New Anglo/U.S. obesity and cardiometabolic specialist Verdiva Bio Ltd. has launched with a massive $411 million series A and a portfolio of GLP-1 and amylin agonists in-licensed from China. The lead asset, a once-weekly oral GLP-1 agonist, is ready for phase II development. An intravenous formulation of the drug already has been filed for marketing approval in China by its developer, Sciwind Bioscience Co., adding extra momentum to Verdiva’s substantial funding. The company also has ex-China and South Korea rights from Sciwind to a once-weekly oral amylin agonist, which will be developed both as a monotherapy and in combination with the oral GLP-1 drug, and to a long-acting subcutaneously administered amylin agonist.

Maat Pharma hits its phase III primary endpoint in graft-vs.-host disease

Top-line data from Maat Pharma SA’s phase III study of MaaT-013, an enema microbiome ecosystem therapy for acute graft-vs.-host disease, has hit its primary endpoint. The company reported the standardized, pooled-donor treatment produced a significant gastrointestinal overall response rate at day 28 of 62%, which was the primary endpoint. The single-arm Ares study comprises 66 adults who are refractory or intolerant to ruxolitinib and received Maat-013 as a third-line treatment at 50 sites in Europe. Maat-013 is a microbiome ecosystem therapy designed to restore symbiosis between the patient’s functional gut microbiome and their immune system. It has orphan drug designation in the U.S. and Europe.

2024 a banner year for US biosimilar approvals

It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in terms of biosimilar approvals. The agency actually hit 63 in 2024, thanks to 18 new biosimilar approvals that stretched the number of biologics referenced from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024. In addition, CDER approved 50 new therapies, including a first-in-class drug for schizophrenia, three novel antibiotics and new drugs for many types of cancer.

FDA panel to debate Ferring’s condoliase in leg pain

The U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee is taking up Jan. 10 the matter of Ferring Pharmaceuticals Inc.’s SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc herniation. In the summer of 2016, privately held Ferring was granted the exclusive worldwide rights, excluding Japan, to SI-6603, which by then had reached the phase III stage, from Seikagaku Corp. Panel members will be asked to consider the significance of Study 1131, which had a negative outcome, in the context of two other experiments that turned out positive.

Coave taking on gene delivery with $33M series A

Coave Therapeutics SA has completed the transition to becoming a genetic medicines specialist, after divesting its single ophthalmology program and raising $33 million in a series A round. The new money enables the company to advance its technology for targeted delivery of genetic payloads to sites outside the liver, and in particular to take forward programs in amyotrophic lateral sclerosis and Parkinson’s disease. The technology uses a range of ligands, including small molecules, peptides and antibodies, which are conjugated to adeno-associated viral vectors or to non-viral vectors, to direct the vector to specific organs.

Biopharma IPOs rebound slightly, as class of 2024 lags with a 29% average decline

Modest signs of recovery were seen in the biopharma IPO market in 2024, though activity remains significantly below the levels seen during the 2018-2021 boom. In 2024, 32 biopharma companies went public, a slight increase from 27 in 2023 but a decline from 35 in 2022. These figures pale in comparison to the peak years, with 134 IPOs in 2021, 106 in 2020 and even 65 in 2019. Both the total value and volume of IPOs continue to lag far behind those earlier highs.

Map is first step toward healthy brains into old age

2024 saw the completion of several cellular-resolution brain maps, including the entire fly brain and a comprehensive connections map of a cubic centimeter of human brain. 2025 began with the addition of another important map. In the Jan. 1, 2025, issue of Nature, researchers from the Allen Institute presented a map of areas and cell types where aging most affected the mouse brain.

The BioWorld Insider podcast: a year of interviews and insights

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Subjects included quarterly reviews for M&As and financings, the slow but steady growth of funding and partnering for therapies to treat women, the impact of artificial intelligence and quantum computing on drug development, rare disease drug development, the costs of delays in clinical trials, and an overview of the one of the year’s biggest conferences, the annual American Society of Clinical Oncology gathering in Chicago.

2024 BioWorld Year in Review

BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025.

2024 BioWorld MedTech Year in Review

BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as med tech forges ahead in 2025.

2024 BioWorld Science Year in Review

Taking a look back at the achievements in research this year, including brain maps, pandemic breakthroughs and advances in pregnancy health.

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