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FDA Approvals News 18 December 2025 - 23 December 2025

Amgen Stock After Hours (AMGN) on Dec. 22, 2025: FDA Clears New Prolia/Xgeva Biosimilars, Fitch Upgrades Credit — What to Know Before the Dec. 23 Open

Amgen Stock After Hours (AMGN) on Dec. 22, 2025: FDA Clears New Prolia/Xgeva Biosimilars, Fitch Upgrades Credit — What to Know Before the Dec. 23 Open

Amgen Inc. (NASDAQ: AMGN) ended Monday, December 22, 2025, modestly higher, but the more important story for Tuesday’s open is what hit after the closing bell: fresh FDA approvals for new denosumab biosimilars that reference Amgen’s blockbuster bone-drug franchises Prolia and XGEVA—plus a credit-rating upgrade from Fitch that underscores improving balance-sheet flexibility. Below is a complete, investor-focused rundown of what…
23 December 2025
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Cytokinetics (CYTK) Stock Hits 52-Week High as FDA Approval of Myqorzo Triggers Analyst Price-Target Hikes

Cytokinetics (CYTK) Stock Hits 52-Week High as FDA Approval of Myqorzo Triggers Analyst Price-Target Hikes

Cytokinetics, Incorporated (NASDAQ: CYTK) surged on Monday, December 22, 2025, extending a sharp rally that followed the company’s first-ever U.S. drug approval. Shares traded around $69.68 in the session, up roughly 11% from the prior close, after reaching an intraday high near $70.86—a move that pushed the biotech to fresh 52-week highs and re-focused Wall Street on the commercial potential…
22 December 2025
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Johnson & Johnson (JNJ) Stock Week Ahead: Drug-Pricing Politics, Talc Verdicts, and Fresh FDA Wins Set the Tone (Dec 22–26, 2025)

Johnson & Johnson (JNJ) Stock Week Ahead: Drug-Pricing Politics, Talc Verdicts, and Fresh FDA Wins Set the Tone (Dec 22–26, 2025)

As the market heads into a Christmas-shortened trading week, Johnson & Johnson (NYSE: JNJ) is entering the final stretch of 2025 with an unusually headline-heavy mix of catalysts: U.S. drug-pricing negotiations tied to the White House, new talc-related jury verdicts, and a string of FDA and clinical updates that reinforce the company’s longer-term growth narrative. As of the latest close…
21 December 2025
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Biotechnology Stocks Week Ahead (Dec. 22–26, 2025): BioMarin–Amicus Deal, Cytokinetics FDA Win, IPO Filings, and Drug-Price Policy Risks

Biotechnology Stocks Week Ahead (Dec. 22–26, 2025): BioMarin–Amicus Deal, Cytokinetics FDA Win, IPO Filings, and Drug-Price Policy Risks

Biotechnology stocks head into the Christmas-shortened trading week with fresh momentum—and plenty for investors to digest—after a dense run of catalysts between December 19 and December 21, 2025. In the span of 48 hours, the sector saw a major rare-disease acquisition, a closely watched FDA approval in cardiology, IPO paperwork from both biotech and medtech, and a sweeping wave of…
21 December 2025
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Amgen Stock (AMGN) News Today: TrumpRx Drug-Price Deal, FDA Approvals, Dividend Update, and 2026 Analyst Forecasts

Amgen Stock (AMGN) News Today: TrumpRx Drug-Price Deal, FDA Approvals, Dividend Update, and 2026 Analyst Forecasts

December 20, 2025 — Amgen Inc. (NASDAQ: AMGN) is closing out the year with a rare combination of near-term policy headlines and company-specific catalysts that matter to investors: a new U.S. drug-pricing deal tied to the TrumpRx rollout, fresh FDA approvals that expand the growth runway, reaffirmed shareholder returns via dividends, and a split—but active—Wall Street outlook heading into 2026.…
20 December 2025
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GSK plc Stock News and Forecast (Dec. 20, 2025): TrumpRx Pricing Deal, Exdensur FDA Approval, Buybacks, and Analyst Targets

GSK plc Stock News and Forecast (Dec. 20, 2025): TrumpRx Pricing Deal, Exdensur FDA Approval, Buybacks, and Analyst Targets

GSK plc (LSE: GSK; NYSE: GSK) heads into the weekend with a rare “everything-bagel” mix of catalysts: a new U.S. drug-pricing agreement tied to tariff relief, a fresh FDA approval that could reshape severe-asthma dosing schedules, expanding vaccine indications in Europe, and a steady drumbeat of buybacks. For investors tracking GSK stock, the headline isn’t just one event—it’s the way…
20 December 2025
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Merck (MRK) Stock News and Forecasts for Dec. 19, 2025: Drug-Pricing Deals, FDA Fast-Track Catalysts, and Wall Street Targets

Merck (MRK) Stock News and Forecasts for Dec. 19, 2025: Drug-Pricing Deals, FDA Fast-Track Catalysts, and Wall Street Targets

Merck & Co., Inc. (NYSE: MRK) stock traded higher on Friday, December 19, 2025, as investors balanced two big forces that tend to move large-cap pharma: U.S. drug-pricing policy headlines and pipeline-driven growth prospects. Shares were around $101.71, up about 1% from the prior close, as the market digested White House signals on new pricing agreements and fresh read-throughs from…
19 December 2025
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Disc Medicine (NASDAQ: IRON) Stock Tumbles on Insider-Selling Headlines as Bitopertin FDA Decision Nears — News, Analyst Forecasts, and What to Watch (Dec. 19, 2025)

Disc Medicine (NASDAQ: IRON) Stock Tumbles on Insider-Selling Headlines as Bitopertin FDA Decision Nears — News, Analyst Forecasts, and What to Watch (Dec. 19, 2025)

Disc Medicine, Inc. stock (NASDAQ: IRON) sank sharply on Friday, Dec. 19, 2025, with IRON down about 10% in late-morning trading and swinging through a wide intraday range that, at one point, dipped into the low $70s before rebounding toward the low $80s. MarketScreener The timing matters: the selloff arrives just weeks before investors expect clarity on Disc’s most important…
19 December 2025
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Johnson & Johnson Stock (JNJ) After Hours Today (Dec. 18, 2025): FDA Approvals, Analyst Targets, and Talc Litigation in Focus Ahead of Friday’s Open

Johnson & Johnson Stock (JNJ) After Hours Today (Dec. 18, 2025): FDA Approvals, Analyst Targets, and Talc Litigation in Focus Ahead of Friday’s Open

Johnson & Johnson (NYSE: JNJ) finished Thursday’s regular session lower even as the broader market moved higher, then ticked modestly upward in after-hours trading—leaving investors with a familiar year-end setup: solid pipeline/MedTech progress on one side, and talc litigation headlines on the other. JNJ stock price after the bell: the key numbers investors are watching tonight JNJ shares closed the…
19 December 2025
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Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

December 18, 2025 — Merck & Company, Inc. (NYSE: MRK) is back in the spotlight for investors today as three threads converge: a fresh Wall Street upgrade tied to Merck’s post‑Keytruda strategy, a potentially meaningful FDA fast‑track development for two pipeline assets, and new Phase 3 momentum for the company’s blockbuster oncology franchise in earlier‑stage bladder cancer. Merck shares traded…
18 December 2025
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Johnson & Johnson Stock (JNJ) News Today: FDA Approvals, Analyst Price Targets, and the 2026 Outlook (Dec. 18, 2025)

Johnson & Johnson Stock (JNJ) News Today: FDA Approvals, Analyst Price Targets, and the 2026 Outlook (Dec. 18, 2025)

Johnson & Johnson (NYSE: JNJ) stock traded around $208 on Thursday, December 18, 2025, with shares modestly lower on the session as investors weighed a busy late-year news cycle that includes fresh FDA wins in MedTech and oncology, new Wall Street target updates, and the continued legal overhang from talc litigation. For long-term holders, the story remains familiar: J&J is…
18 December 2025
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GSK Stock News Today (Dec. 18, 2025): Buyback Update, New FDA Approvals, and Analyst Forecasts for GSK plc

GSK Stock News Today (Dec. 18, 2025): Buyback Update, New FDA Approvals, and Analyst Forecasts for GSK plc

GSK plc (LSE: GSK; NYSE: GSK) is ending 2025 with a busy headline tape—exactly the kind of environment where investors tend to re-check both the “story” and the spreadsheet. On Thursday, December 18, 2025, GSK published a fresh share buyback update, while markets continue to digest a string of regulatory milestones across respiratory, vaccines, and infectious diseases that could shape…
18 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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