Modular Medical Secures IRB Approval for Feasibility Study of Pivot System
Study Approval: Modular Medical received Institutional Review Board approval to conduct a feasibility study of its next-generation Pivot insulin delivery system using sterile saline, simulating real-world conditions for up to 90 days with adult participants.
Device Development: The study aims to gather data on usability, performance, and user feedback to refine the Pivot pump, which builds on the FDA-cleared MODD1 patch pump, with a 510(k) submission to the FDA expected in October 2025.
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- Financing Update: Plus Therapeutics announced the pricing of 39,473,684 units at $0.38 each, expecting to raise approximately $15 million, which will provide fresh capital to advance its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers.
- Market Performance: Connect Biopharma's stock rose 5.96% to $2.31 without any new news, reflecting ongoing investor interest in its lead candidate rademikibart's new mechanism of action data and strategic priorities for 2026.
- Sector Momentum: ABVC BioPharma's shares increased by 3.37% to $2.15, suggesting that investor interest may be driven by broader momentum in the biotech sector despite the absence of new corporate updates.
- Clinical Progress: Traws Pharma's stock rose 2.82% to $1.82 following its announcement of filing a U.S. IND application for tivoxavir marboxil, further supporting investor optimism around the company's pipeline.
- Earnings Beat: Tilray Brands reported Q2 earnings of $0.01 per share, surpassing the market expectation of a $0.20 loss, indicating a significant improvement in profitability that boosts investor confidence.
- Revenue Growth: The company achieved quarterly revenue of $217.51 million, exceeding the consensus estimate of $210.95 million, demonstrating success in market demand and sales strategies, which further solidifies its market position.
- Stock Price Surge: Following the positive earnings report, Tilray Brands' shares rose 7.3% to $9.80 in pre-market trading, reflecting investor optimism about the company's future growth potential.
- Positive Market Reaction: The strong performance post-earnings release may attract more investor attention, enhancing the company's appeal in a competitive market landscape.
DBV Technologies Surge: DBV Technologies S.A. experienced a dramatic 61.29% increase in after-hours trading after announcing successful results from its Phase 3 study of the VIASKIN Peanut patch for peanut-allergic children, reigniting investor interest.
Modular Medical Offering: Modular Medical, Inc. saw a modest gain of 3.53% amid ongoing investor analysis of its recent public offering announcement, which includes over 12 million shares priced at an effective cost of $0.38 per share.
Other Small Gains: Several other companies, including Co-Diagnostics, Elutia Inc., and Treace Medical Concepts, posted small increases in after-hours trading, attributed to light-volume activity rather than specific news.
Amylyx Pharmaceuticals Update: Amylyx Pharmaceuticals advanced 4.83% following its recent presentation of early Phase 1 trial data for AMX0114, which showed promising safety and tolerability, with further enrollment expected soon.
Public Offering Announcement: Modular Medical, Inc. has initiated an underwritten public offering of its common stock and warrants, aimed at adult users of its FDA-cleared insulin delivery patch pump.
Underwriter Details: Newbridge Securities Corporation is the sole bookrunner for the offering, which includes a potential 30-day option for the underwriter to purchase an additional 15% of the shares.
Regulatory Compliance: The offering is conducted under an effective shelf registration statement with the SEC, and all securities will be sold by Modular Medical.
Company Mission: Modular Medical aims to enhance insulin delivery technology, making it more accessible and user-friendly for individuals with diabetes, moving beyond just "superusers."

Biotech Stocks Surge: Several biotech and life sciences companies experienced significant gains in after-hours trading on November 26, indicating strong investor interest despite a lack of major news.
Modular Medical's Approval: Modular Medical, Inc. saw an 11.51% increase in share price after receiving Institutional Review Board approval for its Pivot insulin delivery system study, which aims to gather critical data on device usability.
Standard BioTools Collaboration: Standard BioTools Inc. advanced 4.90% following a strategic partnership announcement with Molecular Instruments to enhance protein imaging capabilities through next-generation Imaging Mass Cytometry workflows.
Ongoing Investor Optimism: Companies like Werewolf Therapeutics, Cogent Biosciences, and Longeveron also reported gains, reflecting continued investor confidence in their research and development efforts, despite no new corporate updates.

Lucas GC Limited Financial Results: Lucas GC Limited's shares surged 36.2% to $3.73 in pre-market trading after reporting H1 2025 earnings per share (EPS) of $1.47 on sales of $54.008 million.
Other Notable Gainers: MSP Recovery, Inc. saw a dramatic 262% increase to $0.7706, while SMX (Security Matters) Public Limited Company rose 72% to $3.47, among other significant pre-market gains.
Stocks Experiencing Losses: ZOOZ Strategy Ltd. dropped 28.3% to $1.01, and Alvotech fell 21.6% to $6.00, reflecting a trend of declines in several stocks after previous gains.
Market Overview: The pre-market trading session showed a mix of significant gains and losses across various stocks, indicating volatility in the market following recent trading activities.









