Clinical Trials

The drugs have been slow to catch on since approval more than two years ago, but results showing reduction in cardiovascular events could help it gain traction.

The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.

The Swiss major’s CDK4/6 inhibitor has met the primary endpoint in a Phase II trial in first-line aggressive advanced breast cancer, supporting off-label use as the firm goes head to head with Pfizer’s rival drug Ibrance.

Nkarta has updated its early results for its natural killer cell therapy, where it has shown promising efficacy and potentially superior safety to existing CAR-Ts.

Yuhan’s oncology drug lazertinib is set to expand its indications in Korea to the first-line treatment of EGFR mutation-positive advanced NSCLC, based on new top-line Phase III data showing clinical benefits for all patient sub-groups.

The UK firm has announced an extension of its series C financing which means it has raised just shy of $150m in the last 18 months to fund clinical development, manufacturing scale-up and preparations for the potential commercialization of opelconazole.

The drug is dosed once every four weeks – compared with Mounjaro and Wegovy’s weekly dosing – but the company also signaled it is considering extended dosing intervals.

The major’s radioligand therapy has succeeded in an earlier line of prostate cancer therapy that presents a large market opportunity, but some observers are keen to see full data before raising their sales projections.

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.

In this week's podcast edition of Five Must-Know Things: safety debate as more lecanemab data reported; amyloid discussions continue at Alzheimer’s meeting; China COVID unrest affect country’s biotech sector; and Merck’s CMO talks about post-Keytruda plans.

The firms unveiled positive Phase III data from their respective assets for treating the agitation seen in Alzheimer’s disease with Lundbeck’s candidate set to become first-to-market for the challenging behavioral symptom.

GSK’s PD-1 inhibitor will not be able to make up much ground on Keytruda, but new studies suggest it is a match for the market-leading PD-1 inhibitors.