Transcend Therapeutics announces completion of acquisition by Otsuka Pharmaceutical. June 12, 2026 NEW YORK, June 12, 2026 / PRNewswire/ - Transcend Therapeutics today announced the completion of its acquisition by Otsuka America Inc., a subsidiary of Otsuka Pharmaceutical Co., Ltd. (Otsuka), marking a significant milestone in Transcend's mission to develop rapid-acting treatments for neuropsychiatric diseases, including post-traumatic stress disorder (PTSD). The acquisition was originally announced on March 27, 2026. With the completion of the transaction, Transcend is now a wholly owned subsidiary of Otsuka America, Inc. "Today marks an important milestone for Transcend and people suffering from PTSD," said Blake Mandell, co-founder and CEO of Transcend Therapeutics. "In just a few years, our team advanced TSND-201 into Phase 3 clinical development. By joining Otsuka, this work will move forward with greater resources and reach. We are incredibly proud of what our team has accomplished and look forward to continuing this work together with Otsuka to bring meaningful new treatment options to patients in need." The acquisition follows a period of significant clinical and regulatory progress for Transcend. TSND-201, a rapid-acting neuroplastogen being developed by Transcend, demonstrated favorable results in IMPACT-1, its Phase 2 clinical trial, with results published in JAMA Psychiatry. In 2025, TSND-201 received FDA Breakthrough Therapy Designation for the PTSD indication, and earlier this year was awarded an FDA Commissioner's National Priority Voucher, recognizing the program's potential to address a significant unmet need in mental health. A Phase 3 trial with TSND-201 for the treatment of PTSD is currently ongoing. Since its founding in 2021, Transcend has focused on developing rapid-acting treatments for neuropsychiatric disorders, with the goal of addressing significant unmet needs for patients who have not benefited from existing therapies. "Transcend's innovative approach reflects Otsuka's legacy and commitment to addressing the significant unmet needs in mental health, including PTSD," said Tarek Rabah, president and CEO, Otsuka North America Pharmaceutical Business. "Together, we are well positioned to accelerate the development of new neuropsychiatric therapeutic options and bring meaningful innovation to patients." About TSND-201 TSND-201 (methylone) is a rapid-acting neuroplastogen developed by Transcend. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5-HT2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication. About Transcend Therapeutics Transcend, founded in 2021 and based in New York City, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Its medical-related business provides treatments and diagnostics for both physical and mental health. Its nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of its corporate philosophy: Otsuka-people creating new products for better health worldwide. www.otsuka.co.jp/en/.

FDA awards priority vouchers to 3 undisclosed companies for investigational psychedelics. April 24, 2026 | While the FDA did not announce the recipient names of the Commissioner's National Priority Vouchers, the agency's descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute. The FDA followed up President Donald Trump's April 18 executive order on Friday, awarding Commissioner's National Priority Vouchers to three companies developing psychedelic therapies. The FDA did not disclose the specific companies to receive Commissioner's National Priority Vouchers (CNPVs) in its Friday morning release and declined to comment on the record when contacted by BioSpace. However, it did say in its Friday release that the recipients are developing psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD) and methylone for post-traumatic stress disorder (PTSD). Shortly after the FDA announcement, Compass Pathways issued a press release announcing that it had received one of the vouchers for its psilocybin-based candidate COMP360 for TRD. The FDA also approved Compass' new drug rolling review request in post-traumatic stress disorder (PTSD). Meanwhile, the other two voucher recipients remain undisclosed, though a few companies match up with the agency's descriptions. Transcend Therapeutics, for example, is developing methylone-based TSND- 201 for PTSD. TSND-201 received the agency's Breakthrough Therapy designation in July 2025 - a requirement stated in the president's executive order for the three expected CNPVs. At the time, Transcend was in the process of initiating a Phase 3 trial. There's also Usona Institute, which received the FDA's Breakthrough Therapy designation in 2019 for its psilocybin-based candidate designed to treat MDD. Notably, none of the listed products match those in development at Definium Therapeutics, which was widely believed to be in the running for one of the priority review vouchers. Definium's lead candidate DT120 is a pharmaceutically optimized formulation of lysergide (LSD) D-tartrate in Phase 3 trials for MDD and generalized anxiety disorder. The company has an earlier-stage MDMA-based asset in Phase 2 development for autism spectrum disorder. A new executive order could usher in psychedelics as the "key next wave" of mental health therapies, according to analysts at RBC Capital Markets. April 20, 2026 Friday's update follows an executive order signed by Trump last Saturday morning in the Oval Office. The order, which is aimed at accelerating the development of and facilitating broader access to psychedelic therapies for serious mental health conditions, instructed the FDA to grant three CNPVs to psychedelics in development that also hold Breakthrough Therapy designation. The priority voucher program, announced in June 2025, aims to shorten review times for products that meet national priorities down to 1-2 months from the usual 10-12 months. "There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat," Tracy Beth Høeg, acting director of the FDA's Center for Drug Evaluation and Research (CDER), said in a statement on Friday. "At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today's actions." While the reaction to this new psychedelic therapies push has been largely positive, some experts have questioned, in particular, its origin. The executive order came about after Joe Rogan sent Trump information on the benefits of ibogaine - a particularly tricky psychedelic - for opioid use disorder, the pundit said during Saturday's signing. Rogan recalled Trump's response: "Sounds great. You want FDA approval, let's do it." Holly Fernandez Lynch, associate professor of Medical Ethics and Law at the University of Pennsylvania, pointed to this as a particular point of concern. "What Trump was saying around the executive order during the press conference was kind of mind blowing," she told BioSpace on Monday. "Like this idea that his buddies could just send him a text and he'll offer them FDA approval is not acceptable." In addition to the CNPVs, the FDA intends to release final guidance "imminently" to sponsors regarding the development of psychedelics. "Designing clinical trials to evaluate serotonin-2A agonists [a class to which psychedelics belong] and related products presents unique scientific and methodological challenges," according to the release. With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner's National Priority Vouchers this week, it's full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field? April 22, 2026