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FDA News News 30 December 2025 - 1 January 2026

Axsome Therapeutics (AXSM) stock jumps after FDA sets April 30 decision for Alzheimer’s agitation drug

Axsome Therapeutics (AXSM) stock jumps after FDA sets April 30 decision for Alzheimer’s agitation drug

NEW YORK, January 1, 2026, 16:58 ET — Market closed Axsome Therapeutics shares jumped about 23% in the most recent session on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental application for AXS-05 to treat agitation in Alzheimer’s disease and granted the filing priority review. The stock last traded at $182.64, after swinging between…
1 January 2026
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Corcept Therapeutics stock tanks on FDA relacorilant setback — what happens next for CORT

Corcept Therapeutics stock tanks on FDA relacorilant setback — what happens next for CORT

NEW YORK, January 1, 2026, 3:46 PM ET — Market closed. Corcept Therapeutics (CORT.O) shares ended the last U.S. session down 50.4% at $34.80 after the Food and Drug Administration declined to approve the company’s drug relacorilant for a rare hormonal-disorder-related blood-pressure condition. StockAnalysis U.S. stock markets are closed on Thursday for New Year’s Day, leaving investors to digest the…
1 January 2026
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Axsome (AXSM) stock jumps after FDA sets April decision date for Alzheimer’s agitation filing

Axsome (AXSM) stock jumps after FDA sets April decision date for Alzheimer’s agitation filing

NEW YORK, January 1, 2026, 07:18 ET — Market closed Key points: With U.S. markets closed on Thursday for the New Year’s Day holiday, Axsome Therapeutics shares were last up 22.9% at $182.64 after the company said the FDA granted priority review for its Alzheimer’s disease agitation filing. The stock swung between $148.79 and $184.40 in Wednesday’s session. Volume was…
1 January 2026
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Outlook Therapeutics stock drops after FDA issues another Lytenava CRL for wet AMD

Outlook Therapeutics stock drops after FDA issues another Lytenava CRL for wet AMD

NEW YORK, January 1, 2026, 04:59 ET — Market closed Outlook Therapeutics, Inc. (Nasdaq: OTLK) shares fell sharply in after-hours trading on Dec. 31 after the U.S. Food and Drug Administration again declined to approve its ONS-5010/LYTENAVA (bevacizumab-vikg) filing for wet age-related macular degeneration. The stock closed down 15.51% at $1.58 and slid to $0.58 after hours. Nasdaq The decision…
1 January 2026
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Corcept Therapeutics stock tanks 50% after FDA relacorilant setback — what’s next for CORT

Corcept Therapeutics stock tanks 50% after FDA relacorilant setback — what’s next for CORT

NEW YORK, January 1, 2026, 04:13 ET — Market closed Corcept Therapeutics Incorporated shares last closed down 50.4% at $34.80 on Wednesday. Yahoo Finance The selloff followed news that the U.S. drug regulator will not approve relacorilant in its current form for an expanded use tied to a rare hormonal disorder. The decision matters now because relacorilant was the company’s…
1 January 2026
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Axsome stock jumps 23% after FDA sets April 30 deadline for Alzheimer’s agitation review

Axsome stock jumps 23% after FDA sets April 30 deadline for Alzheimer’s agitation review

NEW YORK, January 1, 2026, 03:20 ET — Market closed Axsome Therapeutics Inc shares jumped 22.9% to $182.64 in Wednesday’s session, after touching $184.40, with about 3.1 million shares traded. The CNS drugmaker said the U.S. Food and Drug Administration accepted and granted priority review to its supplemental new drug application for AXS-05 (dextromethorphan-bupropion) — marketed as Auvelity for major…
1 January 2026
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Corcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertension

Corcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertension

NEW YORK, December 31, 2025, 18:31 ET — After-hours Corcept Therapeutics Inc shares sank about 50% in after-hours trading on Wednesday after the U.S. Food and Drug Administration declined to approve its oral drug relacorilant for a Cushing’s-related hypertension use. The stock was last at $34.80, down $35.39 from the prior close. Reuters The decision hits at a key moment…
1 January 2026
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Axsome Therapeutics (AXSM) stock jumps 23% after FDA priority review for Alzheimer’s agitation filing

Axsome Therapeutics (AXSM) stock jumps 23% after FDA priority review for Alzheimer’s agitation filing

NEW YORK, December 31, 2025, 14:41 ET — Regular session Axsome Therapeutics shares jumped 23% in afternoon trading on Wednesday after the company said U.S. regulators accepted its application and granted a faster review for AXS-05 to treat agitation in Alzheimer’s disease. GlobeNewswire The FDA’s acceptance puts a hard deadline on the next major catalyst for Axsome, with an April…
31 December 2025
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Corcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch next

Corcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch next

NEW YORK, December 31, 2025, 13:58 ET — Regular session Shares of Corcept Therapeutics Incorporated (CORT.O) sank nearly 50% on Wednesday after the U.S. Food and Drug Administration issued a complete response letter for the company’s relacorilant application in hypertension secondary to hypercortisolism, also known as Cushing’s syndrome. The stock was down 49.7% at $35.31 in afternoon trading. Nasdaq The…
31 December 2025
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Why Cogent Biosciences stock is down today after its FDA filing for bezuclastinib

Why Cogent Biosciences stock is down today after its FDA filing for bezuclastinib

NEW YORK, December 30, 2025, 14:40 ET — Regular session Shares of Cogent Biosciences, Inc. fell 2.7% to $36.88 on Tuesday after the biotech said it submitted a New Drug Application to the U.S. Food and Drug Administration for its drug candidate bezuclastinib in nonadvanced systemic mastocytosis. Yahoo Finance An NDA is the formal request asking the FDA to review…
30 December 2025
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Mineralys Therapeutics (MLYS) stock slides today as biotech weakens; FDA filing timeline in focus

Mineralys Therapeutics (MLYS) stock slides today as biotech weakens; FDA filing timeline in focus

NEW YORK, December 30, 2025, 13:38 ET — Regular session Shares of Mineralys Therapeutics Inc fell 3.3% to $35.61 by early afternoon on Tuesday, after touching a session low of $35.17. About 513,000 shares had changed hands, versus a previous close of $36.83. Mineralys has a market value of about $2.9 billion and remains up about 183% over the past…
30 December 2025
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Outlook Therapeutics stock jumps ahead of FDA’s Dec. 31 Lytenava decision

Outlook Therapeutics stock jumps ahead of FDA’s Dec. 31 Lytenava decision

NEW YORK, December 30, 2025, 01:25 ET — Market closed Outlook Therapeutics, Inc. shares closed Monday up 8.8% at $1.98 after trading between $1.78 and $1.98. The stock was last up about 2% at $2.02 in late after-hours trading, with about 5.7 million shares changing hands. StockAnalysis Traders are zeroed in on a Dec. 31 deadline at the U.S. Food…
30 December 2025
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Stock Market Today

  • Orion OEC: 26% Rally Fails to Hide Revenue Decline; P/S at 0.2x vs Industry
    January 18, 2026, 9:25 AM EST. Orion S.A. (NYSE: OEC) has jumped 26% in the past month, yet shares remain down about 56% over the last year. The stock trades at a price-to-sales ratio of about 0.2x, well below the industry's roughly 1.1x median. Revenue has declined-4.3% in the last 12 months and 6.7% over three years-underpinning questions about growth. Five analysts project a 0.9% annual decline in revenue over the next three years, versus industry peers forecast to grow about 9.8% annually. The subdued top line explains the low P/S and cautions against extrapolating the rally. Investors will watch for any material revenue improvement that could support a higher multiple. Until then, the P/S may stay under pressure.
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