Weekly international regulatory approvals, licensing collaborations, mergers & acquisitions, clinical developments, and financial performance of leading global pharmaceutical companies — July 20–26, 2026

• Merck & Co.: On July 21, Gilead Sciences and Merck announced that detailed results from the Phase III ISLEND-1 and ISLEND-2 clinical trials will be presented for the first time at the 26th International AIDS Conference. At Week 48, the primary endpoint results showed that the once-weekly oral single-tablet HIV treatment regimen—comprising islatravir 2 mg and lenacapavir 300 mg—was effective in adult HIV-infected patients whose viral load was already suppressed and who had switched from globally recommended standard-of-care regimens: BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) (ISLEND-1), or other standard daily oral antiretroviral regimens (ISLEND-2). In ISLEND-1, the combination therapy demonstrated non-inferiority to BIKTARVY in maintaining virologic suppression at Week 48; none (0%) of participants who switched to the combination had HIV-1 RNA ≥50 copies/mL at Week 48, versus one (0.3%) in the group continuing BIKTARVY. In ISLEND-2, the combination also demonstrated non-inferiority to daily standard oral HIV therapy at Week 48: 0.3% of participants receiving the combination had HIV-1 RNA ≥50 copies/mL, compared with 1.3% in the group continuing standard antiretroviral therapy. Lenacapavir’s multi-stage mechanism of action distinguishes it from other approved antiretroviral drug classes. While most antiretrovirals target only a single stage of viral replication, lenacapavir is designed to inhibit HIV activity across multiple stages of its life cycle and, in vitro, shows no known cross-resistance to other existing antiretroviral drug classes. Islatravir (MK-8591), developed by Merck, is a potent next-generation nucleoside analog that blocks HIV-1 replication through multiple mechanisms—including inhibition of reverse transcriptase translocation leading to immediate chain termination, and induction of structural alterations in viral DNA (delayed chain termination). • AbbVie: On July 23, Genmab A/S and AbbVie announced results from the Phase III EPCORE DLBCL-1 study evaluating subcutaneous epcoritamab—a T-cell–engaging CD3×CD20 bispecific antibody—as monotherapy versus investigator-selected immunochemotherapy regimens (rituximab + gemcitabine + oxaliplatin, or bendamustine + rituximab) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplantation. Preliminary results were first disclosed on January 16, 2026, and additional data were presented at the European Hematology Association (EHA) 2026 Annual Congress on June 12, 2026.

Weekly international regulatory approvals, licensing collaborations, mergers & acquisitions, clinical developments, and financial performance of leading global pharmaceutical companies — September 6, 2026

• Vertex Pharmaceuticals: On September 1, Vertex announced the successful completion of its acquisition of Crinetics Pharmaceuticals, Inc., a biopharmaceutical company focused on novel therapies for endocrine disorders. As announced on July 6, 2026, Vertex will acquire Crinetics for a total equity value of approximately $10 billion, with a net purchase price of approximately $8.8 billion after deducting expected cash on Crinetics’ balance sheet. Beyond adding several other pipeline assets, the acquisition brings PALSONIFY (paltusotine) and atumelnant into Vertex’s portfolio. PALSONIFY is the first and only once-daily oral therapy approved for acromegaly in the U.S. and authorized in the EU, and is currently under review by other regulatory authorities worldwide. Atumelnant is a once-daily oral corticotropin-releasing hormone (CRH) receptor antagonist (targeting ACTH signaling) currently in Phase 3 clinical development for congenital adrenal hyperplasia (CAH) and Phase 2 for Cushing syndrome. Clinical developments: • AbbVie: On September 3, AbbVie announced preliminary positive results from the Phase 3 CERVINO study evaluating etentamig—a investigational BCMA×CD3 bispecific T-cell–engaging protein—versus standard-of-care therapy in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). The study met both co-primary endpoints: objective response rate (ORR) and progression-free survival (PFS). Full results will be presented at the 23rd International Myeloma Society Annual Meeting. The Phase 3 CERVINO trial enrolled 393 patients, who had received a median of three prior lines of therapy. With a median follow-up of 11.4 months, etentamig demonstrated statistically and clinically meaningful efficacy: ORR was significantly higher than standard therapy (74.0% vs. 45.7%); PFS was significantly improved (hazard ratio = 0.40); and 12-month overall survival (OS) was 87.9% in the etentamig arm versus 72.0% in the control arm. At the time of data cutoff, the prespecified OS efficacy boundary had not been crossed. Etentamig comprises a low-affinity CD3-binding domain (designed to reduce cytokine release syndrome [CRS] and infection risk), a high-affinity bivalent BCMA-binding domain, and retains FcRn-binding capacity—enabling monthly (every-4-weeks) dosing following a single step-up dose. • GlaxoSmithKline: On September 1, GlaxoSmithKline presented positive Phase II data for its mRNA seasonal influenza vaccine candidate at the 13th OPTIONS Conference on Influenza Prevention. The candidate elicited higher immune responses against all tested influenza strains—compared with both licensed standard-dose and high-dose inactivated influenza vaccines—in both younger and older adult populations, and demonstrated favorable overall tolerability. This is the first mRNA influenza vaccine targeting both hemagglutinin (HA) and neuraminidase (NA)—the two major surface antigens responsible for influenza virus binding and transmission.

European Shares Rise as Genmab Surges on AbbVie Drug Trial Results

1 day ago

European stocks rose near one-week highs led by Genmab, which surged 7.6% after positive late-stage trial results for its blood cancer drug combo with AbbVie. The healthcare sector advanced as bond yields eased amid regional economic concerns.

reuters

2026-10-06

European Shares Rise as Genmab Surges on AbbVie Drug Trial Results

European Shares Rise as Genmab Surges on AbbVie Drug Trial Results

FAQ