Company News

A small molecule drug that has shown benefits for patients with a type of non-alcoholic liver disease is being recommended for a conditional approval in Europe following a similar decision in 2024 by the US Food and Drug Administration. The drug, resmetirom, works by activating the thyroid hormone receptor-beta which is expressed in the liver, kidneys and pituitary gland and regulates metabolic activity. Reduced levels of thyroid hormones, particularly associated with a reduced activity of the receptor, can lead to a build-up of fat in the liver.

A long-acting treatment for HIV, first approved in the US in 2022, has returned to the market with a new indication – this time as a prophylactic that only needs to the administered twice per year. The drug, lenacapavir, is a synthetic compound that interferes with the life cycle of the HIV virus by binding to the virus’ capsid and inhibiting its replication at multiple stages of its lifecycle. Developed by Gilead Sciences Inc, lenacapavir was first approved as Sunlenca in 2022 for people who had been heavily treated with HIV drugs and become resistant.

France-based Enterome SA has raised $19 million to accelerate development of a microbiome therapy that has shown promise in treating two types of lymphoma. The funds will be used to complete an ongoing Phase 1/2 study of the therapy, EO2463, and prepare for a registrational study. The Institute for Follicular Lymphoma Innovation (IFLI) of California, US, is a new investor, contributing $9 million to the project, with the balance coming from existing shareholders including Seventure Partners of France and Lundbeckfonden BioCapital of Denmark.

Eli Lilly and Co is to acquire Verve Therapeutics Inc of Boston, US, in a share transaction valued at $1 billion upfront in order to broaden its portfolio of treatments for people at risk of cardiovascular disease. Announced on 17 June, the deal comes two years after the companies entered a collaboration to explore the use of in vivo gene editing to develop therapies for genetic diseases. With a candidate medicine for artherosclerotic cardiovascular disease now in Phase 1b, the companies have decided to merge.

BioNTech SE, developer with Pfizer Inc of the first messenger RNA (mRNA) vaccine, is to strengthen its position in the growing field of RNA therapeutics with the acquisition of CureVac NV. Both companies have mRNA technologies, both are located in Germany and both have listings on the Nasdaq market in the US. In addition to experience with infectious diseases, both companies are developing candidate therapies for cancer.

Novo Nordisk A/S, developer of the semaglutide and liraglutide injectable medicines for obesity, has enlisted the help of Deep Apple Therapeutics Inc to enlarge its portfolio by discovering new small molecules that can treat obesity as well as other cardiometabolic diseases. The Danish company is to pay up to $812 million to secure the collaboration, which will give it access to an algorithm to screen potential compounds against a chosen target. The target is a non-incretin G-protein coupled receptor (GPCR).

SpliceBio SL, a clinical-stage genetic medicines company in Spain, has received $135 million in Series B financing to advance a new therapy for Stargardt disease, an inherited condition that can lead to the progressive loss of vision and blindness. The financing was co-led by EQT Life Sciences and Sanofi Ventures, with participation from the Roche Venture Fund and existing investors. It will help finance an ongoing Phase 1/2 trial of the company’s lead gene therapy candidate SB-007.

A French start-up company located in Strasbourg has been awarded €11.25 million in seed funding to develop neuroplastogens, a class of small molecule drug, for depression and neuropsychiatric disorders. Elkedonia SAS received the funding from a syndicate co-led by Kurma Partners and including Angelini Ventures, the venture capital arm of Angelini Industries of Italy.

The Philadelphia, US, based biotech company NodThera Ltd has started dosing patients in a trial of a small molecule drug for obesity that targets a protein in an inflammasome complex in the brain. The Phase 2 study will enrol 160 patients who are obese and may or may not also have type 2 diabetes. The trial will be carried out over 24 weeks with headline data expected in the second quarter of 2026. Although it is small, the trial is being positioned to test a relatively new concept: whether it is possible to change the course of obesity by correcting underlying metabolic dysfunction.

The European Medicines Agency is to update the side effect profile for semaglutide following evidence from epidemiological studies that use of the drug is associated with a very rare eye condition known as non-arteritic anterior ischaemic optic neuropathy (NAION). This may cause loss of vision. The decision was announced on 6 June and will affect the labelling of three approved semaglutide products, Ozempic, Rybelsus and Wegovy. All three are produced by Novo Nordisk A/S and are on the market in the EU.