Peptide News Digest

#Merck

29 stories

Merck's peptide story is anchored by enlicitide (LIPFENDRA), a macrocyclic peptide oral PCSK9 inhibitor FDA-approved July 16, 2026 as the first once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia (including heterozygous familial hypercholesterolemia). The Phase 3 CORALreef program delivered 56-59% placebo-adjusted LDL-C reductions across CORALreef Lipids and CORALreef HeFH, matching injectable PCSK9 monoclonal antibodies. Merck priced the tablet at $315 per month, roughly one-third the injectable class. The molecule is also notable for its manufacturing chemistry: the May 7, 2026 Science paper from the Merck process group described an engineered-enzyme biocatalytic cascade that cuts synthesis step count by more than half.

The broader peptide footprint includes the April 2025 Cyprumed deal worth up to $493M in milestones for oral peptide delivery platform access, the longstanding peptide-drug-conjugate research program, and a Q1 2026 Keytruda revenue baseline of $7.9B — recently overtaken by Eli Lilly's Mounjaro ($8.66B) as the world's top-selling drug per Bloomberg May 6. Merck's Q1 oncology cycle also included new ASCO-GU bladder and kidney cancer data plus continued peptide-radioligand work.

Stories here cover trial readouts, partnership economics, and the broader macrocyclic strategy. See #enlicitide, #pcsk9, and #keytruda.

Industry · View digest

Sell-Side Analysts Published Tuesday August 25, 2026 Projections That Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) Intismeran Autogene (V940 / mRNA-4157, the Individualized Neoantigen Therapy That Encodes Up to 34 Tumor-Specific Neoantigen Peptides From Each Individual Patient's Tumor Mutation Signature Delivered as a Lipid Nanoparticle mRNA Injection) Will Exceed $1 Billion in Annual Sales by 2031 Following the August 19 Positive Phase 3 INTerpath-001 Melanoma Readout That Met the Primary Endpoint of Recurrence-Free Survival and Key Secondary Endpoint of Distant Metastasis-Free Survival in Adults With Completely Resected Stage IIB-IV Melanoma; The Sales Trajectory Assumes Approvals Across Additional Adjuvant Indications Currently in Phase 3 Development Including Non-Small-Cell Lung Cancer, Renal Cell Carcinoma, and Cutaneous Squamous Cell Carcinoma

Sell-side analysts published Tuesday August 25, 2026 projections that Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) intismeran autogene (V940 / mRNA-4157) will exceed $1 billion in annual sales by 2031 following the August 19 positive Phase 3 INTerpath-001 melanoma readout. Product context: intismeran autogene is an individualized neoantigen therapy that uses each individual patient's tumor mutation signature to design a personalized mRNA vaccine encoding up to 34 tumor-specific neoantigen peptides. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The INTerpath-001 Phase 3 trial met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in adults with completely resected Stage IIB-IV cutaneous melanoma. The $1+ billion 2031 sales trajectory assumes approvals across additional adjuvant indications currently in Phase 3 development including non-small-cell lung cancer (INTerpath-002), renal cell carcinoma (INTerpath-003), and cutaneous squamous cell carcinoma (INTerpath-005). Manufacturing scale-up remains a substantial commercial constraint because each patient dose requires an individualized manufacturing run driven by that patient's tumor sequence, unlike traditional off-the-shelf drugs; Moderna is investing in automated manufacturing infrastructure to support the projected launch volumes. The sales trajectory reset materially resets investor expectations about the personalized neoantigen therapy modality that had traded largely on Phase 2 data until the August 19 confirmatory Phase 3 result.

Clinical Trials · View digest

Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) Announced Wednesday August 19, 2026 That the Phase 3 INTerpath-001 Trial of Intismeran Autogene (V940 / mRNA-4157, an Individualized Neoantigen Therapy) Plus Pembrolizumab (Keytruda) Met Its Primary Endpoint of Recurrence-Free Survival (RFS) and Key Secondary Endpoint of Distant Metastasis-Free Survival (DMFS) in Adults With High-Risk (Stage IIB-IV) Resected Cutaneous Melanoma Compared to Keytruda Alone; The Readout Is the First Positive Phase 3 for an Individualized Neoantigen Therapy and the First Phase 3 to Demonstrate Substantial Improvement Over Keytruda Alone in the Adjuvant Melanoma Setting; Phase 2b KEYNOTE-942 Five-Year Follow-Up Data Presented at ASCO 2026 Had Shown a 49% Reduction in Risk of Recurrence or Death and a 59% Reduction in Risk of Distant Metastasis or Death Versus Keytruda Alone

Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) announced Wednesday August 19, 2026 that the Phase 3 INTerpath-001 trial of intismeran autogene (V940 / mRNA-4157, an individualized neoantigen therapy) plus pembrolizumab (Keytruda) met its primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS) in adults with high-risk (Stage IIB-IV) resected cutaneous melanoma compared to Keytruda alone. Mechanism: intismeran autogene is a personalized mRNA therapy that encodes up to 34 tumor-specific neoantigen peptides selected from the individual patient's tumor mutation signature. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The Phase 3 readout is the first positive Phase 3 for an individualized neoantigen therapy and the first Phase 3 to demonstrate substantial improvement over Keytruda alone in the adjuvant melanoma setting. Trial design: randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 evaluating safety and efficacy of the combination versus Keytruda alone. Phase 2b KEYNOTE-942 five-year follow-up data presented at the 2026 ASCO Annual Meeting had shown a 49% reduction in risk of recurrence or death and a 59% reduction in risk of distant metastasis or death for the combination versus Keytruda alone, and the Phase 3 readout confirms and extends those benefits. The result validates the personalized neoantigen mRNA vaccine platform and opens a substantial commercial pathway for the Merck-Moderna collaboration in adjuvant oncology settings beyond melanoma including non-small-cell lung cancer, renal cell carcinoma, and cutaneous squamous cell carcinoma where INTerpath studies are ongoing.

Industry · View digest

PeptiDream Inc. (TSE: 4587), the Kawasaki-Based Peptide Discovery Platform Company That Operates the Peptide Discovery Platform System (PDPS) for Constrained Cyclic Peptide Design and Runs an Extensive Partnership Book With Novartis, Merck, Genentech, AbbVie, Bristol Myers Squibb, and Eli Lilly Among Others, Announced the Appointment of Three New Executive Vice Presidents Extending the Leadership Restructure That Has Accompanied the Company's Multi-Year Deal-Book Growth and the Increasing Preclinical-to-Clinical Progression of Its Partnered Peptide Programs; PeptiDream's PDPS Platform Screens Trillion-Scale Diverse Non-Standard Peptide Libraries to Identify Molecules That Bind Target Proteins With High Affinity and Specificity, With Applications Spanning Oncology, Immunology, and Rare Disease Peptide Drug Development

PeptiDream Inc. (TSE: 4587), the Kawasaki-based peptide discovery platform company, announced the appointment of three new Executive Vice Presidents. The leadership restructure accompanies the company's multi-year deal-book growth and the increasing preclinical-to-clinical progression of its partnered peptide programs. Company background: PeptiDream operates the Peptide Discovery Platform System (PDPS), a proprietary technology for designing constrained cyclic peptides. PDPS uses genetic-code reprogramming to generate trillion-scale diverse libraries of non-standard peptides (containing modified amino acids not found in natural proteins), which are then screened to identify molecules that bind target proteins with high affinity and specificity. Applications span oncology (peptide-drug conjugates, radioligand-conjugated peptides), immunology (novel immune-modulating peptides), and rare disease peptide drug development. Partnership book: PeptiDream has active collaborations with Novartis (multiple targets), Merck (peptide-radioligand programs), Genentech/Roche (immuno-oncology), AbbVie (multiple targets), Bristol Myers Squibb, Eli Lilly (including the recent obesity-adjacent partnership), and multiple mid-cap biopharmaceutical companies. The constrained cyclic peptide modality PeptiDream specializes in sits between traditional linear peptides (subject to protease degradation and short half-lives) and small-molecule drugs (limited target diversity), and has grown as a distinct drug modality throughout the 2020s as GLP-1 and other peptide successes have expanded the industry's willingness to invest in peptide chemistry platforms.

Industry · View digest

Q2 2026 Peptide-and-Obesity Earnings Week Wrap: Merck (MRK) $16.61B Revenue Beat + Raised Guidance With LIPFENDRA Launch Focus and $5.7B Terns Acquisition Charge; Pfizer (PFE) $15B Revenue Beat + Raised Guidance With Obesity Program Momentum; Amgen (AMGN) $10.05B Revenue Beat + Raised Guidance and Discontinued AMG 513 Early-Stage Obesity Candidate Leaving MariTide as Sole Focus; Eli Lilly (LLY) $23B Revenue (+48%) Blowout + Raised Guidance to $85-87B With Foundayo $98M First Commercial Quarter; Novo Nordisk (NVO) H1 78.49B DKK ($12.09B) + Raised Guidance but Shares -5% on Margin Concerns; Alnylam (ALNY) Extends 30% Selloff on Amvuttra Guidance Cut + Eplontersen Setback

The peptide-and-obesity Q2 2026 earnings week (Merck August 4, Pfizer August 4, Amgen August 4, Eli Lilly August 5, Novo Nordisk H1 August 4-5) delivered mixed signals across the pharma sector. Merck (NYSE: MRK) posted $16.61 billion Q2 revenue (+5% YoY, beat consensus by $250M), raised FY revenue guidance to $66.3-67.3 billion but cut adjusted EPS guidance to $2.66-2.76 due to a $5.7 billion Terns Pharmaceuticals acquisition charge; Keytruda reached $8.37 billion (+5%) and LIPFENDRA (enlicitide) launched at $315/month with $5 billion peak sales potential by 2034. Pfizer (NYSE: PFE) reported $15 billion revenue and $0.77 adjusted diluted EPS, raised FY revenue guidance midpoint to $60.5-62.5 billion, and CEO Bourla said the obesity program (danuglipron plus Metsera pipeline) is advancing with substantial momentum. Amgen (NASDAQ: AMGN) reported $10.05 billion Q2 revenue (+10% YoY), raised FY guidance to $38.2-39.4 billion, discontinued AMG 513 early-stage obesity candidate leaving MariTide as sole obesity focus. Eli Lilly (NYSE: LLY) delivered $23 billion Q2 revenue (+48% YoY blowout), raised FY guidance to $85-87 billion, Mounjaro reached $9.9 billion (+91%), Zepbound $4.9 billion US (+44%), and Foundayo generated $98 million in first fully operational commercial quarter. Novo Nordisk H1 reached 78.49 billion DKK ($12.09 billion, +3% CER) with Wegovy pill at 5 million+ prescriptions and raised guidance; NVO shares fell 5% on margin concerns. Alnylam (NASDAQ: ALNY) extended a 30% selloff (approximately $12 billion market cap lost) since the July 30 Q2 report on the Amvuttra TTR guidance cut plus eplontersen setback.

Industry · View digest

Merck (NYSE: MRK) Q2 2026 Earnings Tuesday August 4 Beat Consensus With Revenue of $16.61 Billion (+5% YoY vs $16.36 Billion Consensus) Driven by Keytruda (Pembrolizumab) at $8.37 Billion (+5% YoY, Including $463 Million From the Newly-Launched Injectable Keytruda Formulation), Highlights the July 16, 2026 LIPFENDRA (Enlicitide) Oral Macrocyclic Peptide PCSK9 Inhibitor FDA Approval as the First Once-Daily Oral PCSK9 in the Class; Full-Year 2026 Revenue Guidance Raised to $66.3-67.3 Billion but Adjusted EPS Guidance Cut to $2.66-2.76 (Including a One-Time $5.7 Billion / $2.31 Per Share Charge Tied to the Terns Pharmaceuticals Acquisition)

Merck (NYSE: MRK) reported Q2 2026 earnings Tuesday August 4, 2026 before market open with quarterly revenue of $16.61 billion (+5% year-over-year), beating analyst consensus of $16.36 billion. Keytruda (pembrolizumab) generated $8.37 billion in Q2 sales (+5% YoY), exceeding analyst expectations of $8.27 billion; the total includes $463 million from the newly-launched more convenient injectable Keytruda formulation. Merck highlighted the July 16, 2026 LIPFENDRA (enlicitide) FDA approval as the first once-daily oral macrocyclic peptide PCSK9 inhibitor in the class, priced at $315 per month with peak sales potential of $5 billion by 2034. Full-year 2026 revenue guidance was raised to $66.3-67.3 billion from the prior $65.8-67 billion range, but adjusted EPS guidance was cut to $2.66-2.76 to reflect a one-time $5.7 billion ($2.31 per share) charge tied to the Terns Pharmaceuticals acquisition that closed in H1 2026. Merck shares rose 0.6% in early trading to $128.54. Broader pipeline highlights include continued growth of Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma), and Capvaxive (pneumococcal vaccine), plus the integration of Terns and Cidara acquisitions. Merck has beaten consensus in each of the trailing four quarters.

Industry · View digest

Merck (NYSE: MRK) Q2 2026 Earnings Pre-Day Positioning Ahead of the Tuesday August 4 Before-Market-Open Report With Analyst Focus on Keytruda (Pembrolizumab) Sales Trajectory Ahead of the 2028 US Patent Cliff, the Initial Commercial Ramp of LIPFENDRA (Enlicitide) Oral Macrocyclic Peptide PCSK9 Inhibitor Following the July 16 FDA Approval With Peak Sales Potential of $5 Billion by 2034, Zacks Consensus of $16.33 Billion Revenue and $1.36 Diluted EPS (Down 36.2% Year-Over-Year From $2.13), and Potential 2026 Revenue Guidance Revisions From the Prior $65.8-67 Billion Range

Merck (NYSE: MRK) Q2 2026 earnings pre-day positioning ahead of the Tuesday August 4, 2026 before-market-open report. Zacks analyst consensus: $16.33 billion revenue, $1.36 diluted EPS (down 36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory (Zacks estimate $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum) ahead of the 2028 US patent cliff that ends Keytruda exclusivity; the initial commercial ramp of LIPFENDRA (enlicitide) oral macrocyclic peptide PCSK9 inhibitor following the July 16, 2026 FDA approval, with peak sales potential estimated at $5 billion by 2034 and analyst commentary describing the safety label as 'the cleanest in the class'; contribution from Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma), and Capvaxive (pneumococcal vaccine); and the integration of the Terns Pharmaceuticals and Cidara Therapeutics acquisitions closed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise; analyst attention also on potential FY 2026 revenue guidance revision from the prior $65.8-67 billion range and non-GAAP EPS guidance from $5.04-5.16.

Industry · View digest

Merck (NYSE: MRK) Q2 2026 Earnings Preview for Tuesday August 4 Before Market Open With Zacks Analyst Consensus at $16.33 Billion Revenue and $1.36 Diluted EPS (-36.2% Year-Over-Year From $2.13 in Q2 2025); Analyst Focus Areas Include Keytruda (Pembrolizumab) Sales Trajectory (Zacks Estimate $8.06 Billion Q2, Driven by Earlier-Stage Indication Uptake and Continued Metastatic-Setting Momentum), the Initial Commercial Launch of LIPFENDRA (Enlicitide) Macrocyclic Peptide Oral PCSK9 Inhibitor Following the July 16 FDA Approval With Peak Sales Potential Estimated at $5 Billion by 2034, and the Emerging Contribution of Winrevair, Welireg, and Capvaxive Plus the Terns and Cidara Acquisitions

Merck (NYSE: MRK) reports Q2 2026 earnings Tuesday August 4, 2026 before market open with Zacks analyst consensus at $16.33 billion revenue and $1.36 diluted EPS (-36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory with the Zacks estimate at $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum ahead of the 2028 US patent cliff; the initial commercial launch of LIPFENDRA (enlicitide) macrocyclic peptide oral PCSK9 inhibitor following the July 16, 2026 FDA approval at $315/month list price ($10.50 per tablet), with peak sales potential estimated at $5 billion by 2034; the emerging contribution of Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma and VHL disease), and Capvaxive (pneumococcal vaccine); and pipeline signal from the Terns Pharmaceuticals and Cidara Therapeutics acquisitions completed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise. Beyond Q2 specifically, analyst attention will focus on the FY 2026 revenue guidance ($65.8-67 billion range on the prior call) and non-GAAP EPS guidance ($5.04-5.16 range) for revisions.

Industry · View digest

Q2 2026 Earnings Preview for the Peptide-and-Obesity Big Three Next Week: Merck (NYSE: MRK) Reports Tuesday August 4 With Analyst Consensus at $1.36 Diluted EPS Down 36.2% YoY From $2.13 (Reflecting Post-Keytruda Loss-of-Exclusivity Repositioning and LIPFENDRA/Enlicitide Launch Costs), Eli Lilly (NYSE: LLY) Reports Wednesday August 5 With Analyst Consensus at $20.26 Billion Revenue and $6.71 EPS (Prediction Markets Show 70% Probability of Another Earnings Beat, 96.4% Odds Mounjaro Clears $7.5 Billion Q2, 87% Odds Zepbound Tops $4 Billion Q2, and Foundayo Weekly Prescriptions Near 20,000 as the Analyst Focus Number), and Novo Nordisk Reports Wednesday August 5 H1 2026 Results

Q2 2026 earnings from the peptide-and-obesity big three arrive next week. Merck (NYSE: MRK) reports Tuesday August 4 before market open with analyst consensus at $1.36 diluted EPS (down 36.2% year-over-year from $2.13 in Q2 2025), reflecting post-Keytruda loss-of-exclusivity strategic repositioning and LIPFENDRA (enlicitide, oral macrocyclic peptide PCSK9 inhibitor approved July 16, 2026) launch costs. Eli Lilly (NYSE: LLY) reports Wednesday August 5 before market open with analyst consensus at $20.26 billion revenue and $6.71 EPS. Prediction markets put a 70% probability on another Lilly earnings beat, 96.4% odds Mounjaro (tirzepatide) clears $7.5 billion Q2, 87% odds Zepbound (tirzepatide) tops $4 billion Q2, and Foundayo (orforglipron, oral small-molecule GLP-1) weekly prescriptions near 20,000 as the primary analyst focus number after the April 2026 FDA approval. Novo Nordisk reports Wednesday August 5 H1 2026 results (Novo reports half-year rather than quarterly), with Wegovy pill (oral semaglutide 25/50 mg) Q1 2026 sales of approximately $354 million providing the H1 baseline. The three earnings prints together will frame second-half 2026 obesity market trajectory and the competitive positioning across incretin, macrocyclic peptide, and small-molecule oral GLP-1 franchises.

Regulatory · View digest

President Trump's Section 232 Pharmaceutical Tariffs Take Effect Friday July 31, 2026 for the 17 Companies Named in the Initial Tranche of the Section 232 National-Security Investigation Announced April 1, 2025 and Formally Initiated April 30, 2026; The Broader Pharmaceutical Industry Faces a September 29 Deadline for Additional Tariff Applicability, With the Peptide-and-Obesity Sponsors (Novo Nordisk, Eli Lilly, Merck, AstraZeneca, Sanofi, AbbVie, Roche, Bristol-Myers Squibb, Amgen, Pfizer, and Biogen) All Facing Potential 25% Import Duties Depending on Manufacturing-Location Documentation

President Trump's Section 232 pharmaceutical tariffs took effect Friday July 31, 2026 for the 17 companies named in the initial tranche of the Section 232 national-security investigation. The Section 232 pathway allows the President to impose tariffs on imports that threaten national security; the pharmaceutical investigation was announced April 1, 2025 by the Commerce Department under the Trump administration and formally initiated April 30, 2026. Companies in the initial tranche face tariffs on active pharmaceutical ingredient (API) and finished-drug imports depending on manufacturing-location documentation; the broader pharmaceutical industry faces a September 29 deadline for additional tariff applicability. Peptide-and-obesity-relevant sponsors including Novo Nordisk (Wegovy/Ozempic semaglutide, primarily manufactured in Denmark), Eli Lilly (Zepbound/Mounjaro tirzepatide and Foundayo orforglipron, primarily manufactured in Ireland and Indiana), Merck (LIPFENDRA/enlicitide macrocyclic peptide PCSK9, manufacturing across US and Ireland), AstraZeneca (elecoglipron and biologics portfolio), Sanofi (Dupixent dupilumab), AbbVie (Skyrizi and Rinvoq), Roche, Bristol-Myers Squibb, Amgen, Pfizer, and Biogen all face potential 25% import duties depending on manufacturing-location documentation. President Trump also announced Tuesday July 21 that imported generic drugs would face zero tariffs for two years starting August 2028, providing a two-year runway before generic tariffs begin.

Clinical Trials · View digest

The 26th International AIDS Conference (AIDS 2026) Closes Friday July 31 at Riocentro in Rio de Janeiro Brazil After Six Days of Programming (July 26-31) With Approximately 10,000 In-Person and Virtual Attendees Under the Conference Theme 'Rethink. Rebuild. Rise.'; Signature Presentations Across the Week Included the Wednesday July 29 Gilead-Merck ISLEND-1 and ISLEND-2 Late-Breaker on the Investigational Once-Weekly Oral Islatravir/Lenacapavir HIV Treatment Regimen, Gilead's Twice-Yearly Injectable Lenacapavir PURPOSE 1 and PURPOSE 2 52-Week Open-Label Extension Data, and the UNAIDS 'United to End AIDS' 2025 Data Report Documenting 2025 HIV Funding Cuts

The 26th International AIDS Conference (AIDS 2026) closed Friday July 31, 2026 at Riocentro in Rio de Janeiro, Brazil after six days of programming under the conference theme 'Rethink. Rebuild. Rise.' Approximately 10,000 attendees participated in person and virtually. Signature presentations across the week: the Wednesday July 29 Gilead-Merck ISLEND-1 and ISLEND-2 late-breaker with Week 48 detailed Phase 3 data on the investigational once-weekly oral single-tablet islatravir 2 mg / lenacapavir 300 mg regimen (0% ISLEND-1 vs 0.3% daily Biktarvy at Week 48; 0.3% ISLEND-2 vs 1.3% daily standard-of-care); Gilead's twice-yearly subcutaneous lenacapavir (Yeztugo for HIV prevention) 52-week open-label extension data from Phase 3 PURPOSE 1 and PURPOSE 2 (zero new infections across 7,178 person-years, one infection across 5,295 person-years); the Monday July 27 UNAIDS 'United to End AIDS' 2025 data report on 2025 HIV funding cuts; and Thursday July 30 lenacapavir implementation-science programming with a cross-country demand generation playbook for scale-up. Generic lenacapavir from Dr. Reddy's Laboratories, Hetero Labs, and four other manufacturers is expected in 2027 at approximately $40 per person per year across 120 low- and lower-middle-income countries. The next International AIDS Conference (AIDS 2028) will be held in Barcelona, Spain.

Clinical Trials · View digest

AIDS 2026 Late-Breaker Wednesday July 29: Gilead-Merck ISLEND-1 and ISLEND-2 Detailed Week 48 Phase 3 Data for Investigational Once-Weekly Oral Single-Tablet Islatravir 2 mg / Lenacapavir 300 mg (ISL/LEN) Presented at Riocentro in Rio de Janeiro; Zero Percent of ISLEND-1 Participants and 0.3% of ISLEND-2 Participants Reached HIV-1 RNA at 50 Copies/mL or Higher, With Safety Profile Generally Similar to Comparator Daily Biktarvy and Standard-of-Care Regimens

Gilead Sciences (NASDAQ: GILD) and Merck (NYSE: MRK) presented detailed Phase 3 ISLEND-1 and ISLEND-2 Week 48 data during the late-breaking session at AIDS 2026 Wednesday July 29, 2026 in Rio de Janeiro. The investigational once-weekly oral single-tablet regimen of islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) demonstrated non-inferior efficacy versus daily standard-of-care antiretroviral therapy in virologically-suppressed adults living with HIV who switched from daily Biktarvy (ISLEND-1) or other daily oral regimens (ISLEND-2). Primary endpoint results: 0% of ISLEND-1 participants on once-weekly ISL/LEN had HIV-1 RNA at 50 copies/mL or higher at Week 48 compared to 0.3% remaining on daily Biktarvy; in the open-label ISLEND-2 trial, 0.3% of participants on ISL/LEN had HIV-1 RNA at 50 copies/mL or higher versus 1.3% on daily standard-of-care regimens. Safety profile was generally similar to comparator regimens with no new safety signals identified. The Week 48 data will support planned regulatory submissions for the first once-weekly oral HIV treatment regimen. Lenacapavir is Gilead's first-in-class HIV capsid inhibitor; islatravir is Merck's nucleoside reverse transcriptase translocation inhibitor (NRTTI).

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26th International AIDS Conference (AIDS 2026) Main Conference Opens Monday July 27, 2026 at Riocentro in Rio de Janeiro Brazil (Opening Ceremony 15:00-16:30 Local Time in the Global Village) With Release of the UNAIDS 'United to End AIDS' 2025 Data Report Documenting the Severity of 2025 HIV Funding Cuts and the WHO's First Global Mid-Term Assessment of Progress Under the Global Health Sector Strategies on HIV Viral Hepatitis and Sexually Transmitted Infections Marking the Halfway Point to the 2030 Targets — Peptide-Adjacent HIV Modality Content This Week Includes Gilead Sciences Lenacapavir PURPOSE 1 and PURPOSE 2 Long-Term Extension Data and Gilead-Merck Islatravir/Lenacapavir Phase 3 ISLEND-1 and ISLEND-2 Late-Breaker Wednesday July 29

The 26th International AIDS Conference (AIDS 2026) main conference opened Monday July 27, 2026 at Riocentro in Rio de Janeiro, Brazil. The opening ceremony ran 15:00-16:30 local time in the Global Village. UNAIDS released its 'United to End AIDS' 2025 data report on the opening day, documenting the severity of 2025 HIV funding cuts and their impact on HIV prevention, community services, key populations, and the sustainability of the global AIDS response. The WHO launched its first global mid-term assessment of progress under the Global Health Sector Strategies on HIV, viral hepatitis, and sexually transmitted infections, marking the halfway point to the 2030 targets and providing a comprehensive overview of where the world stands on the SDG 3.3 targets. Peptide-adjacent HIV modality content this week includes Gilead Sciences's twice-yearly lenacapavir (first-in-class HIV capsid inhibitor) PURPOSE 1 and PURPOSE 2 long-term extension data and the Gilead-Merck once-weekly oral islatravir/lenacapavir Phase 3 ISLEND-1 and ISLEND-2 detailed data late-breaker scheduled for Wednesday July 29. Merck plans separate presentations across daily, weekly, and monthly HIV treatment and prevention pipeline including alimatravir (MK-8527), the investigational once-monthly oral HIV prevention pill licensed July 24 to Aspen Pharmacare and six other generic manufacturers for 129 low- and middle-income countries.

Clinical Trials · View digest

26th International AIDS Conference (AIDS 2026) Opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and Runs Through Friday July 31; Gilead Sciences to Present Twice-Yearly Lenacapavir (First-in-Class HIV Capsid Inhibitor) Long-Term Extension Data From the Phase 3 PURPOSE 1 Trial (Zero New HIV Infections Across 7,178 Person-Years of Follow-Up at Week 52) and the Phase 3 PURPOSE 2 Trial (One HIV Infection Across 5,295 Person-Years of Follow-Up), and Gilead-Merck Once-Weekly Oral Islatravir/Lenacapavir ISLEND-1 and ISLEND-2 Phase 3 Detailed Data Late-Breaker on Wednesday July 29

The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through Friday July 31. Two peptide-adjacent HIV modality readouts anchor the industry program. Gilead Sciences (NASDAQ: GILD) will present twice-yearly lenacapavir (first-in-class HIV capsid inhibitor) long-term open-label extension data from the Phase 3 PURPOSE 1 trial, where zero new HIV infections occurred among participants receiving lenacapavir across more than 7,178 person-years of follow-up at Week 52, and from PURPOSE 2, where one HIV infection occurred among participants continuing lenacapavir across 5,295 person-years of follow-up. Separately, Gilead and Merck's once-weekly oral single-tablet islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 detailed data is scheduled for the late-breaking session on Wednesday July 29. Topline released July 21 showed 0% of ISLEND-1 once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 (versus 0.3% remaining on daily Biktarvy). Merck plans separate presentations across its daily, weekly, and monthly HIV treatment and prevention pipeline including alimatravir (MK-8527), the investigational once-monthly oral HIV prevention pill licensed Friday July 24 to Aspen Pharmacare and six other generic manufacturers for 129 low- and middle-income countries.

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Merck (MSD) Announces Friday July 24 Voluntary Licensing Agreements With Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in Sub-Saharan Africa Plus Aurobindo, Cipla, Emcure, and Viatris in India for Investigational Once-Monthly Oral HIV Prevention Pill MK-8527 (Alimatravir) Covering 129 Low- and Middle-Income Countries Including Every African Nation; Late-Stage Phase 3 Clinical Trial Results for Alimatravir Are Not Expected Until Late 2027

Merck (MSD) announced Friday July 24, 2026 seven voluntary, royalty-free, non-exclusive licensing agreements with generic drug manufacturers covering the investigational once-monthly oral HIV prevention pill MK-8527 (alimatravir). The licensees are Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in sub-Saharan Africa, plus Aurobindo, Cipla, Emcure, and Viatris in India. The territorial scope covers 129 low- and middle-income countries including every African nation. Alimatravir is an investigational late-stage once-monthly long-acting oral medicine for HIV-1 prevention, currently in Phase 3 development. Phase 3 topline results are not expected until late 2027. Alimatravir is designed to provide one month of protection from HIV-1 starting within one hour after dosing. Coverage frames the licensing structure as one of the broadest generic-access pre-approval commitments Merck has undertaken for an HIV asset. The announcement follows the April 7 STAT reporting that Merck's experimental HIV prevention pill could be made for less than $5 a year at manufacturing cost. Merck plans to file for regulatory approval in 2027-2028 with market launch dependent on Phase 3 outcome.

Clinical Trials · View digest

AIDS 2026 Conference (26th International AIDS Conference) Opens Sunday July 26, 2026 in Rio de Janeiro, Brazil With Gilead Sciences and Merck's Investigational Once-Weekly Oral HIV Treatment Regimen Islatravir 2 mg / Lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 Detailed Data Scheduled for the Late-Breaking Session Wednesday July 29; Topline Numbers Released July 21 Showed 0% of Once-Weekly ISL/LEN Participants Had HIV-1 RNA at 50 Copies/mL or Higher at Week 48 in ISLEND-1 Versus 0.3% Remaining on Daily Biktarvy

The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through July 31. Gilead Sciences and Merck's Phase 3 ISLEND-1 and ISLEND-2 detailed data on the investigational once-weekly oral HIV treatment regimen islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) is scheduled for the late-breaking session on Wednesday July 29. Topline numbers released July 21 showed 0% of once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 in ISLEND-1 (versus 0.3% of participants who remained on daily Biktarvy). In ISLEND-2, 0.3% of participants receiving weekly ISL/LEN had HIV-1 RNA at 50 copies/mL or higher versus 1.3% on daily standard of care regimens. Safety profile was generally similar to comparator regimens with no new signals identified. Lenacapavir is a first-in-class HIV capsid inhibitor (peptide-adjacent modality); islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI). The data will support planned regulatory submissions and represents the first once-weekly oral HIV treatment regimen to clear Phase 3 endpoints. Merck also plans to present daily, weekly, and monthly HIV treatment and prevention pipeline updates at AIDS 2026.

Industry · View digest

Q2 2026 Earnings Season for the Peptide-and-Obesity Big Three Opens Next Week With Merck Reporting Tuesday August 4, Eli Lilly Wednesday August 5, and Novo Nordisk Thursday August 6: Analyst Focus Areas Include Merck's LIPFENDRA (Enlicitide) FDA Approval Milestone One Week Old at Report Time, Eli Lilly's Foundayo (Orforglipron) First-Quarter-Out US Retail Sales, Zepbound Growth Versus the Wegovy Pill Franchise, and Novo Nordisk's Response to Analyst Concerns About 2027 Wegovy List Price Reset to $675 That Would Represent a 50% Cut From the Current Level

Q2 2026 earnings season for the peptide-and-obesity big three opens next week. Merck reports Tuesday August 4 at 9:00 AM ET with the LIPFENDRA (enlicitide) FDA approval milestone (July 16) roughly one week old at report time; analyst focus areas include the pricing strategy at $10.50 per tablet ($315 per 30-day supply), the pharmacy-benefit distribution model, and initial payer coverage momentum. Eli Lilly reports Wednesday August 5 before market open; analyst focus areas include Foundayo (orforglipron) first-quarter-out US retail sales (Q1 sales were not yet in the books at the last report), Mounjaro and Zepbound growth versus the Wegovy pill franchise, and TRIUMPH-2 and TRIUMPH-3 readouts for retatrutide expected later in 2026. Novo Nordisk reports Thursday August 6; analyst focus areas include the Wegovy pill uptake beyond the 3 million-prescription milestone documented at ADA 2026 (June), the impact of Novo's price cuts in China and India, the Vivani implant partnership announced July 7, and the response to analyst concerns about the January 2027 Wegovy list price reset to $675 (a 50% cut from current levels). The three earnings prints together are expected to frame the second-half 2026 obesity market trajectory and the competitive positioning of the incretin, amylin, and macrocyclic peptide franchises against each other.

Industry · View digest

Merck LIPFENDRA (Enlicitide) US Retail Launch Details Confirm $10.50 Per Tablet List Price ($315 Per 30-Day Supply Before Insurance and Manufacturer Support), Distribution Through Standard Retail and Mail-Order Pharmacies Under the Pharmacy Benefit (Unlike Novartis Leqvio Which Runs Through the Medical Benefit), and Expected Pharmacy Availability Within Weeks Following the Thursday July 16 FDA Approval as the First and Only Once-Daily Oral PCSK9 Inhibitor

Merck LIPFENDRA (enlicitide) commercial-launch details firmed up in the days following Thursday July 16, 2026 FDA approval. List price: $10.50 per tablet, or $315 per 30-day supply before insurance discounts, manufacturer support, or pharmacy benefit adjustments. Distribution channel: standard retail and mail-order pharmacies under the pharmacy benefit, which contrasts with Novartis Leqvio (inclisiran) that runs through the medical benefit due to healthcare-provider subcutaneous administration. Expected pharmacy availability: within weeks of approval. The pharmacy benefit pathway matters for real-world access because it eliminates the buy-and-bill logistics that have slowed injectable PCSK9 adoption (Repatha, Praluent, Leqvio) and puts LIPFENDRA on the same pharmacy shelf as statins and cheaper oral non-statin drugs like Nexletol (bempedoic acid) and Zetia (ezetimibe). The macrocyclic peptide's ability to survive gastrointestinal enzymes is what allows the oral delivery model that unlocks the pharmacy-benefit distribution advantage.

Regulatory · View digest

House Select Committee on the Chinese Communist Party Response Deadline Passed at 5:00 PM ET Friday July 17 for Five Drugmakers on Records of Clinical Trials at Xinjiang-Region Hospitals and Chinese Military Medical Centers; Committee Now Reviews Submitted Records for Due Diligence Standards, Data Protection Processes, and Site Selection Practices at Merck (224 China Studies), Eli Lilly (220+), Pfizer (43 Military), AbbVie (17 Xinjiang), and Bristol-Myers Squibb (180 China Studies) — Committee Letters Explicitly State No Evidence of Illegal Activity or Wrongdoing

The House Select Committee on the Chinese Communist Party (chaired by Rep. John Moolenaar, R-Michigan) received responses from five drugmakers by the 5:00 PM ET Friday July 17, 2026 deadline: Merck, AbbVie, Eli Lilly, Pfizer, and Bristol-Myers Squibb. The June 29 letters had requested records on due diligence processes, data protection standards, informed consent procedures, and oversight practices at Chinese clinical-trial and manufacturing sites, particularly at Xinjiang-region hospitals and hospitals affiliated with the People's Liberation Army. Documented trial counts: Merck 224 China studies since 2005 (31 Xinjiang + 40 military); Eli Lilly 220-plus studies since 2003 (11 Xinjiang + 16 military 2016-2024); Pfizer 6 Xinjiang + 43 military; AbbVie 100-plus studies since 2007 (17 Xinjiang + 16 military); Bristol-Myers Squibb 180 studies since 2004 (8 Xinjiang + 17 military 2015-2024). The Committee letters explicitly state there is no evidence any of the five drugmakers has engaged in illegal activity or wrongdoing. The next phase is Committee review of the submitted records and potential public hearings if oversight questions remain unresolved.