The after-hours market delivered a mixed but generally positive tone on Tuesday evening, with several small- and mid-cap names posting modest gains. One biotech, however, stole the spotlight with a dramatic surge following major clinical news.DBV Technologies S.A. (DBVT) dominated the after-hours session, soaring 61.29% to $29.00, up $11.02, after announcing a pivotal clinical milestone. The company reported that VITESSE, its Phase 3 study evaluating the VIASKIN Peanut patch in peanut-allergic children age ...

Core Points - Modular Medical, Inc. has announced a public offering of 12,173,000 shares of common stock along with warrants to purchase an additional 6,086,500 shares [1] - The offering price is set at $0.77 for two shares of common stock and one accompanying warrant, resulting in an effective price of $0.38 per share and $0.01 per warrant [1] Company Overview - Modular Medical specializes in insulin delivery technology and has developed the first FDA-cleared patch pump aimed at adult "almost-pumpers" [1] - The company's product is designed to be user-friendly and affordable, targeting a specific segment of the diabetes management market [1]

Core Insights - Several biotech and life sciences companies experienced significant gains in after-hours trading on November 26, indicating strong investor interest despite a quiet news cycle [1] Company Summaries - Modular Medical, Inc. (MODD) shares increased by 11.51% to $0.4380 after a previous decline of 1.80% at the close, following the IRB approval for its Pivot insulin delivery system study announced on November 17 [2] - Standard BioTools Inc. (LAB) saw a 4.90% rise to $1.50 after a 0.70% gain during regular trading, following a strategic collaboration with Molecular Instruments announced on November 19 [3] - Werewolf Therapeutics, Inc. (HOWL) rose 4.39% to $1.0199 after a strong 7.33% gain during regular trading, reflecting continued investor optimism despite no new updates [4] - Cogent Biosciences, Inc. (COGT) climbed 6.09% to $42.85 in after-hours trading, building on a 1.69% rise during regular trading, indicating strong investor confidence in its pipeline [5] - Longeveron Inc. (LGVN) shares increased by 4.59% to $0.6772, extending gains from a 7.02% rise during regular trading, with upcoming presentation of Alzheimer's study results at CTAD 2025 highlighting ongoing research [6] - AbCellera Biologics Inc. (ABCL) gained 3.85% to $3.78 after a 0.55% increase during regular trading, reflecting renewed investor interest in its antibody discovery platform [7]

Core Insights - Modular Medical, Inc. has received Institutional Review Board (IRB) approval to conduct an in-house study of its next-generation Pivot™ insulin delivery system targeting the diabetes market [1] Company Overview - Modular Medical is focused on innovative insulin delivery technology aimed at the $3 billion adult "almost-pumpers" diabetes market [1] - The company offers user-friendly and affordable patch pumps for diabetes management [1] Regulatory Approval - The IRB approval is a significant step in compliance with U.S. Food and Drug Administration (FDA) regulations for conducting biomedical research involving human subjects [1]

Financial Performance - The company incurred a net loss of approximately $14.5 million for the six months ended September 30, 2025, compared to a net loss of $9.1 million for the same period in 2024[89]. - As of September 30, 2025, the company had a cash balance of $5.3 million and an accumulated deficit of approximately $99.2 million[89]. Research and Development - Research and development (R&D) expenses for the three months ended September 30, 2025, were $3.7 million, a 51.1% increase from $5.6 million in the same period of 2024[82]. - R&D expenses for the six months ended September 30, 2025, totaled $6.9 million, reflecting a 55.3% increase from $10.7 million in the prior year[82]. - The full-time R&D employee headcount increased to 56 as of September 30, 2025, from 42 a year earlier[85]. - The company submitted a 510(k) premarket notification for its next-generation patch pump, Pivot, on November 13, 2025, with expected regulatory approval in Q1 2026[75]. - The company is actively working to commercialize its Pivot product and expand its market presence in the diabetes device sector[75]. Operating Expenses - Selling, general and administrative (SG&A) expenses for the three months ended September 30, 2025, were $1.3 million, a 72.8% increase from $2.2 million in the same period of 2024[86]. - SG&A expenses for the six months ended September 30, 2025, amounted to $2.3 million, a 69.2% increase from $3.9 million in the prior year[86]. Cash Flow and Investments - For the six months ended September 30, 2025, cash used in investing activities was approximately $1.7 million, compared to $1.0 million for the same period in 2024[91]. - Cash provided by financing activities for the six months ended September 30, 2025 was approximately $4.7 million, an increase from $3.0 million in 2024[92]. - As of September 30, 2025, the company had outstanding purchase orders for machinery and equipment totaling approximately $1.7 million[93]. Fundraising - In September 2025, the company raised approximately $3.9 million through a warrant inducement offering[77].

Core Insights - The manufacturing line for the Pivot Controller has been validated for human-use production, supporting an expected market launch in Q1 2026 [1] - Pivot aims to introduce the first two-part tubeless patch pump, targeting the $3 billion market for adult "almost-pumpers" with a design that is affordable, user-friendly, and easy to learn [1]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Insights - Modular Medical is progressing towards CE Mark certification under the EU Medical Device Regulation, with a target completion date set for 2026 [1] - The company has successfully completed its Stage 1 ISO 13485:2016 audit, which is a significant milestone in the certification process [1] - Stage 2 of the audit is planned for the first half of 2026, indicating ongoing commitment to meeting regulatory standards [1]

Group 1: Modular Medical Inc. (MODD) - Modular Medical Inc. experienced a significant stock price increase of 30.68% to $0.9150 after completing a clinical study for its MODD1 insulin pump, which aims to simplify diabetes management [1] - The company plans to submit its Pivot pump product to the FDA for clearance in October 2025 [1] - Insider activity has been notable, with executives purchasing over $500,000 worth of shares, contributing to heightened trading volume of over 4.5 million shares, significantly above the average of around 200,000 [2] Group 2: Galectin Therapeutics Inc. (GALT) - Galectin Therapeutics Inc. saw its stock rise over 14% to $6.78, continuing a remarkable year-to-date gain of over 360% [3] - The company reached a new 52-week high of $5.99 during intraday trading on September 11, 2025 [3] - CEO Joel Lewis indicated ongoing analysis of additional biomarkers for their lead candidate, belapectin, which is designed to treat MASH cirrhosis and portal hypertension [4] Group 3: Exicure Inc. (XCUR) - Exicure Inc. shares rose 11.11% to $4.00, despite no new company-specific news, indicating speculative interest or technical momentum [5] - The company reported a second-quarter net loss of $2.6 million, wider than the $0.6 million loss in Q2 of 2024, primarily due to higher operating expenses from the acquisition of GPCR USA [6] - Exicure is pursuing new clinical directions, including a completed Phase 2 study of GPC-100 for stem cell mobilization in multiple myeloma patients [6] Group 4: PepGen Inc. (PEPG) - PepGen Inc. rebounded 6.67% to $1.44 after a previous decline, with the movement likely driven by technical factors or speculative interest [6] - The company has shifted focus to PGN-EDODM1 for treating myotonic dystrophy type 1 (DM1) after discontinuing its Duchenne muscular dystrophy program [7] - The FREEDOM-DM1 trial is currently underway, with topline data expected in early Q4 2025, which is considered a key near-term catalyst [8] Group 5: BioSig Technologies Inc. (BSGM) - BioSig Technologies Inc. closed at $6.10 with a sharp gain of 37.08%, followed by a 4.09% rise in after-hours trading to $6.35 [8] - The company has officially rebranded as Streamex Corp., effective September 12, 2025, and will trade under the new ticker symbol "STEX" [8] - The rebranding follows a merger with Streamex Exchange Corp., marking a strategic pivot towards real-world asset tokenization, including an exclusive partnership with Monetary Metals for tokenized, yield-bearing gold products [9]

Core Insights - Modular Medical, Inc. has successfully completed a clinical study with its MODD1 pump, which is designed for Type 1 diabetes patients [1] - The MODD1 pump targets the estimated $3 billion adult "almost-pumpers" market with a user-friendly and affordable design [1] - The study involved nine clinicians who currently use continuous glucose monitors and other pumps, providing valuable real-world feedback for product refinement [1] Company Overview - Modular Medical specializes in insulin delivery technology and has developed the first FDA-cleared patch pump specifically for Type 1 diabetes [1] - The company is preparing for the launch of its next-generation Pivot pump product based on insights gained from the clinical study [1] Market Context - The adult "almost-pumpers" market is estimated to be worth $3 billion, indicating significant potential for growth in insulin delivery solutions [1] - The successful completion of the clinical study positions Modular Medical to capitalize on this market opportunity with its innovative product offerings [1]