Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy. Previously known as Orca-T, Tregzi is indicated for use in matched-donor HSCT with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-vs.-host disease (GVHD)-free survival, in the treatment of adults with hematological malignancies such as acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome and mixed-phenotype acute leukemia. Orca Bio submitted the BLA in 2025 based on data from the phase III Precision-T trial.

Pancreatic phase IIa outcome boosts Can-Fite

Shares of Ramat Gan, Israel-based Can-Fite Biopharma Ltd. (NYSE:CANF) were trading at $4.53, up $1.56, or 52%, after the company said its phase IIa study evaluating namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) achieved its primary safety endpoint and turned up durable overall (OS) survival outcomes, with median OS extending past five months. The open-label experiment enrolled 20 patients with advanced disease who had progressed despite standard therapies. Fourteen PDAC patients were given the drug as third-line treatment, five as second-line, and one as fourth-line. Described as a small orally bioavailable therapy that binds with high affinity and selectivity to the A3 adenosine receptor, namodenoson proved well-tolerated in the latest effort, with a safety profile similar to previous studies.

In 2nd deal of week, Ipsen buys Memo’s kidney transplant antibody

Ipsen SA announced its second acquisition of the week, saying it will pay €700 million (US$797 million) for Memo Therapeutics AG and its phase III-ready drug potravitug, a treatment for BK virus-associated infections and nephropathy in immune-compromised kidney transplant patients. Shareholders in Zurich-based Memo will receive €200 million on closing, with the €500 million balance tied to onward clinical development, marketing approval and sales milestones. Although technically Ipsen is acquiring Memo, all other assets apart from potravitug and staff working on that program are to be spun into a newly-formed company, Memorises Bio AG, which will be owned by Memo’s existing shareholders.

China trial retractions put data transparency in spotlight

As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims. As previously reported by BioWorld, Nature Medicine retracted a paper on the phase III Lungtime-C01 study that claimed that administering PD-1 immunotherapy before 3 p.m. could nearly double progression-free survival in advanced non-small-cell lung cancer. Just four months after publication, the journal retracted the paper after identifying major inconsistencies in trial registration, study protocols and reported data patterns. Retraction Watch co-founder Ivan Oransky, who is also executive director of The Center for Scientific Integrity, said the speed of the retraction was unusual and, in one sense, encouraging. “The average retraction still takes years,” Oransky told BioWorld.

Some clinical trials in China under US congressional scrutiny

The House Select Committee on China launched an investigation into clinical trials U.S. companies are conducting at Chinese military hospitals and in Xinjiang, China. Eli Lilly and Co. and Merck & Co. Inc. are specifically under scrutiny for their trial activity in China. In letters to both companies, committee Chair John Moolenaar, R-Mich., said there’s no evidence that Lilly and Merck have engaged in illegal activity or wrongdoing, but he warned that conducting clinical trials in China, especially in Xinjiang and military hospitals, “exposes American companies to ethical and security risks – some of which even the most robust due diligence may not be sufficient to mitigate."

Large VC financings improve in H1 2026

Nearly 60% of venture capital financing rounds in the first half (H1) of 2026 were over $100 million, with the volume of those deals topping $7.5 billion, up 23% from the year-ago semester. BioWorld takes a look at recent funding rounds, including comments from panelists at a BIO International Convention 2026 session who gave insights into how their companies secured large funding rounds and made predictions about what it means for the industry's future.

‘Cool move’ by Zimmer part of med-tech’s tuck-in deals trend

Zimmer Biomet Holdings Inc.’s deal to buy Pacira Biosciences Inc.’s Iovera system for up to $140 million and Eurobio Scientific SA’s acquisition of Caredx Inc.’s lab products business for $171.2 million are symptomatic of a broader trend among med-tech and diagnostics companies using targeted acquisitions to strengthen specific areas of their portfolio.

US primaries continue to rattle congressional health leadership

Regardless of whether the Republicans or Democrats come out on top in November’s midterm congressional elections, some of the state primaries in the U.S. have already guaranteed major shuffles in key House and Senate committees overseeing national health issues. The latest shakeup occurred yesterday in Colorado’s Democratic primary when 30-year House veteran Diana DeGette lost her bid for a 16^th term representing a heavily Democratic district based in Denver. For the past several years, DeGette has been the senior Democrat on the House Energy and Commerce’s Health Subcommittee, serving as ranking member or chair, depending on which party held the majority.

Follow-ons lead a mixed first half of 2026 for med-tech financing

Through the first half of 2026, med-tech financings totaled $12.28 billion, landing between 2024 and 2023 and revealing a sector that has stabilized above its recent lows. Follow-on offerings led by category, reaching $5.01 billion, more than double 2025's $1.95 billion over the same period.

HK biotech listings gain traction in Q2 with trio of June IPOs

Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million). In the second quarter of 2026, Metis Techbio Co. Ltd.’s HK$2.1 billion May 13 IPO led the pack, followed by antibody developer Longbio’s HK$1.36 billion listing. Yangzhou, China-based Alebund’s offering of 56.75 million H shares secured about HK$1.28 billion in gross proceeds, expected to support a clinical pipeline of kidney disease assets.

Also in the news

Abivax, AC Immune, Arcutis, Ascendis, Aurenar, Beone Medicines, Biomérieux, Candela, Catalyst, Cogent, Envoy, Fibrobiologics, Flare, Genelux, Genmab, Hengrui, Innovent Biologics, Kyowa Kirin, Lilly, Moleculin, Monopar, Novocure, Nurexone, Nuvectis, Oblique, Orion, Pasithea, Plus, Praxis Precision Medicines, Pyxis Oncology, Roche, Saluda, Sanofi, Sarepta, Shilpa Medicare, Skyhawk, Smartbax, Starmed, Unicycive, Vistagen, Vivos