Modular Medical Starts Production Validation Lots for Pivot Pump
Modular Medical announced the start of production of validation lots for its Pivot tubeless patch pump's disposable cartridge and infusion set. Achievement of this manufacturing milestone keeps the Company on schedule for commercial launch in Q1 2026, subject to receipt of FDA 510(k) clearance. "We are excited to hit this pivotal manufacturing validation on schedule, bringing us closer to delivering our Pivot pump's game-changing simplicity to patients underserved by current options," said Jeb Besser, CEO. "This further derisks our expected path to Q1 2026 commercialization, which is subject to FDA response to our current 510(k) application, and would put us in position to drive market disruption."
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- 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.
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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.
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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."
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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.
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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.
