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FDA News News 4 December 2025 - 16 December 2025

Corcept Therapeutics (CORT) Stock Drops on Dec. 16, 2025: UBS Neutral Call, Relacorilant FDA Catalyst, and Updated Price Targets

Corcept Therapeutics (CORT) Stock Drops on Dec. 16, 2025: UBS Neutral Call, Relacorilant FDA Catalyst, and Updated Price Targets

Corcept Therapeutics Incorporated (NASDAQ: CORT) ended Tuesday, December 16, 2025, sharply lower after a strong 2025 run that had pushed expectations—and valuation—into the spotlight. Shares closed at $79.44, down $7.86 (about 9%) from the prior close, after trading as low as $78.84 on the day. The day’s narrative around Corcept Therapeutics stock wasn’t driven by a single blockbuster headline like…
16 December 2025
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uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

Dec. 16, 2025 — uniQure N.V. (NASDAQ: QURE) is back in the spotlight Tuesday after a notable extended-hours rebound. The gene therapy developer’s shares were highlighted among top pre-market gainers, rising about 15% to roughly $23.50 in early trading, following a strong after-hours move the prior session. StockAnalysis The snapback comes at a time when the fundamental narrative around uniQure…
16 December 2025
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Sanofi Stock (SAN.PA, SNY) Slides After Tolebrutinib Double Setback: FDA Delay, Trial Miss, and Fresh Analyst Forecasts (Dec. 15, 2025)

Sanofi Stock (SAN.PA, SNY) Slides After Tolebrutinib Double Setback: FDA Delay, Trial Miss, and Fresh Analyst Forecasts (Dec. 15, 2025)

Sanofi stock is under pressure on December 15, 2025, after the French drugmaker disclosed two setbacks tied to its experimental multiple sclerosis (MS) medicine tolebrutinib—a regulatory delay in the U.S. for one progressive MS form and a failed Phase 3 endpoint in another. The update pushed Sanofi shares down about 4% in Paris trading, as investors recalibrated expectations for one…
15 December 2025
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Incannex Healthcare (NASDAQ: IXHL) Stock: FDA Fast Track Catalyst, Nasdaq Compliance Clock, and the Latest Forecasts as of Dec. 15, 2025

Incannex Healthcare (NASDAQ: IXHL) Stock: FDA Fast Track Catalyst, Nasdaq Compliance Clock, and the Latest Forecasts as of Dec. 15, 2025

Incannex Healthcare Inc. (NASDAQ: IXHL) is back on traders’ radar heading into mid-December, with the stock hovering around $0.42 in early Monday pricing on December 15, 2025, after closing near $0.40 in the prior session. The renewed attention isn’t coming out of nowhere. Over the past several weeks, Incannex has stacked up a series of developments that matter to speculative…
15 December 2025
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Eli Lilly Stock (NYSE: LLY) in Focus: Retatrutide’s Near-30% Weight-Loss Data, FDA Fast-Track Questions for Orforglipron, and Fresh Analyst Forecasts (Dec. 12, 2025)

Eli Lilly Stock (NYSE: LLY) in Focus: Retatrutide’s Near-30% Weight-Loss Data, FDA Fast-Track Questions for Orforglipron, and Fresh Analyst Forecasts (Dec. 12, 2025)

Eli Lilly (LLY) stock is moving as investors weigh standout retatrutide Phase 3 results, a Reuters report on FDA review timing for orforglipron, and updated Wall Street price targets. Published: December 12, 2025 Eli Lilly and Company stock (NYSE: LLY) is back in the spotlight on December 12, 2025, as the market digests a rapid sequence of obesity-pipeline headlines—alongside new…
12 December 2025
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HeartBeam (BEAT) Stock Soars After FDA Clearance: Latest News, Forecasts and Analyst Views

HeartBeam (BEAT) Stock Soars After FDA Clearance: Latest News, Forecasts and Analyst Views

As of December 11, 2025, HeartBeam, Inc. (NASDAQ: BEAT) has abruptly moved from obscure micro‑cap to one of the hottest tickers in medtech, after winning a pivotal U.S. FDA clearance for its cable‑free, at‑home 12‑lead ECG synthesis software. The stock closed at $1.55 on December 10, up roughly 92% from the prior close of $0.81, with trading volume exploding to…
11 December 2025
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Teva Pharmaceutical Industries (TEVA) Stock: FDA Filing, Analyst Upgrades and 2026–27 Outlook on December 10, 2025

Teva Pharmaceutical Industries (TEVA) Stock: FDA Filing, Analyst Upgrades and 2026–27 Outlook on December 10, 2025

December 10, 2025 – New York / Tel Aviv Teva Pharmaceutical Industries Limited (NYSE: TEVA; TASE: TEVA) is trading around its 52‑week highs as a wave of fresh news hits the stock: a new U.S. FDA filing for a once‑monthly schizophrenia drug, a string of bullish analyst upgrades, stronger long‑term cash‑flow guidance and notable institutional activity. At around $29 per…
10 December 2025
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Praxis Precision Medicines (PRAX) Soars on FDA Momentum and 760-Dollar Target: December 9, 2025 Stock Deep Dive

Praxis Precision Medicines (PRAX) Soars on FDA Momentum and 760-Dollar Target: December 9, 2025 Stock Deep Dive

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) has turned into one of 2025’s most dramatic biotech stories. On December 9, 2025, the stock is trading around $265–270 per share, near its 52‑week high of about $278 and far above its low near $26.70, giving the company a market capitalization of roughly $6.6 billion. StockAnalysis Behind that move is a mix of…
9 December 2025
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Moderna (MRNA) Stock on 8 December 2025: Institutional Tug‑of‑War, FDA Shockwaves and 2026–2030 Forecasts

Moderna (MRNA) Stock on 8 December 2025: Institutional Tug‑of‑War, FDA Shockwaves and 2026–2030 Forecasts

Published: 8 December 2025 – all data and news current to this date. This article is informational only and not investment advice. Key takeaways Where Moderna stock stands today As of 8 December 2025, Moderna shares trade around $27.70, roughly flat after a powerful rebound that saw the stock jump 8–9% on 5 December on heavy volume. StockInvest Over the…
8 December 2025
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INO Stock: Inovio’s FDA BLA Milestone, New Equity Offerings and 2026 Catalyst – Latest News and Forecasts (December 7, 2025)

INO Stock: Inovio’s FDA BLA Milestone, New Equity Offerings and 2026 Catalyst – Latest News and Forecasts (December 7, 2025)

Published: December 7, 2025 Inovio Pharmaceuticals (NASDAQ: INO) has quietly turned 2025 into a make‑or‑break year. The small‑cap biotech has completed a Biologics License Application (BLA) for its lead DNA immunotherapy INO‑3107, raised fresh capital through two stock offerings, and attracted a flurry of new analyst ratings and algorithmic “Strong Buy” labels — all while still burning cash and generating…
7 December 2025
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Tempus AI (TEM) Stock: FDA Wins, Q3 Earnings, and Analyst Forecasts – December 6, 2025

Tempus AI (TEM) Stock: FDA Wins, Q3 Earnings, and Analyst Forecasts – December 6, 2025

Updated: December 6, 2025 Tempus AI Inc. (NASDAQ: TEM) has quickly become one of the most closely watched artificial intelligence stocks in healthcare. After a year marked by multiple FDA clearances, strong revenue growth and high-profile partnerships, Wall Street is now debating whether the current share price in the mid‑$70s still leaves meaningful upside. Business Wire Fresh research notes and…
6 December 2025
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Incannex Healthcare (IXHL) Stock Soars on FDA Fast Track: December 2025 Outlook, Forecast & Key Risks

Incannex Healthcare (IXHL) Stock Soars on FDA Fast Track: December 2025 Outlook, Forecast & Key Risks

Incannex Healthcare Inc. (Nasdaq: IXHL) is back on traders’ radar after the U.S. Food and Drug Administration granted Fast Track designation to its lead sleep-apnoea drug candidate, IHL‑42X. The move caps a busy 2025 that also brought strong Phase 2 data in sleep apnoea and psilocybin-assisted therapy, a major clean-up of warrant overhang, and a fight to keep the company’s…
4 December 2025
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Stock Market Today

  • TryHard Holdings Valuation Mixed as THH Trades Near $0.96
    January 18, 2026, 10:45 AM EST. TryHard Holdings (THH) trades near $0.9601 after a streak of mixed short-term results. One-day and weekly moves are modest at about 0.87% and 0.97%, with 1- and 3-month gains near 0.94% and 0.88% and YTD around 0.95%. The price action suggests the market is reassessing risk despite the latest close. Valuation shows a Price-to-Sales (P/S) of 2.1x, above the US Entertainment industry average (1.4x) and a peer average (1.8x). With low profit margins and revenue noted as ¥3,538.922, THH is exposed to event, hospitality, and restaurant demand cycles. The question: is THH undervalued or has the market already priced in growth? Readers can review the detailed valuation breakdown for context and risks.
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