Life science news 4 May 2026: Eli Lilly’s record $19.8 billion quarterly earnings, the FDA’s real-time clinical trial revolution and a landmark week for UK regulatory reform define a momentous seven days for global life science.
Eli Lilly reported worldwide revenue of $19.8 billion for the first quarter of 2026 on 30 April, a 56% increase compared with the same period a year earlier and a result that substantially beat analyst expectations. Growth was led by Mounjaro and Zepbound, with Mounjaro alone generating $8.66 billion in worldwide sales, more than doubling year-on-year. Non-GAAP earnings per share came in at $8.55 against a consensus estimate of $6.66. The company raised its full-year 2026 revenue guidance to between $82 billion and $85 billion and lifted its non-GAAP EPS guidance to a range of $35.50 to $37.00. Shares rose more than 10% on the day of the announcement.
The FDA announced on 28 April a major initiative to transform how clinical trials are conducted and regulated. Two proof-of-concept real-time clinical trials are already live: one with AstraZeneca in a Phase 2 study in mantle cell lymphoma, and one with Amgen in an early-stage lung cancer programme. Under the new model, trial endpoints and safety data are transmitted to the FDA continuously as they are generated, rather than compiled and submitted at the end of each phase. Commissioner Marty Makary noted that approximately 45% of drug development time from Phase 1 to final submission is currently spent without an active trial in progress. The FDA has also issued a Request for Information on a broader pilot programme incorporating AI for safety monitoring and dose selection, with public comments open until 29 May 2026 and pilot selections expected in August.
Also on 30 April, the FDA proposed to formally exclude semaglutide, tirzepatide and liraglutide from its 503B bulks list, the regulatory mechanism that allows large-scale compounding facilities to produce drugs from bulk substances. The agency concluded there is no clinical need for outsourcing facilities to compound these drugs, as FDA-approved versions remain commercially available. The active ingredients concerned are found in Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. If finalised, the rule would close one of the last remaining regulatory pathways for the compounded GLP-1 market that grew rapidly during drug shortages from 2022 onwards. A public comment period is open until 29 June 2026.
Seaport Therapeutics and Hemab Therapeutics priced upsized initial public offerings on 1 May, raising a combined $556 million and pushing the total raised by newly public biotech companies in 2026 to nearly $3.2 billion. Seaport, a neuropsychiatric spinout of PureTech Health developing treatments for major depressive disorder and anxiety, raised $254.9 million. Hemab Therapeutics, a rare bleeding disorder specialist whose lead candidate is the bispecific antibody sutacimig, raised approximately $301 million. Six of the ten biotechs to go public in 2026 have raised at least $300 million each, a concentration of scale not seen since the pandemic peak.
AbbVie reported first-quarter 2026 net revenues of $15.0 billion on 29 April, up 12.4% year-on-year, driven by strong growth in its immunology and neuroscience portfolios. Skyrizi and Rinvoq were the primary contributors, with the immunology portfolio generating $7.29 billion in global revenues in the quarter. Adjusted diluted EPS of $2.65 beat the analyst consensus of $2.59. AbbVie raised its full-year 2026 adjusted EPS guidance to a range of $14.08 to $14.28 and separately announced a $1.4 billion investment to build a pharmaceutical manufacturing campus in Durham, North Carolina.
The FDA approved Auvelity (AXS-05) on 30 April for the treatment of agitation in patients with Alzheimer’s disease, making it the second FDA-approved treatment specifically indicated for this condition. Developed by Axsome Therapeutics, Auvelity is an oral combination of dextromethorphan hydrobromide and bupropion hydrochloride, supported by four randomised, double-blind clinical trials. Agitation is among the most prevalent and burdensome behavioural symptoms in Alzheimer’s disease, affecting patients and carers alike.
In further life science news 4 May 2026, analysis published during the week confirmed that the pace of pharmaceutical M&A in 2026 is running at its highest level since 2019. Biopharma M&A totalled $84 billion in the first quarter alone, nearly double the $44.4 billion recorded in the same period a year earlier. If the current pace holds, full-year deal value could exceed $250 billion according to a Stifel analysis, driven primarily by the approaching loss of exclusivity for blockbuster medicines including Merck’s Keytruda, which faces patent expiry in 2028. Eli Lilly, Gilead Sciences and Merck have led acquisition spending in 2026.
The MHRA published its annual Results and Forecast report on 28 April, confirming it had met or exceeded all statutory performance targets for the 2025/26 financial year across licensing, clinical trials and safety decisions. Strategic highlights include the launch of a new MHRA-NICE aligned pathway to accelerate patient access to innovative medicines, inaugural membership of the HealthAI global regulatory network and new collaboration with the FDA on medical device regulation. The agency closed the year in a strong financial position with a healthy surplus, and announced plans to publish a new five-year strategy later in 2026, covering the period to 2030 and focused on patient safety, NHS priorities, scientific innovation and economic growth in the UK’s £100 billion life sciences sector. The MHRA’s strong year-end performance was a notable regulatory highlight in life science news 4 May 2026, reinforcing the UK’s ambition to position itself as a leading destination for pharmaceutical innovation.
The UK’s most significant overhaul of clinical trial regulation in over 20 years came into force on 28 April 2026. Introduced by the MHRA and Health Research Authority, the reforms establish faster assessment routes for first-in-human trials, a new fast-track notifiable trials pathway for lower-risk studies, and create a legal requirement for the first time in the UK to register all clinical trials in a public registry and publish results within 12 months of completion. Combined MHRA and HRA review times have already fallen from 169 days to 122 days during the implementation period. The government described the package as a significant step in strengthening the UK’s position as a global destination for clinical research.
That’s your life science news digest for 4 May 2026, back next Monday with the latest from pharma, biotech and healthcare. For daily updates from across the global pharmaceutical and biotech industry, visit www.lifesciencedaily.news.
Missed last weeks roundup – view it here Weekly News Roundup 27 April 2026
This weekly digest is produced by the Life Science Daily News editorial team. All stories are selected and written independently.
