BioNTech Shares Drop After FDA Clinical Hold

BioNTech (NASDAQ:BNTX) shares fell on Friday after the company was informed by partner OncoC4 that the FDA placed a partial clinical hold on the Phase 3 study of BNT316/ONC-392 (gotistobart) for non-small cell lung cancer (NSCLC).

The hold was due to "varying results between the squamous and non-squamous NSCLC patient populations," according to BioNTech's announcement. As a result, shares dropped more than 1.5%.

The PRESERVE-003 trial is a two-stage, open-label, randomized study aimed at assessing the efficacy and safety of the antibody candidate BNT316/ONC-392 as a single-agent therapy for metastatic NSCLC patients who have previously undergone PD-(L)1-inhibitor treatments.

An independent data monitoring committee recently found potential variances in the trial data among different NSCLC patient populations. Consequently, OncoC4 and BioNTech have voluntarily paused the enrollment of new patients and notified the FDA of the observed variances for further review and guidance.

Despite the partial clinical hold, existing participants in the trial will continue to receive their treatments as planned. BioNTech clarified that trials evaluating BNT316/ONC-392 for other indications remain unaffected.

Earlier this year, BioNTech reported that its quarterly losses had quadrupled as the company shifts its strategy towards new cancer treatments, following a significant decline in sales of its COVID-19 vaccine. In the second quarter, the biotech firm reported revenues of 807.8 million euros ($885 million), up from 190.4 million euros a year earlier, though it experienced a 23% drop in revenue to 128.7 million euros due to declining COVID-19 vaccine sales in partnership with Pfizer (NYSE:PFE).