The BioWorld Biopharmaceutical Index (BBI) extended its downward trend over April and May, closing the latter month down 6.47% after reaching a peak gain of 9.64% at the end of February. Stock movements among BBI companies were largely driven by first-quarter financial results and clinical updates. Incyte Corp. gained on the back of strong earnings and product performance, while Sarepta Therapeutics Inc. and Apellis Pharmaceuticals Inc. declined following disappointing Q1 reports.

EMA warns Ozempic linked to ‘very rare’ side effect

The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy (NAION) is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.” That “very rare” designation has translated into a doubling in the number of cases in Denmark, where the incidence of NAION increased from 67.6 per year in 2018, when Ozempic was approved, to 148 per year in 2024.

Allay’s $57.5M extends postsurgical pain relief with ATX-101

As it advances its analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, is designed to offer non-opioid pain relief following total knee arthroplasty. The series D consists of $45 million in funding received in January, plus $12.5 million raised more recently. It will help the company to “complete that phase IIb study,” Adam Gridley, Allay’s president and CEO, told BioWorld. “We started that in February of this year. We should complete enrollment in the next month or so.” Data, if positive, in the fourth quarter of 2025 would lead to a phase III study beginning in mid-2026, followed by results in 2027 and a possible 505(b)(2) NDA filing with the U.S. FDA thereafter.

Microneedles could solve vaccine distribution challenges

Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology. The challenge for low- and middle-income countries is the delivery of vaccines, because they require a cold chain, and that requires a large infrastructure to ship, store and deliver vaccines while maintaining the right temperature along each part of that journey. Microneedles have the potential to change this landscape, because the microarray patch technology allows the vaccine to be embedded in the micro patch, which is applied to the dermal layer of the skin and then thrown away. It doesn’t require trained personnel to deliver, and the technology makes the vaccine itself more stable.

Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes

Researchers from the University of Arizona have unveiled that coordinated Y chromosome loss in both cancer cells and immune cells may explain the worse prognosis in people with this alteration. The loss of the Y chromosome (LOY) is one of the most frequent somatic mutations in men, particularly with advancing age. More specifically, LOY shows increasing prevalence in circulating blood cells, affecting around 2.5% of 40-year-old men and up to 40% of 70-year-old men. This alteration has been linked to elevated risk for numerous age-related conditions, including cardiovascular disease, neurodegenerative disorders and more.

Biopharma financings rise to $5.55B in May, with VC deals at $1.83B

Biopharma financings totaled $21.38 billion through May 2025, down sharply from $62.57 billion during the same period in 2024, but roughly in line with levels seen in 2023 and 2022. Biopharma companies raised $5.55 billion in May, more than doubling the $2.4 billion raised in April.

Also in the news

Alvotech, Akeso, Avadel, Basilea, Casma, Cellectar, Corcept, Cullinan, Dr. Reddy’s, Duality, Formycon, Genrix, Harmony, Hutchmed, Immunic, Immunoprecise, Innovent, Kailera, Lupin, Maia, Neurop, Novartis, Ocugen, Orca, Pincell, Pfizer, Qure, Regenxbio, Scinai, Sellas, Seyltx, Shuttle, Sydnexis, Telix, Tempest, Tirmed, Vigeneron