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Regenxbio: Cautiously Bullish After FDA Setbacks
Seeking Alpha· 2026-02-13 11:07
Core Viewpoint - The article does not provide any specific insights or analysis related to companies or industries, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and Computer Applications from various institutions [1]. - The author collaborates professionally with another individual, ensuring independent analyses while adhering to guidelines [1]. - There is no indication of any stock or derivative positions held by the author in the companies mentioned, nor plans to initiate such positions in the near future [2].
Biotech Beat Nvidia in 2025. Can It Do It Again?
The Motley Fool· 2026-02-11 14:51
Industry Overview - The biotech industry had a strong performance in 2025, outperforming NVIDIA, with continued enthusiasm into 2026 [5] - There are concerns regarding the FDA's regulatory environment, described as chaotic, which may impact drug approvals [5][9] FDA Regulatory Environment - Richard Pasdur, a former senior FDA executive, expressed concerns about the breach of the firewall between political appointees and drug reviewers, indicating potential risks for the pharma industry [7] - The FDA's current commissioner, Marty Makary, aims to speed up drug approvals, but there are conflicting signals regarding the actual operating reality [9] Company Earnings Predictions Eli Lilly (Ticker: LLY) - Expected earnings per share range from $6.99 to $7.86, with a consensus estimate of $7.48 and revenue of $17.85 billion, indicating over 30% year-over-year earnings growth [15] - Analysts predict a likely earnings beat due to a history of exceeding expectations [15][16] Novo Nordisk (Ticker: NVO) - Earnings per share expectations are between $0.89 and $0.90, with revenue projected at $11.96 billion, showing a flat to slightly down trend [17] - Analysts express a higher possibility of a miss compared to Eli Lilly, citing recent struggles and a new CEO's uncertain direction [17][19] Twist Bioscience (Ticker: TWST) - Reported revenue of $104 million for Q1 2026, consistent with preliminary results, though still unprofitable [20] - The company has shown consistent revenue growth despite industry challenges, reducing cash burn and moving towards profitability [20]
X @Bloomberg
Bloomberg· 2026-02-09 21:48
US regulators rejected a gene therapy from Regenxbio to treat a rare disease that causes brain damage in boys, the latest sign that the Trump administration is taking a hard line on drug approvals for uncommon conditions https://t.co/LbeZaVu5dC ...
US FDA declines to approve Regenxbio's rare disease drug
Reuters· 2026-02-09 21:13
Core Viewpoint - Regenxbio announced that the U.S. Food and Drug Administration has declined to approve its drug for a rare disease [1] Company Summary - Regenxbio's drug was intended for a rare disease but has not received FDA approval [1]
X @Bloomberg
Bloomberg· 2026-01-28 14:23
Regenxbio shares sank after US regulators placed a hold on the company’s gene therapy trials because a patient was found to have a brain tumor https://t.co/T4dqJ9omx9 ...
盘前:科技板块表现强劲 纳指期货涨0.95%
Xin Lang Cai Jing· 2026-01-28 13:47
Market Overview - Technology stocks have driven U.S. markets higher for the second consecutive day, with investors positioning ahead of major tech earnings and the Federal Reserve's interest rate decision [2][25] - As of the latest update, Dow futures rose 0.04%, S&P 500 futures increased by 0.37%, and Nasdaq futures climbed 0.95% [3][26] - The MSCI global stock index is hovering near record highs, with the Nasdaq 100 index futures approaching last October's record [3][26] - The overall optimistic market sentiment is attributed to expectations that the Federal Reserve will maintain its current interest rates, with pricing indicating potential rate cuts in 2026 [3][26][27] Sector Performance - The technology sector is expected to continue driving market gains, with UBS Wealth Management's Chief Investment Officer suggesting that the current rebound is not over yet [4][27] - Semiconductor equipment manufacturer ASML reported a significant increase in orders, leading to a 7.5% rise in its stock price [3][26] - Asian tech stocks also saw gains, influenced by SoftBank's discussions to invest $30 billion in OpenAI [3][26] Individual Stock Movements - Seagate Technology shares rose over 10%, Western Digital increased by 7.5%, SanDisk gained 5.2%, and Micron Technology saw a nearly 4% rise in pre-market trading [12][33] - Starbucks stock jumped 10% after reporting first-quarter net revenue exceeding expectations [34] - Texas Instruments shares rose over 7% with Q4 revenue and Q1 guidance surpassing forecasts [35] - AT&T's stock increased by 3.4% following a higher-than-expected annual earnings forecast [36] - Intel shares continued to rise by 4.8%, reportedly due to Nvidia's plans to shift some chip production to Intel [37] - C3.ai stock surged over 11% as it discusses a merger with Automation Anywhere [38] Economic Indicators - The U.S. dollar index rose 0.25% to 96.16 after previously hitting a four-year low [31] - Gold prices surged to over $5,280 per ounce, reflecting increased geopolitical and economic risks [10][32] - Brent crude oil futures reached a four-month high, slightly above $68 per barrel [32]
美股异动丨Regenxbio盘前暴跌32%
Ge Long Hui A P P· 2026-01-28 12:59
Group 1 - The core point of the article is that Regenxbio's stock price plummeted by 32% in pre-market trading following the FDA's decision to impose a clinical hold on its gene therapy trial [1] Group 2 - The FDA's action indicates potential regulatory challenges for the company, which may impact its future development and commercialization plans [1] - The significant drop in stock price reflects investor concerns regarding the viability of Regenxbio's gene therapy program [1] - The clinical hold could delay the timeline for potential product launches, affecting the company's revenue projections [1]
US FDA places clinical hold on Regenxbio's gene therapy trials
Reuters· 2026-01-28 12:46
Core Viewpoint - Regenxbio announced that the U.S. Food and Drug Administration has placed a clinical hold on two of its experimental gene therapy programs for rare childhood diseases due to the discovery of a brain tumor in one treated patient [1] Company Summary - The clinical hold affects two gene therapy programs that are currently under development by Regenxbio [1] - The hold was initiated following a serious adverse event involving a brain tumor in a patient who received treatment [1]