Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants. The randomized, controlled trial recruited 64 patients with advanced kidney disease who were receiving dialysis and on the transplant waiting list. Half received imlifidase; it was up to the treating physician to decide on desensitization strategies in the control arm. The study evaluated kidney function at 12 months, as measured by mean estimated glomerular filtration rate. In the imlifidase arm, the mean was 51.5 mL/minute vs. 19.3 mL/minute in the control, giving a highly statistically significant p-value. The company plans to file a BLA before the end of the year.

Immuneering’s atebimetinib scores in phase IIa for pancreatic

Immuneering Corp. unveiled positive updated survival and safety data from the ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. Nine months was the median follow-up point. The data will be presented by New York-based Immuneering this week at the Pancreatic Cancer Action Network Scientific Summit in Boston. Shares (NASDAQ:IMRX) – having jumped yesterday from $9.23 to $14.10, a rise of 41% – were trading at $8.39, down 77 cents. Separately, the firm priced an underwritten public offering of about 18.9 million shares of class A common stock at an offering price of $9.23 each, for proceeds of about $175 million.

Hengrui and Glenmark sign $1B deal for HER2-targeting ADC

Jiangsu Hengrui Pharmaceuticals Co. Ltd. struck another $1 billion-plus deal, this time for a HER2-targeting antibody-drug conjugate (ADC), trastuzumab rezetecan (SHR-A1811), with Glenmark Pharmaceuticals Ltd.’s subsidiary Glenmark Specialty SA. Glenmark will pay Hengrui an up-front payment of $18 million, and Hengrui is eligible to receive regulatory and commercial milestone payments up to $1.093 billion, plus sales-based royalties. In exchange, Glenmark gains rights to develop and commercialize trastuzumab rezetecan globally, excluding major markets and other countries. Developed internally by Hengrui, trastuzumab rezetecan is the first China-developed ADC approved for HER2-mutated non-small-cell lung cancer.

More US federal layoffs, future of SBIR on the table

The struggle to avoid a U.S. government shutdown in five calendar days is getting a lot of attention, with the stakes getting higher every day of the political standoff. The Trump administration’s latest bid to get Senate Democrats to fold is a threat for more massive layoffs at federal agencies – not just furloughs – if the government shuts down. Meanwhile, Sept. 30 also could be the end of the 43-year-old Small Business Innovation Research (SBIR) program, which has been a boon for biotech and med-tech startups, if Congress can’t come together on a reauthorization bill. A few options are on the table, including a temporary extension.

Capricor and FDA agree on Duchenne therapy’s path

The winding regulatory road for the BLA to Capricor Therapeutics Inc.’s cell therapy for Duchenne muscular dystrophy (DMD) has more clarity. The company received a complete response letter in July regarding CAP-1002 (deramiocel), which consists of allogeneic cardiosphere-derived cells. The two held a type A meeting and agreed that the already completed HOPE-3 phase III study satisfies the agency’s request in the letter for more clinical data. Capricor said top-line data to support the BLA’s resubmission is expected sometime in the fourth quarter of 2025. The company’s stock (NADSAQ:CAPR) had jumped 8% higher at midday, with shares trading at $6.69 each.

Condensates and innate immunity in Clarivate’s Citation Laureates

Clarivate plc has unveiled the 2025 Citation Laureates. Widely considered a predictor of the Nobel Prizes, this recognition has highlighted the discovery of biomolecular condensates in chemistry and the innate immunity signaling pathway in physiology or medicine, as well as the identification of leukemia stem cells and ghrelin, the so-called hunger hormone. Since 2002, 83 Citation Laureates have received the Nobel award from the Royal Swedish Academy of Sciences and the Karolinska Institutet. The 2025 list includes 22 scientists whose work has a global impact. For the first time, there is a name coming from mainland China. Ten are based in the U.S., three in France, two each in Germany, Japan and Switzerland, and one each in Canada and the Netherlands.

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