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Major Pre-Market Movers: FDA Rejection Sends Outlook Therapeutics Plunging 60%

MarketDash Editorial Team
3 hours ago
Outlook Therapeutics shares crashed in pre-market trading Friday after the FDA issued a complete response letter rejecting its key drug application. Several other stocks also declined sharply despite futures pointing to a positive market open.

U.S. stock futures climbed Friday morning, with Nasdaq 100 futures up around 1%, but not every company was enjoying the optimistic mood.

The biggest casualty? Outlook Therapeutics Inc. (OTLK), which saw its shares crater after dropping some seriously bad news. The company revealed that the FDA issued a complete response letter regarding its ONS-5010/LYTENAVA biologics license application resubmission. For those unfamiliar with FDA-speak, that's essentially a rejection notice—the agency is saying it cannot approve the application in its current form for treating wet age-related macular degeneration.

Outlook Therapeutics shares nosedived 60.9% to $0.62 in pre-market trading, the kind of move that ruins breakfast plans.

Other Notable Decliners

Outlook Therapeutics wasn't alone in the pre-market pain trade. Here's who else was moving lower:

Intelligent Bio Solutions Inc. (INBS) dropped 19.2% to $7.70 after announcing a $10.0 million private placement priced at-the-market under Nasdaq rules. Dilution concerns, anyone?

Net Lease Office Properties (NLOP) slid 8.9% to $23.50 in pre-market action, continuing the office real estate sector's ongoing struggles.

Progressive Corp (PGR) tumbled 5.8% to $214.60, a significant decline for the insurance giant.

Old Republic International Corp (ORI) slipped 4.8% to $43.42, mirroring weakness across the insurance space.

Cango Inc – ADR (CANG) fell 4% to $1.44 in early trading.

Xeris Biopharma Holdings Inc (XERS) declined 3.6% to $7.57, giving back some gains after rising over 7% on Wednesday.

Biohaven Ltd (BHVN) dropped 2.6% to $11.00 in pre-market activity.

RealReal Inc (REAL) slipped 2.3% to $15.41 as trading got underway.

All this while the broader market was signaling a positive open—sometimes individual company news matters more than the tape.

Major Pre-Market Movers: FDA Rejection Sends Outlook Therapeutics Plunging 60%

MarketDash Editorial Team
3 hours ago
Outlook Therapeutics shares crashed in pre-market trading Friday after the FDA issued a complete response letter rejecting its key drug application. Several other stocks also declined sharply despite futures pointing to a positive market open.

U.S. stock futures climbed Friday morning, with Nasdaq 100 futures up around 1%, but not every company was enjoying the optimistic mood.

The biggest casualty? Outlook Therapeutics Inc. (OTLK), which saw its shares crater after dropping some seriously bad news. The company revealed that the FDA issued a complete response letter regarding its ONS-5010/LYTENAVA biologics license application resubmission. For those unfamiliar with FDA-speak, that's essentially a rejection notice—the agency is saying it cannot approve the application in its current form for treating wet age-related macular degeneration.

Outlook Therapeutics shares nosedived 60.9% to $0.62 in pre-market trading, the kind of move that ruins breakfast plans.

Other Notable Decliners

Outlook Therapeutics wasn't alone in the pre-market pain trade. Here's who else was moving lower:

Intelligent Bio Solutions Inc. (INBS) dropped 19.2% to $7.70 after announcing a $10.0 million private placement priced at-the-market under Nasdaq rules. Dilution concerns, anyone?

Net Lease Office Properties (NLOP) slid 8.9% to $23.50 in pre-market action, continuing the office real estate sector's ongoing struggles.

Progressive Corp (PGR) tumbled 5.8% to $214.60, a significant decline for the insurance giant.

Old Republic International Corp (ORI) slipped 4.8% to $43.42, mirroring weakness across the insurance space.

Cango Inc – ADR (CANG) fell 4% to $1.44 in early trading.

Xeris Biopharma Holdings Inc (XERS) declined 3.6% to $7.57, giving back some gains after rising over 7% on Wednesday.

Biohaven Ltd (BHVN) dropped 2.6% to $11.00 in pre-market activity.

RealReal Inc (REAL) slipped 2.3% to $15.41 as trading got underway.

All this while the broader market was signaling a positive open—sometimes individual company news matters more than the tape.