Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate, ibezapolstat. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients. Acurx is now preparing to meet with the U.S. FDA and the EMA to lay groundwork for a phase III study. Ibezapolstat has the U.S. FDA’s fast track and qualified infectious disease product designations. Meanwhile, the company stock (NASDAQ:ACXP) had dropped at midday, with shares trading 14% lower at $4.08 each.

Kyverna files for $100M IPO for CAR T therapy in autoimmune disease

Kyverna Therapeutics Inc. has filed to raise up to $100 million in an IPO, becoming the sixth firm to file for a U.S. listing in the new year. The company has not disclosed the number of shares or share price, but it hopes to list on Nasdaq under the ticker KYTX. Founded in 2018, Emeryville, Calif.-based Kyverna emerged from stealth in 2020 and is now in the clinic with lead program KYV-101, an autologous CD19-targeting CAR T-cell therapy for autoimmune disease.

Tepezza in crosshairs as developers march toward new TED therapy

The thyroid eye disease (TED) space continues to heat up, with a handful of players having advanced as far as phase III in bids to improve on outcomes with Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, the TED therapy first greenlighted by the U.S. FDA in January 2020. Horizon, of Dublin, has since been acquired by Thousand Oaks, Calif.-based Amgen Inc.

Canada continues to voice concerns about US drug imports

The U.S. FDA’s approval nearly two weeks ago of Florida’s plan to import about 100 prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies. Reporting on a recent phone call with U.S. Health and Human Services Secretary Xavier Becerra, Minister Mark Holland said yesterday he received assurances that the U.S. government has no intention of harming Canada’s drug supply.

Public funding earmarked for PDC*line’s personalized colorectal cancer vaccine

PDC*line Pharma SA has received €4.7 million (US$5.1 million) in public funding as part of a €12.5 million project to apply its leukemia-derived dendritic cell line in the development of personalized vaccines for treating colorectal cancer. The aim is to overcome current shortcomings of autologous dendritic cell-based vaccines, including lack of reproducibility and the limited number of cells that can be manufactured. The project is getting off the ground as the company awaits results in the second quarter of 2024 from a phase I/II study of its lead program PDC*lung01, an allogeneic vaccine that is available off-the-shelf, in the treatment of stage IV non-small-cell lung cancer. Positive data from the 67-patient study will pave the way for a €55 to €65 million funding round later in the year.

Taiwan’s Bora Pharma to acquire Upsher-Smith for $210M

Taiwan’s Bora Pharmaceuticals Co. Ltd. is acquiring Upsher-Smith Laboratories Inc. from Sawai Group Holdings Co. Ltd. and Sumitomo Corp. of Americas for $210 million to boost its commercial presence in the U.S. Primarily a generics manufacturer, Upsher-Smith was founded in 1919 and has been owned by Sawai since 2017. The move positions Bora to expand its contract research development and manufacturing organization presence and commercial operations in the U.S.

Also in the news

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