Shares of Abivax SA (NASDAQ:ABVX) were trading at $78.98, down 39%, or $50.72, on what the firm characterized as positive top-line data from the phase III Abtect maintenance trial with obefazimod, its oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis. The 25-mg and 50-mg doses of obefazimod met the primary endpoint of clinical remission and all key secondary endpoints at week 44. Wall Street was apparently put off by three cases of malignancies other than non-melanoma skin cancer in the 50-mg cohort: one prostate (which was disclosed during the induction period), one breast and one instance of colonic dysplasia, whereas none turned up in the 25 mg or placebo cohorts.

Travere expands rare kidney portfolio in $1B+ Everest deal

Less than two months after winning FDA approval for a second indication for Filspari (sparsentan), Travere Therapeutics Inc. added to its rare kidney disease pipeline by exclusively licensing civorebrutinib from Everest Medicines Ltd. in a deal that could be worth more than $1.14 billion. The financials include a $112.5 million up-front payment to Everest, with Travere gaining exclusive development and commercialization rights to the oral, covalent reversible BTK inhibitor in all markets outside of China and certain East and Southeast Asia countries. Everest also could earn up to $1.03 billion in milestone payments, plus royalties. Initial efforts will focus on primary membranous nephropathy, an immune-mediated kidney disease for which Everest has generated proof-of-concept data.

ASCO 2026: Celcuity’s positive phase III gets no love from investors

Celcuity Inc. reported positive phase III data for its pan-PI3K/mTORC1/2 inhibitor gedatolisib in the phase III Viktoria-1 study of patients with HR+, HER2-, PIK3CA mutated, locally advanced or metastatic breast cancer. When combined with fulvestrant and palbociclib, the triplet reduced the risk of disease progression or death by 50% compared to alpelisib plus fulvestrant. The doublet of gedatolisib and fulvestrant also performed well, showing a 49% reduction in the risk of disease progression or death compared to the same control. But shares of Celcuity (NASDAQ:CELC) were down 24% in midday trading due to high expectations for both a larger increase in progression-free survival (PFS) over the control arm, which could affect adoption, and a lower-than-expected length of PFS for the doublet and triplet, which will affect duration of use.

Drugmakers go ‘WEE1’ for early data

At the 2026 American Society of Clinical Oncology annual meeting, multiple companies presented data for their drugs targeting WEE1, a checkpoint for the transition from G2 into mitosis. Aprea Therapeutics Inc. presented phase 1 data for its WEE1 inhibitor APR-1051 in patients with advanced solid tumors showing two patients with endometrial cancers achieved partial responses in the dose-escalation study. Likewise, Zentalis Pharmaceuticals Inc. had tantalizing early results from a phase Ib study showing azenosertib plus paclitaxel in patients with platinum-resistant ovarian cancer produced an overall response rate of 39% with a median progression-free survival of 7.3 months.

IMU’s $53M series A to advance high definition immune profiling tech

IMU Bioscience Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company’s formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world’s largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts. The profiles are compiled by interrogating multiomics data from blood samples with IMU’s machine learning analytics. A single blood sample generates more than 100 million datapoints, creating what the company said is the most detailed picture of the human immune system to date.

FDA clears Shionogi’s Xocova as first COVID-19 prevention pill

The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic (PEP) option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16. Japanese regulators first granted emergency approval to the oral antiviral as a treatment for COVID-19 in November 2022, followed by full approval in March 2024. Japan’s Ministry of Health, Labour and Welfare cleared Xocova as a PEP therapy in March 2026.

China deals highlight biopharma evolution – LEK

In 2025, China’s outbound life sciences and biopharma deals reached nearly $100 billion, about 12 times the level seen in 2021, underscoring how quickly global appetite for Chinese assets has accelerated, according to a recent report by L.E.K. Consulting. “Today we can safely say that Chinese innovation has arrived,” said Helen Chen, L.E.K.’s global sector co-head of healthcare and life sciences and author of the report titled, “Outbound ‘Newcos’ Created from Chinese Innovative Biopharma Assets.” The momentum reflects a two-decade evolution in China’s drug industry, moving from “me-too” products in the 2000s to fast-followers in the 2010s and now to first- and best-in-class innovation that is increasingly competitive on the global stage.

EASL spotlight: TUNE-401 advances epigenetic silencing in HBV

Several presentations at EASL highlight a new generation of therapies coming into view, with the work from TUNE Therapeutics Inc. standing out as one of the most relevant for the novelty it represents and the step forward it signals. During a late-breaking session closing this year’s EASL meeting, Edward Gane, professor of medicine at the University of Auckland and a leading hepatologist, presented results from the phase Ib/IIa proof-of-concept TUNE-401-001 study.

FDA advises leveraging what’s already known in gene therapy R&D

Rather than re-inventing the wheel for every gene therapy that uses genome editing, the U.S. FDA is advising sponsors on leveraging existing knowledge, be it publicly available or platform-based, to more efficiently advance the development of their products. The agency issued a draft guidance today outlining how sponsors can use available information – including chemistry, manufacturing and controls data, nonclinical study results and clinical information – to streamline regulatory submissions for gene therapies that use genome editing, both ex vivo and in vivo, in human somatic cells.

Also in the news

Actinium, Aditxt, Agios, Akeso, Astrazeneca, Avenzo, Biogen, Biond, BMS, Briacell, Cercare, Circio, Cstone, Defence, Disc, Dizal, Foundation, Fractyl, Genassist, Grail, Haisco, Idorsia, Immuneering, Jada, Kamada, Kelonia, Kelun, Lixte, Lungpacer, Mannkind, Nouscom, Oak Hill, Oculis, Oscotec, Outlook, Pantherna, Polypid, Rallybio, Revolution, Serac, Shionogi, Skyhawk, Summit, Sunshine, Surgentec, T-Curx, TG, UCB, Vertex, Wockhardt, Yoltech