AIDS 2026 ISLEND Late-Breaker, PURPOSE 1/2 52-Week OLE, Biogen Q2 Beat + LEQEMBI IQLIK At-Home Dosin

AIDS 2026 ISLEND Late-Breaker, PURPOSE 1/2 52-Week OLE, Biogen Q2 Beat + LEQEMBI IQLIK At-Home Dosing FDA Approval

AIDS 2026 late-breaker: Gilead-Merck ISL/LEN Week 48 details. PURPOSE 1/2 52-week OLE. Biogen Q2 beat + LEQEMBI IQLIK approval. Alnylam Q2 preview on Thursday.

4 stories · Covering clinical trials, industry

Editor's Note

Wednesday marked the center of AIDS 2026 week in Rio de Janeiro. Gilead Sciences and Merck presented detailed Phase 3 ISLEND-1 and ISLEND-2 late-breaker data on the investigational once-weekly oral islatravir/lenacapavir (ISL/LEN) HIV treatment regimen, following the July 21 topline release. The Week 48 data supports planned regulatory submissions for the first once-weekly oral HIV treatment regimen. Separately, Gilead presented 52-week open-label extension long-term data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials of twice-yearly injectable lenacapavir (Yeztugo) for HIV prevention, demonstrating continued high efficacy, strong adherence, and a consistent safety profile across geographically diverse populations already using the drug in 10 priority sub-Saharan African countries. On the earnings front, Biogen (NASDAQ: BIIB) reported Q2 2026 earnings before market open Wednesday with revenue of $2.74 billion (+3% YoY), non-GAAP diluted EPS of $3.60, and announced FDA approval of LEQEMBI IQLIK for at-home initiation dosing. The Apellis acquisition that closed May 14 contributed $128 million in combined SYFOVRE and EMPAVELI revenue in the partial quarter. Alnylam Pharmaceuticals will report Q2 2026 earnings Thursday, July 30, before market open, with analyst consensus of $2.05 EPS (+540.6% YoY) and $1.32 billion revenue (+70.4% YoY).

CLINICAL TRIALS

AIDS 2026 Late-Breaker Wednesday July 29: Gilead and Merck Present Detailed Week 48 Phase 3 Data for Investigational Once-Weekly Oral Single-Tablet Islatravir 2 mg / Lenacapavir 300 mg (ISL/LEN) in ISLEND-1 and ISLEND-2 Trials at Riocentro, Rio de Janeiro; Zero Percent of ISLEND-1 Participants and 0.3% of ISLEND-2 Participants Achieved HIV-1 RNA Levels of 50 Copies/mL or Higher, With a Safety Profile Generally Similar to the 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 on 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 compared with 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 levels 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 levels at 50 copies/mL or higher versus 1.3% on daily standard-of-care regimens. The safety profile was generally similar to comparator regimens, with no new safety signals identified. These 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).

CLINICAL TRIALS

AIDS 2026 Wednesday, July 29 Also Features Gilead Sciences 52-Week Open-Label Extension (OLE) Data From the Phase 3 PURPOSE 1 and PURPOSE 2 Trials of Twice-Yearly Subcutaneous Lenacapavir (Yeztugo) for HIV Prevention (Pre-Exposure Prophylaxis, PrEP): Sustained High Efficacy, Strong Adherence, and Consistent Safety Across Geographically Diverse Populations Already Using the Drug in 10 Priority Sub-Saharan African Countries

Gilead Sciences (NASDAQ: GILD) presented 52-week open-label extension (OLE) long-term data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials of twice-yearly subcutaneous lenacapavir (Yeztugo, FDA-approved June 2025) for HIV prevention (pre-exposure prophylaxis, PrEP) at AIDS 2026 on Wednesday, July 29, 2026. PURPOSE 1 recorded zero new HIV infections among participants receiving twice-yearly lenacapavir across more than 7,178 person-years of open-label follow-up through Week 52; PURPOSE 2 documented one HIV infection among participants continuing lenacapavir across 5,295 person-years. The 52-week OLE data confirms sustained high efficacy, strong adherence (participants reliably return for their twice-yearly injections), and a consistent safety profile across broad, geographically diverse populations. Yeztugo is now being deployed in 10 priority sub-Saharan African countries—including South Africa (national program launched June 5, 2026 by President Cyril Ramaphosa in Secunda, Mpumalanga)—Zambia, and Eswatini through PEPFAR and Global Fund investments. Generic versions from Dr. Reddy's Laboratories, Hetero Labs, and four other manufacturers are expected to be available in 2027 at approximately $40 per person per year across 120 low- and lower-middle-income countries.

INDUSTRY

Biogen (NASDAQ: BIIB) reports Q2 2026 earnings before market open on Wednesday, July 29, with revenue of $2.74 billion (+3% year-over-year), GAAP EPS of $0.66, and Non-GAAP EPS of $3.60, all beating Wall Street consensus. The company also announced FDA approval for LEQEMBI IQLIK (lecanemab-irmb subcutaneous autoinjector) for at-home initiation dosing. Additionally, the May 14, 2026 acquisition of Apellis contributed $128 million in combined partial-quarter revenue from SYFOVRE (pegcetacoplan intravitreal) and EMPAVELI (pegcetacoplan subcutaneous), with estimated run-rate synergies of at least $250 million exiting 2027.

Biogen (NASDAQ: BIIB) reported Q2 2026 earnings before market open on Wednesday, July 29, 2026, with total revenue of $2.74 billion (+3% year-over-year), GAAP diluted EPS of $0.66, and non-GAAP diluted EPS of $3.60, beating Wall Street consensus. Growth portfolio drugs (LEQEMBI, SKYCLARYS, SYFOVRE, and EMPAVELI) delivered year-over-year growth, and combined growth portfolio revenue exceeded $1 billion for the quarter, surpassing Biogen's legacy multiple sclerosis franchise. Two major pipeline milestones anchored the earnings call: the FDA approved LEQEMBI IQLIK (lecanemab-irmb, a subcutaneous autoinjector formulation) for at-home initiation dosing (following the earlier approval of LEQEMBI IQLIK for maintenance dosing), enabling patient-friendly dosing throughout the treatment course; and the Apellis acquisition that closed on May 14, 2026, contributed $128 million in combined SYFOVRE (pegcetacoplan intravitreal, for geographic atrophy) and EMPAVELI (pegcetacoplan subcutaneous, for paroxysmal nocturnal hemoglobinuria and C3 glomerulopathy) revenue during the partial quarter. Biogen expects approximately 0.85 EPS dilution from the Apellis acquisition in 2026, with accretion in 2027 and estimated run-rate synergies of at least $250 million by the end of 2027. Revenue guidance raised to mid-single-digit growth, with non-GAAP EPS guidance of $12-13.

INDUSTRY

Alnylam Pharmaceuticals (NASDAQ: ALNY) Q2 2026 Earnings Preview for Thursday, July 30, Before Market Open With 8:30 AM ET Conference Call: Wall Street Consensus of $2.05 Earnings Per Share (+540.6% Year-Over-Year) on Revenue of $1.32 Billion (+70.4% Year-Over-Year), Reflecting Continued Ramp-Up of Amvuttra (Vutrisiran) for Both Hereditary Transthyretin Amyloid Polyneuropathy and Cardiomyopathy Following Q1 2026 Amvuttra Revenue of $889.9 Million (+187% YoY). Analyst Focus Includes the ALN-6222 Obesity siRNA Phase 1 Program (NCT07624071) and the ALN-2232 Phase 1 Readout Expected in H2 2026.

Alnylam Pharmaceuticals (NASDAQ: ALNY) reports Q2 2026 earnings Thursday, July 30, 2026 before market open with an 8:30 AM ET conference call. Wall Street consensus estimates: EPS of $2.05 (+540.6% year-over-year) and revenue of $1.32 billion (+70.4% year-over-year), reflecting the continued commercial ramp of Amvuttra (vutrisiran) across both hereditary transthyretin amyloid polyneuropathy (hATTR-PN) and hereditary transthyretin amyloid cardiomyopathy (hATTR-CM) following the Q1 2026 Amvuttra revenue of $889.9 million (+187% YoY). Analyst focus areas beyond the base-business ramp include: the ALN-6222 first-in-human Phase 1 obesity siRNA program (NCT07624071), which opened enrollment in July 2026 as a randomized, double-blind, placebo-controlled, single-ascending-dose study of an undisclosed-target subcutaneous siRNA in adults with BMI 30-40 kg/m²; the ALN-2232 Phase 1 obesity program (Alnylam's second obesity-track siRNA), with Phase 1 readout expected in the second half of 2026; the Alnylam-PeptiDream peptide-siRNA conjugate extrahepatic delivery platform milestone announced December 2025; and the broader Alnylam 2030 strategy launch positioning beyond the Amvuttra franchise.