Tristan Manalac

Roche's decision to discontinue the Ionis-partnered trials came soon after the biotech sustained a late-stage failure in ATTR-CM.

The failure of AstraZeneca and Ionis' Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam's next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.

The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency's portal.

The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science's decision not to resume them was a matter of prioritization, not safety, the biotech said.

Leqembi Iqlik can now be given at home throughout the entire course of treatment, setting it apart from Eli Lilly's Kisunla, the only other anti-amyloid Alzheimer's disease therapy on the market.

Dizal Pharmaceutical's Zegfrovy is approved in the U.S. for locally advanced or metastatic non-small cell lung cancer. For $600 million upfront, AstraZeneca will gain global rights to advance and commercialize the asset.

Spero Therapeutics is putting over $1 billion on the line in exchange for rights to develop SP001, an anti-CD40L antibody, for IgG4-related disease. A Phase 2 study is planned for the second quarter of 2027.

Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?

The FDA has given the go-ahead to Celcuity's kinase inhibitor gedatolisib as part of a treatment regimen for certain patients with locally advanced or metastatic breast cancer.

Eli Lilly's anti-amyloid Alzheimer's drug is designed to be stopped after patients drop below a certain amyloid level in the brain. However, at the Alzheimer's Association International Conference on Wednesday, Lilly revealed it is studying the potential of maintenance therapy for patients who need it.