First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and filleted out responses to the tariff question by CEOs and senior executives, to get an overview of how the sector as a whole is responding. One thing is very clear: While pharmaceuticals are for now exempt from tariffs, the industry has been bracing for their imposition, whilst at the same time lobbying strongly against them on the grounds that drug shortages could result.

Biopharma funding drops 71% from 2024, but in line with prior years

Total biopharma financings for the first four months of 2025 reached $15.48 billion, a 71% decline from $53.49 billion in 2024. Despite this, the current year's performance is more in line with previous years, down about 11% from $17.42 billion in 2023 and $17.5 billion in 2022.

FDA delay for aficamten dents Cytokinetics

Cytokinetics Inc. shares (NASDAQ:CYTK) dipped to $35.42, a loss of $7.50, or 17%, on word that the U.S. FDA has extended the PDUFA date for the NDA related to aficamten. The drug is a myosin inhibitor designed to treat obstructive hypertrophic cardiomyopathy. Regulators pushed out the decision date by three months to Dec. 26, saying they need more time to evaluate South San Francisco-based Cytokinetics’ proposed risk evaluation and mitigation strategy.

Three Korea biotechs prep for May IPOs

Among three Korean biotech companies slated to sell shares on the Korea Exchange this month, Immuneoncia Therapeutics Inc. is the latest to price a ₩33.9 billion (US$24 million) Kosdaq IPO for May 19. Regenerative cell therapy maker Organoid Sciences Ltd. and antibody-drug conjugate specialist Intocell Inc. are also gearing up for respective Kosdaq listings starting next week. The trio of public financings add to a growing list of Korea biopharma IPOs this year, which includes Orum Therapeutics Inc.’s ₩50 billion raise in February and GI Innovation Inc.’s ₩111.2 billion IPO in March.

AACR 2025: Induced proximity strategy, beyond degraders

In targeted protein degradation, drugs form molecular tethers between proteins, inducing interactions between those proteins. In proteolysis-targeting chimeras, ubiquitin ligases are leashed to target proteins to tag them for destruction by the proteasome. Targeted protein degradation has yet to notch its first approval, and the clinical data reported in March were mixed for vepdegestrant. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical validation appears to be a matter of time. Earlier in the biomedical pipeline, researchers are broadening the kinds of achievements that are possible by tethering proteins to each other. At the 2025 Annual Meeting of the American Association for Cancer Research (AACR), held in Chicago from April 25-30, investigators presented new methods to broaden what induced proximity can do.

100 days of uncertainty

Massive terminations. Axed programs. Canceled grants and contracts. Communication freezes. Threats and more threats of tariffs. Lawsuit upon lawsuit. Policy whiplash. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe.

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4D Molecular Therapeutics, Akari, Altesa, Armata, Arvinas, Aspen, Biocryst, Concentra, Design, Eccogene, Enara, Frazier, Kronos, Okyo, Rion, Satsuma, Tris, Zucara