Articles from Click Therapeutics, Inc.

NEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Click Therapeutics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (marketing authorization) for Motivista, a prescription digital therapeutic (PDT) indicated for the treatment of negative symptoms of schizophrenia, as an adjunct to clinician-managed outpatient care, including antipsychotic therapy in patients 18 years of age and older with clinically stable positive symptoms. Motivista is the first FDA-authorized treatment indicated specifically for the treatment of negative symptoms of schizophrenia in the United States.

Click Therapeutics, Inc., (“Click”) a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company’s prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product’s FDA premarket review.

Click Therapeutics, Inc. (“Click”), a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has launched an updated brand identity and new website to reflect the company’s evolution and vision for the future of medicine. This brand update follows a year of significant successes for Click including the FDA clearance of the first prescription digital therapeutic for the adjunctive treatment of major depressive disorder symptoms, the successful outcome of the CT-132 pivotal study for the preventive treatment of episodic migraine, the launch of a new product offering, Click SE™, and a completed Series C financing, with the investment round led by Dassault Systèmes and Medidata.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, announced the launch of Software-Enhanced Drug™ therapies, part of a new product offering called Click SE™. With this launch, Click Therapeutics is pioneering a new prescription digital therapeutic product category in response to increasing interest in U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS).

David Benshoof Klein, founder and chief executive officer of Click Therapeutics, has been honored as a PharmaVoice 100 winner. The annual list recognizes the most inspiring people in the life sciences industry.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced meeting the primary endpoint in the pivotal randomized, double-blind, controlled, decentralized, study of CT-132 for the preventive treatment of migraine, ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900).

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced plans to accelerate its development initiatives in obesity and cardiometabolic disease through the acquisition of the assets of Better Therapeutics, Inc. The assets acquired include AspyreRx (BT-001), the first FDA-authorized prescription digital therapeutic for type 2 diabetes, and BT-004, which was recently granted FDA Breakthrough Device Designation for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Other assets are BT-002, for the reduction of blood pressure in patients with hypertension, and BT-003, for the reduction of LDL cholesterol in patients with hyperlipidemia. This acquisition strengthens Click’s portfolio of innovative digital treatments for patients by immediately advancing its pipeline in obesity, diabetes and cardiometabolic diseases, complementing existing assets in psychiatry, CNS and pain disorders.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that the investigational CT-155 prescription digital therapeutic (PDT), co-developed by Boehringer Ingelheim and Click Therapeutics, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). CT-155 is a novel software accessible on mobile devices that is being studied for use adjunctive to standard of care pharmaceutical therapy and is designed to treat the negative symptoms of schizophrenia. It is one of multiple digital therapeutics under joint-development by the companies for the treatment of schizophrenia.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that David Benshoof Klein, Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11th at 10:00 am PST.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will participate in the following investor conferences this month.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has closed on a $20 million term loan from HSBC Innovation Banking, a division of HSBC Bank USA, N.A. The term loan was partially drawn at closing, with the proceeds used to retire Click’s previous term loan. The undrawn balance remains fully available to help advance Click’s prescription digital therapeutic pipeline.

Click Therapeutics today announced the execution of a new collaboration agreement with Indivior for the development and commercialization of prescription digital therapeutics to treat substance use disorders, beginning with Opioid Use Disorder (OUD). Through a novel mobile application, CT-102, the collaboration aims to help close major gaps in OUD treatment, such as access to high-quality, personalized psychosocial treatment.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that company management will participate in the following investor events this month.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the launch of its second active randomized clinical trial in migraine, ReMMiD-C, Reduction in Monthly Migraine Days-CGRP study, a fully remote and decentralized trial designed to investigate the efficacy and safety of digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine currently receiving Calcitonin-Gene-Related Peptide (CGRP) inhibitor therapy. Click also recently launched the ReMMi-D study, a phase 3 pivotal registration study in approximately 558 patients, in March (NCT05853900). To execute this latest fully remote trial, Click has selected Syneos Health® (Nasdaq:SYNH), a leading fully integrated biopharmaceutical solutions organization.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the CONVOKE Study, a registrational clinical trial to investigate the use of prescription digital therapeutics as an adjunct treatment to standard of care antipsychotic therapy to treat the negative symptoms of schizophrenia in patients 18 years and older. The pivotal, randomized, multi-site trial will enroll approximately 432 patients nationwide. The study intervention period will be 16 weeks and efficacy will be assessed by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure scale (CAINS-MAP). The CAINS-MAP measures experiential negative symptoms, the clinical target of interest in the evaluation of efficacy in this study. The CAINS was developed and validated with National Institute of Mental Health (NIMH) funding in response to the limitations of existing treatment and assessment approaches to negative symptoms identified at the NIMH-MATRICS Consensus conference in 2005.1

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the ReMMi-D, Reduction in Monthly Migraine Days study, a fully remote and decentralized pivotal trial designed to investigate the efficacy and safety of prescription digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the 22nd Annual Needham Virtual Healthcare Conference on Monday, April 17, 2023 at 2:15 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that company management will participate in two investor conferences this month.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today shared multiple accomplishments and advances in its research and development (R&D) programs. Over the past year, Click has broadened and accelerated its digital therapeutic R&D programs, supporting initiation or completion of 10 clinical trials across 9 therapeutic areas including neurology, oncology, inflammatory disease and serious mental illness. In sum, Click has enrolled more than 1,000 patients in early and late stage studies. Click’s R&D efforts represent a continued commitment to building prescription digital therapeutics that integrate clinical science with patient-centric design to build efficacious and engaging treatments in therapeutic areas with high unmet need, combined with the rigors of traditional therapeutic development. Highlights from the year include:

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132. Click’s CT-132 prescription digital therapeutic is under development as an adjunctive preventive treatment for episodic migraine in patients aged 18 years and older.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced their partnership with The Massachusetts Medical Society (“MMS”), a statewide professional association for physicians and medical students, supporting more than 25,000 members.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that company management will participate in the following investor conferences in November and December.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the following virtual investor conferences in September.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the Canaccord Genuity 42nd Annual Growth Conference on Thursday, August 11, 2022 at 12:30 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the H.C. Wainwright 1st Annual Mental Health Conference on Monday, June 27, 2022 at 11:00 a.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the Jefferies Healthcare Conference on Thursday, June 9, 2022 at 4:30 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the UBS Global Healthcare Conference on Wednesday, May 25, 2022 at 12:15 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has secured a $15 million term loan from Silicon Valley Bank. Proceeds from the financing were used in part to retire Click’s existing term loan facility with K2 HealthVentures (K2HV). The remaining proceeds supplement the company’s current equity capital and will be used to advance Click’s prescription digital therapeutic pipeline.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at Chardan’s Prescription Digital Therapeutics Summit on Monday, April 11, 2022 at 2:30 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the formation of a Scientific Advisory Board (SAB) comprised of an esteemed group of world-renowned healthcare and technology leaders who will help provide scientific guidance to the company as it expands its therapeutic area reach and continues to develop clinically validated, best in class digital therapeutic solutions.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that David Benshoof Klein, Co-Founder and CEO, and Randall Stanicky, Chief Financial Officer, will take part in the virtual BTIG Digital Health Forum on Monday, November 15, 2021. As part of the event, Mr. Klein will participate in a digital therapeutics panel discussion: “Setting the Pace: Commercializing Prescription Digital Therapeutics (PDTs) and Expanding the Pipeline” at 2 p.m. ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has closed a $52 million upsized Series B financing. The financing round was co-led by new investors H.I.G. BioHealth Partners (“H.I.G. BioHealth”) and Accelmed Partners II (“Accelmed”), with participation from Health Catalyst Capital, Revelation Partners, and a top biotechnology hedge fund, and from existing investors Sanofi Ventures, K2 HealthVentures, Hikma Ventures, and Ridgetop Health. Proceeds from the Series B financing will be used to accelerate the development and commercialization of Click’s internal prescription digital therapeutic pipeline and advance Click’s platform capabilities.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ solutions as medical treatments, today announced that David Benshoof Klein, founder and CEO, will participate in the Commercialization of Digital Therapeutics panel discussion at the Cowen 6th Annual FutureHealth Conference on Thursday, June 17, 2021 at 1:40pm ET.

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced three corporate governance additions to further position the organization for continued growth and advancing its mission to develop and commercialize software as treatments. Wall Street veteran Randall Stanicky has joined the company leadership as Chief Financial Officer; accomplished digital healthcare executive Lee Shapiro has joined the Board of Directors; and former biopharmaceutical executive Muzammil Mansuri, Ph.D. has expanded his role at Click through appointment as Board Chair.