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FDA Approvals News 23 December 2025 - 30 December 2025

Praxis Precision Medicines stock jumps after FDA Breakthrough Therapy tag for tremor drug, BTIG lifts target

Praxis Precision Medicines stock jumps after FDA Breakthrough Therapy tag for tremor drug, BTIG lifts target

NEW YORK, December 30, 2025, 05:21 ET — Premarket Praxis Precision Medicines Inc shares rose 13.25% on Monday to close at $304.58, after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for its essential tremor candidate ulixacaltamide, a filing showed. The stock opened at $317.72 and traded between $298 and $317.72, and was down about 1% in after-hours…
30 December 2025
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Praxis Precision Medicines (PRAX) stock jumps 13% after FDA breakthrough designation for tremor drug

Praxis Precision Medicines (PRAX) stock jumps 13% after FDA breakthrough designation for tremor drug

NEW YORK, December 30, 2025, 00:52 ET — Market closed. Praxis Precision Medicines shares climbed about 13% in Monday’s session, last trading at $304.58, after the company said U.S. regulators granted Breakthrough Therapy Designation for its experimental essential tremor treatment. The stock swung between $318.08 and $275.00 during the day. The designation, known as BTD, is an FDA pathway meant…
30 December 2025
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Intuitive Surgical (ISRG) News, Analyst Forecasts and 2026 Outlook: FDA Expansion for da Vinci SP, Wall Street Targets, and What’s Next (Dec. 25, 2025)

Intuitive Surgical (ISRG) News, Analyst Forecasts and 2026 Outlook: FDA Expansion for da Vinci SP, Wall Street Targets, and What’s Next (Dec. 25, 2025)

December 25, 2025 — Intuitive Surgical, Inc. (NASDAQ: ISRG) is ending 2025 with two storylines that rarely move in sync: fresh regulatory momentum for its single-port robotic platform and a renewed valuation debate as analysts model what the next wave of procedure growth could look like in 2026. With U.S. markets closed for Christmas Day, ISRG was last quoted around…
25 December 2025
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Abbott Laboratories (ABT) News and Stock Outlook on Dec. 25, 2025: FDA Clears Volt PFA, FreeStyle Libre Alert Persists, Exact Sciences Deal Looms

Abbott Laboratories (ABT) News and Stock Outlook on Dec. 25, 2025: FDA Clears Volt PFA, FreeStyle Libre Alert Persists, Exact Sciences Deal Looms

Dec. 25, 2025 — Abbott Laboratories (NYSE: ABT) heads into the year-end stretch with a rare mix of near-term product momentum and headline-level risk management. Over the past several weeks—culminating in key December announcements—Abbott has (1) secured U.S. FDA approval for a next-generation atrial fibrillation ablation platform, (2) expanded its push into consumer biowearables, (3) navigated an FDA early alert…
25 December 2025
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Merck & Co. (MRK) Enters 2026 in the Spotlight: BMO Upgrade to $130, FDA Fast-Track Vouchers and TrumpRx Pricing Deal Reframe the Post-Keytruda Story

Merck & Co. (MRK) Enters 2026 in the Spotlight: BMO Upgrade to $130, FDA Fast-Track Vouchers and TrumpRx Pricing Deal Reframe the Post-Keytruda Story

December 25, 2025 — Even with U.S. markets closed for Christmas Day, Merck & Co., Inc. (NYSE: MRK) is ending 2025 as one of the most-watched large-cap pharma names on Wall Street. The stock closed at $106.45 on Wednesday, Dec. 24, and commentary published today points to a six-day winning streak that has pushed investors back into “what’s next” mode:…
25 December 2025
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Healthcare Stocks Outlook (Dec. 25, 2025): Wegovy Pill Breakthrough, FDA Approvals, and a New Wave of M&A Heading Into 2026

Healthcare Stocks Outlook (Dec. 25, 2025): Wegovy Pill Breakthrough, FDA Approvals, and a New Wave of M&A Heading Into 2026

December 25, 2025 — U.S. markets are closed for Christmas, but healthcare stocks are ending the year with a burst of sector-defining catalysts: a landmark oral GLP‑1 approval for weight loss, multiple FDA green lights that moved biotech names sharply, and a renewed M&A drumbeat as big pharma and rare-disease specialists shop for growth. Below is a detailed, news-driven roundup…
25 December 2025
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Novo Nordisk Stock (NVO): Wegovy Pill FDA Approval, CagriSema Filing, and the 2026 Outlook Investors Are Watching (Dec. 25, 2025)

Novo Nordisk Stock (NVO): Wegovy Pill FDA Approval, CagriSema Filing, and the 2026 Outlook Investors Are Watching (Dec. 25, 2025)

December 25, 2025 — Christmas Day is a market holiday in the U.S., but Novo Nordisk A/S is still doing what it’s done for most of the past two years: pulling attention (and capital) toward anything labeled GLP‑1. NASDAQ Trader The headline catalyst is straightforward and extremely investable: the U.S. FDA has approved Novo Nordisk’s Wegovy pill, making it the…
25 December 2025
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Bristol-Myers Squibb (BMY) Stock News, Forecasts and Outlook as of Dec. 25, 2025: Breyanzi FDA Win, Eliquis Medicaid Deal, and 2026 Catalysts

Bristol-Myers Squibb (BMY) Stock News, Forecasts and Outlook as of Dec. 25, 2025: Breyanzi FDA Win, Eliquis Medicaid Deal, and 2026 Catalysts

Bristol-Myers Squibb Company (NYSE: BMY) heads into Dec. 25, 2025 with its stock anchored in the mid-$50s — and with investors juggling two competing storylines: With U.S. markets effectively pausing for the holiday, the most recent available NYSE quote showed BMY around $54.71 (last trade timestamp recorded Dec. 24), after trading between roughly $54.20 and $54.75 intraday. Bristol Myers Squibb…
25 December 2025
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Omeros (OMER) Stock Surges After FDA Approval of Yartemlea: Latest News, Analyst Forecasts, and 2026 Outlook

Omeros (OMER) Stock Surges After FDA Approval of Yartemlea: Latest News, Analyst Forecasts, and 2026 Outlook

December 25, 2025 — Omeros Corporation (NASDAQ: OMER) is having the kind of week biotech investors daydream about: a long-awaited U.S. regulatory win, a sharp stock re-rating, and a sudden pivot from “development-stage hope” to “commercial-stage execution.” The spark was the U.S. FDA approval of YARTEMLEA® (narsoplimab-wuug) as the first and only therapy indicated for hematopoietic stem cell transplant–associated thrombotic…
25 December 2025
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Omeros (OMER) Stock Surges After Hours on Dec. 24, 2025 After FDA Approves Yartemlea — What to Know Before the Next Market Open

Omeros (OMER) Stock Surges After Hours on Dec. 24, 2025 After FDA Approves Yartemlea — What to Know Before the Next Market Open

Omeros Corporation (NASDAQ: OMER) is ending Christmas Eve 2025 as one of the market’s most volatile and news-driven movers after the U.S. Food and Drug Administration approved the company’s first commercial product — a moment investors have waited years to see. As of 2:35 p.m. ET in after-hours trading on Wednesday, Dec. 24, 2025, OMER stock traded around $15.36, up…
24 December 2025
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Novo Nordisk (NVO) Stock Jumps as FDA Approves Wegovy Weight-Loss Pill: Latest News, Forecasts, and What Investors Watch Next

Novo Nordisk (NVO) Stock Jumps as FDA Approves Wegovy Weight-Loss Pill: Latest News, Forecasts, and What Investors Watch Next

December 23, 2025 — Novo Nordisk A/S (NYSE: NVO) is back in the spotlight after U.S. regulators approved a pill version of Wegovy, a milestone that could reshape the fast-growing obesity drug market—and potentially reset the narrative around a stock that’s had a bruising 2025. In U.S. trading on Dec. 23, Novo Nordisk shares traded around $52, up roughly 9%…
23 December 2025
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Novo Nordisk (NVO) Stock Jumps After FDA Approves Wegovy Pill: Today’s News, Analyst Forecasts, and 2026 Catalysts (23 December 2025)

Novo Nordisk (NVO) Stock Jumps After FDA Approves Wegovy Pill: Today’s News, Analyst Forecasts, and 2026 Catalysts (23 December 2025)

Novo Nordisk A/S (NYSE: NVO) is back in the market’s spotlight on 23 December 2025 after a major regulatory milestone: the U.S. Food and Drug Administration approved a pill version of Wegovy, making it the first oral GLP‑1 receptor agonist cleared for chronic weight management in the U.S. The news sent Novo Nordisk shares sharply higher in early trading and…
23 December 2025
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Stock Market Today

  • Nutanix appears undervalued after price slump, DCF suggests
    January 17, 2026, 3:39 PM EST. Nutanix Inc. NTNX closed at $45.74, after a 7-day decline of 14.5% and a year-to-date drop of 9.6%. Seven days aside, three- and five-year returns run 70.7% and 36.5%, but the stock is down 29.8% over the last 12 months. The shares carry a valuation score of 3 out of 6, signaling mixed sentiment about cloud-infrastructure software and subscription models. A two-stage Free Cash Flow to Equity (FCF; cash available to equity holders) model yields an intrinsic value of about $74.61 per share, suggesting ~38.7% undervaluation versus the current price. The model is anchored by a trailing twelve-month FCF of about $773.8 million and projects roughly $1.55 billion in 2035, underscoring the sector's sensitivity to subscription dynamics.
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