Germany-based TME Pharma NV has received a Fast Track designation from the US Food and Drug Administration for its investigational treatment for glioblastoma giving it access to more regulatory support during the clinical development of the therapy. The drug, NOX-A12, is an RNA oligonucleotide targeting a chemokine protein in the tumour microenvironment with the goal of breaking tumour protection against the immune system.
Novo Nordisk A/S is to acquire Cardior Pharmaceuticals GmbH of Germany for up to €1.025 billion in a deal that will significantly expand its presence in the field of cardiovascular medicine. Although Novo’s primary focus is diabetes, it has been rapidly expanding into related areas, most notably treatments for obesity. Obesity has been identified as a risk factor for cardiovascular disease.
Venture capital-financed Amolyt Pharma SAS has agreed to be acquired by AstraZeneca Plc in a deal that capitalises on the French company’s portfolio of treatments for rare endocrine diseases. The deal value is up to $1.05 billion, which consists of $800 million upfront and a payment of $250 million contingent on the achievement of a regulatory milestone. The acquisition will bolster AstraZeneca’s rare disease portfolio which is managed by its Alexion business unit. AstraZeneca acquired Alexion in 2021.
AstraZeneca Plc is to spend up to $2.4 billion to acquire Fusion Pharmaceuticals Inc of Canada, a biopharmaceutical company developing alpha-particle radiotherapeutics for treating cancer. The company’s pipeline consists of radioconjugates where a radioactive chemical is linked to a cell-targeting molecule, injected into the body, and directed against cancer cells. Under the terms of the agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion’s outstanding shares for $21 per share in cash and a contingent value right of $3 per share.
Novartis is to acquire a group of assets directed against inflammatory diseases following the acquisition of IFM Due Inc, a Boston, US-based biotech incubator. The deal is valued at up to $835 million. IFM Due is a subsidiary of IFM Therapeutics Inc, a company that was set up by scientists and venture capitalists in 2015 to discover and develop small molecules modulating targets in the innate immune system, the body’s first line of defence against pathogens.
Capstan Therapeutics Inc, a US biotech company with proprietary lipid nanoparticle technology, closed an oversubscribed Series B financing round on 20 March to advance an in vivo cell therapy product for autoimmune disorders. The round was led by RA Capital Management with participation from five new investors including Forbion, Johnson & Johnson Innovation, and Sofinnova Investments. The proceeds will be used to advance CPTX2309, an in vivo engineered chimeric antigen receptor (CAR) T cell therapy and to further develop the company’s pipeline.
The US Food and Drug Administration approved a new therapy for a rare genetic disease on 18 March, indicating a widening of the scope of regulatory authorisations where there is a serious unmet medical need. The product, Lenmeldy (atidarsagene autotemcel), is a gene therapy intended as a one-time treatment for children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD). MLD is a rare genetic disease that affects the brain and nervous system.
A drug for the treatment of patients with Duchenne muscular dystrophy (DMA) was approved by the US Food and Drug Administration on 22 March. Duvyzat (givinostat) is the first nonsteroidal drug for patients with all genetic variants of the disease. DMD is a rare neurological disorder which causes progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, individuals with the disease experience muscle weakness that can lead to problems with walking, breathing and an early death.
The US Food and Drug Administration has approved Rezdiffra (resmetirom), a small molecule agonist of the thyroid hormone receptor beta (THR-beta), to treat non-alcoholic steatohepatitis (NASH) in adults with moderate to advanced liver scarring. The developer is Madrigal Pharmaceuticals Inc. The approval, announced on 14 March, is the first for a product that directly addresses liver scarring and is to be used alongside diet and exercise.
Privately-owned Tubulis GmbH has raised €128 million in an upsized venture round in order to advance its lead antibody-drug conjugate (ADC) products into the clinic. Announced on 14 March, the Series B2 round was co-led by the private equity group EQT Life Sciences and Nextech Invest Ltd of Switzerland. Several US investors participated including Frazier Life Sciences and Deep Track Capital. The financing follows a Series B round of €60 million in 2022.