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REGENXBIO Shares Decline 17% After FDA Imposed Clinical Holds On Gene Therapy Programs
RTTNews· 2026-01-28 18:01
Core Viewpoint - REGENXBIO Inc. experienced a significant stock decline of 17.75% following the FDA's clinical hold on two investigational gene therapy programs [1] Group 1: Stock Performance - The company's shares closed at $11.03 after a drop of $2.38 [1] - The stock opened at $9.60, down from the previous close of $13.41, and traded between $9.51 and $11.50 during the session [3] - Trading volume reached approximately 3.88 million shares, significantly higher than the average volume of about 690,186 shares [3] Group 2: FDA Clinical Hold - The FDA imposed a clinical hold on the RGX-111 program, which was under investigation for treating MPS I or Hurler syndrome, due to a preliminary review of a neoplasm case involving a central nervous system tumor in a trial participant [2] - This hold has raised concerns regarding the safety and viability of the gene therapy programs [2] Group 3: Historical Stock Range - REGENXBIO's stock has fluctuated within a 52-week range of $5.03 to $16.19 [4]
Biotech Inventiva's 50% surge shows investor optimism over liver disease drug
Reuters· 2026-01-28 15:39
Core Insights - A significant increase in Inventiva shares, approximately 50% in the initial weeks of 2026, indicates strong investor interest in the company despite its current loss-making status [1] Company Summary - Inventiva is a French biotech firm poised to enter a rapidly growing market, attracting attention from investors looking for potential opportunities [1]
BioNTech SE (BNTX): A Bull Case Theory
Yahoo Finance· 2026-01-28 14:13
Group 1: Company Overview - BioNTech SE is a biotechnology company focused on developing and commercializing immunotherapies for cancer and infectious diseases in Germany [2] - As of January 26th, BioNTech's share price was $118.00, with trailing and forward P/E ratios of 166.87 and 7.04 respectively [1] Group 2: Financial Position - The company enters 2026 with substantial cash reserves of approximately $17 billion, providing strategic flexibility for pipeline development [2] - Management expects a modest decline in Covid-related revenues due to changes in vaccination recommendations and a shift from government procurement to private-market supply [3] Group 3: Clinical Development - 2026 is anticipated to be a pivotal year for BioNTech, with multiple late-stage oncology readouts planned across various cancer types, including breast, lung, colorectal, and head-and-neck cancers [4] - Several programs are in phase III development, with regulatory filings in preparation for select assets, indicating readiness for potential commercialization [4] Group 4: Strategic Focus - Management has intentionally lowered short-term financial expectations to prioritize clinical execution, emphasizing the importance of upcoming phase III results for the company's future [5] - Positive outcomes from these trials could significantly alter BioNTech's narrative and establish a sustainable growth trajectory beyond Covid, while setbacks would still leave the company with a strong balance sheet [5]
Nuvation Bio price target raised to $13 from $11 at Truist
Yahoo Finance· 2026-01-28 13:28
Group 1 - Truist raised the price target on Nuvation Bio (NUVB) to $13 from $11 while maintaining a Buy rating on the shares [1] - The firm believes the Ibtrozi franchise has demonstrated strong initial uptake, positioning it as the preferred ROS1 agent compared to competitors [1] - The analysis highlights that the uptake of Ibtrozi has been stronger than anticipated despite facing seasonal headwinds [1]
Gilead price target raised to $145 from $140 at Truist
Yahoo Finance· 2026-01-28 13:20
Core Viewpoint - Truist has raised the price target for Gilead (GILD) to $145 from $140 while maintaining a Buy rating, reflecting positive sentiment ahead of Q4 earnings in the Biotech sector [1] Group 1: Price Target and Rating - Truist increased Gilead's price target to $145 from $140 [1] - The firm continues to hold a Buy rating on Gilead shares [1] Group 2: Q4 Earnings Preview - The research note is part of a broader preview for Q4 earnings in the Biotech industry [1] - Adjustments to Yeztugo numbers are being made in anticipation of Q4 EPS [1] Group 3: Product Launches and Estimates - Timelines are being tweaked based on updated guidance for near-term product launches, including BIC/LEN in 2H25 and the US launch of Hepcludex [1] - There are expansion opportunities for Livdelzi, and estimates for the anito-cel launch are being fine-tuned following FDA guidance [1]
X @Bloomberg
Bloomberg· 2026-01-28 12:22
Eli Lilly struck a deal worth more than $1.1 billion with German biotech Seamless to develop gene therapies for hearing loss https://t.co/CV98mp39Pf ...
11 Best High Short Interest Stocks With Biggest Upside Potential
Insider Monkey· 2026-01-28 12:05
分组1 - Sherry Paul from Morgan Stanley discusses market volatility, emphasizing it as a normal part of investing and indicating a shift from the 'Magnificent Seven' to 'magnificent thematics' such as AI automation and innovation [1][2] - The MAG7 companies are evolving into diversified holding companies, with traditional sector labels becoming distorted as tech firms venture into new industries [2] - Paul recommends an equal-weight approach for ETF investors to avoid over-concentration in mega-cap stocks and suggests focusing on the remaining 473 stocks in the S&P 500 for investment opportunities [2] 分组2 - Apellis Pharmaceuticals Inc. (NASDAQ:APLS) has an average upside potential of 47.33%, with Bank of America upgrading its rating to Buy, citing undervalued prospects for its drug Empaveli in treating rare kidney diseases [7][8] - Wells Fargo has reduced its price target for Apellis to $26 from $29, reflecting a slower-than-expected commercial ramp for Empaveli, while cutting revenue estimates for 2026-2030 by 20% to 50% [9][10] - Vera Therapeutics Inc. (NASDAQ:VERA) shows an average upside potential of 55.09%, with Bank of America raising its price target from $48 to $66 due to increased revenue forecasts for its lead drug [11][12] - Goldman Sachs and JPMorgan have also raised their price targets for Vera Therapeutics, reflecting a broader market potential and positive developments in its drug pipeline [12][13]
Oppenheimer Upgrade Fuels Relay Therapeutics Rally On Zovegalisib Optimism
Seeking Alpha· 2026-01-28 11:38
Group 1 - Oppenheimer upgraded Relay Therapeutics Inc. (RLAY) to Outperform from Perform, resulting in a significant increase in stock price since the upgrade on the 26th [1] - The stock price of Relay Therapeutics has seen a considerable boost following the upgrade, indicating positive market sentiment [1] Group 2 - The focus of the analysis is on identifying promising biotechnology companies that are innovating through unique mechanisms of action, first-in-class therapies, or platform technologies [1] - The approach emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]
Should You Buy Alnylam Pharmaceuticals Before Feb. 12?
Yahoo Finance· 2026-01-28 10:04
Core Insights - Alnylam Pharmaceuticals is expected to report its Q4 2025 results around February 12, 2026, with investors anticipating a positive catalyst for the stock [1] - Wall Street forecasts total Q4 revenue of $1.16 billion and adjusted earnings per share of $1.50 for Alnylam [2] - The company is likely to report significant growth in Amvuttra sales, which increased by 162% year over year in Q3 2025, primarily driven by its use in transthyretin cardiac amyloidosis (ATTR-CM) [2] Financial Performance - Alnylam's full-year 2025 guidance projects combined sales of Amvuttra and Onpattro at $2.5 billion at the midpoint, with expected growth in Q4 primarily from Amvuttra due to declining sales of Onpattro [3] - The contribution of international markets to Amvuttra sales in Q4 is expected to be modest, with stronger growth anticipated in Germany and Japan in 2026 [4] Operational Updates - As Amvuttra sales increase, the company may experience a decline in gross margin due to rising royalty rates paid to partners [5] - Alnylam is expected to provide updates on its pipeline, including the initiation of a Phase 3 study for nucresiran targeting hereditary ATTR with polyneuropathy and a Phase 2 trial for mivelsiran in Alzheimer's disease [6] Investment Outlook - Alnylam is viewed as a strong long-term investment opportunity, with Amvuttra showing robust momentum and a promising pipeline featuring several late-stage candidates [7]
Tuesday After-Hours Session Sees Broad Gains Across Healthcare And Biotech
RTTNews· 2026-01-28 03:58
Group 1: Stock Performance - Several healthcare and biotech stocks experienced significant gains in after-hours trading, with movements largely occurring without specific company news [1][2][3][4] - Acumen Pharmaceuticals, Inc. (ABOS) rose by 8.09% to close at $2.94, adding $0.22 to its share price [1] - Fulgent Genetics, Inc. (FLGT) increased by 5.98% to $28.90, gaining $1.63 in extended trading [1] - Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23, up $0.11 after hours [1] - Coeptis Therapeutics Holdings, Inc. (COEP) finished up 4.14% at $13.85, a gain of $0.55 [2] - Jin Medical International Ltd. (ZJYL) saw an increase of 4.04% to $0.16, up $0.0061 [2] - Alignment Healthcare, Inc. (ALHC) gained 5.92% to $22.20, adding $1.24 in after-hours trading [2] - Orthofix Medical Inc. (OFIX) rose 4.58% to $13.94, up $0.61 [3] - Alto Neuroscience, Inc. (ANRO) advanced 4.52% to $17.57, gaining $0.76 [3] - Immix Biopharma, Inc. (IMMX) increased by 3.87% to $6.17, adding $0.23 [3] - Amneal Pharmaceuticals, Inc. (AMRX) rose 3.76% to $14.35, up $0.52, and is set to replace TTM Technologies in the S&P SmallCap 600 index [3] - Tyra Biosciences, Inc. (TYRA) gained 3.76% to $32.58, adding $1.18 in extended trading [4]