European biopharmas saw a huge surge in new funding in the second quarter of 2024, raising a collective $4.1 billion, compared to $1.9 billion in the same period of 2023. With the IPO market in Europe still virtually non-existent, $1.45 billion of this was venture capital, while $2.64 billion was raised in follow-on funding. The majority of VC funding was raised by companies in five countries, with $799.6 million raised in the U.K., $272.5 million in Switzerland, $201.8 million raised in Germany, $59 million in France and $25.7 million in Sweden.

Biopharma IPO volume at 10-year low; Actuate raises $22.4M

The year 2024 squeaked through another IPO this week, that of Actuate Therapeutics Inc., which raised $22.4 million becoming the 15th biopharma company to debut on U.S. exchanges this year. Out of 17 companies total, including one listing on the Hong Kong Stock Exchange and another on the SIX Swiss Exchange, the industry has raised a total of $4.8 billion through IPOs. The majority of those IPOs – 10 of them – occurred in the first quarter, with the following five months marked by a significant slowing. Only four were completed in the second quarter and just three more since then.

PBC landscape shifting with FDA go-ahead for Gilead’s Livdelzi

Gilead Sciences Inc.’s accelerated approval by the U.S. FDA of the oral peroxisome proliferator-activated receptor-delta drug Livdelzi (seladelpar) put primary biliary cholangitis (PBC) in the spotlight. The competitive landscape includes Ipsen Pharma SA’s dual PPAR alpha/delta agonist Iqirvo (elafibranor), licensed from Genfit SA and cleared in June 2024, plus Ocaliva (obeticholic acid), the first-in-class farnesoid X receptor agonist from Intercept Pharmaceuticals Inc., greenlighted for PBC in May 2016. (Intercept was acquired in September 2023 by Alfasigma SpA.) Foster City, Calif.-based Gilead’s Livdelzi gained clearance for use in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate the latter. Leerink analyst Thomas Smith said in an Aug. 15 report that he “expect[s] strong prescriber preference for Iqirvo and Livdelzi over Ocaliva, based on the PPAR agonists’ superior biochemical responses, cleaner safety/tolerability, and improvement in patient symptoms (especially pruritus).”

July FDA approvals target Alzheimer's, myeloma and wet AMD

The U.S. FDA approved 17 drugs in July, down from 28 in June, which marked the third-highest month in BioWorld’s records. On average, the FDA approved approximately nearly 19 drugs per month so far in 2024, compared to 16 per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020. In July, the FDA approved one new molecular entity (NME), bringing the monthly average for NME approvals to slightly above three per month in 2024.

Presenilin mutations kill neurons, no amyloid-β required

Scientists at Harvard Medical School have shown that in mice lacking amyloid beta (Aβ), the fundamental hallmark of Alzheimer’s disease, neurons died from the effect of the most harmful mutation of this neurodegenerative disease. They showed that presenilin could be behind the origin of the disease without the need for Aβ. They maintain that it is time to update theories and redirect efforts.

Also in the news

Aarvik, Abata, Actuate, Akeso, Alvotech, Arrivent, Arrowhead, Astrazeneca, Avidity, Dermbiont, Enplusone, FSD, Genmab, Gilead, Incyte, Kalvista, Lykos, Nuntius, Pathos, Sagesse, Siga, Silo, Syndax, Tempest, Turnstone, Xgene