Galera Therapeutics, a clinical-stage biopharmaceutical company, experienced a significant drop in its share price following a decision by the Food and Drug Administration (FDA). The company's new drug application for its cancer drug avasopasem manganese did not receive the desired approval, leading to a plummet of 82% in the company's stock, which now stands at 38 cents per share.
Workforce Reduction and Restructuring
To navigate the aftermath of the FDA decision and extend its cash runway, Galera Therapeutics has announced a comprehensive restructuring plan. As part of this plan, the company will reduce its workforce by 70%. This measure aims to optimize resource allocation and ensure long-term sustainability.
The FDA expressed concerns regarding the effectiveness and safety of avasopasem in reducing severe oral mucositis for patients with head and neck cancer. In response, Galera Therapeutics intends to request a Type A meeting with the FDA. This meeting will focus on discussing the rationale behind the FDA's decision and determining the necessary steps to support a resubmission for approval of the new drug application.
Strategic Focus and Ongoing Trials
Galera Therapeutics will also concentrate efforts on defining the future path for avasopasem and advancing its ongoing clinical trials for rucosopasem. The latter product candidate aims to enhance the anti-cancer efficacy of stereotactic body radiation therapy for patients with non-small cell lung cancer and locally advanced pancreatic cancer.
As of June 30, Galera Therapeutics estimated its available funds, including cash, cash equivalents, and marketable securities, to be $38.8 million. This estimation offers a clearer understanding of the company's financial position as it moves forward with its restructuring plan.
The future remains uncertain for Galera Therapeutics as it navigates the aftermath of the FDA decision. However, the company's strategic focus on clinical trials and its determination to address the concerns raised by the FDA suggest a commitment to finding a path towards new drug application resubmission and eventual approval.
Shares of tinyBuild fall as they project lower-than-expected revenue. The company plans to reduce costs and consider a future equity fundraise.
U.S. stock futures rebound as Dow Jones, S&P 500, and Nasdaq rise after recent decline. Media companies surge and President Biden offers support to auto workers...
Consumer companies assess positive spending trends while considering inflation risks. Kroger experiences surge in shares after selling stores to address merger...