Company News

A retrospective, observational study of semaglutide 2.4 mg (Wegovy) has shown that adults who are overweight with an established cardiovascular disease, but no diabetes, were able to reduce their risk of a major cardiovascular event over a period of years. Called SCORE, the trial compared outcomes for semaglutide users with non-users and established benefit for the drug taken as an adjunct to diet and exercise. The study started in 2018, enrolled 17,604 adults, and was conducted in 41 countries at more than 800 sites.

The European Medicines Agency issued a negative opinion on 28 March to Eli Lilly and Co which applied to market its Alzheimer’s treatment Kisunla (donanemab) in the EU for patients with amyloid beta plaques in the brain and mild cognitive impairment. Lilly said that it will appeal against the decision.

MaaT Pharma SA of France expects to make its first regulatory submission to the European Medicines Agency in June following a successful Phase 3 trial of its microbiome therapy and a capital increase of €13 million from a private share placement. The capital increase was announced on 27 March, not long after the company reported the latest clinical data for its therapy. The therapy, MaaT013, is being developed for patients with acute graft-versus-host disease with gastrointestinal involvement. 

Owlstone Medical Ltd is to receive an equity investment of up to $2.3 million from the US Cystic Fibrosis Foundation to develop a new breath test to detect a bacterial infection in patients with cystic fibrosis. The UK company has developed technology that can detect biological information from volatile organic compounds and respiratory droplets in breath. The newest project will involve developing a test for Pseudomonas aeruginosa, a Gram negative bacterial infection that can be particularly dangerous for people with compromised immune systems.

Novo Holdings A/S and Jeito Capital have co-led a new financing for Augustine Therapeutics NV of Belgium to support clinical development of the company’s candidate treatment for Charcot-Marie-Tooth disease, an inherited disorder that can cause nerve damage. The oversubscribed Series A financing raised a total of €78 million which includes an earlier sum of €17.5 million generated in 2024. Altogether 11 investors supported the company, including the US-based Charcot-Marie-Tooth Research Foundation. The closing of the Series A round was announced on 24 March.

A new biotech company has been launched in Seattle, US, and Singapore, with the goal of advancing the technology for antibody-drug conjugates - treatments for cancer that use an antibody and linker to deliver a cytotoxic agent to cancer cells. The company, Callio Therapeutics Inc, is developing ADCs that would be equipped with more than one cytotoxic payload. The company says this structure could increase the efficacy of ADCs, a drug class which is attracting developers across the industry.

Valneva SE, developer of the world’s first vaccine against chikungunya virus, is forecasting higher sales this year and more investment in R&D as it advances new products in the clinic against infectious diseases. Product sales this year are expected to reach €170 to €180 million, up from €163.3 million in 2024. This will drive positive cash flow for the business enabling an increase in R&D spending to between €90 to €100 million, up from €74.1 million in 2024.

InflaRx NV has extended its cash runway into 2027 following a public share offering in February that raised €28.7 million. The forecast was issued on 20 March in the German company’s 2024 annual report which showed an operating loss of €53 million on the back of significant outlays for research and development. R&D expenditure was €35.4 million, more than twice the sums spent to cover the company’s other business expenses. Founded in 2007, InflaRx is building a portfolio of drugs for inflammatory diseases that target the complement system, a key component of the innate immune system.

Zealand Pharma A/S is partnering with the Roche Group to co-develop a candidate drug for obesity discovered by the Danish company with potential as both a monotherapy and in combination with other drugs. This includes in combination with an obesity asset owned by Roche. The drug is petrelintide, a long-acting amylin analogue which has delivered reductions in body weight of up to a mean 8.6% in early clinical studies. Amylin is a peptide hormone that restores sensitivity to leptin, a satiety hormone that enables people to feel naturally full after having eaten a meal.

The US Food and Drug Administration has approved a new allogeneic encapsulated, cell-based gene therapy for a rare neurodegenerative disease that affects the macula, a portion of the eye that processes central vision. The product, Encelto (revakinagene taroretcel) is a therapy that delivers a recombinant protein to the retina to slow down the progression of the disease. Delivery is by way of a surgical intravitreal implant by an ophthalmologist.