NEW YORK – Legend Biotech said this week that it received notice from the Nasdaq Listing Qualifications Department that it is not in compliance with listing rules after failing to file an interim balance sheet and income statement with the US Securities and Exchange Commission in a 6-K filing for Q2 ending June 30, 2022, or Q4 ending Dec. 31, 2022. In a statement, Legend said the filing delay is due to a planned restatement of audited financial statements for 2019, 2020, and 2021 and unaudited interim financial information for the three months ending March 31, 2022. Legend has until March 7, 2023, to submit a proposal to regain compliance with Nasdaq's listing rules, and if Nasdaq grants an extension, Legend could have until June 29, 2023, to regain compliance. Legend said it intends to comply with these timelines.
Point Biopharma said this week that it has completed patient enrollment in the randomized portion of its Phase III SPLASH trial evaluating its radioligand therapy 177Lu-PNT2002 in prostate-specific membrane antigen (PSMA)-expressing metastatic castration-resistant prostate cancer patients who previously received androgen receptor pathway inhibitor therapy and who either aren't eligible for or refuse chemotherapy. The firm enrolled 390 patients and randomized them to receive either 177Lu-PNT2002 or hormone therapy.
Astra Zeneca and Daiichi Sankyo this week said that Health Canada approved Enhertu (trastuzumab deruxtecan) for treating patients with unresectable or metastatic HER2-low breast cancer who have received at least one prior line of therapy. The decision was based on the results of the DESTINY-Breast04 Phase III trial, which showed that Enhertu reduced the risk of disease progression or death by 49 percent compared to physician's choice of therapy.
Takeda said this week that China's National Medical Products Administration approved Exkivity (mobocertinib) for patients with locally advanced or metastatic non-small cell lung cancer bearing EGFR exon20 insertion mutations who have progressed on platinum-based chemotherapy. The approval is based on results from a Phase I/II trial in 114 patients with EGFR exon20 insertion-positive NSCLC showing a 28 percent overall response rate, a median duration of response of 15.8 months, and overall survival of 20.2 months.
San Diego-based microbiome-based liquid biopsy firm Micronoma said this week that its OncobiotaLung assay has received breakthrough device designation from the US Food and Drug Administration. The test can categorize lung nodules into high risk or low risk of malignancy with a simple blood draw.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.