrease to net income $1,084 $532 Pipeline and Portfolio Highlights In the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad range of therapeutic areas. Oncology: U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial. The European Commission (EC) also approved this KEYTRUDA regimen for this population. In April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11 trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types. In April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01 trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo. FDA set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026. FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase 3 LITESPARK-022 trial. FDA set PDUFA date of June 19, 2026. FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd (Eisai). FDA set PDUFA date of Oct. 4, 2026. Announced positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery. KEYNOTE-B15 is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an earlier-stage cancer. In April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial. FDA set PDUFA date of Aug. 17, 2026. In a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant improvement in the primary endpoints of progression-free survival and OS in patients with advanced clear cell RCC. In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint of EFS in certain patients with locally advanced unresectable esophageal carcinoma. In a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection. Vaccines and Infectious Diseases: In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these patients in March. Presented data from three Phase 3 trials evaluating DOR/ISL at the 33 rd Conference on Retroviruses and Opportunistic Infections (CROI), including: Results from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and similar safety pro Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide 6 [(50 mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment. Results from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other antiretroviral therapies, including BIC/FTC/TAF. In April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, based on Phase 2b/3 CLEVER and Phase 3 SMART trials. Announced positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons. European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion for an expanded indication for CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumococcal pneumonia in certain children and adolescents at increased risk of pneumococcal disease. Cardiometabolic and Respiratory: Presented new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26) including: Positive results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions at eight weeks compared to guideline-recommended oral non-statin therapies when added to background statins. This is the third positive Phase 3 study of enlicitide. Positive data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study. Animal Health: FDA approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older. Business Development: Announced an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary. Expands hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic myeloid leukemia (CML). Transaction expected to close in May. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial EC Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial I-DXd Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date of Oct. 10, 2026 FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026 KEYTRUDA Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial KEYTRUDA Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial KEYTRUDA Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX WELIREG Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026 The Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced RCC Vaccines and Infectious Diseases FDA Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials The Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living With HIV-1, at CROI 2026 EC Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results From Phase 2b/3 CLEVER and Phase 3 SMART Trials The Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial The Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary HPV Congress 2026 Cardiometabolic and Respiratory Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial Positive Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF Ophthalmology The Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration Animal Health FDA Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic Dermatitis Research The Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine The Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation *References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. Contacts Media Contacts: Michael Levey michael.levey@msd.com John Cummins john.cummins2@msd.com Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here

iStock, Dragon Claws Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher. Merck’s cholesterol-lowering pill, which late last year received a Commissioner’s National Priority Voucher, significantly outperformed other oral non-statin drugs in patients with hypercholesterolemia, results that analysts say paint a “competitive” pro the pharma’s asset. Merck’s drug candidate, dubbed enlicitide, has “antibody-like efficacy,” RBC Capital Markets told investors in a note on Monday, pointing to the pill’s “strong efficacy” versus comparators. “There are no surprises in this data, which should cement enlicitide’s place in the market.” Consensus estimates put 2034 sales for enlicitide at around $4 billion, according to the note, but RBC is more optimistic and forecasts $5 billion in earnings that year, though “pricing will be critical for uptake.” In December 2025, the drug was granted the Commissioner’s National Priority Voucher, a regulatory ticket that aims to cut down the FDA’s review period to 1-2 months from the usual 10-12 months. With the voucher, RBC estimated on Monday that Merck could enlicitide’s approval by summer “and secure approval in fall 2026,” though the pharma hasn’t laid out a specific timeline for a submission. FDA 9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher. March 23, 2026 · 7 min read · Heather McKenzie Read more That submission will be supported by the new results, from the Phase 3 CORALreef AddOn trial in which Merck pitted enlicitide against Organon’s Zetia and Esperion’s Nexletol and Nexlizet in more than 300 patients with hypercholesterolemia. All study participants were on background statin therapy. Results showed that at eight weeks, enlicitide cut low-density lipoprotein cholesterol (LDL-C) concentrations by 56.7% versus Nexletol and by 36% versus Zetia. Compared with Nexlizet, which combines the active ingredients of Zetia and Nexletol, enlicitide elicited a 28.1% greater reduction in LDL-C. All three comparisons achieved statistical significance in favor of enlicitide, according to Merck’s news release. Aside from lowering LDL-C, enlicitide also significantly lowered apolipoprotein B levels versus the active comparators, a key study outcome. As for safety, Merck’s pill did not trigger a clinically meaningful excess of adverse events versus the control drugs. There were no serious toxicities attributed to enlicitide. These findings were presented Monday at the 2026 Scientific Session and Expo of the American College of Cardiology. Designed to be taken orally, enlicitide works by blocking the PCSK9 enzyme, in turn lowering LDL-C levels. Merck is building its case for enlicitide through the comprehensive Phase 3 CORALreef program, which spans more than 19,000 patients with hypercholesterolemia. Aside from CORALreef AddOn, the program involves two more pivotal trials: CORALreef Lipids and CORALreef HeFH, both of which have already read out. Data from the former, presented in November 2025 , showed a 55.8% LDL-C reduction versus placebo at 24 weeks. The latter, meanwhile, toplined in June that year though Merck did not release specific data at the time.