Legend Biotech's Ying Huang, Ph.D., resigned after a six-year stint as CEO. Merck briefly posted—and then quickly deleted—a clinical trial plan to test its PD-1xVEGF bispecific in combination with its Kelun-partnered TROP2 ADC. The FDA approved a new class of ADHD therapy in Otsuka's Simtriyo. And more.
1. Legend Biotech CEO abruptly steps down without permanent replacement
Legend Biotech’s CEO, Ying Huang, Ph.D., has resigned. As Legend searches for a permanent replacement, Alan Bash, who has been leading Legend’s commercial activities as president of Carvykti since 2024, has become interim CEO. Huang’s resignation was not due to any disagreement with the company, Legend said.
2. Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination
Merck briefly posted and then deleted information on a phase 2 trial to combine its PD-1xVEGF bispecific antibody, MK-2010, and its TROP2-directed antibody-drug conjugate, sac-TMT, in advanced solid tumors. Merck has been keeping its PD-1xVEGF strategy close to its chest, citing a fiercely competitive market. Both drugs were originally developed by Chinese companies.
3. FDA approves Otsuka’s ADHD drug Simtriyo, teeing up its ‘next major CNS launch’
The FDA has approved Otsuka’s first-in-class triple norepinephrine, dopamine, serotonin reuptake inhibitor, Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD). Calling the drug Otsuka’s “next major CNS launch,” Jefferies analysts noted that an upcoming Drug Enforcement Administration classification will be key in determining its market potential.
4. GSK partner Hansoh reports another phase 3 win for priority ADC
A phase 3 trial of the B7-H3-targeted ADC, risvutatug rezetecan (ris-rez) in relapsed osteosarcoma has hit its primary endpoint of progression-free survival. The Chinese trial was conducted by Hansoh Pharmaceutical, representing another positive phase 3 for the GSK-partnered drug mere weeks after a small cell lung cancer readout.
5. How 2 FDA citations complicate Hengrui, Elevar’s push for liver cancer combo approval
Hengrui Pharma has quickly resolved an FDA Form 483 cited in the agency's recent complete response letter for its Elevar Therapeutics-partnered combination of camrelizumab and rivoceranib. However, a second Form 483, which arrived less than a week before the CRL and was not mentioned in the rejection letter, now stands in the way of a potential fourth approval bid by the companies.
Other News of Note:
6. Takeda scraps another phase 2 celiac disease therapy, narrowing pipeline to one
7. InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test
8. Merck stages expanded access to monthly HIV PrEP pill ahead of approval