Zasocitinib

Graham Heap, MD, PhD, formerly Vice President and Program Leader for Takeda's global TYK2 immunology franchise, appointed President, Research and Development Also appointed: Ezequiel Neimark, MD, Head of Clinical Development; Taylor Spector, PhD, Head of Medical Affairs; Scott Stirn, DSc, Head of CMC cAMPfield Therapeutics is advancing prifemilast, a once-daily oral PDE4 inhibitor, for the treatment of inflammatory bowel disease (IBD) into global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn's disease SAN DIEGO, Aug. 3, 2026 /PRNewswire/ -- cAMPfield Therapeutics, Inc. (cAMPfield), a clinical-stage biopharmaceutical company formed to develop well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, today announced key executive appointments to its senior leadership team. Continue Reading Graham Heap Graham Heap, MD, PhD joins as President, Research and Development (R&D), with responsibility for leading all the Company's research and development activities. Ezequiel Neimark, MD joins as Head of Clinical Development and will lead clinical execution for the prifemilast program in ulcerative colitis (UC) and Crohn's disease (CD). Taylor Spector, PhD joins as Head of Medical Affairs and will lead medical strategy, evidence generation, scientific communications, and external engagement. Scott Stirn, DSc joins as Head of Chemistry, Manufacturing, and Controls (CMC) and will lead drug substance and drug product development, manufacturing scale-up, analytical development, and clinical supply of prifemilast. These appointments deepen cAMPfield's leadership bench as the company advances prifemilast, a potentially best-in-class once-daily oral PDE4 inhibitor, into global Phase 2 trials in moderate-to-severe UC and CD. "Building a world-class leadership team with a proven track record of developing therapies for immune-mediated diseases is critical to our success," said Bill Gerhart, Chief Executive Officer of cAMPfield. "Graham, Ezequiel, Taylor, and Scott each bring deep expertise in inflammatory disease drug development and share our passionate belief that patients with IBD need better oral treatment options. Their considerable experience and leadership will be instrumental as we advance prifemilast through global Phase 2 development and position cAMPfield as a leader in IBD." "The treatment landscape for IBD continues to evolve, yet many patients still do not achieve durable disease control with existing therapies," said Dr. Heap. "I've long believed the potential of the PDE4 pathway has been underappreciated in IBD. Prifemilast combines a differentiated mechanism with encouraging clinical data, and I believe it can become an important new oral treatment option for patients with IBD. I look forward to working with the team to advance its development and to help build a broader pipeline beyond it." In addition to these appointments, cAMPfield's leadership team includes other accomplished executives building the company's technical, operational, clinical, and regulatory foundation. Patricia Turney, MBA, Chief Technical Officer, leads technical operations and manufacturing, bringing prior experience from Acelyrin, Arcutis, and Amgen. John Kempen, MS, Senior Vice President of Clinical Development Operations, oversees clinical execution for the prifemilast program, drawing on prior experience from Gossamer Bio, Receptos/Celgene, Ardea Biosciences/AstraZeneca, Allergan, PPD, and ICON. Rita Shah, PharmD, Vice President of Regulatory Affairs, directs the company's global regulatory strategy, leveraging prior experience from Vertex Pharmaceuticals, MBX Biosciences, AstraZeneca, and Johnson & Johnson. Biographies Graham Heap, MD, PhD – President, R&D A physician-scientist with an academic foundation in IBD and extensive development experience across gastroenterology, dermatology and rheumatology, Dr. Heap brings broad leadership expertise advancing therapies for immune-mediated diseases. Most recently, he served as Vice President and Program Leader for Takeda's global TYK2 immunology franchise, leading a large global cross-functional organization responsible for the strategy and execution of a late-stage development portfolio spanning six immune-mediated disease indications. He led zasocitinib from program integration through Phase 2 and Phase 3 readouts, including head-to-head trials against multiple comparators, while expanding the portfolio into five additional indications in Phase 2 or Phase 3 development. Prior to Takeda, Dr. Heap advanced multiple immunology and UC development programs at AbbVie, including risankizumab and ravagalimab. He earned his MBBS from St. George's, University of London and his PhD from Barts and The London School of Medicine and Dentistry. Ezequiel Neimark, MD – Vice President, Head of Clinical Development During more than a decade at AbbVie, Dr. Neimark held senior development leadership roles across gastroenterology, dermatology, and rheumatology and contributed to multiple pivotal IBD programs with adalimumab and risankizumab. He most recently served as Head of Asset/Indication for Skyrizi®, Humira®, ABBV-547, and ABBV-423, and is a physician-scientist trained in gastroenterology and hepatology. Taylor Spector, PhD – Executive Director, Head of Medical Affairs Dr. Spector brings nearly 15 years of Medical Affairs experience across all stages of the product lifecycle advancing programs in immune-mediated inflammatory diseases. Most recently she served as Global Medical Lead for Takeda's TYK2 program in Dermatology. Previously, she held Medical Affairs and Commercial leadership roles at Sobi, Alexion Pharmaceuticals, Sage Therapeutics, Amarin, and AstraZeneca. Scott Stirn, DSc – Executive Director, Head of CMC Dr. Stirn brings over two decades of experience advancing the product development and manufacturing of small molecules, peptides, and biologics from discovery through clinical development. Most recently, as Director and Head of Early Phase Product Development at Neurocrine Biosciences, he served as a global program and CMC lead across multiple small-molecule, peptide, and gene therapy programs, and contributed to the CMC regulatory filings supporting approved therapies including Ingrezza® (valbenazine) and Crenessity® (crinecerfont). Earlier in his career, he led formulation and product development efforts at Pharmatek, Celgene, and Arena Pharmaceuticals, spanning oral and injectable programs—including the development of lorcaserin (Belviq®) and S1P receptor modulator assets. About Inflammatory Bowel Disease Inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, is a chronic immune-mediated inflammatory disease that affects more than 2.4 million people in the United States and remains an area of substantial unmet medical need. Despite significant advances in treatment, many patients fail to achieve durable remission or lose response over time, resulting in frequent treatment switching. While biologic therapies have transformed outcomes for many patients, there remains a need for additional effective, well-tolerated treatment options. Convenient oral therapies are an important part of the treatment landscape, yet currently approved oral agents for IBD are limited by tolerability, safety concerns and/or modest efficacy. About Prifemilast Prifemilast is an investigational, once-daily, PDE4B-selective inhibitor that has been studied in more than 700 participants to date, including more than 250 participants treated for up to 52 weeks. Prifemilast preferentially inhibits PDE4B, the isoform most closely associated with anti-inflammatory activity, while minimizing inhibition of PDE4D, an isoform associated with dose-limiting adverse effects. Across clinical studies, prifemilast has been well tolerated, with treatment discontinuation rates comparable to placebo, and with demonstrated efficacy thus far in Phase 3 clinical trials in plaque psoriasis. About cAMPfield Therapeutics cAMPfield Therapeutics is a clinical-stage biopharmaceutical company focused on developing well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, including inflammatory bowel disease. cAMPfield was founded by Mountainfield Venture Partners in partnership with executives who played key roles in the development and/or commercialization of Entyvio®, Humira®, Otezla®, and Zeposia®. cAMPfield holds exclusive global development and commercialization rights to prifemilast outside Greater China through a license agreement with Newsoara Biopharma Co., Ltd. The company is headquartered in San Diego, California. For more information, visit . Media and Investor Contact Rayne Rodgers [email protected] cAMPfield Therapeutics All third-party product names, company names, and logos are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them. 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iStock, Phiwath Jittamas Orzeyful is the first orexin agonist cleared by the FDA, and is the first narcolepsy therapy that addresses the full host of disease symptoms. It is “likely to reshape the treatment paradigm” for the condition, Jefferies told investors. The FDA has signed off on Takeda’s oveporexton for the treatment of narcolepsy type 1. The drug will carry the brand name Orzeyful and will be available later this year after the scheduling process with the U.S. Drug Enforcement Administration. Orzeyful is the first orexin receptor 2 agonist to make it to the market, and is also the first drug indicated to address the full range of manifestations of narcolepsy type 1 (NT1) rather than its individual symptoms, according to the FDA’s Wednesday announcement of the approval. “To us, this is the first mechanistically differentiated entrant into a sleep base already contending with once-nightly Lumryz and Wakix, and the FDA’s framing of NT1 as ‘a complete disorder’ rather than a symptom cluster is the more consequential piece,” Truist Securities wrote to investors on Thursday morning. The firm’s analysts noted, however, that Orzeyful is approved only for adults. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Orzeyful’s approval suggests that “restoration of orexin signaling is likely to reshape the treatment paradigm,” Jefferies told investors in a Wednesday note, pointing to the drug’s efficacy numbers. The Phase 3 pivotal FirstLight and RadiantLight trials showed significant improvements over placebo in areas including cataplexy (sudden muscle weakness) and quality of life. Neuroscience Takeda Establishes Lead in Narcolepsy Race With Back-to-Back Phase III Wins Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts. July 14, 2025 · 2 min read · Tristan Manalac Read more Wakefulness, as measured by the Epworth Sleepiness Scale, was also significantly better in patients treated with Orzeyful, with scores improving by up to 9.8 points versus placebo, according to the drug’s label . These figures bring patients “close to the normal range,” according to Jefferies. Orzeyful’s performance, the firm continued, compares “favorably with currently available narcolepsy therapies.” While Jefferies didn’t name a specific Orzeyful competitor, another FDA-approved drug in the space is Harmony Biosciences’ daily pill Wakix. That drug’s label lists Epworth Sleepiness Scale score improvements of up to 3.1 points relative to placebo. Wakix brought in $261.3 million in the second quarter, a 30% year-on-year increase, Harmony announced Tuesday. Aside from its efficacy edge, which Jefferies said is the key differentiator of Orzeyful, Takeda’s drug also has a “manageable abuse potential,” the firm noted, suggesting that it is likely to get a Schedule IV designation, one of the DEA’s most lenient classifications. “If confirmed, this would represent a less restrictive scheduling category” than other narcolepsy drugs, Jefferies added, and “could modestly support physician adoption and market access.” Orzeyful’s approval is a victory for Takeda, which has tapped the drug as one of three crucial product launches as it enters what new CEO Julie Kim called a “ year of transition .” The two other assets are Protaganist-partnered polycythemia vera candidate rusfertide, which is under FDA review with a target decision date in the third quarter of the calendar year, plus the psoriasis pill zasocitinib, for which an application is slated to occur in Takeda’s current fiscal year. Business Takeda enters transitional year as new CEO seeks return to growth For the 2026 fiscal year, Takeda anticipates declines in revenue and profit, highlighting what CEO-elect Julie Kim says is the need for the company to “invest in future growth.” June 24, 2026 · 2 min read · Tristan Manalac Read more