Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says the three-year analysis from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter. Uniqure also disclosed that during the recent type B meeting with the agency, the two agreed to align on a confirmatory trial design that does not necessarily require a potentially controversial sham-controlled element. The firm expects to receive final minutes from the meeting within 30 days, but the news offered a significant stock boost, with shares of Uniqure (NASDAQ:QURE) shooting up more than 70% in morning trading. It’s also another sign that regulatory flexibility might be returning to the FDA following certain recent departures.
Rx tariff just around the corner
In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised Section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration. The big pain point could come Sept. 29 when the tariff kicks in for small drug companies with limited resources for onshoring.
mRNA flu vaccine can activate broad germinal center response
On the eve of the June 17 Vaccines and Related Biological Products Advisory Committee meeting, which will discuss Moderna Inc.’s mRNA-1010, researchers at Washington University School of Medicine in St. Louis have reported that the vaccine conferred broader and more durable protection than a standard flu shot. The vaccine’s benefits are unlikely to be permanent. “We do not think this would be as long-lasting as a measles vaccine, which is one of the more durable vaccines, because the influenza virus continuously changes to evade immunity,” Hanover Matz told BioWorld. “However, based on our data we do think the breadth of binding exhibited by the mRNA vaccine would be an improvement over the immunity induced by the regular vaccine. This could offer better protection over multiple seasons of influenza.” Matz is a postdoctoral fellow at Washington University, and the first author of the paper reporting the findings, which appeared in Nature Immunology on June 15, 2026.
Spyre’s Skyline-UC double win lifts hopes for IBD antibody combos
Spyre Therapeutics Inc.’s striking “two for two” data on ulcerative colitis (UC) candidates, SPY-001 and SPY-002, drew applause from multiple analysts, putting eyes on the Boston biotech’s upcoming top-line data of anti-IL-23 antibody SPY-003 – the third biologic module in a six-strong inflammatory bowel disease (IBD) lineup. Waltham, Mass.-based Spyre announced June 15 that SPY-002, a potential best-in-class TNF-like ligand 1A (TL1A)-targeting antibody, met all key objectives in an open-label assessment of the first leg of the phase II Skyline trial of patients with moderately to severely active UC.
HMNC raises $50M series B to prep depression drugs for phase III
HMNC Brain Health GmbH has raised $50 million in the first close of a series B, enabling the company to prepare the way for phase III trials of its two lead programs. The first of these, Ketabon (KET01), is an oral, prolonged-release formulation of ketamine that will be positioned as a competitor to Johnson & Johnson Inc.’s blockbuster inhaled esketamine, Spravato, in treatment-resistant depression. The second program, Nelivabon (BH-200), is a first-in-class oral vasopressin V1B receptor antagonist that was taken to phase II in depressive disorders and subsequently parked by Sanofi SA. The drug’s revival is based on genetic biomarkers of vasopressin biology that were shown in a phase IIb study to identify responders.
GLP-1s need technologies for long-term use
For the long-term impact of GLP-1 therapies in obesity to be realized, they must be paired with data and digital tools. While the drugs are effective, challenges are well known, such as loss of muscle mass, compliance and accessibility. With more treatments moving through the pipeline, innovation and technology will be key to supporting long-term use, delegates heard at the HLTH Europe conference in Amsterdam on June 17.
China’s Micot targets HK$1.2B IPO to advance metabolic portfolio
Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. The Xi'an-based company filed for a listing on the Hong Kong Stock Exchange under Chapter 18A, the pathway designed for pre-revenue biotechnology companies. The global offering consists of 58.05 million shares with a maximum offer price of HK$21 per share. Shares are expected to begin trading on June 24. Founded in 2007, Micot initially focused on medical device development before shifting to innovative drug research in 2011. Since then, the company has built a portfolio centered on bifunctional and multifunctional polypeptides for cardiovascular, metabolic, and inflammatory diseases.