Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.

Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
Celldex’s urticaria candidate impresses in post-treatment findings
Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
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%.
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.
Today's news in brief
BioWorld briefs for June 13, 2025.
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.
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.

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Analysis and data insight

Another BiTE in autoimmune: Cullinan deals $712M for Genrix asset
Deals and M&A
Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma-targeting BCMAxCD3 bispecific T-cell engager (BiTE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race
Clinical
3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock
Deals and M&A
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
Biopharma financings rise to $5.55B in May, with VC deals at $1.83B
Financings
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.

Financings

Startup Elkedonia raises €11M to advance neuroplastogen in depression
Newco news
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which...

Science

Gut microbiome leads to metabolic and immune changes after transplant
Gastrointestinal
Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions to analyze the microbiome differences and their effects after...

Open-source AI model can predict small-molecule binding affinity
Artificial intelligence
Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI model that can predict the binding strength of small molecules as well as structures of proteins and biomolecular complexes. The model, which is called Boltz-2 and was...
Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes
Cancer
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...

Newco news

Corestemchemon preps US BLA filing for stem cell ALS therapy
Clinical
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that...
Signify Bio’s $15M round advances in situ protein therapeutics
Protein
Turning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which emerged with an oversubscribed $15 million initial financing to advance three platforms with broad potential across therapeutic areas.
Nibec stock soars 30% on $435M peptide deal with US biotech
Deals and M&A
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
Epimab sells bispecific T-cell engager to Juri in $210M deal
Analysis and data insight
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
Alteogen merges two subsidiaries, forming Alteogen Biologics
Analysis and data insight
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.

U.S.

23andme genetic privacy concerns garner Congressional scrutiny
Policy
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.

Europe

EMA: New clinical guideline includes pregnant, breastfeeding patients
Clinical
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.

Korea pharma exports rise to quarterly high of $2.5B in Q1
Analysis and data insight
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of...
Pharma execs speak out: UK pricing rebates scare investors
Regulatory
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.

Clinical

In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol
Cardiovascular
In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The...
Regenxbio’s Duchenne gene therapy data positive as shares falter
Musculoskeletal
Regenxbio Inc.’s gene therapy in treating Duchenne muscular dystrophy (DMD) produced positive initial phase I/II results from its first five patients. However, the company’s stock (NASDAQ:RGNX) shuddered on June 5 as shares closed at $8.36 each, a...
ASCO 2025: Dizal's new chemical entities for lung, blood cancers
Conferences
Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors,...
Kymera’s phase I data lead big week for STAT6 space
Gastrointestinal
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a...
Next IgAN contenders line up; Vera preps a BLA for atacicept
Immune
With a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults.
ASCO 2025: Verastem has positive cancer data but stock sags
Conferences
New dose-escalation data from Verastem Oncology’s phase I/II cancer study in China prompted the company to say it was encouraged by the efficacy results. However, investors felt otherwise, as the stock lost about 20% of its value the day the...

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

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