Pharmaceutical Industry Update: GSK's Blenrep Revival, FDA Eases Camzyos Monitoring, and Biotech Liquidation Pressure

GSK Prepares for Blenrep Relaunch as UK Grants Approval

GSK has received approval from UK regulators for its multiple myeloma drug Blenrep, marking a significant comeback for the treatment. The drug, which was withdrawn from the market three years ago following a failed confirmatory trial, has now been cleared for use in patients whose multiple myeloma has progressed after one line of therapy.

This approval comes after GSK successfully conducted additional studies that have positioned Blenrep for a relaunch. The pharmaceutical giant is now awaiting a decision from the U.S. Food and Drug Administration (FDA) on a new approval, with a verdict expected by July 23, 2025.

FDA Relaxes Risk Monitoring Requirements for Bristol Myers Squibb's Camzyos

In a move that could expand access to an important cardiac treatment, the FDA has updated the prescribing information for Bristol Myers Squibb's hypertrophic cardiomyopathy drug Camzyos. The changes include easing risk monitoring requirements and reducing the number of contraindicated therapies.

Specifically, the updated prescribing information lowers the frequency of echocardiogram monitoring for some patients and removes two types of inhibitor drugs from the list of contraindicated therapies. This development is expected to facilitate the growth of the cardiac myosin inhibitor market, of which Camzyos is a key player.

Camzyos generated $602 million in sales last year and may soon face competition from Cytokinetics' aficamten, which is currently under review by U.S. regulators.

Activist Investors Challenge "Zombie" Biotechs, Pressing for Liquidation

Investment firm BML Capital Management has called for cancer drug developer Elevation Oncology to liquidate and return all of its cash to shareholders. This move comes after Elevation dropped its lead drug, laid off a majority of its staff, and began a strategic review following disappointing study data last month.

BML, which owns 9.9% of Elevation stock, argues that winding down is the company's "best course of action" given the current state of equity markets and the poor performance of many recent reverse mergers. This pressure on struggling biotechs is not isolated, as other companies, including cancer drug developer Essa Pharma, have faced similar activist challenges recently.

The situation highlights the increasing scrutiny of underperforming biotech firms and the difficult decisions facing companies in the wake of clinical setbacks.