Breakthrough – or even better, revolutionary breakthrough – is perhaps the most overused term in drug development. But the discovery and development of GLP-1 receptor agonists (GLP-1RAs), which was honored with the 2024 Lasker-DeBakey Clinical Medical Research Award just last week, is one of the rare innovations that is deserving of the title.
As of the end of August 2024, the BioWorld Neurological Diseases Index (BNDI) reported a decline of 8.89%, lagging behind the Nasdaq Biotechnology Index, which gained 11.7%, and the Dow Jones Industrial Average, which rose by 7.05%. While a slight recovery from BNDI’s lowest point this year, in late April when it was down 12.2%, the index had shown modest gains over recent months before slipping again.
In one of the largest private rounds raised by an Italian biotech, Genespire Srl has closed a €46.6 million (US$51.88 million) series B, enabling it to lay the ground for a phase I/II clinical trial of its lead program, Gene-202, and to further develop its proprietary lentiviral vectors. The vectors are designed to be applicable to a range of liver-related metabolic disorders and, as its first indication, the company intends to treat methylmalonic acidemia, a serious genetic condition that results in impaired metabolism of certain amino acids and lipids.
Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
One of Australia’s newest biotech investment funds is set to triple investments on the back of its success and strong investor demand. The three-year old Merchant Biotech Fund (MBF) invested in several high growth ASX-listed and private life sciences companies and finished the past financial year up more than 70%. It is up 10% for the current financial year, Portfolio Manager Reece O'Connell told BioWorld.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Acurx, Biogen, Cassava, Eli Lilly, Enlivex, George Medicines, Lipella, Metsera, Silexion, UCB, Wave Life.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, Aurinia, Capricor, Catalyst, Dydo, GSK, Hutchmed, Nxera, Santhera, Takeda, Vifor, Zeria.
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