Shares of Engene Holdings Inc. (NASDAQ:ENGN) were trading at $10.34, up $4.33, or 72%, on word of additional preliminary data from the pivotal cohort of its ongoing phase II Legend trial testing detalimogene voraplasmid (also known as detalimogene and previously called EG-70) in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease. So far, the results continue to support the planned BLA submission next year, Engene said. Last fall, the company amended the study’s protocol after a peek at early findings with the nonviral gene therapy.

Trump’s MFN price deals a wake-up call for governments in Europe

The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation pricing and reduce the U.S./EU price gap are governments facing up to the reality that they will have to pay more for new drugs. “I think the shame for me is that it’s taken the U.S. administration to raise it, before [European governments] listen to the industry,” Louise Houson, regional president Europe and Canada, Merck & Co. Inc (MSD in Europe), said during a panel at the FT Global Pharma and Biotech Summit in London.

Bluejay way: Positive phase II data for treating hepatitis D

Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus (CHD). All patients in the trial had a virologic response in all the study’s dose arms, and as many as 82% hit a combined endpoint of virologic response and normalization of alanine aminotransferase in their blood. Both efficacy measures were seen in the study’s week 48 results, which were presented at the Liver Meeting 2025 of the American Association for the Study of Liver Diseases in Washington. There are no approved CHD treatments in the U.S.

Positive readouts validate pipelines, fuel drug developer rally

Drug developer stocks strengthened further through September and October, with the BioWorld Drug Developers Index (BDDI) closing up 28.96% at October’s close. The BDDI outperformed both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which finished October up 24.49% and 11.8%, respectively. The top performer on the BDDI over September and October was Nektar Therapeutics Inc., which climbed 117% over the two months. Shares rose 15% after the company presented new phase IIb Rezolve-AD data showing that rezpeg achieved statistical significance on the primary endpoint.

UK launches strategy to replace animals in research as scientists voice concern

The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals. The commitment to phase out animal testing in the U.K. parallels the announcement in April 2025 by the U.S. NIH that it would in the future be favoring “human-focused” research and reducing animal research.

Also in the news

Adarx, Alpha-9, Amgen, AN2, Anaptysbio, Apogee, Astrazeneca, Atai Beckley, Avenzo, Bioinvent, Bluejay, Boehringer, Camurus, Celldex, City, Cogent, Damora, Eli Lilly, Evommune, Galecto, Genfit, GSK, Inflarx, Ionis, Mannkind, Meiragtx, Merck, Mineralys, Neurogastrx, Novo Nordisk, Nurix, Onchilles, Organon, Quralis, Roche, Simris, Swedish Orphan Biovitrum, Teva, Tenaya, Transition, UCB, Vera, Vor, Voyager