Palisade Bio(PALI)
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Palisade Bio Announces First Patients Dosed in Phase 1b Study of Oral First-In-Class PDE4 Inhibitor Prodrug, PALI-2108, for the Treatment of Fibrostenotic Crohn's Disease (FSCD)
Globenewswire· 2025-10-20 12:45
Core Insights - Palisade Bio has initiated a Phase 1b clinical study for PALI-2108, a first-in-class PDE4 inhibitor prodrug targeting fibrostenotic Crohn's disease (FSCD), with topline data expected in Q1 2026 [2][3][5] Group 1: Clinical Development - The Phase 1b study will enroll approximately 6 to 12 patients and aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 over a 14-day treatment period [3][4] - PALI-2108 is designed for targeted activation in the terminal ileum and colon, providing high local tissue exposure with minimal systemic absorption [3][6] - The study will also assess tissue-level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs) [4] Group 2: Future Plans - Data from the Phase 1b study, along with results from the Phase 1a/1b ulcerative colitis program, are expected to support Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026 [5] - The company aims to transform the treatment landscape for autoimmune, inflammatory, and fibrotic diseases through its targeted therapeutic approach [7]
Palisade Bio Granted Canadian Patent Covering Composition of Lead Product Candidate PALI-2108
Globenewswire· 2025-10-13 12:45
Core Insights - Palisade Bio has developed PALI-2108, a first-in-class PDE4 inhibitor specifically targeting the terminal ileum and colon for treating fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC) to meet significant unmet medical needs [1][4] Intellectual Property - The Canadian Intellectual Property Office has granted patent number 3,174,137 for PALI-2108, providing composition-of-matter protection until May 28, 2041 [2] - The patent covers the unique design of PALI-2108, which includes a galactose-derived sugar moiety that minimizes absorption until activated by colonic bacteria [2] Clinical Development - Palisade Bio is advancing PALI-2108 in a Phase 1b study for FSCD, with patient dosing expected to start in the second half of 2025 and topline data anticipated in the first quarter of 2026 [3] - Results from the Phase 1b study, along with data from completed Phase 1a/1b trials in UC, will support a planned Phase 2 IND submission to the FDA in the first half of 2026 [3] Product Overview - PALI-2108 is an orally administered prodrug designed for gut-restricted delivery, achieving high local tissue concentrations while minimizing systemic exposure [4] - The mechanism of action aims to maximize anti-inflammatory and anti-fibrotic effects while reducing common tolerability issues associated with systemic PDE4 inhibitors [4] Company Background - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [5]
After-Hours Rally Lifts PALI, HCTI, NTRB, KPTI, EDIT, And CGON On Mixed News And Strategic Moves
RTTNews· 2025-10-10 05:38
Key Points - Several biotech stocks experienced notable after-hours gains on October 9, driven by new data and corporate developments [1] Company Summaries Palisade Bio Inc. (PALI) - Shares traded at $2.26 in after-hours, reflecting a 7.62% gain from the prior close of $2.10, which was up 5% on the day [1] - The company cancelled its special meeting of stockholders due to lack of quorum, withdrawing all proposals from consideration [2] Healthcare Triangle Inc. (HCTI) - Shares traded at $2.88 in after-hours, up 4.35% from the regular session close of $2.76, which was down 17.86% [3] - The company signed a non-binding Letter of Intent to acquire Teyame.AI, projected to generate $34 million in revenue for fiscal year 2025 [4] Nutriband Inc. (NTRB) - Shares traded at $8.25 in after-hours, up 4.30% from the regular session close of $7.91, which was down 6.94% [5] - The company filed a provisional patent application with the USPTO to strengthen its intellectual property for its AVERSA abuse deterrent transdermal [5] Karyopharm Therapeutics Inc. (KPTI) - Shares traded at $6.08 in after-hours, up 4.46% from the regular session close of $5.82, which had declined 1.36% [6] - The company announced financing transactions expected to provide $100 million in financial flexibility, extending its cash runway into Q2 2026 [6] Editas Medicine Inc. (EDIT) - Shares traded at $4.22 in after-hours, up 3.43% from the regular session close of $4.08, which was down 1.69% [7] - The company presented new preclinical proof-of-concept data for its therapy EDIT-401, showing a 90% LDL-C reduction in non-human primates and mice [7] CG Oncology Inc. (CGON) - Shares traded at $45.40 in after-hours, up 2.11% from the regular session close of $44.46, which gained 9.21% [8] - No official news releases or filings were issued during the day [8]
Palisade Bio Announces Cancellation of Special Meeting of Stockholders
Globenewswire· 2025-10-09 21:00
Core Viewpoint - Palisade Bio, Inc. has decided to cancel its special meeting of stockholders originally scheduled for October 10, 2025, due to the lack of a required quorum [1][2]. Group 1: Special Meeting Details - The special meeting was previously adjourned to September 26, 2025, but was adjourned again without any business being conducted due to insufficient proxies to form a quorum [2]. - The company has not received the necessary proxies to constitute a quorum and has withdrawn the proposals set forth in the definitive proxy statement filed with the U.S. Securities and Exchange Commission on August 18, 2025 [2]. Group 2: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases [3]. - The company aims to transform the treatment landscape through a targeted approach with its novel therapeutics [3].
Steven Cohen Doubles The S&P 500 — And His Next Bet's All Gut
Benzinga· 2025-10-08 15:30
Group 1 - Point72 Asset Management, led by Steven Cohen, has achieved a remarkable 131% cumulative return on its top 20 holdings over the past three years, significantly outperforming the S&P 500's 64% return [2] - The hedge fund reported an 18% return in the second quarter, showcasing its ability to navigate market trends, particularly in AI and biotech sectors [2] - Cohen's recent investment in Palisade Bio Inc, a clinical-stage biotech company, involves a $7.6 million position, representing a small 0.03% of his portfolio, indicating a strategic approach to identifying potential market opportunities [3] Group 2 - Palisade Bio recently completed a $138 million public offering to support Phase 2 trials for its lead drug PALI-2108, which targets ulcerative colitis, a chronic intestinal condition [4] - The stock of Palisade Bio has experienced a nearly 200% surge in the past month, with an additional 11% increase in pre-market trading, driven by investor interest in its autoimmune therapy developments [4] - Cohen's investment strategy reflects a focus on identifying inflection points in the market, suggesting that future investment opportunities may arise from the biotech sector, particularly in gut health therapies [5]
Why AMD Shares Are Trading Higher By Over 34%; Here Are 20 Stocks Moving Premarket - Arteris (NASDAQ:AIP), Advanced Micro Devices (NASDAQ:AMD)
Benzinga· 2025-10-06 13:01
Group 1 - Advanced Micro Devices, Inc. (AMD) shares increased significantly by 34.2% to $221.10 in pre-market trading following a major agreement with OpenAI to deploy up to 6 gigawatts of AMD Instinct GPU power for AI infrastructure [1][2] - The initial phase of the agreement includes a rollout of 1 gigawatt of AMD Instinct MI450 GPUs scheduled for the second half of 2026, with plans for further expansions across multiple generations of AMD's data center chips [1]
Morning Market Movers: SOPA, CRML, SANM, PALI See Big Swings
RTTNews· 2025-10-06 12:20
Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Society Pass Incorporated (SOPA) has increased by 139% to $3.34 - Critical Metals Corp. (CRML) has risen by 79% to $14.30 - Sanmina Corporation (SANM) is up 26% at $144.61 - Palisade Bio, Inc. (PALI) has gained 25% to $2.00 - Advanced Micro Devices, Inc. (AMD) has increased by 24% to $205.07 - Odyssey Marine Exploration, Inc. (OMEX) is up 22% at $2.46 - Youxin Technology Ltd (YAAS) has risen by 21% to $3.14 - NioCorp Developments Ltd. (NB) is up 18% at $9.38 - Snow Lake Resources Ltd. (LITM) has increased by 14% to $5.66 - Plug Power Inc. (PLUG) is up 7% at $4.10 [3] Premarket Losers - Rich Sparkle Holdings Limited (ANPA) has decreased by 15% to $22.10 - CCH Holdings Ltd Ordinary Shares (CCHH) is down 15% at $3.73 - Xcel Brands, Inc. (XELB) has fallen by 14% to $2.04 - Quantum Computing Inc. (QUBT) is down 13% at $21.39 - Rent the Runway, Inc. (RENT) has decreased by 12% to $4.70 - MDJM Ltd (UOKA) is down 11% at $2.96 - CID HoldCo, Inc. (DAIC) has fallen by 9% to $2.72 - Algorhythm Holdings, Inc. (RIME) is down 9% at $2.47 - Corbus Pharmaceuticals Holdings, Inc. (CRBP) has decreased by 8% to $13.50 - Art's-Way Manufacturing Co., Inc. (ARTW) is down 7% at $2.58 [4]
After-Hours Movers: Biotech And Medtech Stocks Jump On Volume And News
RTTNews· 2025-10-03 04:08
Group 1: Reviva Pharmaceuticals Holdings Inc. (RVPH) - RVPH experienced a significant after-hours rally, increasing 18.27% to $0.58 after a 35.1% surge during regular trading, with a trading volume of over 40.5 million shares, nearly nine times its daily average [2][3] - The company has a market cap of $47 million and is focused on its lead candidate brilaroxazine, which targets neuropsychiatric and respiratory conditions [3] Group 2: Penumbra Inc. (PEN) - PEN surged 7.97% in after-hours trading to $273.69, following a 1.55% gain during the regular session, with a market cap nearing $9.9 billion [4][5] - The company has increased its revenue guidance for FY25 to a range of $1.355 billion - $1.370 billion, indicating a growth of 13% to 15% over 2024 [6] Group 3: Palisade Bio Inc. (PALI) - PALI jumped 10% in after-hours trading to $1.87, extending a 29.8% surge during the regular session, driven by a $138 million public offering [7][8] - The company has a market cap of $15.8 million and is gaining attention due to recent clinical updates and licensing agreements [8] Group 4: IO Biotech Inc. (IOBT) - IOBT rose 5.08% in after-hours trading to $0.4571, following a 22.3% surge during the regular session, with heavy trading volume of 16.7 million shares [9] - The company announced plans to design a new registrational study for its cancer vaccine candidate Cylembio after receiving regulatory feedback from the FDA [10] Group 5: Rallybio Corp. (RLYB) - RLYB increased 11.2% in after-hours trading to $0.5688, reversing a modest dip during the regular session, with a market cap of $21.4 million [11][12] - The company recently completed dosing in its Phase 1 study for RLYB116 and received a $12.5 million milestone payment for progress on the REV102 program [12] Group 6: Vor Biopharma Inc. (VOR) - VOR rose 3.6% in after-hours trading to $38.00, recovering from a 6.6% decline during the regular session, with a market cap of $251 million [13][14] - The company is focusing on its trem-cel platform and CD33-directed therapies for acute myeloid leukemia, alongside new executive appointments [14]
Palisade Bio Announces Closing of Upsized $138 Million Public Offering of Common Stock and Including Full Exercise of Over-Allotment Option
Globenewswire· 2025-10-02 20:05
Core Insights - Palisade Bio, Inc. has successfully closed an underwritten public offering, raising approximately $138 million to support the Phase 2 clinical development of PALI-2108 for Ulcerative Colitis [1][2] Group 1: Offering Details - The offering consisted of 197,154,844 shares of common stock priced at $0.70 per share [3] - The offering was led by B Group Capital and Columbia Threadneedle Investments, with participation from several notable investors [1] Group 2: Use of Proceeds - Proceeds from the offering will be utilized to advance the clinical development program for PALI-2108, which targets significant unmet medical needs in inflammatory bowel disease (IBD) [2] Group 3: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [6]
Recent Market Movements Highlight Top Gainers
Financial Modeling Prep· 2025-10-01 22:00
Core Insights - Recent market movements have highlighted significant price changes in several companies, attracting investor attention Company Summaries - **Palisade Bio, Inc. (PALI)**: Experienced an 83.77% price surge to $1.57, supported by a trading volume of 143,677,281. The company raised $120 million through an upsized underwritten public offering, selling 171 million shares at $0.70 each, to advance its novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [1][6] - **Ouster, Inc. (OUSTZ)**: Saw a 76.55% price increase to $0.09, with a volume of 150,580. This reflects growing confidence in Ouster's high-resolution lidar technology, which serves various industries including automotive and robotics [2][6] - **Ryvyl Inc. (RVYL)**: Formerly known as GreenBox POS, experienced a 72.64% price jump to $0.511, supported by a substantial volume of 231,813,941. The company focuses on blockchain-based payment solutions, showcasing resilience and innovation in the technology sector [3] - **Klotho Neurosciences, Inc. (KLTOW)**: Saw a 50.11% price increase to $0.14, with a volume of 134,508. The company is advancing gene therapy product candidates, and its ALS therapy received Orphan Drug Designation from the U.S. FDA, contributing to a rise in shares [4] Industry Overview - The top gainers reflect diverse industries, including biotechnology, healthcare, technology, and financial services, underscoring the dynamic nature of the market and varied investment opportunities [5]