Revolution Medicines shares fell 6% after FDA review documents released Thursday suggested its pancreatic cancer drug Rasonque may be less broadly effective than previously thought. The documents showed tumor responses were markedly better than chemotherapy in patients with the KRAS G12V mutation, more modest in the larger G12D group, and worse in those with G12R. Some analysts called the sell-off overdone, but Leerink Partners' Andrew Berens described the disclosure as a 'crack in the armor.'
Zealand Pharma reported that its experimental drug petrelintide, developed with Roche, helped people with obesity and diabetes lose up to 9% of their body weight over 28 weeks in a Phase 2 trial, about 7 percentage points more than placebo. Blood sugar reductions were 0.6 to 0.9 percentage points better than placebo, which analysts found less impressive. They noted the weight loss was comparable to an Eli Lilly amylin analog and the safety profile appeared benign, but predicted the drug would likely be used mainly in a maintenance setting.
In other news, Pfizer's Tukysa received FDA clearance for first-line HER2-positive breast cancer as part of a chemotherapy-free maintenance regimen with Herceptin and Perjeta, cutting the risk of disease progression or death by 36%. Ultragenyx raised $210 million by selling a priority review voucher tied to its gene therapy Glenglycos, and TCGX closed a $600 million fund to support biotech companies in Asia, with new offices in Shanghai and Hong Kong.