Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.
FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.
The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.
Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.
Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.
Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.
Looking to improve on the efficacy and safety of Roche’s Esbriet and BI’s Ofev, Avalyn has inhalable formulations of those drugs in Phase IIb and Phase I, respectively.
The drugmaker plans to build a large manufacturing center in Virginia as the centerpiece of an effort to invest $50bn in the US by 2030.
FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.
Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.
With drug sector indexes underperforming the broad market in the first half of 2025, investors may have been anticipating tariff-related and other headwinds. But impending loss of exclusivity on key products may be provoking more anxiety at this point.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.
