Core Viewpoint - ImmunityBio's stock surged by 17.39% to close at $6.48, driven by positive FDA discussions regarding the ANKTIVA label expansion for bladder cancer, with significant trading volume indicating strong investor interest [1][3]. Company Performance - ImmunityBio's trading volume reached 209.3 million shares, approximately 1,000% higher than its three-month average of 19.1 million shares, reflecting heightened investor activity [1]. - Since its IPO in 2015, ImmunityBio's stock has experienced an 81% decline, highlighting the volatility and challenges faced by the company [1]. Market Context - The broader market saw declines, with the S&P 500 falling by 2.06% and the Nasdaq Composite down by 2.39%, indicating a mixed performance in the biotechnology sector [2]. - Within biotechnology, Moderna and Novavax showed positive movements, closing at $43.00 (+4.56%) and $8.20 (+0.49%) respectively, suggesting stock-specific catalysts are influencing performance rather than overall sector trends [2]. Future Outlook - The FDA's End-of-Phase meeting provided a potential resubmission path for ANKTIVA, which could lead to a label expansion for treating BCG-unresponsive papillary bladder cancer, representing a significant opportunity for ImmunityBio [3][4]. - ANKTIVA has shown triple-digit sales growth, albeit from a small base, and its expanding list of potential indications and markets suggests substantial upside potential for the stock [4].

Core Insights - ImmunityBio Inc. plans to submit additional information to the FDA regarding its supplemental biologics license application for Anktiva in treating papillary non-muscle invasive bladder cancer (NMIBC) within 30 days [1][2] - The stock has seen significant trading activity, with a session volume of 178.91 million compared to an average of 15.9 million [1] FDA Interaction - The FDA provided feedback during discussions on Anktiva in combination with Bacillus Calmette-Guérin for patients with BCG-unresponsive papillary NMIBC, which supports a potential resubmission of the sBLA filed initially in 2025 without requiring a new clinical trial [2] Clinical Results - Updated clinical results presented included over five years of follow-up data, showing disease-specific survival of approximately 96% at 36 months and cystectomy avoidance rates of 92% at one year and 82% at three years [3][4] - The safety profile of Anktiva is consistent with its currently approved indication in carcinoma in situ [4] Trial Data - The QUILT-3.032 Phase 2/3 trial, which enrolled 80 patients with high-grade, papillary-only BCG-unresponsive NMIBC, met its primary endpoint with a 12-month disease-free survival rate of 58.2% and progression-free survival rates of 94.9% at 12 months and 83.1% at 36 months [5] Market Performance - Anktiva is already approved in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ [6] - Preliminary net product revenue for Anktiva reached approximately $113 million for fiscal 2025, reflecting a 700% year-over-year increase [7] - For Q4 2025, revenue was about $38.3 million, marking a 20% quarter-over-quarter increase and a 431% year-over-year increase [7] Analyst Ratings - Piper Sandler maintains an Overweight rating for ImmunityBio and raises the price forecast from $5 to $7, while D. Boral Capital maintains a Buy rating with a price forecast of $24 [8] - ImmunityBio shares were up 20.44% at $6.64, reaching a new 52-week high [8]

Market Overview - U.S. stocks experienced a decline, with the Nasdaq Composite falling 1.5% amid President Trump's tariff threats related to the Greenland dispute [1] - The Dow decreased by 1.17% to 48,780.92, while the S&P 500 dropped 1.32% to 6,848.33 [1] - European shares also fell, with the eurozone's STOXX 600 down 0.92% and major indices in Spain, London, Germany, and France experiencing declines [8] Company Earnings - D.R. Horton, Inc. reported net income of $594.8 million, or $2.03 per diluted share, for Q1 of fiscal 2026, down from $844.9 million, or $2.61 per diluted share, in the same quarter last year [3] - Revenue for D.R. Horton was $6.887 billion, a decrease from $7.613 billion year-over-year, but exceeded the consensus estimate of $6.603 billion [4] Stock Movements - Rapt Therapeutics Inc shares surged 64% to $57.52 following GSK's announcement of an acquisition [9] - Corvus Pharmaceuticals Inc shares increased by 107% to $16.66 after positive clinical trial results [9] - Immunitybio Inc shares rose 23% to $6.78 after a meeting with the FDA regarding its application for a cancer treatment [9] - Bakkt Holdings Inc shares fell 19% to $17.42 after announcing a $300 million ATM equity program [9] - NovaBay Pharmaceuticals Inc shares dropped 45% to $8.07 following a stock offering announcement [9] - Synlogic Inc shares decreased by 38% to $0.70 after receiving a Nasdaq delisting notification [9] Commodities - Oil prices increased by 2% to $60.62, while gold rose by 3.6% to $4,759.30 [7] - Silver saw a significant increase of 7.1% to $94.845, whereas copper fell by 0.8% to $5.7845 [7]

Group 1 - The core point of the article is that ImmunityBio (IBRX.US) has seen a significant pre-market increase of over 13%, bringing its year-to-date surge to 178%, with the current share price at $6.31 [1]

Core Viewpoint - ImmunityBio's stock has surged over 178% this year, with a pre-market increase of over 13% on Tuesday, currently trading at $6.31 per share [1] Group 1: Company Developments - ImmunityBio announced that the FDA is seeking additional information related to its supplemental biologics license application for Anktiva in combination with BCG for treating non-muscle invasive bladder cancer in patients with papillary tumors [1] - The FDA has requested certain additional information to support a potential resubmission of the application initially submitted last year for the papillary indication [1] - The company plans to submit the required information to the FDA within the next 30 days, and the additional information does not involve initiating or designing new clinical trials [1]

Core Viewpoint - ImmunityBio's stock has surged over 13% in pre-market trading and has increased by 178% year-to-date, currently priced at $6.31 [1] Group 1: FDA Interaction - The U.S. Food and Drug Administration (FDA) is seeking additional information related to ImmunityBio's supplemental biologics license application concerning Anktiva combined with Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer in patients with papillary tumors [1] - The FDA has suggested that the company provide certain additional information to support a potential resubmission of the application initially submitted last year for the papillary indication [1] - ImmunityBio plans to submit the required information to the FDA within the next 30 days, and the additional information does not involve initiating or designing new clinical trials [1]

Core Viewpoint - Three stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1] Group 1: Stock Performance - Venus Concept Inc (NASDAQ:VERO) has seen its stock price increase by approximately 451.8%, closing at $7.89, with a 52-week high of $14.50 and an RSI value of 95.9 [5][3] - ImmunityBio Inc (NASDAQ:IBRX) experienced a stock price rise of 39.8%, closing at $5.52, with a year-to-date increase of over 100% and an RSI value of 95.4 [5][4] Group 2: Investment Activity - Madryn Asset Management disclosed a 91% stake in Venus Concept Inc for investment purposes, indicating strong institutional interest in the company [5]

Core Insights - Three stocks in the health care sector are signaling potential warnings for momentum-focused investors as of January 20, 2026 [1] Group 1: Overbought Stocks - Venus Concept Inc (NASDAQ:VERO) has an RSI value of 95.9, with shares gaining 451.8% to close at $7.89 on Friday, and a 52-week high of $14.50 [2][5] - ImmunityBio Inc (NASDAQ:IBRX) has an RSI value of 95.4, with shares rising 39.8% to close at $5.52 on Friday, and a year-to-date increase of over 100% [2][5]

Core Viewpoint - ImmunityBio, Inc. has engaged in a Type B End-of-Phase meeting with the U.S. FDA regarding its supplemental Biologics License Application for ANKTIVA® in treating BCG-unresponsive non-muscle invasive bladder cancer [1] Group 1 - The meeting focused on the clinical status of ANKTIVA® (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG) [1]

Regulatory Developments - Atossa Therapeutics, Inc. (ATOS) received Orphan Drug Designation from the U.S. FDA for (Z)-endoxifen to treat Duchenne muscular dystrophy, leading to a 12.98% increase in stock price to $0.69 [1] - ImmunityBio, Inc. (IBRX) reported that enrollment in its QUILT-2.005 trial for bladder cancer exceeded expectations, with over 85% enrollment, anticipating full enrollment by Q2 2026 and FDA submission by year-end 2026, resulting in a 9.43% stock price increase to $6.04 [2] Financing Updates - Foghorn Therapeutics Inc. (FHTX) closed a $50 million registered direct financing at a 30% premium, contributing to a 4.02% increase in stock price to $6.26 [4] - Femasys Inc. (FEMY) received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement, allowing until July 13, 2026, for compliance, leading to a 10.68% increase in stock price to $0.72 [3] Investor Sentiment - Theravance Biopharma, Inc. (TBPH) saw a 5.00% increase in stock price to $21.01 despite no new announcements [5] - Daré Bioscience, Inc. (DARE) experienced a modest gain of 1.04% to $1.95 without any new news [4]