Corporate Events

Nxera Pharma Co., Ltd., Q2 2026 Earnings Call, Aug 07, 2026

Nxera Pharma Co., Ltd. announced that they will report Q2, 2026 results on Aug 07, 2026

Nxera Pharma Co., Ltd. - Special Call

Nxera Pharma Co., Ltd. announced that it has joined OpenFold, a non-profit AI research consortium that promotes the development of open-source AI software tools for biology and drug discovery. Technology companies, including Amazon Web Services, Microsoft and NVIDIA, participate in OpenFold as supporting members and the consortium has expanded into an international ecosystem comprising numerous pharmaceutical companies, biotechnology companies, technology companies and academic institutions, including Bristol Myers Squibb, Novo Nordisk, Bayer and Roche. OpenFold’s mission is provide researchers from academia and industry with access to powerful AI-enabled tools to create the medicines of tomorrow, to accelerate basic biological research, and bring new cures to market that would be impossible to discover without AI. Nxera’s participation in OpenFold is aligned with the Company’s policy to enhance R&D productivity and business efficiency through the use of AI technologies, as presented at the Company’s 36th Ordinary General Meeting of Shareholders held on 25 March 2026. Nxera’s proprietary NxWave platform combines the Company’s long-standing expertise in GPCR structure-based drug discovery, proprietary data, computational chemistry and AI-enabled approaches to advance drug discovery research. Through its participation in the OpenFold Consortium, Nxera aims to create synergies with Nxera’s AI-driven computational chemistry and quantum-inspired biophysical approaches to accelerate progress from target validation and discovery to clinical development with highly differentiated and optimized candidates, continuously use and evaluate state-of-the-art open-source structural prediction models, including OpenFold and OpenFold3-preview, conduct GPCR target-focused performance evaluations and benchmarking through its computational chemistry team, and contribute to future research and development directions through consortium governance meetings and receive technical support. Nxera is participating in the consortium as a user of its open-source tools and is not required to contribute any proprietary data or intellectual property to the consortium.

Nxera Pharma Co., Ltd. announced that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026. MFDS's ODD framework applies to medicines intended for diseases affecting fewer than 20,000 patients in South Korea, for diseases with no available alternative treatment, or for medicines that demonstrate significantly improved safety and efficacy compared with existing treatments. The GIFT designation is a priority review pathway introduced by MFDS in September 2022 to accelerate the regulatory review of innovative medicinal products targeting life-threatening or serious diseases, including rare diseases. Under the GIFT framework, the standard MFDS review timeline of 120 working days may be shortened to up to 90 working days through rolling review and close communication with reviewers, potentially helping accelerate patients access to innovative therapies in South Korea. Nxera believes that the GIFT designation for vamorolone will help accelerate access to this medicine for DMD patients in South Korea. About vamorolone: Vamorolone is a dissociative corticosteroid approved for the treatment of Duchenne muscular dystrophy (DMD). It binds selectively to the glucocorticoid receptor and triggers anti-inflammatory activity through inhibition of NF-?B-mediated gene transcription, while inducing reduced transactivation of other genes. Vamorolone is not a substrate for 11-ß-hydroxysteroid dehydrogenase (11ß-HSD) enzymes, which are involved in the local amplification of glucocorticoid activity in tissues and have been implicated in corticosteroid-associated toxicity. This pharmacological profile is the basis for its classification as a dissociative corticosteroid, designed to preserve anti-inflammatory efficacy while reducing the systemic effects associated with long-term conventional corticosteroid therapy. In the pivotal Phase 2b VISION-DMD study, vamorolone met its primary endpoint, demonstrating a statistically significant improvement in Time to Stand (TTSTAND) velocity versus placebo at 24 weeks (p = 0.002) [4]. The most commonly reported adverse reactions were cushingoid features, vomiting, weight increase, increased appetite, and irritability; most were mild to moderate in severity.

Nxera Pharma Co., Ltd. Presents at Jefferies Global Healthcare Conference 2026, Jun-03-2026 03:45 PM. Venue: Marriott Marquis, New York, New York, United States. Speakers: Christopher Cargill, Representative Executive Officer, President, CEO & Chairman.

Nxera Pharma Co., Ltd. announced that Dr. Patrik Foerch, Nxera’s Chief Scientific Officer and President of Nxera Pharma UK, has joined NewCo’s Board of Directors. Through this representation, Nxera will continue the work with NewCo under appropriate governance on development execution and key strategic decisions, with the joint aim of accelerating and maximizing the value of the program.

Nxera Pharma Co., Ltd. reported earnings results for the first quarter ended March 31, 2026. For the first quarter, the company reported sales was JPY 11,256 million compared to JPY 6,644 million a year ago. Net income was JPY 1,793 million compared to net loss of JPY 760 million a year ago. Basic earnings per share from continuing operations was JPY 19.82 compared to basic loss per share from continuing operations of JPY 8.45 a year ago. Diluted earnings per share from continuing operations was JPY 17.13 compared to diluted loss per share from continuing operations of JPY 8.45 a year ago.

NewCo announced that it has raised funding on May 11, 2026. The transaction included participation from new investors Nxera Pharma Co., Ltd. and a syndicate of leading healthcare and life sciences-focused investors. The company issued common stock in the transaction.

As announced on 12 February 2026, Nxera Pharma Co., Ltd. entered into a license agreement with a newly established company to advance a specific GPCR-targeted program owned by Nxera. Nxera announces that, in connection with the closing of a Series A financing undertaken by NewCo, Nxera and a syndicate of leading healthcare and life sciences-focused investors have entered into an investment agreement with NewCo. NewCo will accelerate preclinical studies of a GPCR program against a target discovered using Nxera’s NxWave™ technology platform and advance the program toward global clinical trials. By participating in the Series A financing, Nxera will continue its partnership with NewCo to maximize impact for patients and the value of the program for shareholders.Under the terms of the license agreement, Nxera has granted NewCo an exclusive worldwide license to develop, manufacture and commercialize a GPCR program currently at pre-clinical stage (target undisclosed), excluding Japan and certain Asia-Pacific territories. Nxera is eligible to receive up to USD 275 million in milestone payments based on development and commercial progress, plus tiered royalties. In addition, following NewCo’s formation, the execution of the license agreement and completion of the Series A financing, Nxera holds a significant minority equity stake in NewCo on a fully diluted basis. The program is outside Nxera's core metabolic and rare endocrine focus, and the spin-out structure allows it to be advanced with dedicated external capital and leadership.

Nxera Pharma Co., Ltd. announced that they will report Q1, 2026 results on May 01, 2026

Nxera Pharma Co., Ltd. announced that it has reached a third R&D milestone under its multi-target discovery collaboration with AbbVie focused on neurological diseases, resulting in a payment of USD 10 million to Nxera. Nxera and AbbVie entered this multi-target collaboration in 2022 to leverage Nxera’s NxWave™ platform to discover novel medicines targeting G protein-coupled receptors (GPCRs) associated with neurological disease. This current milestone relates to the identification of validated and differentiated ‘hit’ molecules against a neurology target. Under the terms of the agreement, Nxera is eligible to receive up to USD 40 million in near-term research milestones, as well as further potential option, development and commercial milestones totalling up to USD 1,200 million, plus tiered royalties on global sales. This is the third milestone received in this collaboration; the first milestone was achieved in June 2024 and the second milestone in September 2025.

Nxera Pharma Co., Ltd. announced that its partner Neurocrine Biosciences Inc. has initiated and dosed the first patient(s) in a Phase 2 clinical study of NBI-1117570 in adults with schizophrenia. As a result, Nxera will receive milestone payments of USD 22.5 million from Neurocrine pursuant to the agreement. The milestone payments will be recognised as revenue in the First Quarter Fiscal year 2026. NBI-1117570 is an investigational, orally administered, dual muscarinic M1/M4 receptor agonist discovered using Nxera’s proprietary NxWave drug discovery platform. The Phase 2 study (NCT07288333) is a double-blind, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of NBI-1117570 in adult patients with schizophrenia requiring in-patient treatment. The study is expected to enroll approximately 120 patients. The primary endpoint is change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score, and the key secondary endpoint is treatment-emergent adverse events (TEAEs). NBI-1117570 is an investigational, oral, dual muscarinic M1/M4 agonist. Muscarinic receptors are fundamental to activating signaling pathways in the brain. There are five muscarinic acetylcholine receptors involved in neurotransmission, two of which are selectively targeted by NBI-1117570 (M1 and M4), with M1 clinically validated as a potential drug target in cognition and M4 in psychosis. Neurocrine Biosciences acquired the rights to develop and commercialize NBI-1117570 from Nxera Pharma.

Nxera Pharma Co., Ltd. provided earnings guidance for the fiscal year 2026. For the year, the company expect revenue of JPY 33.8 billion and a core operating profit of JPY 7.8 billion.

Nxera Pharma Co., Ltd. has achieved a second development milestone under its multi-target collaboration and license agreement with Eli Lilly and Company targeting diabetes and metabolic diseases, resulting in a payment to Nxera. The payment amount is undisclosed under the agreement with Lilly. Nxera and Lilly entered the multi-target collaboration in 2022 to leverage Nxera’s GPCR-focused structure-based drug design capabilities and Lilly’s extensive development, commercialization and therapeutic area expertise. The achievement of this development milestone validates the use of Nxera’s NxWave™ platform to successfully identify small molecule binders to GPCR targets and to solve the structure of the receptor in the presence of the small molecule, thus revealing its binding site. Lilly will now be responsible for further development and commercialization. Under the terms of the agreement, Nxera is eligible to receive development and commercial milestones totalling up to USD 694 million, plus tiered royalties on global sales.

Nxera Pharma Co., Ltd. expected to report First-Half, 2026 results on August 7, 2026. This event was calculated by S&P Global (Created on April 1, 2026).

AGM

Nxera Pharma Co., Ltd. announced that at the 36th Annual General Meeting of Shareholders held on March 25, 2026, approved the appointment of Takeo Morooka – Newly appointed External Director. Effective from March 25, 2026.

Nxera Pharma Co., Ltd., Board Meeting, Mar 25, 2026. Agenda: To resolve the Notice Concerning New Management Structure.

Nxera Pharma Co., Ltd. announced that it has submitted a marketing authorisation application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of adult patients with insomnia. This submission follows positive data from the Phase 3 trial of daridorexant in South Korea which met both primary and secondary efficacy endpoints. Daridorexant is a dual orexin receptor antagonist being developed in South Korea by Nxera for the treatment of adult patients with insomnia and is approved and marketed in Japan as QUVIVIQ®. Phase 3 trial of daridorexant in South Korea met both primary and secondary efficacy endpoints of subjective total sleep time (sTST), subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO). Daridorexant is approved and marketed in Japan as QUVIVIQ® under a commercialization agreement between Nxera and Shionogi. QUVIVIQ®, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries, and marketed by Simcere in China and Hong Kong. Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6,500,000-11,000,000 people. Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep. Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. The disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy. According to multiple epidemiological studies, insomnia affects around 15% to 25% of the adult population in South Korea, or approximately 6,500,000-11,000,000 people. The condition is notably more prevalent among women and older adults. Recent data from Korea’s Health Insurance Review and Assessment Service (HIRA) revealed that the number of chronic insomnia patients treated has increased by 21% from 597,529 in 2018 to 722,440 in 2022. Of these patients, 50% are aged 60 or above, and 61% are women. Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness. Orexin regulates wake signaling, which might be overactive at night, preventing people with insomnia from falling asleep or staying asleep. Daridorexant is a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night. The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia. Patients were randomized to receive daridorexant 50 mg or placebo once daily for 28 days. The study met both its primary and secondary efficacy endpoints. At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time (sTST), compared with placebo.

Nxera Pharma Co., Ltd. announced that it has entered into a license agreement with a newly established independent company to advance Nxera's G protein-coupled receptor (GPCR)-targeted program. Under the Agreement, Nxera has received an equity stake in NewCo and upon successful development and commercialization of the asset, Nxera is entitled to receive milestone payments and royalties from sales. Under the terms of the agreement, Nxera has retained certain rights to develop and commercialize the asset in Japan and certain Asia-Pacific territories in the future. No details of these economic terms are being disclosed based on contract confidentiality. By partnering with the NewCo, which has the capability to advance asset development and raise capital, Nxera believes this is the best approach to maximize the value of the Program and enable it to reach patients. Nxera also may choose to participate in a Series A financing round of NewCo in the near future alongside major global investment firms. The impact of this Agreement on Nxera's consolidated financial results for the fiscal year ending 31 December 2026 is currently under review. Nxera will promptly disclose any matters requiring disclosure as they arise.

Nxera Pharma Co., Ltd. reported earnings results for the full year ended December 31, 2025. For the full year, the company reported sales was JPY 29,615 million compared to JPY 28,835 million a year ago. Net loss was JPY 12,530 million compared to JPY 4,838 million a year ago. Basic loss per share from continuing operations was JPY 138.8 compared to JPY 53.92 a year ago. Diluted loss per share from continuing operations was JPY 138.8 compared to JPY 53.92 a year ago.

Nxera Pharma Co., Ltd. expected to report Q1 2026 results on May 1, 2026. This event was calculated by S&P Global (Created on February 16, 2026).

Nxera Pharma Co., Ltd. provided consolidated earnings guidance for the year ending December 31, 2026. For the year, the company expects revenue in the range of JPY 33,800 million to JPY 48,800 million and operating profit of JPY 700 million to JPY 15,700 million.

Nxera Pharma Co., Ltd., Annual General Meeting, Mar 25, 2026, at 10:00 Tokyo Standard Time. Location: Fuji-No-Ma Hall, 4th Floor, Hotel Grand Arc Hanzomon 1-1, Hayabusa-cho, Chiyoda-ku Tokyo Japan Agenda: To consider Business Report, Consolidated Financial Statements, and Reports of Independent Auditor and the Audit Committee on the Consolidated Financial Statements for the 36th fiscal period (from January 1, 2025 to December 31, 2025); to consider Report on the Non-Consolidated Financial Statements for the 36th fiscal period (from January 1, 2025 to December 31, 2025); and to consider Election of 7 Directors.

Nxera Pharma Co., Ltd. announced that Ms. Miwa Seki and Mr. Noriaki Nagai to retire from the Board of Directors as External Directors.

Nxera Pharma Co., Ltd., Q4 2025 Earnings Call, Feb 13, 2026

Nxera Pharma Co., Ltd. announced that positive top-line results were obtained from a Phase 3 study conducted in South Korea evaluating daridorexant 50 mg in adult and elderly patients with insomnia. The Company plans to submit a marketing authorization application for daridorexant in South Korea in the first quarter of 2026, with approval in South Korea expected in the first quarter of 2027. Daridorexant is approved and being marketed in Japan as QUVIVIQ under a commercialization agreement between Nxera and Shionogi. QUVIVIQ, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries, and marketed by Simcere in China and Hong Kong. Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11 million people. The successful Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of daridorexant In adult and elderly patients with insomnia; Patients were randomized to receive daridorexant50 mg or placebo once daily for 28 days. The study met both its primary and secondary efficacy endpoints. About the Orexin system. Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides - small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain - orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system - leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) - to promote wakefulness. Orexin regulates wake signaling, which might be overactive at night, preventing people with insomnia from falling asleep or staying asleep. Daridorexant are a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night.

Nxera Pharma Co., Ltd. Presents at 44th Annual J.P. Morgan Healthcare Conference, Jan-13-2026 01:30 PM. Venue: The Westin St. Francis Hotel, 111 Minna Gallery, 335 Powell Street, San Francisco, California, United States.

Nxera Pharma Co., Ltd. - Special Call

Nxera Pharma Co., Ltd. announced that they will report fiscal year 2025 results on Feb 13, 2026

Nxera Pharma Co., Ltd. announced workforce reduction of approximately 15% across Japan and UK operations to align with focused strategy and objectives. No impact to operations in Switzerland and South Korea.

Nxera Pharma Co., Ltd. announced that Dr. Patrik Foerch has been appointed Chief Scientific Officer (CSO) and President of Nxera Pharma UK, succeeding Dr. Matthew Barnes (effective 3 October 2025). Dr. Patrik Foerch is an accomplished R&D leader across immunology, oncology and neuroscience. Most recently, he served as CSO at Peptone, contributing to an AI-enabled discovery platform and the build-out of an early pipeline targeting intrinsically disordered proteins. Prior to that, at Sitryx he led multiple programs from IND through first-in-human studies under a collaboration with Eli Lilly. Before that, he spent 15 years at the European pharmaceutical company UCB in R&D roles of increasing seniority. Dr. Foerch is an Entrepreneur in Residence at the Francis Crick Institute in London, holds a PhD from EMBL Heidelberg, and completed postdoctoral training at the same institute.

R&D Day

Nxera Pharma Co., Ltd. Presents at Jefferies London Healthcare Conference 2025, Nov-17-2025 12:00 PM. Venue: ME Hotel, London, United Kingdom. Speakers: Christopher Cargill, Representative Executive Officer, President, CEO & Director.

Nxera Pharma Co., Ltd. expected to report Fiscal Year 2025 results on February 13, 2026. This event was calculated by S&P Global (Created on October 31, 2025).

Nxera Pharma announced that its partner, Cancer Research UK, presented data from the successfully completed Phase 1 part of the ongoing Phase 1/2a clinical trial (NCT05944237) of Nxera's immunotherapy drug HTL0039732 (also known as NXE0039732) at the European Society for Medical Oncology Congress (ESMO) 2025 being held 17-21 October 2025 in Berlin, Germany. The first-in-human trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of HTL'732 as a monotherapy (n=13) and in combination with the checkpoint inhibitor atzolizumab (n=22), in patients with advanced solid tumors that were resistant or refractory to standard therapy. The company were encouraged to see partial responses in 1 out of 2ccRCC patients (50%) and 1 out of 11 MSS-CRC patients (9%) in this Phase 1 study. Based on the data presented the recommended Phase 2 dose for progression into cohort expansion studies was selected as 160mg QD in combination with atezolizumab. The Phase 2a trial expands four cohorts of patients from MSS CRC, gastric or gastroesophageal junction (GOJ) ad adocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer backgrounds. The first patient was dosed in the Phase 2a portion of the trial in September 2025. Nxera Pharma holds a license to the results generated.