Shares of Immunovant Inc. (NASDAQ:IMVT) were up 30% in midmorning trading after the firm disclosed early but “compelling” data from a phase IIb study testing next-generation FcRn inhibitor IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis (D2T RA). The study, which enrolled patients who have failed two or more prior advanced lines of therapies such as TNF or JAK inhibitors, remains ongoing, but 16-week open-label findings showed “really great responses rates” across ACR20, ACR50 and ACR70 assessments, according to Matt Gline, CEO of Immunovant parent company Roivant Sciences Ltd., who said next steps include further processing the data and initiating discussions with the U.S. FDA.

All Women data show Allegra edge in female TAVR patients

Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis–patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.

Hengrui, BMS deal watershed moment for China biotech

The recent multibillion-dollar licensing alliance between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd is not an outlier, but rather the clearest sign yet that China’s biotech industry has entered a new phase of global influence. The deal reflects a structural shift that has been building for more than two decades as China systematically strengthened its biotech ecosystem, accelerated development timelines and cultivated a culture more willing to take risks than many Western peers, Treehill Partners founder and CEO Ali Pashazadeh told BioWorld. “We are now at a point where Hengrui has a greater market cap than GSK,” he said, describing the partnership as one of the most important China-related biotech deals he has seen.

FDA approval advances personalized cancer diagnostics

The evolution of cancer diagnostics continues with today’s FDA approval of Guardant Health Inc.’s Guardant360 Liquid CDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results, according to the company. The approval, which arrived a little earlier than expected, could speed the companion diagnostic’s CMS listing as an advanced diagnostic laboratory test, said Leerink Partners’ Puneet Souda. Guardant (NASDAQ:GH) was up as much as 10% this morning over yesterday’s close of $98.19.

Sizing up an epidemic, with diagnostics and bioinformatics

It is not surprising that an outbreak of Ebola disease would be considered a public health emergency of international concern (PHEIC). But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. WHO director general Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. The declaration, which has since been confirmed by an emergency committee that was convened later, frees up funding for a rapid response. But even getting a handle on the size of the outbreak remains challenging; like vaccines and treatments, current diagnostics are optimized for Ebola Zaire, not the Bundibugyo virus that is the cause of the current outbreak.

Subgroup analysis of the Champion-AF trial shows age not a factor

A subgroup analysis of data from Boston Scientific’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris.

US Fed Circuit clarifies standing in the face of licensures

The short story of the U.S. Court of Appeals for the Federal Circuit’s opinion yesterday in Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The longer, broader story is wrapped up in another opinion the appellate court handed down the same day that involved licensed patents on asphalt paving methods. The appellate court’s precedential decision in Zydex, which was reflected in Medtronic, clarified that a patent owner has constitutional standing to bring an infringement case so long as it retains certain rights.

SEC settlements to take on a new look going forward

As of tomorrow, the U.S. SEC’s “no-deny” policy is dead. The agency is rescinding the no-deny rule, which has been reflected in all its settlement agreements for the past 50 years. The settlements go beyond the “no admit/no deny” statement that’s a standard part of the agreement by prohibiting settling defendants from ever publicly denying the agency’s allegations, under threat of further litigation. In light of the rescission of Rule 202.5(e), the SEC said it won’t enforce existing no-deny provisions in existing settlements. Doing away with the rule will give the commission “more flexibility in settling enforcement actions, which conserves resources, provides certainty, and may speed the return of money to injured investors,” the agency said.

‘Detargeted’ targeted gene therapy improves activity in Pompe

A new strategy aims to improve gene therapy for Pompe disease by optimizing both the genetic component that restores the function of a deficient lysosomal enzyme and the vector that delivers it to the target tissue while avoiding the liver. The findings suggest that combining an optimized transgene with a targeted capsid could significantly enhance the effectiveness of gene therapy for Pompe disease. “Pompe disease is a very rare genetic disorder. It is caused by the mutation in the GAA gene, which is an acid α-glucosidase enzyme. This enzyme is responsible for converting glycogen to glucose. It is a glycogen storage disease. In the absence of GAA, the glycogen chain gets accumulated within the tissues, mainly muscles,” first author Prasad Trivedi told BioWorld. Trivedi, PhD candidate at the University of Florida, presented the poster, “Synergistic optimization of capsid biodistribution and enzyme secretion for enhanced Pompe disease gene therapy,” during the ASGCT conference, held in Boston, May 11-15, 2026.

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