Urogen Pharma Ltd. plans to launch its new product July 1 after the firm overcame a decidedly mixed FDA advisory panel meeting to nail down approval June 12 of Zusduri (mitomycin, formerly known as UGN-102), designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer. Shares of the Princeton, N.J.-based firm (NASDAQ:URGN) closed that day at $11.08, up $3.78, or 51%. The news followed the Oncologic Drugs Advisory Committee’s narrowly negative, 4-5 vote May 21 on the intravesical solution’s benefit/risk profile. The hydrogel-based formulation is delivered directly into the bladder during an outpatient procedure using a urinary catheter to enable the treatment of tumors by nonsurgical means. Urogen’s stock was trading June 13 at $12.77, up $1.69, or 15%.

Celldex’s barzolvolimab continues to impress in treating hives

Celldex Inc. presented what it termed “unprecedented” data from its 76-week phase II trial testing barzolvolimab in chronic spontaneous urticaria, or hives, with up to 41% of patients reporting a complete response and 48% reporting that their disease no longer impacts their quality of life, seven months after their last active dose. Data were presented at the EAACI Congress 2025. The company is currently enrolling patients in a phase III trial to evaluate the drug, a monoclonal antibody designed to work by binding the receptor tyrosine kinase KIT, which is expressed in mast cells that mediate in inflammatory responses such as hypersensitivity and allergic reactions.

Safety scares and trial misses drag down neuro biotechs into Q2

The BioWorld Neurological Diseases Index continued its downward slide into 2025, with 15 of the 20 component stocks posting losses. After dipping into negative territory in late February, the index dropped 15.99% by the end of March and closed May down 22.34%. In comparison, broader market benchmarks held up far better over the five-month period: The Nasdaq Biotechnology Index declined 5.37%, while the Dow Jones Industrial Average edged down just 0.64%. Several neuro-focused biopharmas saw mixed fortunes this quarter. Overall, sentiment was driven by safety events, cash runway updates and pivotal trial outcomes.

At EHA 2025, ways to bring immune therapy to AML

“The lack of therapeutic precision in treatment of myeloid malignancies is in sharp contrast with the fact that myeloid cancers represent the perhaps best-characterized cancers of all at the cellular, molecular, and genetic levels,” Johanna Olweus told her audience at the Friday plenary session of the European Hematology Association 2025 Annual Congress. In particular, while CAR T cells have transformed the treatment of B-cell lymphomas, the immunotherapy revolution has not reached acute myeloid leukemia (AML). At the meeting, Olweus and others reported on their efforts to change that.

Korea biotech roundup: four financings, six R&D deals mid-June

Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd. and Salipro Biotech AB, Next & Bio Inc. and GC Cell Corp., Galux Inc. and Hanall Biopharma Co. Ltd., Celltrion Inc. and Onconic Therapeutics Inc., and SK Plasma Co. Ltd. and Aimedbio Inc.

Pfizer’s $6.15B 3Sbio deal tops May’s biopharma activity

Biopharma deal activity continued its record-breaking pace in 2025, reaching $103.76 billion in total value through the first five months, the highest year-to-date total in BioWorld’s records. That figure marks a nearly 20% increase over the $86.68 billion recorded during the same period in 2024. The largest biopharma deal in May was Pfizer Inc.’s agreement to acquire global (ex-China) rights to SSGJ-707, a PD-1/VEGF bispecific antibody developed by 3Sbio Inc. Pfizer will pay $1.25 billion up front, with potential milestone payments reaching $4.8 billion, bringing the total deal value to as much as $6.15 billion.

Enterome raises $19M to advance non-Hodgkin lymphoma therapy

As it prepares to present the latest data from the phase I/II clinical trial of EO-2463, Enterome SA has secured $19 million to expand and complete the study, and to scope phase III development of the microbiome-derived off-the-shelf immunotherapy in the treatment of non-Hodgkin lymphoma (NHL). The financing follows on from positive recent meetings with both the FDA and the EMA, which sketched a clear path to registration for marketing authorizations in watch-and-wait indolent NHL.

Also in the news

Abbvie, ADC, Alkyon, Allarity, Alzinova, Amneal, Angitia, Arthrosi, Astrivax, Beone, Bharat, Biogen, Cabaletta, Citius, Debiopharm, Enanta, Enterome, Enyo, Galderma, Genesis, GSK, Innovia, Insmed, Intensity, Johnson & Johnson, Levicept, Merck, Neurodon, Nona, Novartis, Nurix, Nuvation, Preveceutical, Relay, Samsung Bioepis, Sanofi, Schrödinger, Scinai, Specific Biologics, Syndax, Third Harmonic, UCB, Vascarta, Visterra