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Issued on behalf of Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) NEW YORK and TORONTO, July 21, 2026 /PRNewswire/ -- USA News Group - News Commentary - Depression remains one of the most stubborn problems in modern medicine, and the numbers behind it are staggering. Tens of millions of adults live with major depressive disorder, and the majority never reach full remission on the first medication they try. That persistent treatment gap has drawn a wave of biotech and pharmaceutical companies into what is now one of the most closely watched races in interventional psychiatry, each pursuing a different way to reach patients that current antidepressants leave behind. This week brought a notable step forward. A late-stage program aimed at treating patients whose depression does not respond adequately to standard antidepressants reached a key operational milestone ahead of its own timeline, and it did so against a backdrop of accelerating adoption of clinic-administered mental health treatments across the sector. Key Takeaways Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) completed enrollment in its Phase 3 APPROACH study of HLP003 in major depressive disorder ahead of schedule, with topline data on track for the fourth quarter of 2026. The broader field is heating up, with Compass Pathways (NASDAQ: CMPS), GH Research (NASDAQ: GHRS), Definium Therapeutics (NASDAQ: DFTX), and Johnson & Johnson (NYSE: JNJ) all advancing or commercializing novel approaches to difficult-to-treat depression. Enrollment Wrapped Early on a Closely Watched Depression Trial Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., announced that it has completed enrollment in APPROACH, the first pivotal Phase 3 study of its investigational drug HLP003 in patients living with major depressive disorder (MDD). According to the company, enrollment was finished ahead of schedule, which moves the program toward an expected topline data readout in the fourth quarter of 2026. Helus is a clinical-stage pharmaceutical company developing what it calls novel serotonergic agonists, or NSAs, a class of synthetic molecules designed to activate serotonin pathways believed to support neuroplasticity. HLP003, the company's lead candidate, is an investigational deuterated psilocin analogue that has already received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. That designation is intended to speed the development and review of drugs that show early promise against serious conditions, though it is not a guarantee of approval. The APPROACH study enrolled 223 participants with moderate to severe MDD, defined by a MADRS score of at least 24, who remain on a stable dose of antidepressant medication but continue to respond inadequately. Participants were randomized on a one-to-one basis to receive either HLP003 at 16 milligrams or placebo, with each arm evaluating a two-dose regimen given three weeks apart. The primary endpoint is the change from baseline in the Montgomery-Asberg Depression Rating Scale, or MADRS, at six weeks after the first dose compared with placebo, with a key secondary endpoint measuring the same scale at 12 weeks. "Completion of enrollment in APPROACH ahead of schedule demonstrates the focus, urgency and execution of our clinical team, investigators and study partners," said Eric So, Interim Chief Executive Officer of Helus Pharma. "With participant enrollment now complete, our focus turns to completing the study and preparing for topline data in Q4 2026." So added that the company believes the durability, remission rates, and overall profile shown in its earlier Phase 2 study support the potential of HLP003 to improve outcomes for patients with MDD, and pointed toward a potential FDA New Drug Application in 2028. As with any drug in development, those timelines depend on many variables and are not assured. Why the Adjunctive Angle Matters Current first-line antidepressants work for only a portion of MDD patients. For those who do not reach remission, FDA-approved adjunctive atypical antipsychotics can offer modest additional benefit, but their use is often limited by side effects such as weight gain, cardiometabolic problems, movement disorders, and sedation, which frequently lead patients to discontinue treatment. Helus frames HLP003 as a potential adjunctive intermittent option that could offer a more practical real-world solution, layered on top of a patient's existing antidepressant rather than replacing it. The company has pointed to its Phase 2 data as the basis for that optimism. In that earlier study, Helus reported a mean reduction of roughly 23 points on the MADRS scale from baseline at 12 months following two 16-milligram doses administered three weeks apart, along with high response and remission rates. Phase 2 findings, however, are a signal rather than proof, and results in a larger, placebo-controlled Phase 3 setting can differ materially. "The early completion of enrollment in APPROACH brings us closer to determining whether HLP003 can provide a durable clinical benefit within a practical adjunctive treatment model for people with MDD," said Amir Inamdar, Chief Medical Officer of Helus Pharma. Enrollment is continuing in EMBRACE, the second pivotal study in the company's Phase 3 PARADIGM Program. Eligible participants from both APPROACH and EMBRACE may roll over into EXTEND, a long-term extension study designed to further evaluate safety, durability of clinical effect, and the potential role of redosing. Beyond its clinical work, Helus has built an intellectual property portfolio with more than 350 patent applications filed and over 100 patents granted worldwide. A Market That Keeps Expanding The milestone arrives as demand for innovative, clinic-administered depression treatments continues to build. Helus noted that Johnson & Johnson reported worldwide SPRAVATO sales of US$584 million in the second quarter of 2026, up roughly 25% from the prior quarter and about 40.8% from the same period a year earlier. While HLP003 and SPRAVATO are distinct treatments with different mechanisms and development pathways, the company sees that continued growth as evidence of significant patient and provider demand for new approaches to depression. Helus also emphasized that the APPROACH study and the broader PARADIGM Program were designed around key considerations in the FDA's recently finalized guidance for this class of therapies, including rigorous placebo-controlled evaluation, measures to support the interpretability of results, assessment of outcomes beyond the primary endpoint, defined safety monitoring, and the collection of longer-term safety and durability data through EXTEND. Track the Signals Before the Crowd The best positioning happens before the crowd catches on. Eagle Eye is a real-time investor signal-intelligence platform that surfaces sentiment shifts, news flow, and trending tickers as they form, so you see attention building instead of chasing it. Watch it live at eagle-eye.dev. The Broader Field of Depression Innovators Helus is one of several companies pushing to redefine how difficult-to-treat depression is managed. A cluster of peers, each at a different stage and with a different mechanism, has helped turn interventional psychiatry into one of biotech's more active corners in 2026. Compass Pathways (NASDAQ: CMPS) Compass Pathways has moved to the front of the psilocybin field with its COMP360 program for treatment-resistant depression. In July 2026, the company reported 26-week results from the second of its two pivotal Phase 3 trials, COMP006, involving nearly 600 patients, confirming what it described as a rapid-onset and durable profile. Compass said 39% of participants in the 25-milligram arm achieved a clinically meaningful reduction in depression scores by week six and, on average, maintained benefit through at least week 26. The company has a rolling New Drug Application underway with the FDA and has pointed to a potential U.S. launch in 2027, subject to regulatory approval. GH Research (NASDAQ: GHRS) GH Research is developing GH001, an inhaled formulation of mebufotenin, also known as 5-MeO-DMT, for treatment-resistant depression. In March 2026, the company announced that the primary results from its Phase 2b trial had been published in JAMA Psychiatry, reporting a MADRS reduction of 15.5 points from baseline at the study's primary endpoint. Earlier in the year, the FDA lifted a clinical hold on GH001, clearing the way for U.S. enrollment as the company works toward a global Phase 3 pivotal program that aims to replicate its Phase 2b design. GH Research's approach centers on a short in-clinic experience, a model it argues could fit more practically into real-world psychiatric care. Definium Therapeutics (NASDAQ: DFTX) Definium Therapeutics delivered one of the sector's standout results in June 2026, when its Phase 3 Emerge study of DT120, an orally disintegrating tablet, met its primary and all key secondary endpoints in major depressive disorder. The company reported that a single 100-microgram dose produced an 8.1-point placebo-adjusted improvement in MADRS total score at week six, with statistically significant results, and it has a second pivotal study, Ascend, underway. Notably, Helus itself referenced Definium's Emerge readout in its own materials, an acknowledgment of how directly the two programs speak to the same major depressive disorder opportunity. Johnson & Johnson (NYSE: JNJ) Johnson & Johnson represents the commercial reality that newer entrants are chasing. Its SPRAVATO, an esketamine nasal spray for treatment-resistant depression and depressive symptoms, has become a bellwether for how quickly clinic-administered depression treatments can scale. The company reported worldwide SPRAVATO sales of US$584 million in the second quarter of 2026, including US$514 million in the United States, up roughly 25% from the prior quarter. For clinical-stage developers like Helus, that trajectory is often cited as evidence that patients, providers, and payers are increasingly willing to adopt novel, supervised treatments for depression, even as each individual program must still prove itself on its own data. A Sector Approaching Its Proof Points What ties these companies together is timing. Several of the most closely watched depression programs are converging on major data readouts and regulatory decisions over the next 12 to 24 months, and the FDA's recently finalized guidance has given the field a clearer framework to work within. For Helus, finishing APPROACH enrollment early removes one variable from a long and uncertain path, and turns attention to the topline data expected in the fourth quarter of 2026, which will offer the first pivotal-stage look at whether HLP003 can back up the promise of its earlier results. For a sector that has spent years building its case, the coming quarters are shaping up to be where the science meets the scoreboard. CONTACT: USA News Group [email protected] Article Source: [1] Helus Pharma, "Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule," press release, July 21, 2026. DISCLAIMER Nothing in this publication should be considered personalized financial advice. We are not licensed under securities laws to address your particular financial situation, and no communication from us should be deemed personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor a recommendation to buy or sell any security. We hold no investment licenses and are neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group, which is wholly owned and operated by Market Equities Limited ("MEL"). MEL has been paid a fee for Helus Pharma advertising and digital media from Creative Direct Marketing Group ("CDMG"). MEL also expects to receive further compensation as part of an ongoing digital media effort to increase visibility for the company. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged not to use this publication as the basis for any investment decision. The content in this article has been reviewed and approved on behalf of Helus Pharma by CDMG. MEL and its owner/operators do not own any shares of Helus Pharma, but reserve the right to buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing, in the open market, through private placements, and/or through other investment vehicles. There may also be third parties who hold shares of Helus Pharma and may liquidate their shares, which could have a negative effect on the price of the stock. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in this publication is not trustworthy unless verified by their own independent research. Because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may lose some or all of your investment. Cautionary Note Regarding Clinical Results. Statements regarding HLP003 and the APPROACH, EMBRACE, and EXTEND studies refer to an investigational drug candidate that has not been approved by the FDA or any other regulatory authority. Breakthrough Therapy Designation does not constitute approval and does not guarantee that HLP003 will ever be approved or marketed. The Phase 2 data referenced, including the reported MADRS reduction and response and remission rates, reflect earlier-stage findings and are not proof of efficacy; results from a larger, placebo-controlled Phase 3 study may differ materially. Completion of enrollment does not indicate the outcome of the trial. Drug development is lengthy, expensive, and uncertain, and there is no assurance that stated timelines, including the anticipated Q4 2026 topline readout or a potential 2028 New Drug Application, will be met. Cautionary Note Regarding Peer Companies. References to Compass Pathways, GH Research, Definium Therapeutics, Johnson & Johnson, and any of their respective products or clinical programs are for comparative and illustrative context only. Helus Pharma is not a party to, and is not affiliated with, the studies, products, or corporate transactions of those companies, and nothing in this article should be interpreted as implying any partnership, endorsement, or that Helus Pharma is the subject of any acquisition, merger, or similar transaction. Each company's programs carry their own independent risks and must be evaluated on their own data. Neither Cboe Canada nor the Nasdaq Global Market has approved or disapproved the contents of this article. This article contains forward-looking statements that involve risks and uncertainties. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made. SOURCE USA News Group 21% more press release views with Request a Demo

2026年过半，强生交出了一份近乎“压线冲刺”的成绩单：上半年总营收493.72亿美元，同比增长8.2%，距离年初设定的千亿美元目标仅剩一步之遥。但比数字更值得玩味的，是增长背后的结构逻辑——肿瘤板块以近20%的增速领跑，Carvykti、IL-23单抗Tremfya、双抗组合三大产品线分别交出55%、71%和70%的爆发式增长。这不再是传统巨头“大象起舞”的匀速叙事，而是一场由精准治疗、免疫赛道重构和多抗技术平台共同驱动的增长裂变。 表2026H1强生核心业务数据 肿瘤“铁三角”成型 2026年上半年，强生创新制药六大细分板块中，肿瘤业务以19.9%的超高增速领跑，创收143.79亿美元，成为唯一实现高双位数增长的核心赛道，彻底扛起集团创新增长大旗。当前强生肿瘤板块已形成“单抗基石、CAR-T提速、双抗补位”的铁三角格局，层级清晰、优势互补，完美覆盖血液瘤与实体瘤、后线难治与前线初治全场景，成为支撑整体增速的核心支柱，有效对冲了自免、代谢板块的业绩下滑压力。 作为基石大单品，Darzalex（达雷妥尤单抗）持续展现超长生命周期韧性，上半年收入81.71亿美元，同比增幅高达20.6%，再度验证其不可替代的市场地位。在多发性骨髓瘤治疗体系中，Darzalex早已突破传统后线治疗局限，全面渗透一线诱导、巩固、维持全治疗周期，凭借成熟的循证医学证据、完善的真实世界数据、优异的安全性可控性，成为全球骨髓瘤治疗的黄金标准。即便面临全球生物类似药逐步落地的行业压力，其凭借全线序适应症布局、医患处方惯性、联合治疗方案的持续迭代，依旧实现稳健双位数增长，成为强生肿瘤业务最稳固的现金流压舱石。 CAR-T产品Carvykti（西达基奥仑赛）则成为高增长核心变量，上半年销售额12.54亿美元，同比大幅增长55.1%，增速持续领跑全球细胞治疗赛道。其高速增长的核心驱动力来自两大维度：一是产能瓶颈持续解除，规模化生产能力落地，有效解决早期商业化供给不足的痛点；二是适应症持续拓展，从重度难治后线患者逐步向前线治疗渗透，大幅拓宽用药人群与市场空间。相较于竞品Abecma，Carvykti凭借更优的深度缓解率、更长的生存期获益、更低的复发风险，实现持续市场份额分化，稳固全球Best-in-class地位，成为细胞治疗赛道的标杆产品。 与此同时，强生双抗军团正式进入规模化收获期，Tecvayli、Talvey、Rybrevant三款产品合计创收13.34亿美元，较去年同期8.29亿美元大幅增长超60%，其中Talvey与Rybrevant增速更是突破70%。双抗的崛起具备极强的战略意义，精准填补了CAR-T疗法的临床短板。CAR-T疗效优异但存在制备周期长、成本高昂、患者适配门槛高、仅能覆盖血液瘤的局限，而强生双抗均为现货型、可及性高、成本可控，同时覆盖血液瘤与肺癌等实体瘤赛道，实现难治性肿瘤治疗场景的全覆盖。现货型双抗与定制化CAR-T形成高低搭配、场景互补的产品矩阵，让强生在肿瘤免疫赛道形成独家平台优势。整体来看，肿瘤板块近20%的高增速具备可持续性，足以抵消自免、代谢板块的阶段性收缩，成为集团业绩增长的核心压舱石。自免与神经科学“攻守道” 相较于肿瘤赛道的高增态势，强生自免板块呈现明显的结构性分化，整体收入72.24亿美元，同比下滑6.2%，凸显成熟赛道迭代阵痛。传统王牌产品Stelara（乌司奴单抗）受专利到期、生物类似药冲击影响持续萎缩，带动板块整体收缩，但旗下IL-23重磅单抗Tremfya（古塞奇尤单抗）实现逆势狂飙，上半年收入36.54亿美元，同比增速高达70.6%，以一己之力撑起自免板块基本盘，形成“独木成林”的增长格局。 Tremfya的高速增长，本质是靶点迭代与临床替代的双重结果。随着临床循证数据持续丰富，IL-23靶点相较于传统IL-12/IL-23双靶点疗法，展现出更强的特异性、更长的长效性与更优的安全性，在中重度银屑病、克罗恩病、溃疡性结肠炎等适应症中，持续替代Stelara及传统TNF-α抑制剂。面对生物类似药的行业冲击，Tremfya凭借差异化靶点机制、长效给药优势、持续拓展的新适应症、丰富的长期真实世界数据，构建起稳固的产品壁垒，有效对冲老品专利到期的下滑压力，成为强生自免赛道的全新增长核心。 神经科学赛道则交出超预期答卷，成为集团第二增长曲线。核心产品Spravato（艾司氯胺酮鼻喷雾剂）上半年销售额突破10亿美元，达10.52亿美元，同比增长43.2%，持续高速放量。作为难治性抑郁症领域的差异化创新产品，Spravato最大的临床优势在于**快速起效**，突破了传统抗抑郁药起效慢、重度患者应答率低的治疗瓶颈，为难治性抑郁症患者提供全新治疗方案。随着全球医保覆盖范围持续扩大、临床指南地位提升、真实世界疗效数据不断积累，临床医生处方认知与患者接受度持续提高，产品放量节奏进一步加快，成为神经科学板块45.12亿美元营收（同比+22.0%）的核心驱动力。 综合来看，强生当前正处于典型的产品迭代阵痛期：自免老品、代谢板块老产品持续退潮，带动相关板块分别下滑6.2%、9.2%，而Tremfya、Spravato等新品种已完成临床验证，进入高速放量周期。未来两年是业绩承接的关键窗口期，2027年前两款核心新品能否持续扩容、完全对冲老品下滑缺口，将直接决定强生创新制药板块的增长韧性，也是其能否稳固千亿营收底盘的核心变量。千亿预期上调背后的隐忧与底气 本次强生小幅上调全年营收预期，看似幅度有限，却释放出管理层对下半年业绩的充足信心。上调逻辑主要依托两大确定性支撑：其一，Carvykti细胞治疗产能持续释放，前线适应症渗透加速，有望延续高增速；其二，秋冬季节呼吸道疾病高发，带动相关抗感染、呼吸产品季节性放量，叠加各创新产品商业化节奏提速，下半年业绩确定性进一步增强。但在千亿营收规模背后，强生依旧面临多重行业与产业风险，长期增长并非毫无隐忧。 风险层面，首先是经典大单品的专利悬崖压力，Darzalex欧美地区专利保护逐步到期，未来两年将持续面临生物类似药冲击，存在增速放缓、价格承压的风险；其次，Carvykti等细胞治疗产品仍未摆脱行业共性难题，生产成本偏高、医保支付门槛严格、商业化可及性受限，长期放量存在天花板；此外，双抗赛道热度持续攀升，罗氏、辉瑞等巨头持续布局同类产品，未来赛道内卷加剧，强生双抗军团的先发优势将逐步弱化。多重风险叠加，意味着强生单纯依靠单品放量的规模增长模式已接近瓶颈。 而支撑强生穿越周期、完成长期增长的核心底气，在于其从“规模扩张”向“技术平台驱动”的底层转型。一方面，医疗科技板块持续稳健增长，上半年同比增长6.0%，以器械、介入设备、手术机器人为核心的业务矩阵持续稳定输血，为创新药研发、管线并购提供充足现金流，形成“器械养药、新药迭代”的良性循环；另一方面，创新制药业务毛利率持续优化，产品结构升级带动盈利质量稳步提升，盈利能力持续改善。更关键的是，强生已搭建起成熟的**细胞治疗、双抗、自免新靶点**三大技术平台，并非依赖单一爆款。其多抗平台在肺癌围手术期治疗、难治性血液瘤领域的临床突破，有望在2027年后打开全新增长空间，构筑第二成长曲线。 最后 半年逼近500亿营收、上调全年千亿预期，强生的亮眼业绩绝非偶然，而是肿瘤、自免、神经科学三大赛道完成结构性迭代的必然结果。Darzalex、Carvykti、双抗军团构筑肿瘤铁三角，扛起增长大旗；Tremfya、Spravato实现新旧动能切换，对冲板块下滑压力；稳健的医疗科技底盘与平台化技术布局，筑牢长期发展壁垒。对于强生而言，千亿营收只是阶段性结果，真正的核心价值在于其完成了从“老品放量的规模叙事”到“平台驱动的技术叙事”的战略升级。在药企普遍面临专利悬崖、赛道内卷的当下，这种持续迭代、自我革新的能力，才是跨国巨头穿越行业周期、维持长期竞争力的核心密码。 信息来源：强生公司官网 立即扫码加入药事纵横交流群