Kailera Therapeutics Inc.’s “obesity-first” approach continues to resonate with investors, with the company pricing an upsized IPO, offering 39 million shares at $16 apiece for gross proceeds of $625 million. Full exercise of the underwriters’ option could add another $93.8 million, bringing the total to nearly $719 million, easily topping Sana Biotechnology Inc.’s $675.6 million 2021 IPO and setting a new record for U.S. biopharma IPOs, according to BioWorld data. Read More
As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office. Read More
Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy. Read More
Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval. Read More
Genes that are switched on or off in the human brain differ between men and women. Moreover, these differences are not uniform. They vary across cortical regions and cell types. Scientists at the National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA) used single-cell sequencing and unveiled distinct gene expression patterns regulated by hormones and sex chromosomes. This detailed map of the brain’s molecular biology shows how women and men switch on and off more than 3,000 brain genes differently and expands the catalogue of X chromosome genes that escape inactivation. Read More
The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated strong agreement with in vivo imaging data across multiple inhalation scenarios. Read More
Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology. Read More
New hires and promotions in the biopharma and med-tech industries, including: Achieve Life Sciences, Aktis, Araceli, Assureckd, Cubit, Envoy, Eton, Greywolf, Harbour, Helus, Juvisé, Neutrolis, Prime, Xilo. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Achieve Life Sciences, Acurx, Adlai, Meiragtx, Onward, Pamdx. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Acerand, Axena, Boehringer Ingelheim, Bold, Eli Lilly, Freya, Xvivo. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aligos, Amgen, Amoytop, Astellas, Caredx, Cathether, Daiichi, Eurobio, Interna, Johnson & Johnson, Mabwell, Meiragtx, Sanofi, Vir. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Adimab, Aicuris, Bavarian Nordic, Cumberland, Fertilai, Grifols, Mabwell, Medera, Royal Philips, Savara, Surgentec, Waiv. Read More
