StockNews.AI
CODX
Benzinga
176 days

Penny Stock Co-Diagnostics Withdraws FDA Application For COVID-19 Test, Plans To Submit Enhanced Version

1. CODX withdrew its FDA 510(k) application due to shelf‐life stability concerns. 2. An enhanced COVID-19 test version will be submitted after additional clinical data is collected. 3. The new submission incorporates updated PCR platform developments for improved manufacturing. 4. Premarket price down 14.9%, indicating immediate investor concerns.

3m saved
Insight
Article

FAQ

Why Bearish?

The withdrawal signals regulatory issues causing immediate investor nervousness, similar to past biotech delays that triggered short-term price declines.

How important is it?

Regulatory setbacks affecting core COVID-19 test strategy are critical, explaining the sharp price drop and potential near-term volatility.

Why Short Term?

The decision has triggered an instant negative reaction with a premarket drop; benefits from enhanced submission may only materialize later.

Related Companies

Related News