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]

NESS ZIONA, Israel, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease. Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept study did not show differentiation between SGT-210 and vehicle on the study’s ...

Core Insights - Sol-Gel Technologies, Ltd. reported financial results for Q3 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, primarily due to lower licensing revenue [6][8] - The company is advancing its late-stage pipeline, particularly focusing on SGT-610 for Gorlin syndrome and exploring its potential for high-frequency basal cell carcinoma (BCC) [4][5] - Sol-Gel has secured additional partnerships and regulatory approvals, which are expected to enhance its revenue streams and market presence [3][5] Financial Performance - Total revenue for Q3 2025 was $0.4 million, a decrease from $5.4 million in Q3 2024, with the previous revenue primarily derived from various licensing agreements [6] - Research and development expenses increased to $5.7 million in Q3 2025 from $4.8 million in Q3 2024, attributed to higher manufacturing and clinical trial costs [7] - The company reported a net loss of $5.9 million for Q3 2025, compared to a net loss of $0.4 million in Q3 2024, resulting in a loss of $2.13 per share [8] Corporate Developments - Sol-Gel is pursuing high-frequency BCC as an additional indication for SGT-610, which could potentially double the drug's commercial value if approved [5] - The company received Health Canada approval for EPSOLAY in September 2025 and signed a licensing agreement with Viatris for commercialization in Australia and New Zealand [5][6] - Sol-Gel's ongoing Phase 3 trial for SGT-610 is expected to yield top-line results in Q4 2026, with growing interest from physicians regarding its use in severe BCC cases [4][5] Market Outlook - Sol-Gel anticipates that TWYNEO and EPSOLAY will launch in new territories by 2028 and 2027, respectively, with projected annual royalty revenue reaching approximately $10 million by 2031 [3] - The company aims to leverage its partnerships to unlock the value of its approved products and create non-dilutive revenue streams [4][5] - The market for SGT-610 and SGT-210 is expected to grow, particularly in the context of rare dermatological diseases, with a focus on addressing significant unmet medical needs [6][12]

Core Insights - Sol-Gel Technologies, Ltd. has received a Notice of Compliance from Health Canada for EPSOLAY, a treatment for inflammatory lesions of rosacea in adults, marking a significant regulatory milestone for the company [1][2][3] Group 1: Product Approvals and Partnerships - The approval of EPSOLAY is a result of Sol-Gel's partnership with Searchlight Pharma, which holds the exclusive license for commercializing EPSOLAY in Canada [2] - Sol-Gel is eligible to receive up to $11 million in potential payments related to TWYNEO and EPSOLAY in Canada, along with tiered royalties on net sales, enhancing the company's financial position [2][3] - The company aims to commercialize EPSOLAY and TWYNEO globally, with launches expected in various territories starting in 2027 and 2028 [3] Group 2: Financial Outlook - Ex-U.S. contributions to the company's EBITDA are projected to gradually increase, potentially reaching approximately $10 million annually by 2031, excluding milestone payments [3] - The non-dilutive revenue from partnerships is expected to support Sol-Gel's growth strategy and strengthen its balance sheet [2][3] Group 3: Product Details - EPSOLAY is a topical cream containing 5% benzoyl peroxide, designed to treat inflammatory lesions of rosacea using a patented technology for sustained release [5] - TWYNEO is a fixed-dose combination cream for acne vulgaris, containing 0.1% tretinoin and 3% benzoyl peroxide, utilizing micro-encapsulation technology to enhance efficacy [4] Group 4: Clinical Trials and Pipeline - Sol-Gel is conducting a Phase-3 clinical trial for SGT-610, a potential treatment for Gorlin syndrome, which could be the first to prevent basal cell carcinomas in affected patients [1][9] - The company is also investigating SGT-210 for the treatment of rare hyperkeratinization disorders, indicating a diverse pipeline in dermatological therapies [9]

Core Insights - Sol-Gel Technologies, Ltd. is advancing its clinical pipeline with a focus on SGT-610 for Gorlin syndrome and SGT-210 for Darier disease, aiming to address significant unmet medical needs in dermatology [4][6][17] - The company reported a substantial increase in revenue for Q2 2025, totaling $17.2 million, compared to $5.4 million in Q2 2024, driven by product sales and licensing agreements [8] - Sol-Gel's financial position is strengthened by a recent agreement with Mayne Pharma, which is expected to extend its cash runway into Q1 2027 [5][7] Clinical Developments - Enrollment for the Phase 3 trial of SGT-610 has been completed, with top-line results anticipated in Q4 2026; this product has the potential to generate peak revenues exceeding $300 million annually if approved [4][6] - The ongoing Phase 1b trial for SGT-210 is facing recruitment challenges but is believed to have additional indications beyond Darier disease, with market potential estimated between $200 million to $300 million [6][9] - SGT-610 is designed to be the first therapy to prevent new basal cell carcinomas in Gorlin syndrome patients, addressing a critical need in this underserved population [4][14] Financial Performance - Research and development expenses increased to $4.6 million in Q2 2025 from $2.4 million in Q2 2024, primarily due to higher manufacturing and clinical trial costs for SGT-610 [9] - The company reported a net income of $11.6 million for Q2 2025, a significant turnaround from a net loss of $1.9 million in Q2 2024, reflecting improved operational performance [10] - As of June 30, 2025, Sol-Gel had $24.2 million in cash and marketable securities, which is expected to support operations into early 2027 [11] Product Portfolio - TWYNEO and EPSOLAY are two approved products in Sol-Gel's portfolio, with a recent agreement for their purchase in the U.S. for $16 million, enhancing the company's revenue stream [5][8] - TWYNEO is a topical cream for acne treatment, while EPSOLAY is designed for rosacea, both utilizing innovative delivery technologies to improve efficacy [12][13] - The company is focused on translating the global demand for these products into meaningful revenues, with expectations of royalties from international markets potentially reaching $10 million by 2031 [7]

Core Viewpoint - Sol-Gel Technologies, Ltd. reported financial results for the first quarter of 2025, showing an increase in total revenue but a higher net loss compared to the same period in 2024 [2][4]. Financial Performance - Total revenue for the first quarter of 2025 was $1 million, a 100% increase from $0.5 million in the same period in 2024 [2]. - Research and development expenses rose to $8.8 million from $5.3 million in the first quarter of 2024, primarily due to supplier-led manufacturing development for SGT-610 [3]. - General and administrative expenses decreased to $1.3 million from $1.8 million in the same period in 2024, attributed to cost measures taken in 2024 [4]. - The net loss for the first quarter of 2025 was $8.8 million, compared to a net loss of $6.3 million in the first quarter of 2024, with a basic and diluted loss per share of $3.2 compared to $2.3 in 2024 [4]. Cash Position - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities, expected to fund operations into the first quarter of 2027 [5]. Company Overview - Sol-Gel Technologies focuses on developing and commercializing drug products for skin diseases, with FDA-approved products TWYNEO and EPSOLAY for acne and rosacea, respectively [6]. - The company's pipeline includes SGT-610, an Orphan Drug candidate for basal cell carcinoma prevention, and SGT-210 for rare skin keratodermas [7].

Core Points - Sol-Gel Technologies Ltd. announced a 10-for-1 reverse share split to increase the per share market price and regain compliance with Nasdaq's minimum bid price requirement [4][5][6] Group 1: Reverse Share Split Details - The reverse share split will consolidate every ten ordinary shares into one ordinary share, effective at 11:59 p.m. Eastern Time on May 2, 2025 [3][5] - The first trading day on Nasdaq under the new share structure is expected to be May 5, 2025, with the symbol "SLGL" remaining unchanged [3][4] - The par value of the ordinary shares will increase from NIS 0.1 to NIS 1.0, and the total share capital will adjust from 50 million to 5 million ordinary shares [6] Group 2: Shareholder Approval and Process - Shareholders approved the reverse split ratio at a special meeting on April 1, 2025, with the board of directors confirming the 10-for-1 ratio on April 9, 2025 [2] - Equiniti Trust Company, LLC will act as the exchange and transfer agent for the reverse split, and shareholders holding shares electronically will not need to take action to receive post-split shares [7] Group 3: Company Overview - Sol-Gel Technologies is focused on developing and commercializing drug products for skin diseases, with FDA-approved products including TWYNEO for acne and EPSOLAY for rosacea [8] - The company's pipeline includes SGT-610, an orphan drug candidate for Gorlin syndrome, and SGT-210, a topical drug candidate for rare skin keratodermas [9]

Core Viewpoint - Sol-Gel Technologies has entered into a product purchase agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to EPSOLAY and TWYNEO, which will enhance the company's cash position and support the development of its product SGT-610 [1][6][7] Financial Summary - Sol-Gel will receive a total of $16 million from Mayne Pharma, with $10 million in Q2 2025 and $6 million in Q4 2025, extending the company's cash runway into Q1 2027 [1][9] - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities [5] Product Overview - EPSOLAY is a topical cream with 5% encapsulated benzoyl peroxide for treating inflammatory lesions of rosacea in adults [2][14] - TWYNEO is a fixed-dose combination cream containing 3% encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin for treating acne vulgaris [2][13] Development Focus - The company will concentrate on the clinical and commercial development of SGT-610, a hedgehog signaling pathway blocker aimed at preventing basal cell carcinomas in Gorlin syndrome patients [3][15] - The U.S. market potential for SGT-610 is estimated to be between $400 million and $500 million annually [4][9] Clinical Trial Progress - The Phase-III clinical trial for SGT-610 is progressing well, with 80% of the planned patient enrollment completed, and top-line results expected in Q4 2026 [8][9] - The ongoing Phase 1b trial for SGT-210 in Darier disease patients has seen 50% of participants complete the trial [9][12] Market Potential - The global business potential for EPSOLAY and TWYNEO is expected to exceed that of the U.S. market, with many partnership agreements already signed [6][7] - SGT-210 has an estimated market potential of $200 million to $300 million if clinical efficacy is demonstrated [12]