U.S. tariffs on pharmaceuticals have advanced beyond administration talking points. As a precursor to tariffs, Commerce Secretary Howard Lutnick initiated an investigation under section 232 of the Trade Expansion Act to determine the effects on national security of importing prescription drugs, according to a request for public comments scheduled to be published in the April 16 Federal Register. Publication of the notice will kick off a 21-day comment period. Launched April 1, the investigation will look at the national security impact of importing both brand and generic drugs, medical countermeasures, critical inputs such as active pharmaceutical ingredients (APIs) and key starting materials, and derivative products of those items.

Cyprumed, Merck ink $493M peptide pill licensing deal

Oral peptide delivery specialist Cyprumed is about to find out if the high bioavailability of its tablet formulations seen in animal models will translate across to humans, after signing a $493 million license and option agreement with Merck & Co. Inc. Under the terms of the agreement, Merck will have nonexclusive rights to explore the use of Cyprumed’s peptide pill technology against an undisclosed number of targets. There is then an option to take an exclusive license against any specific target for which the technology is a good fit.

Hightide’s HTD-1801 meets phase III endpoints in type 2 diabetes

Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Hightide will submit an NDA to China’s National Medical Products Administration later this year. Developed in-house, lead candidate HTD-1801 is a first-in-class, gut-liver anti-inflammatory metabolic modulator.

Spruce acquires Sanfilippo drug from Biomarin

After dropping development in December of its lead program, Spruce Biosciences Inc. has found new life by acquiring a BLA-ready enzyme replacement therapy for the rare genetic neurodegenerative disease Sanfilippo syndrome. Investors, however, were not impressed, with shares (NASDAQ:SPRB) falling 55% to 14 cents in early trading. Through a deal that requires Spruce to pay up to $22.5 million in development and regulatory milestone payments and up to $100 million in sales milestone payments, plus tiered royalties in the high-single digits to low-teens, the company acquired tralesinidase alfa enzyme replacement therapy (TA-ERT) from Biomarin Pharmaceutical Inc. for Sanfilippo, also known by the name mucopolysaccharidosis type IIIb, which has no approved treatments. “We anticipate making a BLA submission in the first half of 2026,” said Spruce’s CEO Javier Szwarcberg on an investor call.

Pretzel Therapeutics narrows the therapeutic gap for PolG disease

Researchers from Pretzel Therapeutics Inc. and the University of Gothenburg have published new insights on how mutations in the POLG gene affect its functionality and are tied to PolG diseases. They have also presented a compound for its potential treatment, PZL-A, and published their results in Nature on April 9, 2025. Pretzel (the name was inspired by the pretzel-like look of the highly folded inner mitochondrial membrane) was founded in 2019-2020 and pursues rare mitochondrial disorders. The company officially launched in 2022 with a $72.5 million series A financing to pioneer novel therapies to modulate mitochondrial function.

Sanofi advances asthma drug despite phase II miss

Despite missing a phase II study primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III. Preliminary results showed the annualized exacerbation rate wasn’t met at the highest dosage of amlitelimab but there was encouraging data in secondary endpoint of lung function and asthma control. That prompted Sanofi to say the efficacy was compelling in treating a study subgroup with heterogeneous inflammatory asthma and that a phase III study is in the works. The fully human non-T cell depleting monoclonal antibody that blocks OX40-ligand came to Sanofi when it bought Kymab Ltd. in a $1.45 billion deal that closed in 2021.

Kelun posts phase I/II data of China’s first TROP2 ADC for NSCLC

Phase I/II trial results of sacituzumab tirumotecan (Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer. Kelun’s sac-TMT is the first China-made trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate to gain local approval as a third-line therapy to treat specific types of advanced breast cancer and lung cancer.

Also in the news

Accord, Amgen, BMS, Calidi, Cellenkos, Coherus, Cynaptec, Fate, Genentech, Hebe, Inhibikase, Intas, Ironwood, Kinnate, Lobe, Merakris, Mirum, Ottimo, Pfizer, Roche, Sandoz, Senti, Soligenix, Sumitomo, Synox, Third Harmonic, Titan, Verve, Xoma Royalty