To strengthen its development efforts, Novo Nordisk A/S will collaborate in a deal that could bring Replicate Bioscience Inc. about $550 million. In return, Novo is getting an exclusive, worldwide license to use Replicate’s self-replicating RNA (srRNA) platform to develop the candidates. The two are aiming at targets in cardiometabolic diseases that include treatments for obesity and type 2 diabetes.

The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.

With new and positive phase III data in treating agitation in patients – at home instead of in a clinic – with bipolar disorders or schizophrenia, Bioxcel Therapeutics Inc. is preparing to submit an sNDA in the first quarter of 2026 to expand the label of the company’s Igalmi (BXCL-501). These data also bring the company closer to having the first such treatment that is approved by the U.S. FDA for home use. The unmet need for patients is huge, Vimal Mehta, the CEO of Bioxcel, told the BioWorld Insider podcast. Watch the interview, below.

In another deal between the two companies that could be worth more than $1 billion, Abbvie Inc. is buying Gilgamesh Pharmaceuticals Inc.’s lead candidate bretisilocin (GM-2505) for up to $1.2 billion, including an undisclosed up-front payment and development milestones. Privately held Gilgamesh has the psychedelic compound for treating moderate to severe major depressive disorder in a phase II study.

In Ionis Pharmaceuticals Inc.’s second U.S. FDA approval in under a year, the agency approved Dawnzera (donidalorsen) as a prophylactic therapy in the rare and genetic disease hereditary angioedema (HAE). The approval came as scheduled as the NDA had a PDUFA date of Aug. 21. Dawnzera now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development.

Generative AI drug discovery company Vantai Inc. could bring in more than $1 billion in a new collaboration with Halda Therapeutics Inc. Vantai already has collaborations with other companies, including Bristol Myers Squibb Co. (BMS), Janssen Pharmaceutica and Blueprint Medicines Corp.

Superluminal Medicines Inc. and Eli Lilly and Co. are collaborating in a deal to develop cardiometabolic disease and obesity therapies by aiming at undisclosed G protein-coupled receptor targets. The deal could bring Superluminal as much as $1.3 billion, including up-front and near-term investments, an equity investment, development and commercial milestones, plus tiered royalties on net sales.

The U.S. FDA has given a swift and full approval to Precigen Inc.’s gene therapy, Papzimeos (zopapogene imadenovec), for treating adults with recurrent respiratory papillomatosis (RRP), a rare and chronic disease characterized by benign tumors in the respiratory tract.