FDA approves Omeros’ Yartemlea for stem cell patients
The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.

FDA approves Omeros’ Yartemlea for stem cell patients
The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.
Sanofi paying $2.2B for Dynavax; tolebrutinib CRL lands
Reporting sales of its hepatitis B vaccine Heplisav-B pretty much in line with consensus and a phase I/II shingles prospect moving along, Dynavax Technologies Corp. scored a takeover deal with Sanofi SA, which is paying $15.50 per share in cash for a total equity value of about $2.2 billion. The amount is a 39% premium to Dynavax’s closing share price yesterday, Dec. 23.
Hanx Bio sees stock drop 46% in $75M Hong Kong IPO debut
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. raised HK$586 million (US$75.37 million) in its IPO on the Hong Kong Securities Exchange (HKEX:3378) on Dec. 23 to advance its clinical stage immuno-oncology pipeline.
CMS to cross threshold of obesity drug coverage
In a threshold event in the U.S., Medicare is planning to break through its obesity coverage barrier with a voluntary test of a model designed to enable Medicare Part D plans and state Medicaid programs to cover GLP-1 drugs prescribed for weight management.
Today's news in brief
BioWorld briefs for Dec. 24, 2025.
Trump trade and pricing policies piled pressure on Europe in 2025
After an all-night negotiating session that concluded after 5 am on Dec. 12, political agreement was finally reached on the long-awaited EU pharmaceutical legislation. The aim of the new rules is to improve patient access and increase the competitiveness of the sector, but for the industry, it was too little too late in terms of the incentives, and potentially damaging in the measures to improve access.
Gene therapy genie back in the bottle?
Gene therapy has had its commercial struggles in the past year. The cost to patients is in the millions and fewer are stepping forward for treatment than companies would like. While development continues in this game-changing field, some have struggled with regulatory authorities during development while others have just stepped away altogether.
MASHup: Liver disease brings diverse players to table
The year 2025 proved especially active with regard to deals that centered on the indication previously known as nonalcoholic steatohepatitis (NASH).
Top reads 2025
Our 10 most viewed articles of the year.
Holiday notice
BioWorld's offices will be closed in observance of Christmas. No issues will be published Thursday, Dec. 25 or Friday, Dec. 26.

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Analysis and data insight

Big pharma taps fast Asia innovation in search of next Keytruda
Deals and M&A
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.
Rare diseases drive November’s US drug approvals
Regulatory
The U.S. FDA approved 18 drugs in November, down from 20 in October, bringing the total number of clearances to 199 through the first 11 months of the year. The number is about 5% lower than the 209 approvals recorded over the same period in 2024 but more than every prior year.
B7-H3 money tree? Target catching on in ADCs
Cancer
Focused on antibody-drug conjugates (ADCs), Neok Bio Inc. made a moderate splash by emerging from stealth mode in November with a $75 million series A financing led by Abl Bio Inc. – and one aspect of its drug development is gaining momentum in various other quarters, including big pharma.
Clinical momentum lifts biopharma stocks into year-end
The BioWorld Biopharmaceutical Index extended its autumn rally after a more modest September, finishing November up 23.41% for the year. The gain lagged the Nasdaq Biotechnology Index, which surged 34.97% in the first 11 months of the year, but outpaced the broader Dow Jones Industrial Average,...

Financings

Top financings 2025
IPO
IPOs, follow-ons, private placements and VCs this year.

Science

In 2025, science’s biggest story was political
Regulatory
In 2025, science saw its breakthroughs, which BioWorld will be covering as part of our end-of-the-year wrap-up. But the biggest science story of 2025 is not about any scientific advance. It is the politicized destruction of U.S. science, and the dismantling of a scientific ecosystem that has been...

HIV research is close to a cure but far from ending the pandemic
Immune
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their blood. Yet that reality is limited to those with access to treatment. More than 40 million people worldwide live with HIV, with over a...
Alltrna advances tRNA-based strategy for stop codon diseases
Drug design, drug delivery and technologies
Gene editing can repair mutations that prematurely halt protein synthesis, resulting in incomplete peptides that cause various diseases. However, other approaches achieve the same effect without altering the genome. Startup Alltrna Inc. has developed a strategy based on transfer RNA to bypass the...

Newco news

Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery
Protein
Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.
Laigo raises €11.5M seed money for targeted protein degradation
Financings
Laigo Bio BV has raised €11.5 million (US$13.7 million) in a seed round for the further development of a new approach to inducing targeted protein degradation by E3 ubiquitin ligases.
Myrio first to develop binders with high affinity/specificity
Clinical
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Azalea exits stealth to develop its in vivo gene engineering technology
Financings
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
Neok Bio launches with $75M to develop bispecific ADCs
Financings
Neok Bio Inc. was formed earlier this year and is already on schedule to file an IND in a few months for its two bispecific antibody-drug conjugates (ADCs) to treat various types of tumors.

U.S.

Hemophilia trial death with Pfizer’s Hympavzi under scrutiny
Clinical
In a letter to the hemophilia community, Pfizer Inc. reported a death due to cerebellar infarction and subsequent cerebral hemorrhage in a long-term extension trial participant taking the New York-based company’s tissue factor pathway inhibitor antagonist Hympavzi (marstacimab).

Europe

Vitesse finesse pays off: DBV wins in peanut allergy phase III
Clinical
DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S. FDA in the first half of next year. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Dec. 17 at $22.55, up $4.57, or 25%, on...

EU agrees to pharma legislation, but the industry isn’t happy
Regulatory
The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.
Perseus phase III fails to head off MS, review delayed: Sanofi
Clinical
Sanofi SA reported more hitches in the development of Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis (MS) and that the ongoing U.S. regulatory review in non-relapsing secondary...

Clinical

Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer
Cancer
Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5...
Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints
Imaging
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate)...
Immunome’s phase III results in desmoid tumors point to NDA
Cancer
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral...
Arcus shifts effort, bears down on would-be ‘anchor’ in RCC
Cancer
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
Rezolute’s lone drug misses a phase III
Endocrine/metabolic
Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary endpoints in treating the ultra-rare disease...
Lilly’s retatrutide shows solid weight loss, reduced knee pain
Endocrine/metabolic
Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain.

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