Lepu Biopharma Co. Ltd. has out-licensed two preclinical T-cell engagers to Shanghai-based newco Excalipoint in a deal worth $857.5 million plus equity interest. Under the deal terms, Excalipoint gains an exclusive global license to CTM-012 and CTM-013, developed by Lepu’s Topabody T-cell engager platform. In exchange, Lepu will receive $10 million up front and up to $847.5 million in development and commercial-based milestones, plus tiered royalties on sales. Lepu will also receive an equity interest in Excalipoint for 10% of the company’s ordinary shares. As part of the share purchase agreement, Lepu gains a seat on Excalipoint’s board. Excalipoint will also raise a $41 million series A round led by Chinese investors.

Workload reductions figure into FDA’s FY2026 user fees

While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board. The higher fees reflect the formulas set in the current five-year agreements the FDA negotiated with industry, as well as some expected reductions in workload. For instance, the agency is estimating a 13% reduction in the number of ANDAs and an 11% reduction in biosimilar product applications that will be submitted in fiscal 2026.

Sham response variability mars Spine’s phase III pain trial

Spine Biopharma Inc. cited an “inconsistent sham control response” among some of the sites in its phase III study testing SB-01 as an intradiscal treatment for patients with chronic low back pain (CLBP) associated with degenerative disc disease (DDD). The study, dubbed Model, fell short of statistical significance on pain intensity and pain-related function, despite showing numerical and clinically meaningful improvements. However, pointing to the need for treatments for CLBP associated with DDD, Spine said it anticipates meeting with the U.S. FDA to discuss potential approval pathways.

Praxis phase II scores with vormatrigine in focal onset seizures

Praxis Precision Medicines Inc. made public favorable phase II data from the Radiant study with vormatrigine in focal onset seizure (FOS) patients over eight weeks. The sodium channel modulator turned up a 56.3% median reduction in FOS frequency from baseline, with 22% at 100% seizure reduction in the last 28 days. Shares of the Boston-based firm (NASDAQ:PRAX) were trading at $47.84, down $6.26, or 11%.

Also in the news

4D Molecular, Allogene, Altasciences, Arrowhead, Artelo, Biomarin, Biontech, Certara, Endo, Enegenesis, Hemostemix, I-Mab, Kazia, Larimar, Lenz, Mallinckrodt, Medicinova, Moderna, Nosis, Novartis, Novo Nordisk, Oculis, Pfizer, Poltreg, Regeneron, Sanofi, Silexion, Spine, Sumitomo, Visirna, Voxcell, Xbrane, Yolo