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 Biotechnologies Inc.’s $675.6 million 2021 IPO and setting a new record for U.S. biopharma IPOs, according to BioWorld data. The company, which emerged less than two years ago with a $400 million series A, following that up with a $600 million series B in 2025, said proceeds from the IPO will support work on its obesity pipeline, leading with ribupatide (KAI-9531), a once-weekly injectable GLP-1/GIP receptor dual agonist peptide, in phase III testing.

New nominee may need a charm at the CDC

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 yesterday, touting Schwartz’s qualifications 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. Despite, or perhaps because of, her credentials, Schwartz already is facing opposition from a Kennedy colleague who has built a reputation for suing vaccine manufacturers.

Roche plots route to EMA approval for DMD gene therapy

Roche 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. The study aims to generate new placebo-controlled data to overcome the EMA’s reservation in its ruling in July 2025 in response to the failed Embark phase III trial. Although Embark did not meet the primary endpoint, Roche submitted the file to the EMA seeking conditional marketing approval, citing a positive benefit-risk balance and committing to provide more comprehensive data from the long-term phase III follow-up study.

Delta-Fly eyes NDA path despite AML phase III miss

Delta-Fly Pharma Inc. is pressing ahead with discussions with the U.S. 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. The Tokyo-based company said it is preparing for discussions with the agency regarding an NDA for DFP-10917, a deoxycytidine nucleoside analogue, as a monotherapy in relapsed/refractory AML (r/r AML), while simultaneously advancing plans for a pivotal phase III trial combining the drug with BCL-2 inhibitor Venclexta (venetoclax, Abbvie Inc./Roche AG).

Sex differences shape gene activity across the human brain

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 and the National Institute on Aging 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. The findings may help clarify why certain brain-related conditions show sex-biased vulnerability and could potentially guide the development of more personalized therapies.

Ebenbuild’s tech for predicting lung drug deposition validated

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. For example, predictions of lobar deposition achieved a correlation coefficient of 0.95 with experimental data.

Daiichi to divest consumer health unit to Suntory for $1.5B

Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd. (DSHC), to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology. Under the transaction valued at ¥246.5 billion (US$1.54 billion), Daiichi will sell down its stake in DSHC in three stages, with the transaction expected to complete by 2029. The first 30% will transfer to Suntory in June 2026, followed by 40% in June 2027 and the remaining 30% in June 2029. News of the deal was disclosed on the Tokyo Stock Exchange April 15.

Also in the news

Acerand, Achieve Life Sciences, Acurx, Adimab, Adlai, Aicuris, Aktis, Aligos, Amoytop, Araceli, Assureckd, Astellas, Axena, Bavarian Nordic, Boehringer Ingelheim, Bold, CareDx, Cathether, Cumberland, Cubit, Daiichi, Eli Lilly, Envoy, Eton, Eurobio, Fertilai, Freya, Greywolf, Grifols, Harbour, Helus, Interna, Johnson & Johnson, Juvisé, Mabwell, Medera, MeiraGTx, Neutrolis, Onward, Pamdx, Prime, Royal Philips, Sanofi, Savara, Surgentec, Vir, Waiv, Xilo, Xvivo