Dexlansoprazole

Key Highlights: Tegoprazan is the first and only P-CAB reported to demonstrate clinical improvement in both hallmark symptoms of NERD, heartburn and regurgitation, in a prospective U.S. phase 3 clinical trial. Detailed analysis from the randomized, double-blind, placebo-controlled Phase 3 TRIUMpH-NERD study demonstrated that both doses of tegoprazan produced statistically significant improvements in the percentage of 24-hour heartburn free days and days without nighttime heartburn versus placebo through week 4. Prespecified analyses also showed greater percentages of days without regurgitation and without both heartburn and regurgitation with tegoprazan versus placebo. Tegoprazan demonstrated treatment effect from Day 1 and continued improvement in heartburn-free days through the 20-week extension period. A separate ACG Presidential Award recognized post hoc analysis of the TRIUMpH erosive esophagitis (EE) program applied Lyon 2.0 Consensus criteria and found superior EE healing and maintenance of healing with tegoprazan compared to lansoprazole among patients with conclusive GERD. BRAINTREE, Mass., Oct. 11, 2026 /PRNewswire/ -- Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, with a 40-year commitment to gastroenterology, today announced (1) positive results from the Phase 3 TRIUMpH clinical program evaluating tegoprazan in adults with non-erosive reflux disease (NERD) and (2) an American College of Gastroenterology (ACG) Presidential Award recognized post hoc analysis of TRIUMpH EE data at the ACG 2026 Annual Scientific Meeting. "Together, these NERD and EE analyses strengthen the evidence for tegoprazan across major GERD phenotypes and address persistent treatment gaps," said Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals. "These findings represent important progress toward our vision of advancing the treatment of GERD. We are committed to translating meaningful scientific advances into treatments that can make a difference for the millions of patients who still struggle with this disease." ACG 2026 TRIUMpH-NERD Oral Presentation NERD is a common form of gastroesophageal reflux disease (GERD) in which patients experience reflux symptoms without visible erosive damage to the esophagus. Despite currently available therapies, many patients continue to experience persistent heartburn, regurgitation, or both, creating an unmet need for treatments that provide rapid and comprehensive relief. Tegoprazan is an investigational, fast-acting potassium-competitive acid blocker (P-CAB) under development by Braintree Laboratories, Inc. for the treatment of GERD. The Phase 3 TRIUMpH program evaluated tegoprazan in diverse U.S. patient populations with both NERD and erosive esophagitis (EE). TRIUMpH-NERD (NCT05587322) was a randomized, double-blind, placebo-controlled, multicenter study that enrolled 783 adults with symptomatic NERD. Patients received tegoprazan 50mg, tegoprazan 100mg, or placebo once daily for four weeks, followed by a 20-week extension phase. The primary endpoint was the percentage of 24-hour heartburn-free days through Week 4, with the percentage of days without nighttime heartburn through Week 4 as a key secondary endpoint. Regurgitation was assessed as a prespecified exploratory endpoint. Both doses of tegoprazan met the primary and secondary endpoints in the TRIUMpH-NERD study, despite enrolling a population with a high baseline disease burden. The detailed results presented at ACG demonstrated significant improvements in both 24-hour heartburn-free days and nighttime heartburn compared with placebo. Tegoprazan also significantly increased the percentage of days without regurgitation and the percentage of days free of both heartburn and regurgitation. The mean baseline heartburn severity was notable in this study with only 6.2% of patients having 24-hour heartburn free days at baseline. By comparison, in other NERD studies across PPIs and PCABs mean baseline heartburn severity was typically less severe with 12.9% to 22.6% of patients having 24-heartburn free days at baseline.1,2 "For patients with NERD, meaningful treatment benefit requires addressing both heartburn and regurgitation, two symptoms that can substantially affect daily life," said Ronnie Fass, MD, Case Western Reserve University School of Medicine, presenting author of the study. "In this study, tegoprazan demonstrated statistically significant improvements across heartburn, regurgitation, and the combined symptom-free endpoint." Key results: Least-squares (LS) mean 24-hour heartburn-free days through Week 4 were 17.3% with placebo, 26.2% with tegoprazan 50 mg, and 30.1% with tegoprazan 100 mg (p=0.0006 and p<0.0001, respectively), corresponding to relative increases of 51% and 74% over placebo. Improvements in 24-hour heartburn-free days continued to increase over 4 weeks, with rates of 38.9% for tegoprazan 50mg and 45.6% for tegoprazan 100mg compared to placebo of 26.7% measured at Day 28. LS mean days without nighttime heartburn were 27.0%, 36.1%, and 39.9%, respectively (50 mg vs placebo, p=0.0017; 100 mg vs placebo, p<0.0001). Treatment differences were apparent from Day 1, for heartburn-free days and days without regurgitation, supporting rapid onset of symptom improvement. During the open label extension phase of 20 weeks, the LS mean 24‑hour heartburn‑free days averaged 48% with tegoprazan 50mg and 50% with tegoprazan 100mg. Similar results were also seen in the extension phase for percentage of days without regurgitation. For the combined endpoint of days free of both heartburn and regurgitation, tegoprazan demonstrated relative improvements of 60% and 76% over placebo for the 50mg and 100mg doses, respectively through Week 4. Improvement in both heartburn and regurgitation may be particularly meaningful for patients with NERD, as patients report both as the most common recurring symptoms of GERD. In a recent survey among 500 GERD patients, regurgitation was cited as the most common symptom overall, and the primary complaint by 83% of patients who are or have been treated with a PPI.3 ACG 2026 TRIUMpH-EE Presidential Award Abstract A separate ACG Presidential Award-winning post hoc analysis of the TRIUMpH-EE (NCT05587309) data was presented by Dr. Walter Chan of Harvard Medical School. In this analysis, baseline EE was reclassified using Lyon Consensus 2.0: LA Grades B-D as conclusive GERD and LA Grade A as inconclusive GERD. In this study, endoscopies were scored by local readers and then subsequently evaluated by blinded central readers using comprehensive procedural videos. Patients (n = 415) with conclusive GERD taking 100 mg tegoprazan daily demonstrated statistically superior healing at Weeks 2 and 8 and maintenance of healing at Week 24 versus lansoprazole (n = 399). Tegoprazan 50 mg was also confirmed to be superior to lansoprazole at maintenance week 24. No statistically significant differences were observed between groups for inconclusive GERD. Key results: In the modified intention-to-treat (m-ITT) population of 1,245 patients, rates of healed EE were higher with tegoprazan compared to lansoprazole among those with conclusive GERD per Lyon 2.0 (LA grades B-D) at week 2 (75.4% vs 60.7%, p<0.0001) and cumulatively by week 8 (83.4% vs 72.7%, p=0.0005), while no statistically significant between-group differences were observed for inconclusive GERD (LA grade A). Similar results were found in the per protocol (PP) analyses. Both tegoprazan 50mg and 100mg were superior to lansoprazole for maintenance of healing at 24 weeks for conclusive GERD in both the m-ITT (p≤0.0019) and PP analyses (p<0.0001), while no differences were seen in inconclusive GERD. C. Prakash Gyawali, MD, Washington University School of Medicine, primary author of the Lyon 2.0 consensus and senior author of the abstract said, "The Lyon Consensus has established a standardized framework for objectively diagnosing GERD with confidence. These findings support the hypothesis that P-CABs are superior for patients with conclusive GERD and suggest that objective disease classification will help identify patients who may benefit most from treatment." About the TRIUMpH Program The TRIUMpH clinical program comprises two pivotal Phase 3 studies of tegoprazan in US patients with gastroesophageal reflux disease (GERD), including an erosive esophagitis (TRIUMpH-EE; NCT05587309) study and a non‑erosive reflux disease (TRIUMpH-NERD; NCT05587322) study. TRIUMpH-EE evaluated the healing and maintenance of healing of EE and the relief of heartburn vs lansoprazole, while TRIUMpH-NERD evaluated tegoprazan 50mg and 100mg vs placebo in patients with NERD. Across the TRIUMpH program, individual treatment-emergent adverse events occurred at a rate of approximately 3% and were generally mild and transient, and serious events occurred at approximately 2% with similar rates between tegoprazan and active or placebo comparators. Mean serum gastrin levels for tegoprazan and lansoprazole remained within the normal range (0–180 pg/mL) throughout the treatment periods. About Tegoprazan Tegoprazan is a novel, fast-acting, once-daily, oral potassium-competitive acid blocker (P‑CAB) with pH dependent pharmacology, in development in the United States for the treatment of adults with gastroesophageal reflux disease (GERD). P-CABs reversibly inhibit the gastric proton pump through potassium-competitive binding. In Phase 1 pharmacodynamic studies, tegoprazan demonstrated rapid acid control achieving an intragastric pH above 4 within 45 minutes of dosing. Tegoprazan has received marketing authorization in 24 countries worldwide and is marketed as K‑CAB® in several regions outside the United States, including South Korea. In January 2026, Braintree Laboratories, a part of Sebela, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of tegoprazan for the treatment of heartburn associated with non-erosive reflux disease (NERD), the healing of EE, and the maintenance of healing of EE in adults. US approval is anticipated in January 2027. About GERD and Erosive Esophagitis GERD is a chronic, highly prevalent gastrointestinal disorder affecting approximately 65 million people in the United States and characterized by symptoms such as heartburn and regurgitation.4 EE is a phenotype of GERD in which reflux of gastric contents leads to visible erosions in the esophageal mucosa, and patients with severe EE (LA Grade C/D) are at increased risk of complications and often require long‑term maintenance therapy. PPIs have been the mainstay of GERD therapy for decades, yet 35–54% of patients experience incomplete symptom relief, highlighting a significant unmet need.5,6 About Sebela Pharmaceuticals Sebela Pharmaceuticals is building a leading gastroenterology company dedicated to improving the lives of patients. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, a trusted name in gastroenterology for more than 40 years, bringing deep expertise in the development, manufacturing, and commercialization of GI therapies. Sebela has demonstrated a strong track record of pharmaceutical innovation and regulatory execution, securing four FDA approvals over the past six years. Building on this foundation, the company is focused on advancing innovative therapies that address significant unmet needs in gastroenterology. Tegoprazan is Braintree's lead program. An NDA has been submitted based on the successful phase 3 TRIUMpH clinical program, and plans are underway for launch as a treatment for GERD. Sebela Pharmaceuticals has operations in Braintree, MA and Dublin, Ireland. For more information, visit . Forward-Looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "may", "will", "forecast," "estimated," "expected," and "intend," among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to obtaining FDA approval of tegoprazan; the development, launch, introduction and commercial potential of tegoprazan; growth and opportunity, including peak sales and the potential demand for tegoprazan, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the NDA discussed in this press release will be approved or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. K-CAB® is a trademark of HK inno.N Corporation. References: 1Laine L, et al. Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial. CGH. 2024. 2 Fass, R, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009. 3Wakefield Research, Data on File. Braintree Laboratories, Inc., 2026. 4El-Serag HB, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014. 5Chey WD, et al. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci. 2010. 6Armstrong D, et al. Symptom Profile, Proton Pump Inhibitor Therapy, and Diagnostic Testing in Patients with Persistent Reflux-Like Symptoms: Results from a Population-Based Survey. Foregut. 2023. Website: SOURCE Sebela Pharmaceuticals 21% more press release views with Request a Demo

奥赛康人气榜约第47，引用收盘约13.55元涨近10%；从PPI注射剂到利厄替尼医保放量，H1账本承压，位置贴着上轨。 我是那种见过院内注射剂时代的老股民。周六下午刷人气榜，奥赛康跳到大约第47，收盘引用价13.55，一天差不多+9.98%。脑子里先冒出来的不是K线颜色，是医院西药房玻璃门上那层反光——药师隔着窗口对名字，箱子上印着质子泵抑制剂的缩写，护士推车轱辘声从走廊拐过来。后来市面上开始聊三代EGFR靶向药、医保谈判、商业化元年。同一家公司，两张面孔叠在一起。人气够吵，账本够拧，才值得摊开写。 刷到第47，热度不等于有人托底 先把缘起说清楚。今天写奥赛康，不是哪张龙虎榜晒出净买入，也不是谁封板成功率漂亮。缘起是东方财富人气榜随机池——它当时大概在第47。人气榜量的是关注度：有人加自选，有人翻年报，有人在群里甩「利厄替尼」「奥壹新」「创新药」几个词。 关注度可以来自医保标题，可以来自临床数据复读，也可以来自「这票又快板了」这种短线本能。它不告诉你席位性质，更不承诺有人替你托底。上涨股写关注逻辑，最怕写成涨停龙虎榜口吻——这一篇，我偏要把这句话写重一点。 围观很热闹。交割很慢。药盒故事和板价，别写在同一张收据上。 老身份是PPI，新标签是创新药 北京奥赛康药业，根子在南京那一脉研发所。公开材料里，它常被写成国产首支质子泵抑制剂注射剂的选手：奥美拉唑钠注射剂起家，院内消化科场景熟，渠道也熟。后来集采刀子下来，消化类收入占比从高峰往下掉——这种疼，做过仿制药的人都懂。公司也没停，右兰索拉唑注射液这类改良新药还在补消化组群的货架。 可真正让它重新进讨论区的，是另一张脸。2025年被公司自己称作创新药商业化元年：1类创新药利厄替尼片（奥壹新），口服第三代EGFR-TKI，二线、一线双适应症获批，又进了2025版国家医保目录，2026年1月1日执行。临床叙事里常提一线无进展生存期大约20.7个月、脑转移亚组数据好看，还跟信达生物绑了商业化合作。说人话——老产品负责认识医院门牌，新产品负责讲「下一段能不能长大」。 管线也不止这一支。公开口径里还有CLDN18.2单抗ASKB589（III期访视中）、c-Met抑制剂ASKC202、泛RAS相关项目、眼科双抗ASKG712、麦芽酚铁胶囊报产之类。名字一长串，我记不住全称，方向却清楚：小分子靶向加生物药，押的是后续期权，不是下个星期的利润表。 年报还行，中报把温度拧冷了 2025年报读起来像「缓过来了」。营收大约17.79亿，同比几乎持平；归母净利大约2.37亿，同比大约加四成八；扣非大约1.97亿，跟归母剪刀差不算夸张。加权ROE大约7.52%，不算漂亮，但比前两年扭亏期像样。经营现金流大约6.52亿，研发投入大约3.77亿——药企肯烧钱，我认；烧完有没有订单回来，另说。毛利率公开口径大概八成上下，制剂生意的骨架还在。资产负债率大约两成五，杠杆不吓人。 拧巴出在2026年上半年。营收大约8.71亿，同比少大约一成四；归母大约1.21亿，同比少大约两成五；扣非大约1.07亿，方向一致。经营现金流大约1.48亿，同比少大约六成五——这一条比利润标题更刺眼。半年ROE大约3.81%。公司口径爱讲新品推进、研发节奏；市场口径更爱问：商业化元年的「元年」，报表上怎么先凉一截？说白了，创新药放量往往是慢变量，费用和渠道却可能先动起来，半年度数字难看，不一定等于故事当场破产，但足以提醒你别把叙事直接兑成仓位。 总股本大约9.28亿股，按13.55粗算总市值大约126亿。对应中报归母净资产大约32.3亿，市净率大概3.9倍；按2025每股收益大约0.25元粗算，静态市盈率大约54倍。公开渠道里，有的研报目标价曾经写到二十附近，有的对2026年利润预测更保守——覆盖少、分歧大，别把某一页PPT当成秤砣。我自己算账时习惯多留一档折扣：乐观情景留给年报验证，悲观情景留给回撤空间。 所以我的第一反应很土：身份标签在升温，半年度账本在降温。医保鼓点可以响，放量数字得一季一季对。 收盘这几个数，先摆桌上 手机竖屏，先看小表。引用的是假期前最近交易日收盘。 项目 数值 引用收盘 / 涨跌 13.55 元 / +9.98% 人气大致位次 约第 47 RSI(14) / 布林位置 约 61.2 / 约 104.8% MACD 快线 / 信号线 约 +0.095 / -0.125 MA5 / MA20 / MA60 约 12.79 / 11.98 / 12.87 近20日高 / 低 约 13.55 / 11.12 市盈率五十多倍，在化学制药公开对照里也不算「捡漏标签」；市净率靠近四倍，高毛利能解释一部分，解释不了「已经便宜」。融券余额公开口径很小，融资大约一个多亿量级——空头很薄，别幻想轧空剧本。 图上：从十一块附近抽到十三块半 下面这张近半年走势，建议先看均线距离，再听奥壹新故事。 五日线大约12.79，二十日大约11.98，六十日大约12.87。收盘13.55，踩在五日和二十日上方，也压过六十日一线。MACD快线刚翻到信号线之上——金叉可以记，别神话。布林位置超过百分之百，意思很直白：价格已经挤到上轨外侧。 位置也很诚实。近二十日最高就是13.55，最低大约11.12；这根阳线更像从近端低点一带抽回来并摸到箱顶，而不是站在长期高位外侧疯狂加速。近一个月大约+14%，近三个月大约-10%，近半年大约-13%，近一年大约-38%：短线脉冲来了，中线回吐还没完全忘掉。更长维度最大回撤公开复权粗算能到八成上下，波动属性写在脸上。你要是只看这一根大阳线，很容易误判成「趋势回来了」；把时间轴拉开一点，更像深跌之后的情绪修复段。 我盯的两根线 一根是二十日线附近，大约 12.0。缩量踩住，还能当修复段的呼吸点；放量砸穿，短线结构要重新画。另一根是五日线到六十日那一带，大约 12.8–12.9——反弹如果只在这里晃一晃就趴下，更像情绪一日游。近端低点大约 11.12，若阳线后放量跌破，故事再好听也要让位给风控。十三块半附近，我不当做「逻辑兑现价」，只当做人气温度计。 群里两拨人，吵的根本不是同一件事 一拨人握着创新药词。利厄替尼进医保、信达帮忙推、后期管线还在III期门口——听起来像下一阶段收入结构要换血。他们会说：2025年利润已经修好一截，毛利率那么厚，负债那么低，板一下怎么了？口服创新药占比往上抬的句子，也常被拿来当理由。 另一拨人盯着中报和倍数。营收掉、利润掉、经营现金流掉得更凶，静态市盈率五十多倍，布林还在上轨外侧——这种账，老股民看得很烦。他们会问：商业化初期最怕什么？怕费用先抬、销量后到；怕竞品三代TKI把份额切走；怕目标价写在二十一，报表停在「仍在爬坡」。近一年从二十三块附近摔下来的那截记忆，也还没散干净。 我站哪边？两边的事实我都认，买卖上我偏后者的纪律。主题可以跟踪，近涨停价不适合当成「逻辑兑现价」。人气第47只说明今天讨论密度够写一篇，不说明明天还有人接。说白了，我更愿意等价格把情绪吐一点，或者等下一份季报把创新药收入口径和经营现金流再确认一次。 还有个细节容易被刷屏冲掉：控股结构相对稳，真正进出的是主题资金和短线情绪。结构稳不等于股价稳。创新药票吃的就是预期差——预期加速时弹性大，预期落空时回撤也大。五年级别那种深回撤，不是吓唬人，是提醒你仓位别按「稳健白马」去配。 临收盘，我给自己留的几条 阳线后两三日，我先看换手是降温还是越热越危险。然后盯 12.0 附近二十日线有没有量能陪伴；再看 11.12 丢不丢，丢了就先把仓位故事放下。季报出来时，重点翻营收是否止跌、扣非、经营现金流、创新药收入或占比——最好是能核对的数字，而不是只剩临床PPT。利厄替尼跟信达的合作落地，能不能在渠道铺货和医院准入上看出痕迹，这一条我宁可等，也不愿提前写进买入理由。人气若从四十多名快速掉出八十名开外，讨论密度会自己降温，别意外。 药柜玻璃门上的反光是真的，医保目录是真的，近涨停也是真的。三样真叠在一起，最容易让人忘记第四样也是真的：半年度账本还凉，位置并不便宜。我把奥赛康放进创新药观察池，而不是放进「今天必须按13.55动手」的篮子。假若后面真能走出销量爬坡、现金流回暖、站稳均线的组合，那是下一篇复盘的事；今天这根阳线，我只当它把话题送到桌面上。你要是也在看它，不妨先问自己一句：买的是放量数字，还是买的是人气噪声？答案清楚了，仓位才好下手。 （本文基于公开资料整理，仅供研究复盘，不构成投资建议。市场有风险，决策需独立判断。）