Although analysts liked the data – calling them “truly amazing” and “transformational” – Wall Street apparently had qualms about three cancer cases that turned up in phase III top-line data from the Abtect maintenance trial with obefazimod. Paris-based Abivax SA’s oral, first-in-class miRNA-124 enhancer performed well in adults with moderately to severely active ulcerative colitis (UC), but shares of (NASDAQ:ABVX) closed June 2 at $72.50, down 44%, or $57.19. Read More
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. Read More
Minneapolis-based Celcuity Inc. was like the Rolling Stones at the 2026 American Society of Clinical Oncology annual meeting. The company reported positive phase III data for its pan-PI3K/mTORC1/2 inhibitor gedatolisib, but Celcuity (NASDAQ:CELC) couldn’t get any satisfaction from investors who sent shares down 25.7%, or $31.54, to $91.42 on June 2, 2026. Read More
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. Read More
IMU Biosciences 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. Read More
The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16. Read More
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. Read More
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. The company is investigating the use of TUNE-401 as a potential treatment for hepatitis B. Read More
Rather than reinventing 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 their products across multiple stages of development. Read More
Shares of Fulcrum Therapeutics Inc. (NASDAQ:FULC) fell 54% after the company said it is discontinuing work on sickle cell disease (SCD) candidate pociredir, its only clinical-stage candidate, and reviewing strategic alternatives in the wake of the U.S. FDA’s safety concerns regarding the drug target. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Akeso, Astrazeneca, Biogen, Cstone, Dizal, Grail, Idorsia, Immuneering, Jada, Kelonia, Kelun, Oculis, Revolution, Serac, Skyhawk, Summit, TG, UCB. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Agios, Avenzo, Biond, Circio, Disc, Genassist, Lixte, Oscotec, Pantherna, Rallybio, T-Curx. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: BMS, Cercare, Foundation, Haisco, Kamada, Mannkind, Nouscom, Outlook, Polypid, Shionogi, Surgentec, Vertex, Wockhardt. Read More
