The first half of 2026 delivered one of the most consequential periods in recent biopharma history, reshaping competitive landscapes through record dealmaking, landmark regulatory approvals, and pivotal clinical breakthroughs. This biopharma H1 2026 review examines the transactions, therapies, and pipeline developments that defined the opening six months of the year, from Eli Lilly’s acquisition spree to the first successful Phase 3 trial of an in vivo CRISPR gene editing therapy.
Dealmaking Reaches Historic Levels
Mergers and acquisitions surged to levels not seen in years, with 52 transactions completed in the first half of 2026 alone, up from roughly 30 in the same period of 2025. According to STAT News, total deal value across 33 acquisitions valued at one billion dollars or more reached approximately $134 billion by late June, surpassing the full-year 2025 total of $112 billion in just six months.
Eli Lilly emerged as the most prolific acquirer, committing an estimated $25 billion across ten deals. The Indianapolis-based company used its GLP-1 revenue windfall to fuel a diversification push spanning oncology, neuroscience, and cell therapy. Among its largest transactions was the $7.8 billion acquisition of Centessa Pharmaceuticals agreed on 31 March, securing cleminorexton, an orexin 2 receptor agonist in Phase 2a development for narcolepsy and idiopathic hypersomnia. In April, Lilly agreed to acquire Kelonia Therapeutics for up to $7 billion, including $3.25 billion upfront, gaining access to an in vivo CAR-T platform designed to reprogramme T cells inside the body with a single infusion. BioWorld characterised Lilly’s campaign as a GLP-1 fuelled “land grab” across ten deals.
Oncology and Immunology Drive the Largest Single Transactions
Beyond Lilly’s portfolio approach, several individual mega-deals reshaped specific therapeutic areas. India’s Sun Pharma agreed to acquire Organon for $11.75 billion, gaining a leading position in women’s health and biosimilars in what became one of the largest cross-border pharmaceutical transactions of the year.
GSK announced the acquisition of Nuvalent for $10.6 billion in aggregate equity value on 9 June 2026, strengthening its lung cancer pipeline with zidesamtinib (a ROS1 inhibitor under FDA review) and neladalkib (an ALK inhibitor with an FDA target date of November 2026). Luke Miels, Chief Executive Officer of GSK, stated:
“Today’s acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap.”
AbbVie closed the half with its $10.9 billion agreement to acquire Apogee Therapeutics, announced on 22 June 2026, deepening its immunology franchise with zumilokibart, a late-stage monoclonal antibody targeting IL-13 for atopic dermatitis. Robert A. Michael, Chairman and Chief Executive Officer of AbbVie, said:
“The acquisition of Apogee further builds on our existing leadership, strengthening our ability to deliver innovative medicines to patients who need better options.”
Gilead Sciences also moved aggressively, spending $15 billion across three acquisitions. Its $7.8 billion purchase of Arcellx, completed in April, secured anito-cel, an investigational BCMA-directed CAR T-cell therapy for relapsed or refractory multiple myeloma with an FDA decision anticipated in December 2026. Gilead CEO Daniel O’Day stated: “This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients.” Gilead also acquired Ouro Medicines for $2.2 billion, gaining a T-cell engager platform for autoimmune disorders, and Tubulis for $5 billion, adding a potentially best-in-class antibody-drug conjugate platform to its oncology pipeline.
Merck completed its $6.7 billion acquisition of Terns Pharmaceuticals in May, gaining TERN-701, a novel candidate for chronic myeloid leukaemia, as it prepares for the looming Keytruda patent cliff. BMO Capital Markets characterised the deal as “one of the best deals [Merck] has made since its spree began ahead of the Keytruda” patent expiry.
Biopharma H1 2026 Review: 26 Novel FDA Approvals
The US Food and Drug Administration approved 26 novel therapies during the first half of 2026, seven more than the same period in 2025, with oncology and rare diseases dominating the approval landscape. Including supplemental approvals and label expansions, the total reached 79 actions across the six months.
AstraZeneca led all companies with six FDA approvals, including supplementals, in H1 2026, while Johnson and Johnson secured five, including Icotyde (icotrokinra), a peptide pill for moderate-to-severe plaque psoriasis co-developed with Protagonist Therapeutics.
Among the most significant approvals, Lilly’s Foundayo (orforglipron) received FDA clearance on 1 April 2026, becoming the first oral GLP-1 receptor agonist approved for weight management in adults with obesity that can be taken at any time of day without food or water restrictions. The approval marked a pivotal moment in the obesity treatment landscape, potentially broadening patient access beyond injectable formulations.
In rare diseases, Denali Therapeutics’ Avlayah (tividenofusp alfa) gained approval in March as the first treatment addressing the neurological complications of Hunter syndrome. Regeneron’s Otarmeni, the first gene therapy targeting an underlying cause of deafness, also secured approval, representing Regeneron’s first approved gene therapy product.
Other notable approvals included Baxfendy (baxdrostat), the first aldosterone synthase inhibitor approved for hypertension treatment in May, and Hepcludex (bulevirtide), approved for chronic hepatitis delta virus infection. The most recent approval at the time of writing was Trutakna (atacicept) on 7 July 2026, for reducing proteinuria in adults with primary immunoglobulin A nephropathy.
Pipeline Breakthroughs and Clinical Milestones
The first half of 2026 produced several clinical results with the potential to reshape entire therapeutic categories. Most notably, Intellia Therapeutics reported positive Phase 3 results for lonvo-z (lonvoguran ziclumeran) in hereditary angioedema on 27 April 2026, marking the first successful late-stage trial of an in vivo CRISPR gene editing therapy. The study demonstrated an 87% reduction in attacks versus placebo, with 62% of patients remaining entirely attack-free over six months compared to 11% in the placebo group. Dr John Leonard, Intellia’s President and Chief Executive Officer, described the results as representing “a potential paradigm shift” for patients who have spent years battling unpredictable breakthrough swelling attacks. A rolling BLA submission has been initiated, with a US launch anticipated in the first half of 2027.
The GLP-1 competitive landscape also shifted significantly during the period. Novo Nordisk’s CagriSema combination failed a head-to-head Phase 3 comparison with Lilly’s tirzepatide in February, triggering a 15% decline in Novo’s share price and handing Lilly a decisive competitive advantage in the obesity therapeutics space.
Earlier setbacks in the field, including a serious adverse event that paused Verve Therapeutics’ VERVE-101 base-editing trial in 2024, underscore the irreversibility risks associated with gene editing approaches, even as Intellia’s results mark a significant step forward for the platform.
Capital Markets Recovery and Biotech IPO Surge
The dealmaking surge coincided with a broader recovery in biotech capital markets. IPO fundraising exceeded the full-year 2025 total within six months, led by Kailera Therapeutics’ $625 million debut, at the time the largest biotech IPO on record. Parabilis Medicines followed with an approximately $670 million offering, while Isomorphic Labs secured a $2.1 billion Series B round, among the largest ever for an AI drug discovery company.
The IPO window reopening reflected renewed investor confidence driven in part by the M&A supercycle itself. As acquirers paid premium valuations for clinical-stage assets, public market investors grew more willing to back earlier-stage companies with novel platforms. Rising IPO filings and early-stage fundraising rounds among biotechs suggested the momentum would extend into the second half. For a deeper analysis, see our earlier coverage of the biotech IPO surge in 2026.
Asia-Pacific Innovation Reshapes Global Pipelines
A notable theme running through the biopharma H1 2026 review was the growing centrality of Asia-Pacific innovation to global drug development strategies. Chinese out-licensing deals reached $137.7 billion in 2025 and were on pace to surpass that figure in 2026. AstraZeneca licensed obesity candidates from CSPC Pharmaceutical for up to $18.5 billion, illustrating how multinational companies increasingly view China not merely as a manufacturing base but as a source of novel therapeutic innovation.
UCB completed two acquisitions during the period, paying $2.2 billion for Candid Therapeutics (autoimmune focus) and $1.15 billion for Neurona Therapeutics (epilepsy), further demonstrating the appetite for innovative science regardless of geography.
Regulatory and Policy Shifts
The regulatory environment itself underwent significant change in the first half of 2026. A presidential proclamation in April imposed Section 232 tariffs on patented pharmaceuticals, with a default 100% rate reduced to 20% for companies with approved onshoring plans and 0% for those also entering most-favoured-nation pricing agreements. Seventeen major manufacturers were named in the initial tranche. A new National Priority Voucher programme compressed review timelines to one to two months for designated therapies. At the leadership level, Marty Makary resigned as FDA Commissioner after 13 months, with Kyle Diamantas assuming the acting role.
Looking Ahead
The first half of 2026 established a pace of activity that will be difficult to sustain but has fundamentally altered the competitive dynamics of the industry. The second half carries a dense calendar of catalysts. GSK’s zidesamtinib faces a PDUFA target date of 18 September for ROS1-positive lung cancer, with neladalkib following in November. Gilead’s anito-cel, the BCMA CAR-T therapy acquired through the Arcellx deal, has a decision date of 23 December. Novo Nordisk’s CagriSema is expected to receive an FDA decision in Q4, testing whether its placebo-controlled data can secure approval despite the REDEFINE 4 head-to-head setback. Meanwhile, Intellia plans to complete its rolling BLA submission for lonvo-z in the second half, setting up a potential US launch in early 2027 for what would be the first approved in vivo CRISPR gene editing therapy. Several billion-dollar deals, including GSK/Nuvalent and AbbVie/Apogee, remain subject to regulatory clearance and shareholder approval. On the policy side, Section 232 pharmaceutical tariffs take effect on 31 July for the 17 companies named in the initial tranche, with the broader industry facing a 29 September deadline. The biopharma H1 2026 review confirms that the industry’s strategic posture has shifted decisively from caution to conviction, driven by patent cliffs, revenue windfalls, and a renewed appetite for innovation at scale.
For related coverage, see our earlier analysis: Biopharma M&A 2026: Every $1B+ Deal and the Drivers.
