Galera Therapeutics, Inc.’s stock has gone through the floor on the news that regulators in the US have rejected avasopasem manganese, the company's treatment for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer.
Mucositis Drug Rejection Sends Galera Into Tailspin
Workforce Slashed By 70%
Galera's stock has cratered after the US FDA issued a complete response letter for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer.

More from New Products
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.
The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
More from Scrip
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.