Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]

Core Insights - DBV Technologies S.A. (NASDAQ:DBVT) is recognized as one of the 12 best multibagger stocks to consider for investment heading into 2026 due to strong one-year returns and upside potential [1] Group 1: Trial Results and Impact - The pivotal VITESSE study for DBV Technologies met its primary endpoint, showing that after 12 months of treatment with the VIASKIN Peanut patch, 46.6% of children achieved clinically meaningful desensitization compared to 14.8% on placebo, indicating a statistically significant outcome [3] - The trial also demonstrated a favorable safety profile, high compliance, and low discontinuation rates, reinforcing the patch's potential as a non-invasive treatment option for peanut allergies [3] Group 2: Analyst Ratings and Price Targets - H.C. Wainwright raised its price target on DBV Technologies from $35 to $40 while maintaining a "Buy" rating, citing the Phase 3 VITESSE trial as a significant milestone that reduces risks associated with the VIASKIN Peanut program [2] - Citizens also increased its price target from $21 to $45, maintaining an "Outperform" rating, and noted that the success of the VITESSE trial could unlock $181 million in cash, potentially supporting a U.S. launch for the product in the pediatric population [4] Group 3: Company Focus and Market Position - DBV Technologies specializes in developing non-invasive immunotherapies, particularly through its VIASKIN patch technology, which aims to desensitize patients with food allergies, addressing significant unmet needs in pediatric care [5] - The convergence of clinical success and financial flexibility positions DBV Technologies favorably as it approaches regulatory submission for its products [5]

Core Insights - DBV Technologies S.A. has released positive data from the VITESSE Phase 3 study for the VIASKIN Peanut patch, targeting peanut-allergic children aged 4 to 7 years [1][2] Trial Data - The pivotal trial met its primary endpoint, showing a statistically significant treatment effect with 46.6% of children in the VIASKIN Peanut arm meeting treatment responder criteria after 12 months, compared to 14.8% in the placebo arm [2] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after 12 months, indicating a successful treatment response [3] Study Enrollment and Safety - The VITESSE study enrolled 654 children, surpassing the initial target of 600, with 438 in the active arm and 216 in the placebo arm [4] - Safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common treatment-emergent adverse events (TEAEs) [4] - Discontinuation due to TEAEs was low at 3.2% in the treatment arm versus 0.5% in the placebo arm, with no serious treatment-related adverse events reported [5] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) in the United States in the first half of 2026 [6] - Following the trial data release, DBV Technologies shares increased by 35.76% to $24.41, reaching a new 52-week high [6]

Core Insights - The after-hours market showed a generally positive tone with small- and mid-cap stocks experiencing modest gains, highlighted by a significant surge in DBV Technologies following major clinical news [1] Company Highlights - DBV Technologies S.A. (DBVT) experienced a dramatic increase of 61.29%, reaching $29.00, after announcing that its Phase 3 study for the VIASKIN Peanut patch met its primary endpoint, reigniting investor enthusiasm [2] - Modular Medical, Inc. (MODD) saw a slight increase of 3.53% to $0.3549, with no new news but possibly influenced by a recent public offering announcement [3] - Co-Diagnostics, Inc. (CODX) rose 1.58% to $0.25, indicating light-volume trading rather than a specific catalyst [4] - Elutia Inc. (ELUT) gained 1.38% to $0.5525, reflecting broader low-volume momentum without new announcements [4] - Treace Medical Concepts, Inc. (TMCI) increased by 3.70% to $2.80, suggesting gains were driven by light trading activity [5] - Amylyx Pharmaceuticals, Inc. (AMLX) advanced 4.83% to $12.90, potentially reflecting positive early trial data from a recent presentation [6] - Cognition Therapeutics, Inc. (CGTX) gained 3.95% to $1.58, with recent announcements regarding full enrollment in its expanded access program for zervimesine [7]

Core Insights - DBV Technologies announced positive topline results from the Phase 3 VITESSE trial for the VIASKIN Peanut patch, which met its primary endpoint for treating peanut-allergic children aged 4-7 years [1][6] Study Results - VIASKIN Peanut showed a statistically significant treatment effect with 46.6% of children in the treatment group meeting responder criteria after 12 months, compared to 14.8% in the placebo group, resulting in a difference of 31.8% [2][6] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after treatment, with specific thresholds based on their baseline ED [3] Safety Profile - The safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common adverse events; discontinuation due to adverse events was low at 3.2% in the treatment arm [5][6] - No treatment-related serious adverse events were reported, and treatment-related anaphylaxis was low at 0.5% [5] Enrollment and Study Design - The VITESSE study enrolled 654 children, exceeding the target of 600, with a balanced distribution between active and placebo arms [4][6] - The study is noted as the largest immunotherapy clinical trial for food allergies, conducted at 86 sites across multiple countries [16] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) for the VIASKIN Peanut patch in the first half of 2026 [6][7] - The achievement of the primary endpoint will accelerate the exercise period of certain warrants issued in connection with a financing announced in March 2025 [6][11] Industry Context - The VIASKIN patch represents a new class of non-invasive treatment aimed at modifying the immune response to food allergens, addressing a significant unmet medical need in pediatric care [12][14]

Core Insights - DBV Technologies has completed the last patient visit in the Phase 3 VITESSE clinical trial for the VIASKIN Peanut patch aimed at peanut allergic children aged 4-7 years, with topline data expected in Q4 of this year [1][2][3] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN patch technology [4] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT), which introduces microgram amounts of biologically active compounds to the immune system via intact skin [4] Clinical Trial Details - The VITESSE Phase 3 trial involves 654 subjects aged 4-7 years, randomized in a 2:1 ratio, and is conducted across 86 sites in the U.S., Canada, Europe, the UK, and Australia, making it the largest treatment intervention study for peanut allergy [3] - The trial evaluates the efficacy and safety of the VIASKIN Peanut patch over a 12-month period [3] Future Outlook - The completion of the last patient visit is considered a significant milestone for the company, moving closer to potentially providing a treatment option for peanut allergic children if approved [3]

Core Viewpoint - DBV Technologies has established an At-The-Market (ATM) program to offer up to $150 million of American Depositary Shares (ADS) on Nasdaq, aimed at financing activities related to its Biologics License Application (BLA) and the development of its proprietary technology platform, VIASKIN [1][2]. Group 1: ATM Program Details - The ATM program allows DBV Technologies to sell ADSs representing five ordinary shares, with sales dependent on various market factors [1]. - The program is intended to remain effective until the maximum gross amount is sold or terminated according to the sales agreement with Citizens JMP Securities, LLC [1]. - The previous ATM program established on May 2, 2022, has been terminated, but the new program's terms are similar [1]. Group 2: Use of Proceeds - The net proceeds from the ATM program will primarily be used for activities associated with the BLA, potential approval and launch of the VIASKIN Peanut patch for toddlers aged 1-3, and advancing the development of other product candidates [2]. Group 3: Sales Agreement and Pricing - Citizens JMP Securities will act as the sales agent, using commercially reasonable efforts to sell the ADSs to eligible investors [3]. - The sales price of the new ordinary shares will not be less than the last closing price or the volume-weighted average price over a specified period, with a maximum discount of 15% [3]. Group 4: Share Capital and Dilution - The issuance of new ordinary shares will occur without preferential subscription rights, with a maximum potential dilution of approximately 50% based on existing share capital [4]. - The number of underlying ordinary shares will not exceed the limit set by the shareholders and will represent less than 30% of the ordinary shares already admitted to trading over a rolling 12-month period [4][8]. Group 5: Investor Eligibility - Purchases of ADSs under the ATM program are limited to specific categories of investors, including those regularly investing in the pharmaceutical, biotechnological, or medical technology sectors [6]. Group 6: Trading Information - The new ordinary shares will be admitted to trading on Euronext in Paris, while the issued ADSs will trade on the Nasdaq Capital Market [7]. Group 7: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies using its proprietary VIASKIN patch technology [13]. - The company is headquartered in Châtillon, France, with operations in North America [14].