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泰拉生物科学公司（TYRA）：URGN在LG-IR-NMIBC中AdCom会议的解读

2025-05-22 Jefferies 罗鑫涛Robin

Jefferies 分析师对 Tyra Biosciences (TYRA) 的 UGN-102 在局部晚期不可切除非肌肉浸润性膀胱癌 (LG-IR-NMIBC) 适应症中的风险效益进行了评估。FDA 审评委员会以 5-4 的票数反对其风险效益，主要担忧在于缺乏随机对照试验 (RCT) 来评估其真实疗效。尽管如此，FDA 仍倾向于 RCT 的设计。基于此，分析师将 TYRA 的商业化时间表预测调整至约 2031 年。

对于 TYRA-300 在 LG-IR-NMIBC 中的潜在 III 期临床研究，分析师认为 URGN 的 ENVISION 试验可能并非最可靠的基准，因其并非随机对照且以 3 个月无复发生存期 (CR) 为主要终点。相比之下，更可能采用 RCT 设计，预计耗时约 4 年。近期其他类似适应症的 RCT（如 CGON 的 PIVOT-006、Ferring 的 ABLE-32 和 JNJ 的 MoonRISe-1）也采用了 RFS 或 DFS 作为终点，且预计持续时间约为 4 年。

UGN-102 的申请基于 ENVISION 和 ATLAS 两项 III 期临床数据。ENVISION 为单臂研究，以 3 个月 CR 为主要终点。ATLAS 是唯一一项随机对照试验，但因资金问题提前终止，仅入组了计划的 632 名患者中的 282 名。尽管基线人群存在差异，FDA 仍识别出 UGN-102 组和 TURBT 组 51 例和 57 例复发患者，进行头对头比较。结果显示，UGN-102 组的 12 个月 DOR 为 65%，显著高于 TURBT 组的 42%。

尽管 FDA 委员会以 5-4 的票数反对 UGN-102 的风险效益，但分析师认为，鉴于该适应症缺乏获批疗法，FDA 可能最终会权衡此结果。然而，考虑到 FDA 关键决策者的近期变动，UGN-102 获批的可能性已降低。若被拒绝，下一次潜在获批可能不会早于 2029 年，这对 TYRA 来说可能是一个积极因素，因为它有助于在竞争性产品广泛普及之前实现市场进入。

委员会中两位泌尿科医生强烈支持 UGN-102，理由是其有望减少住院负担，其 12 个月 DOR (79% 的应答患者) 和 3 个月 CRR (78% 的 ENVISION 数据) 令人鼓舞，且安全性可接受。他们还指出，TURBT 的真实世界安全性负担在 URGN 的 ATLAS 试验中未得到充分体现。泌尿科医生的支持表明，该适应症在泌尿科领域存在高度未满足的需求，倾向于微创且无手术负担的治疗方案。然而，两位泌尿科医生也确认，在该人群中开展随机对照试验是可行的。

投票反对 UGN-102 风险效益的五位委员主要担心缺乏随机对照试验，难以在异质性人群中评估其真实疗效。其中一位委员质疑以 3 个月 CR 作为惰性疾病的终点，并认为 18 个月的随访期过短。委员会成员还关注 ATLAS 试验中有限的疗效获益——活性组 22 例 TURBT 与对照组 28 例相比，仅显示轻微的手术负担减少。对于潜在定价约为 14 万美元/年的疗法，这引发了成本效益的疑问。

最终，分析师认为 TYRA 可能仍有机会通过独特或更快的路径获得批准，但基于先例和 UGN-102 的 AdCom 会议结论，更快的路径可能性已降低，预计商业化时间表更可能是 2031 年。

Maury Raycroft, Ph.D. * | Equity Analyst(212) 323-3990 | mraycroft@jefferies.comAmin Makarem, Ph.D. * | Equity Associate+1 (332) 236-6822 | amakarem@jefferies.comAmy Qian, Ph.D. * | Equity Associate+1 (212) 707-6465 | aqian@jefferies.comFarzin Haque, Ph.D. * | Equity Analyst+1 (212) 778-8349 | fhaque@jefferies.comJames Stamos, Ph.D. * | Equity Associate(212) 323-7644 | jstamos@jefferies.com$32.00 | +228%$29.60 - $6.42FLOAT (%) | ADV MM (USD)51.3% | 3.05$579.1M^Prior trading day's closing price unless otherwiseEquity ResearchMay 21, 2025 TYRA could still get alignment on a unique/faster path (we are currently estimating launch in2028 assuming ~$2B peak & 15% POS); however, based on precedent and takeaways fromURGN's AdCom, we believe likelihood of a faster path has diminished w/ ~2031 being morerealistic.Please see important disclosure information on pages 3 - 8 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Company DescriptionTyraTyra Biosciences is a precision oncology company focused on developing therapies designed to overcome tumor resistance and provide alternativetreatment options to cancer patients.Company Valuation/RisksTyraOur $32 PT blends DCF+prob-adj EPS. Risks include competition, efficacy, safety, and regulatory talks with FDA.Analyst Certification:I, Maury Raycroft, Ph.D., certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) andsubject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or viewsexpressed in this research report.I, Amin Makarem, Ph.D., certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) andsubject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or viewsexpressed in this research report.I, Amy Qian, Ph.D., certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subjectcompany(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressedin this research report.I, Farzin Haque, Ph.D., certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) andsubject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or viewsexpressed in this research report.I, James Stamos, Ph.D., certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) andsubject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or viewsexpressed in this research report.As is the case with all Jefferies employees, the analyst(s) responsible for the coverage of the financial instruments discussed in this report receivescompensation based in part on the overall performance of the firm, including investment banking income. We seek to update our research as appropriate, butvarious regulations may prevent us from doing so. Aside from certain industry reports published on a periodic basis, the large majority of reports are publishedat irregular intervals as appropriate in the analyst's judgement.Investment Recommendation Record(Article 3(1)e and Article 7 of MAR)Recommendation PublishedRecommendation DistributedExplanation of Jefferies RatingsBuy - Describes securities that we expect to provide a total return (price appreciation plus yield) of 15% or more within a 12-month period.Hold - Describes securities that we expect to provide a total return (price appreciation plus yield) of plus 15% or minus 10% within a 12-month period.Underperform - Describes securities that we expect to provide a total return (price appreciation plus yield) of minus 10% or less within a 12-month period.The expected total return (price appreciation plus yield) for Buy rated securities with an average security price consistently below $10 is 20% or more within a 12-month period as these companies are typically more volatile than the overall stock market. For Hold rated securities with an average security price consistentlybelow $10, the expected total return (price appreciation plus yield) is plus or minus 20% within a 12-month period. For Underperform rated securities with anaverage security price consistently below $10, the expected total return (price appreciation plus yield) is minus 20% or less within a 12-month period.NR - The investment rating and price target have been temporarily suspended. Such suspensions are in compliance with a

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