Shares of Outlook Therapeutics, Inc. (Nasdaq: OTLK) plummeted over 50% in pre-market trading following the company's announcement of receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab intended for treating wet AMD.

While acknowledging the positive outcomes of the NORSE TWO pivotal trial in terms of safety and efficacy, the FDA's decision not to approve the BLA during this review cycle was attributed to several factors, including issues related to CMC, manufacturing inspection findings, and insufficient supporting evidence.

$OTLK was trading at $0.40 in pre-market, down $1.01 (-71.63%).

In other news, JOYY Inc. (Nasdaq: YY), a social media platform provider, posted second-quarter 2023 earnings of $1.29 per share, surpassing the consensus EPS estimate of $0.40. The company reported quarterly sales of $547.33 million, slightly ahead of analysts' projected revenue of $536.38 million.

However, JOYY's Q3 2023 net revenue forecast falls between $537 million and $567 million, differing from the consensus estimate of $572.55 million for the period.

In pre-market, $YY was trading at $33.90, showing a decrease of $0.06 (-0.18%).

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