A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris

To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.

开始日期2019-06-27

申办/合作机构

Sol-Gel Technologies Ltd.

NCT03761784

/ Completed临床3期

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

开始日期2018-12-21

申办/合作机构

Sol-Gel Technologies Ltd.

NCT03761810

/ Completed临床3期

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

开始日期2018-12-14

申办/合作机构

Sol-Gel Technologies Ltd.

100 项与过氧苯甲酰/维A酸相关的临床结果

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100 项与过氧苯甲酰/维A酸相关的转化医学

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100 项与过氧苯甲酰/维A酸相关的专利（医药）

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项与过氧苯甲酰/维A酸相关的文献（医药）

2023-09-01·ANNALS OF PHARMACOTHERAPY

Tretinoin 0.1% and Benzoyl Peroxide 3% Cream for the Treatment of Facial Acne Vulgaris

Review

作者: Steven R. Feldman ; Mallory Zaino ; Christina Kontzias

Objective::

To assess the efficacy, safety, and clinical application of tretinoin 0.1%-benzoyl peroxide 3% cream for the topical treatment of acne vulgaris.

Data Sources::

A systematic review of the literature was performed using the terms Twyneo OR tretinoin and benzoyl peroxide OR S6G5T-3 in MEDLINE (PubMed) and EMBASE. ClinicalTrials.gov was searched to obtain completed clinical trial results not published elsewhere.

Study Selection and Data Extraction::

All human studies published in English prior to November 2022 related to pharmacology, clinical trials, safety, and efficacy were evaluated for inclusion.

Data Synthesis::

In two 12-week, phase 3, randomized, vehicle-controlled clinical trials, tretinoin 0.1%-benzoyl peroxide 3% cream significantly reduced inflammatory and noninflammatory facial acne lesions and significantly improved Investigator Global Assessment (IGA) rating to clear or almost clear. The cream has a suitable safety profile, with application site pain and dryness as the most common adverse events.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Agents::

Tretinoin-BPO had similar IGA success compared to other topical retinoid and retinoid-BPO treatments for acne vulgaris. Compared to individual tretinoin and benzoyl peroxide therapy, the combination product streamlines application, which will improve medication adherence; however, the cost of tretinoin-BPO cream may be prohibitive.

Conclusions::

Tretinoin 0.1%-benzoyl peroxide 3% cream is safe and effective for the treatment of moderate-to-severe acne. Long-term trial data on efficacy and tolerability are not yet available.

2021-02-01·CLINICAL CANCER RESEARCH

The Changing Landscape of Therapeutic Cancer Vaccines—Novel Platforms and Neoantigen Identification

Review

作者: Jou, Jessica ; Zocca, Mai-Britt ; Harrington, Kevin J. ; Cohen, Ezra E.W. ; Ehrnrooth, Eva

Abstract:

Therapeutic cancer vaccines, an exciting development in cancer immunotherapy, share the goal of creating and amplifying tumor-specific T-cell responses, but significant obstacles still remain to their success. Here, we briefly outline the principles underlying cancer vaccine therapy with a focus on novel vaccine platforms and antigens, underscoring the renewed optimism. Numerous strategies have been investigated to overcome immunosuppressive mechanisms of the tumor microenvironment (TME) and counteract tumor escape, including improving antigen selection, refining delivery platforms, and use of combination therapies. Several new cancer vaccine platforms and antigen targets are under development. In an effort to amplify tumor-specific T-cell responses, a heterologous prime-boost antigen delivery strategy is increasingly used for virus-based vaccines. Viruses have also been engineered to express targeted antigens and immunomodulatory molecules simultaneously, to favorably modify the TME. Nanoparticle systems have shown promise as delivery vectors for cancer vaccines in preclinical research. T-win is another platform targeting both tumor cells and the TME, using peptide-based vaccines that engage and activate T cells to target immunoregulatory molecules expressed on immunosuppressive and malignant cells. With the availability of next-generation sequencing, algorithms for neoantigen selection are emerging, and several bioinformatic platforms are available to select therapeutically relevant neoantigen targets for developing personalized therapies. However, more research is needed before the use of neoepitope prediction and personalized immunotherapy becomes commonplace. Taken together, the field of therapeutic cancer vaccines is fast evolving, with the promise of potential synergy with existing immunotherapies for long-term cancer treatment.

2020-01-01·Skinmed

Microencapsulated Benzoyl Peroxide and Tretinoin for the Treatment of Acne Vulgaris: Results from a Phase 2 Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study.

Article

作者: Sugarman, Jeffrey ; Webster, Guy F ; Levy-Hacham, Ofra ; Toledano, Ofer

This phase 2, 12-week, multicenter, randomized, double-blind, active- and vehicle-controlled (VC), parallel-group trial assessed the efficacy and safety of silica encapsulated benzoyl peroxide BP (E-BP), two concentrations of silica encapsulated tretinoin (E-ATRA) and their combinations (TWIN high and low) vs VC in 726 males and females ≥9 years of age with moderate-to-severe inflammatory facial acne. The co-primary efficacy endpoints were Investigators Global Assessment (IGA) success rate ("clear" or "almost clear") and changes from baseline in inflammatory and non-inflammatory lesion counts. TWIN high and low were each significantly superior vs VC for IGA success at 12 weeks (39.7% and 27.4%, respectively, vs 12.3%, P < 0.001 and P < 0.01). TWIN high and low resulted in mean reductions in inflammatory lesions of -16.9 (64%) and -17.0 (60.8%) vs -11.5 (42%) for VC. Reductions in non-inflammatory lesions were -23.7 for TWIN low (54.9%) and -23.6 for TWIN high (53.3%) vs -13.7 (32.4%) for VC (all P < 0.001 vs VC). Results for TWIN were also numerically superior to E-BP and E-ATRA. All treatments were safe with comparable skin tolerability. The significant superiority of both combinations over VC and numerical superiority over E-BP and E-ATRA were achieved without an increase in adverse events or reduced skin tolerability.

132

项与过氧苯甲酰/维A酸相关的新闻（医药）

2026-05-28

·BioSpace

Sol-Gel Reports First Quarter 2026 Financial Results and Provides Corporate Updates

Sol-Gel received a Notice of Allowance for a method-of-use patent extending intellectual property protection for topical patidegib (SGT-610) until 2044 Sol-Gel completed an oversubscribed underwritten offering, raising gross proceeds of approximately $33.1 million from leading healthcare specialist investors Pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome remains ongoing, with top-line results on track for anticipated readout in the fourth quarter of 2026 Sol-Gel signed an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India NESS ZIONA, Israel, May 28, 2026 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. Q 1 202 6 and Recent Corporate Developments In May 2026, the company received a Notice of Allowance (U.S. Patent Application No. 19/266,342) from the U.S. Patent and Trademark Office for our patent application covering a method-of-use that is critical to successful topical patidegib therapy. This patent will provide protection for SGT-610 until 2044. In March 2026, Sol-Gel closed an underwritten offering resulting in aggregate gross proceeds of approximately $33.1 million. The offering included participation from new and existing investors, including Great Point Partners, LLC, Trails Edge Capital Partners, Surveyor Capital (a Citadel company), Affinity Asset Advisors, Squadron Capital Management, Stonepine Capital Management and AuGC BioFund. TD Cowen and LifeSci Capital acted as joint book-running managers for the offering. Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome continues to advance, and the Company remains on track to report top-line results in the fourth quarter of 2026; preparations for a proof-of-concept study of SGT-610 in HF-BCC are ongoing. In April 2026, Sol-Gel entered into an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India. This agreement is in addition to the eight agreements for the commercialization of TWYNEO® and EPSOLAY Sol-Gel signed during 2024 and 2025 in various territories covering most European countries, South Africa, South Korea, Australia and New Zealand. These already signed agreements, together with agreements we anticipate signing in the future covering Latin American countries, Spain and Portugal, have the potential to provide upfront and regulatory milestone payments of up to $4.5 million. The above excludes Sol-Gel's previously signed agreements with Beimei Pharma (China, Hong Kong, Macau, Taiwan and Israel) and Searchlight Pharma (Canada). Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel now expects that TWYNEO and EPSOLAY will launch in the majority of these new territories during 2028 and 2027 respectively, and following launch, these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream with the potential to reach approximately $10 million by 2031 and potentially grow in subsequent years. Mr. Mori Arkin , E xecutive Chairman of Sol-Gel, stated : “The first quarter of 2026 was a period of substantial progress on every front that matters to Sol-Gel. The Notice of Allowance extending the exclusivity of patidegib until 2044 marks a major milestone in the value creation of SGT-610 and Sol-Gel as a company. In parallel, the successful completion of our oversubscribed offering, with broad participation from leading healthcare specialist investors, is expected to provide Sol-Gel with the financial resources to support operations into 2028, allowing us to execute our Phase 3 program of SGT-610 through top-line readout and to support its pre-commercialization activities." Mr. Arkin further commented : "We believe that the combination of our March 2026 financing and the Notice of Allowance for a method-of-use patent protecting topical patidegib until 2044 fundamentally reshapes the long-term opportunity for SGT-610. We now have both the capital and intellectual property runway to pursue the prevention of new BCCs in Gorlin syndrome, for which top-line results are expected in the fourth quarter of 2026. We continue to be excited about the potential of the high-frequency BCC indication, which could double the commercial potential of patidegib, and we look forward to initiating a proof-of-concept study." Lastly, Mr. Arkin commented : "The license agreement with Sun Pharma for India, one of the largest dermatology markets in the world, is another important step in unlocking the global value of TWYNEO through partnerships with leading companies in their respective territories. While the commercialization of our legacy products is a non-core business of Sol-Gel, we believe that this activity has the potential to become an asset of substantial value, in the not-too-distant future. At the appropriate time, we plan to monetize this business and use the non-dilutive funds to support our long-term strategy of developing innovative treatments for unmet medical needs in dermatology." Financial Results for the First Quarter 202 6 Revenue for the first quarter was $0.1 million, compared to revenue of $1.0 million for the same period in 2025. The decrease is mainly attributed to a milestone payment from Searchlight in the first quarter of 2025. Research and development expenses were $2.8 million compared to $8.8 million for the same period in 2025. The decrease of $6.0 million was primarily attributed to a decrease of $3.9 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610 in the first quarter of 2025, a decrease of $1.1 million in clinical trial expenses related to SGT-610 and a decrease of $0.8 million in expenses related to the manufacturing development of EPSOLAY and TWYNEO. General and administrative expenses were $1.2 million compared to $1.3 million for the same period in 2025. Sol-Gel reported a net loss of $3.7 million for the first quarter of 2026 and loss of $1.31 per basic and diluted share, compared to a net loss of $8.8 million and loss of $3.2 per basic and diluted share for the same period in 2025. As of March 31, 2026, Sol-Gel had $10.1 million in cash, cash equivalents, and deposits and $42.7 million in marketable securities, for a total balance of $52.8 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2028. About Sol-Gel Technologies Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety pro to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. including, but not limited to statements regarding the timing of clinical milestones for the Phase 3 program of SGT-610 in Gorlin syndrome, the Company’s cash runway, the timing of the launch of the commercialization of TWYNEO® and EPSOLAY in various territories and the anticipated financial benefits of the Company’s agreements for the commercialization of TWYNEO® and EPSOLAY. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 trial or the success of our clinical trials, a delay in the launch of the commercialization of TWYNEO® and EPSOLAY in various territories, that the financial benefits of the Company’s agreements for the commercialization of TWYNEO® and EPSOLAY will not be as anticipated as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the security situation in Israel. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2026, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. SOL-GEL TECHNOLOGIES LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) (Unaudited) December 31, March 31, 2025 2026 Assets CURRENT ASSETS: Cash and cash equivalents $ 11,033 $ 10,136 Marketable securities 12,966 42,692 Accounts receivables 1,968 1,067 Prepaid expenses and other current assets 1,004 1,894 TOTAL CURRENT ASSETS 26,971 55,789 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,324 1,328 Property and equipment, net 140 136 Operating lease right-of-use assets 1,027 901 Other long-term assets 62 - Funds in respect of employee rights upon retirement 393 396 TOTAL NON-CURRENT ASSETS 2,946 2,761 TOTAL ASSETS $ 29,917 $ 58,550 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable $ 735 $ 782 Other accounts payable 4,941 5,046 Current maturities of operating leases 495 485 TOTAL CURRENT LIABILITIES 6,171 6,313 LONG-TERM LIABILITIES: Operating leases liabilities 496 377 Liability for employee rights upon retirement 439 454 TOTAL LONG-TERM LIABILITIES 935 831 TOTAL LIABILITIES $ 7,106 $ 7,144 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 1 par value – authorized: 5,000,000 as of December 31, 2025 and March 31, 2026, respectively; issued and outstanding: 2,786,158 and 3,268,991 as of December 31, 2025 and March 31, 2026, respectively 774 1,321 Additional paid-in capital 259,047 290,822 Accumulated deficit (237,010 ) (240,737 ) TOTAL SHAREHOLDERS' EQUITY 22,811 51,406 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 29,917 $ 58,550 SOL-GEL TECHNOLOGIES LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands) (Unaudited) Three months ended March 31 2025 2026 REVENUES $ 1,031 $ 108 RESEARCH AND DEVELOPMENT EXPENSES 8,843 2,786 GENERAL AND ADMINISTRATIVE EXPENSES 1,257 1,177 OPERATING LOSS 9,069 3,855 FINANCIAL INCOME, net (261 ) (128 ) LOSS FOR THE PERIOD 8,808 3,727 BASIC AND DILUTED LOSS PER ORDINARY SHARE 3.2 1.31 WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE * 2,785,762 2,836,907 * The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. Sol-Gel I nvestor Relations : Eyal Ben-Or Chief Financial Officer ir@sol-gel.com

2026-05-26

·泉禺

Sol-Gel Technologies：十倍暴涨，一剂孤药的商业密码

当所有人都在追逐肿瘤免疫的星辰大海，一家以色列皮肤科公司却在戈林综合征这个不足3万患者的孤儿病赛道，悄然完成了从谷底到十倍的惊人跃迁。 2026年5月26日，Sol-Gel Technologies（NASDAQ: SLGL）以12.33%的日涨幅领跑美股生物医药板块，股价收于76.73美元。如果将时间轴拉长，过去十二个月，这只股票从6.80美元的52周低点一路攀升至97.97美元高位，年内涨幅已超82%。SLGL的故事，是一堂关于生物医药"反向逻辑"的经典商业课。一、五年过山车：一场教科书式的坠落与重生翻阅SLGL近五年SEC 20-F年报，一场惊心动魄的戏剧跃然纸上。 2021年：唯一的高光。营收3130万美元，净利润320万美元。Galderma为TWYNEO（痤疮药物）和EPSOLAY（红斑痤疮药物）的FDA批准支付了巨额里程碑款，SLGL的二氧化硅微囊化平台证明了技术兑现能力。 2022年：断崖。营收暴跌至390万美元（-87.5%），净亏损1490万美元。里程碑潮水退去，尽管EPSOLAY获批上市，但商业化权已不在SLGL手中。Galderma合作未能兑现预期。 2023年：至暗。营收仅160万美元，净亏损2720万美元。股价跌至合股前0.68美元，市值不足2000万，退市风险如悬剑在顶。 2024年：觉醒。营收1160万美元，净亏收窄至1060万。但真正的战略转折不在财务端——SLGL将全部筹码押注SGT-610，一款针对戈林综合征的局部hedgehog抑制剂。 2025年：反转。营收1940万美元（+67%），净亏收窄至610万。SGT-610获FDA"孤儿药"+"突破性疗法"双重认定。Phase 3完成入组。1-for-10反向股票分拆将股价推上合规门槛。4月，TWYNEO/EPSOLAY美国权益以1600万美元出售给Mayne Pharma，现金跑道延长至2027年Q1。累计亏损2.37亿美元，但亏损曲线已从高峰的2720万美元收窄至610万美元——一条漂亮的收敛弧线。这五年，浓缩了生物医药"价值毁灭+价值重建"的全周期剧本：从依赖外部合作的一次性收入，到聚焦自有管线的内生增长；从双产品获批却无法变现的尴尬，到孤注一掷押注罕见病的战略决断。二、SGT-610：6亿美元的孤药赌局 SLGL目前2.5亿美元市值的唯一支撑，是SGT-610。戈林综合征由PTCH1基因突变导致，患者从青春期开始就会不断在全身长出数十甚至数百个基底细胞癌。现有标准疗法是口服hedgehog抑制剂（如Erivedge），但严重的全身副作用——肌肉痉挛、脱发、味觉丧失——让大量患者无法耐受。 SGT-610的突破在于：利用Sol-Gel专利硅基微囊化技术，将patidegib制成外用凝胶，使药物只在皮肤局部起效，几乎不进入血液循环。疗效不输口服药，安全性却有质的飞跃。峰值销售预估6亿美元。若叠加"高频率BCC患者"扩展适应症，市场体量可能翻倍。值得玩味的是，SLGL目前市值仅2.5亿美元——也就是说，即便按最保守的6亿美元峰值估算，当前市值仅对应0.4倍峰值PS（市销率）。在孤儿药领域，这一估值倍数至少低了一个数量级。三个催化剂同时点火：数据读出的时间窗口（2026年Q4）。 Phase 3入组已完成，确定性从"可能性"变为"时间问题"。突破性疗法认定的信号价值。 FDA认为SGT-610较现有疗法有实质性改善，审评将加速。3310万美元超募发行的机构背书。生物医药融资寒冬中，超额认购释放了强烈的信心信号。三、反向逻辑：为什么"失败经历"是加分项？ SLGL的投资逻辑与主流认知恰好相悖。第一，单一资产不等于高风险。戈林综合征几乎没有竞争。全球不足3万名患者，因为没有有效外用疗法，他们是"被遗忘的群体"。一旦获批，SGT-610享受独占定价权——这正是孤儿药经济学的精髓。第二，商业化失败不等于技术无能。 SLGL的失误在于依赖合作伙伴变现，而非研发能力缺失。当Galderma合作未达预期，公司果断将TWYNEO/EPSOLAY美国权益以1600万美元出售给Mayne Pharma，回笼资金聚焦核心管线。这种战略清醒在Biotech中极为罕见。第三，反向拆股不等于绝望信号。大多数合股是退市前的挣扎。但SLGL的1-for-10合股发生在Phase 3已启动、双重认定已到手之后——本质上是为满足机构投资者的股价门槛（大量基金不碰5美元以下股票），是主动选择而非被动应对。四、风险清单：不容忽视的三重阴影现金风险。当前现金约4560万美元（含3月增发），而2025年研发支出已达2280万。Phase 3完成后若需补充研究，消耗将加速。2027年Q1后的融资窗口存在不确定性。平台信用受损。 2025年12月，管线SGT-210在Darier病的Phase 1b中未能显示疗效，技术平台的泛化能力遭到质疑。虽然与SGT-610的机制和适应症完全不同，但市场对"平台故事"的信任已经打折。二元数据风险。 Phase 3结果将于2026年Q4揭晓。成功则6亿美元峰值估值逻辑成立；失败则核心价值归零。这不是概率计算，而是0或1的博弈。五、产业启示：数智医疗时代的"孤药模式" SLGL的故事对中国数智医疗产业有三重启示。技术维度： Sol-Gel的硅基微囊化平台解决的核心命题——让强效药物只在皮肤起效而不入血——是所有外用制剂的终极追求。这一技术框架不仅适用于hedgehog抑制剂，还可延伸至银屑病的JAK抑制剂、特应性皮炎的PDE4抑制剂等百亿美元级市场。对于正在崛起的中国皮肤科创新药企而言，SLGL的路径验证了一条从"仿制型外用制剂"到"平台型差异化外用制剂"的升级之路。策略维度：反向策略是一种被严重低估的生物医药投资范式。当主流资金追逐GLP-1、ADC、细胞治疗等"性感"赛道时，被遗忘的细分领域可能埋藏着最深护城河。3万名戈林综合征患者，可能比3亿减重用户更能创造持续回报——因为前者没有竞争，后者已是红海。政策维度：中国NMPA近年来持续优化罕见病药物审评审批政策，海南博鳌乐城先行区的"特许药械"政策也为海外孤儿药进入中国提供了绿色通道。SGT-610若在美获批，中国市场的准入路径可能远快于预期——对于中国数智医疗投资者和产业人士而言，这是一个值得提前布局的信号窗口。有时候，最好的投资不是去寻找下一个风口，而是在所有人都转身离去的地方，弯腰捡起那颗被遗忘的珍珠。 SLGL的下一页，将在2026年第四季度翻开。而在此之前，12.33%的涨幅只是一个序章。

2026-04-22

·GlobeNewswire-Health Care

Advancing Drug Pipelines Drive Biotech Valuations as Scientific Progress Gains Financial Recognition

AUSTIN, Texas, April 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: The biotechnology industry is experiencing a subtle yet meaningful transformation that is redefining how value is interpreted within a sector long associated with extended development cycles and inherent uncertainty. As therapeutic candidates advance toward commercialization, scientific achievement is no longer viewed purely as an expense tied to research and development but rather as something that can be quantified as a financial asset. This transition is supported by fair-value accounting principles under U.S. GAAP, which enable life sciences companies to incorporate clinical progress, probability of success and expected commercialization timelines into measurable balance sheet value. Companies at the forefront of this shift, including Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile), are actively leveraging this evolving framework. Operating at the intersection of oncology therapeutics and AI-driven drug development, Oncotelic demonstrates how scientific advancement can influence financial positioning. Through a diversified pipeline and strategic holdings, including a 45% interest in GMP Bio, which was recently assessed at more than $1 billion in enterprise value, the company illustrates how innovation can be reflected in tangible economic terms. As the industry increasingly aligns valuation with development progress rather than current revenue, Oncotelic represents a compelling example of science emerging as a recognized asset class. The company is part of a broader group of organizations developing advanced therapies at the genetic and molecular level, including Autolus Therapeutics plc (NASDAQ: AUTL), Wave Life Sciences Ltd. (NASDAQ: WVE), IO Biotech Inc. (OTC: IOBTQ) and Roche Holding AG (OTC: RHHBY). The biotech sector is transitioning away from a framework dominated by long-term research spending toward one in which scientific progress can be directly reflected in financial valuation.As drug candidates progress through the stages of clinical development, their value tends to rise substantially due to increasing probabilities of success and closer proximity to commercialization.Oncotelic Therapeutics provides a clear example of the growing adoption of fair-value accounting through the remeasurement of its stake in GMP Bio.Based on this evolving investment landscape, Oncotelic Therapeutics is situated to benefit from increasing institutional interest in pipeline-driven valuation.The company operates within this key convergence by combining oncology-focused development with AI-enabled platforms and exposure to manufacturing capabilities. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. Scientific Advancement Emerging as Measurable Value The biotech sector is transitioning away from a framework dominated by long-term research spending toward one in which scientific progress can be directly reflected in financial valuation. Traditionally, investors relied heavily on discounted cash-flow models tied to eventual commercialization outcomes, which often created a disconnect between innovation and perceived value. With the growing adoption of fair-value accounting methodologies under U.S. GAAP, that gap is beginning to close as companies gain the ability to adjust asset valuations in response to clinical and regulatory progress. Under guidance from the Financial Accounting Standards Board, particularly ASC 820, companies can determine the fair value of assets, including early-stage or illiquid investments, using a combination of observable and unobservable inputs. This includes Level 3 classifications, which are frequently applied in biotechnology to assess the value of pipeline programs and strategic holdings. These valuation approaches allow organizations to incorporate factors such as clinical advancement, regulatory status and probability of success into financial reporting. Leading advisory firms have emphasized that valuation in the life sciences sector increasingly depends on forward-looking inputs, including development progress and anticipated commercialization potential. Because fair-value accounting requires assets to be measured from the perspective of market participants, these frameworks inherently incorporate expectations about future economic benefit. As a result, financial reporting becomes more closely aligned with the operational realities of drug development, where revenue generation often lags innovation. This evolving approach is particularly relevant for Oncotelic Therapeutics, whose value is closely tied to the advancement of its therapeutic pipeline. By aligning financial reporting with clinical and strategic milestones, the company reflects a broader industry shift toward recognizing scientific progress as a core driver of enterprise value. Advancing Pipelines and Valuation Acceleration As drug candidates progress through the stages of clinical development, their value tends to rise substantially due to increasing probabilities of success and closer proximity to commercialization. This progression, often described as a valuation inflection point, is widely observed across the biotechnology landscape. Assets in late-stage development, particularly those nearing regulatory approval, frequently represent a disproportionate share of overall company value. Research from McKinsey & Company indicates that value creation within biopharma is heavily concentrated in later-stage programs, where reduced uncertainty and clearer pathways to market translate into stronger expected returns. Additional industry analysis supports the view that assets approaching commercialization often drive significant increases in valuation due to improved probability-adjusted outcomes and anticipated market entry. This trend underscores a broader shift in how investors evaluate biotechnology companies. Rather than concentrating primarily on existing revenue or earnings, attention is increasingly directed toward the maturity and forward trajectory of pipeline assets. Consequently, companies with advanced-stage programs may experience meaningful increases in valuation even prior to generating commercial revenue. For Oncotelic Therapeutics, this dynamic is applicable given its focus on oncology therapies and its positioning within high-value development pathways. As the company’s pipeline advances toward later stages, its valuation profile aligns with the broader industry movement toward pipeline-driven value recognition. Fair-Value Frameworks Gain Momentum in Biotech The growing adoption of fair-value accounting within biotechnology is supporting more accurate and timely representation of asset value. Under GAAP, Level 3 valuation methodologies are applied to assets without observable market prices, using models that rely on forward-looking assumptions such as expected cash flows and probability-weighted scenarios. The ASC 820 framework describes fair value as the price that would be received in an orderly transaction between market participants at the measurement date. It establishes an organized hierarchy for valuing complex or illiquid assets using the best available information and market-based assumptions. This approach ensures that financial reporting reflects a current and economically relevant view of asset value. Oncotelic Therapeutics provides a clear example of this methodology through the remeasurement of its stake in GMP Bio, which reflects an enterprise valuation exceeding $1 billion. This shows how clinical advancement and strategic positioning can translate into measurable balance sheet strength, reinforcing the concept that scientific progress carries financial significance. Institutional Investors Embrace Prerevenue Opportunities Institutional investors are acknowledging the value of clinical-stage biotechnology assets, even in the absence of current revenue. This swing indicates increasing confidence in structured valuation approaches that encompass scientific progress instead of only on traditional financial metrics. In many cases, biotech companies are assessed based mostly on the strength of their development pipelines rather than current income streams. Given the extended timelines required to bring therapies to market, valuation is often driven by factors such as clinical stage, probability of success and regulatory milestones. This framework highlights that value creation in the sector frequently occurs well before commercialization, as investors rely on milestone-based and probability-adjusted methodologies to assess future potential. Based on this evolving investment landscape, Oncotelic Therapeutics is situated to benefit from increasing institutional interest in pipeline-driven valuation. The companys varied assets and strategic investments align with the kinds of opportunities that are attracting capital across the biotechnology sector. Integration of AI, Manufacturing and Market Readiness Technological advancements in artificial intelligence and GMP-compliant manufacturing are fast-tracking development timelines while enhancing scalability throughout the biotechnology sector. These innovations support increasingly efficient clinical workflows, improved data analysis and streamlined production procedures, ultimately decreasing development time and cost. Artificial intelligence is playing a greater role in identifying therapeutic targets, optimizing clinical trial design and analyzing complex datasets. These capabilities improve the likelihood of success in drug-development programs. In addition, advancements in GMP-compliant manufacturing are supporting more consistent and scalable production, which becomes critical as therapies move closer to commercialization. Industry research suggests that data-driven methods are becoming central to value creation in biopharma, with AI and advanced analytics contributing to faster development timelines and improved execution. The intersection of technology, manufacturing and clinical development is redefining how value is generated and assessed within the sector. Companies capable of integrating these capabilities are better positioned to advance therapies efficiently while maintaining regulatory compliance. Oncotelic Therapeutics operates within this convergence by combining oncology-focused development with AI-enabled platforms and exposure to manufacturing capabilities. This cohesive strategy encourages both innovation and financial valuation, placing the company in a key biotech growth trend. The biotechnology industry is seeing a new chapter in which scientific advancement is increasingly recognized as a measurable financial asset rather than mainly a cost center. As fair-value accounting, pipeline maturity and AI-fueled development continue to redefine the sector, the conventional divide between innovation and valuation is decreasing. Savvy companies such as Oncotelic Therapeutics demonstrate how this change is taking place in practice, showing that clinical progress can strengthen financial positioning even prior to revenue generation. As investor focus continues to shift toward pipeline-driven value, the ability to convert scientific progress into measurable economic impact is becoming a defining feature of modern biotechnology. Biotech Advances Drive Valuation Momentum Biotechnology advancements remain central to how companies are valued, as clinical progress, regulatory milestones and platform innovations often serve as key inflection points for both therapeutic development and investor perception. As drug candidates move through trials and toward commercialization, each update can reshape expectations around risk, scalability and long-term revenue potential, reinforcing the close link between scientific progress and market valuation. Autolus Therapeutics plc (NASDAQ: AUTL) is reporting continued progress across its platform, noting that it is developing, manufacturing and delivering next-generation programmed T cell therapies. In its Q4 and FY2025 update, the company noted a strong first year of launch of AUCATZYL in the U.S., building a market-leading position in adult patients with relapsed or refractory B-ALL and demonstrating strong commercial execution, including reliable, high-quality product delivery with consistent turn-around time. Wave Life Sciences Ltd. (NASDAQ: WVE) noted new 2026 developments centered on its RNA-based therapeutics pipeline, including progress in obesity and genetic disease programs. In its latest update, the company emphasized that it is focused on unlocking the broad potential of RNA medicines to transform human health. The announcement underscored advancing clinical trials and expanding applications of RNA editing and RNA interference technologies, reinforcing the growing role of precision genetic medicine in addressing both rare and common diseases. IO Biotech Inc. (OTC: IOBTQ) announced a strategic shift in 2026 as it evaluates future pathways to maximize value. The company is developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines. IO Biotech has a T-win platform based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. Roche Holding AG (OTC: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Gazyva(R)/Gazyvaro(R) (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). The acceptance is based on positive results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks, a measure that assesses changes in disease severity, symptoms and physical condition. These updates reflect a biotechnology sector defined by rapid scientific innovation, platform diversification and increasingly complex development pathways. From cell therapies and RNA-based medicines to immuno-oncology and neurodegenerative research, progress across multiple fronts continues to shape both therapeutic potential and market expectations. As companies advance through clinical milestones and refine their strategic direction, the interplay between innovation and valuation remains a defining feature of the biotech landscape. For more information, visit Oncotelic Therapeutics Inc. About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer’s filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer’s securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. 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100 项与过氧苯甲酰/维A酸相关的药物交易

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
寻常痤疮	美国	Mayne Pharma Ltd.	2021-07-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03664739 (CTgov)	临床3期	寻常痤疮	608	IDP-120 (IDP-120 Gel)	廠構窪鹹獵襯觸築鏇鹽(鹹膚蓋願齋壓襯選膚蓋) = 積顧廠鑰糧蓋鹹膚壓衊餘獵觸繭膚餘範衊簾憲 (鏇積淵艱願構願築鑰築, 10.79) 更多	-	2023-03-29
				IDp-120 (IDP-120 Vehicle Gel)	廠構窪鹹獵襯觸築鏇鹽(鹹膚蓋願齋壓襯選膚蓋) = 醖顧淵蓋壓鹹鑰齋鹹衊餘獵觸繭膚餘範衊簾憲 (鏇積淵艱願構願築鑰築, 9.68) 更多
NCT03664752 (CTgov)	临床3期	寻常痤疮	585	IDP-120 (IDP-120 Gel)	構醖憲願網積積鑰醖淵(積膚願淵壓窪構憲製築) = 憲願膚廠顧範醖構艱醖網鏇艱構膚選餘築鏇築 (餘壓顧壓淵簾窪廠糧餘, 9.50) 更多	-	2023-03-29
				IDP-120 (IDP-120 Vehicle Gel)	構醖憲願網積積鑰醖淵(積膚願淵壓窪構憲製築) = 蓋廠憲蓋膚餘築願範鏇網鏇艱構膚選餘築鏇築 (餘壓顧壓淵簾窪廠糧餘, 9.80) 更多
NCT03761784 (SGT-65-04, CTgov)	临床3期	寻常痤疮	424	S6G5T-3 (S6G5T-3)	選醖鹽壓淵窪衊醖餘廠 = 鹽構淵鏇顧餘觸膚壓蓋積獵構鹹願鹽窪積衊觸 (願窪鑰構顧鬱艱鹹鏇積, 膚鏇齋願構憲糧鹹獵顧 ~ 簾觸鬱鬱簾窪願窪構壓) 更多	-	2021-12-01
				S6G5T-8 (S6G5T-8 Vehicle Cream)	選醖鹽壓淵窪衊醖餘廠 = 積膚積鑰餘憲鑰鑰鬱繭積獵構鹹願鹽窪積衊觸 (願窪鑰構顧鬱艱鹹鏇積, 網築鹽餘夢壓製艱襯鏇 ~ 鹹願製範齋繭糧衊築醖) 更多
NCT03761810 (SGT-65-05, CTgov)	临床3期	寻常痤疮	434	S6G5T-3 (S6G5T-3)	製鑰網衊憲簾選積衊膚 = 蓋鏇製構顧選醖壓鏇餘選襯衊襯選艱積觸繭製 (範繭窪觸蓋襯構遞廠糧, 築衊襯窪鑰鑰鏇鹹觸範 ~ 範範積廠糧淵願築獵構) 更多	-	2021-12-01
				S6G5T-8 (S6G5T-8 Vehicle Cream)	製鑰網衊憲簾選積衊膚 = 衊獵窪膚艱遞願繭鑰積選襯衊襯選艱積觸繭製 (範繭窪觸蓋襯構遞廠糧, 淵衊醖糧範遞齋醖築鏇 ~ 醖鹹鬱網糧願鹹壓網構) 更多
NCT03761784 (SGT-65-04, GlobeNewswire) 人工标引	临床3期	寻常痤疮	424	Benzoyl Peroxide+Twyneo	鹹淵餘遞遞鬱鬱顧壓鹽(繭簾築醖齋蓋製餘鏇築) = 齋糧憲衊觸餘夢膚鹽餘衊壓襯獵繭襯淵膚糧憲 (簾夢憲鬱積夢夢積範製 ) 更多	积极	2019-12-30
				Placebo	鹹淵餘遞遞鬱鬱顧壓鹽(繭簾築醖齋蓋製餘鏇築) = 顧鑰糧積選範遞窪衊艱衊壓襯獵繭襯淵膚糧憲 (簾夢憲鬱積夢夢積範製 ) 更多
NCT03761810 (SGT-65-05, GlobeNewswire) 人工标引	临床3期	寻常痤疮	434	Benzoyl Peroxide+Twyneo	壓網艱築餘醖願膚選醖(獵範鏇窪繭餘遞範鏇夢) = 顧顧鑰範鑰膚觸窪膚製遞衊製衊醖齋鏇鑰網鏇 (淵齋糧鏇鹹範憲鑰積選 ) 更多	积极	2019-12-30
				Placebo	壓網艱築餘醖願膚選醖(獵範鏇窪繭餘遞範鏇夢) = 壓觸餘襯選醖憲醖願願遞衊製衊醖齋鏇鑰網鏇 (淵齋糧鏇鹹範憲鑰積選 ) 更多