Rhizen Pharmaceuticals AG Announces That Its Partnered Asset, Umbralisib (UKONIQ™), Has Received US FDA Accelerated Approval for Adult Patients With Relapsed or Refractory MZL & FL
9.2.2021 07:45:00 EET | Business Wire | Press release
Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of:
- adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete responses and in FL an ORR of 43% with 3% complete responses were achieved, respectively. Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics (NASDAQ:TGTX) at an IND stage (TGR 1202) in 2012. In 2014, both parties entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has retained commercialization rights for India while also being the manufacturing and supply partner for Umbralisib.
Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said: “Umbralisib’s approval offers MZL & FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. This is a momentous occasion in Rhizen’s journey as a successful biotech that speaks of the true ability of our team to discover & develop safe and effective therapies that can last the rigors of drug development. Further, we are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.”
Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director of Alembic Pharmaceuticals Ltd said: “We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval. We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ™. Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts.”
About Umbralisib:
Umbralisib is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. Umbralisib is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information on Umbralisib or UKONIQ™ can be found at https://www.tgtherapeutics.com/prescribing-information/uspi-ukon.pdf.
About Alembic Pharmaceuticals Ltd:
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s products that are marketed through a marketing team of over 5000 are well recognized by doctors and patients.
Information about Alembic can be found at http://www.alembicpharmaceuticals.com/.
(Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)
About Rhizen Pharmaceuticals A.G.:
Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in Basel, Switzerland. For additional information, please visit www.rhizen.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210208005742/en/
Contact information
Samyukta Bhagwati
Manager, Corporate Affairs & Communications
Rhizen Pharmaceuticals AG
+41 32 580 0113
corpcomm@rhizen.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Private Markets Firms Face SPV Execution Pressure as LP Demands Rise3.6.2026 15:30:00 EEST | Press release
As private markets firms navigate a more challenging fundraising and exit environment, limited partners (LPs) are demanding greater transparency, stronger governance rights, and more flexible SPV arrangements from fund managers. In fact, 86% of private markets professionals report increased LP requests for tailored SPV structures over the past 12 months, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC¹ surveyed 410 senior private markets practitioners across private equity, private credit, real estate, and infrastructure to examine how investor demands are reshaping SPV structures, operating models, and execution requirements. The findings are detailed in CSC’s new report SPV Global Outlook 2026: How LP demands and operational complexity are reshaping the SPV model. The research reveals that enhanced transparency and reporting is now the leading LP demand, cited by 76% of respondents. Stronger governance and approval
New Evidence Offers Hope for Ketogenic Therapy in Treatment of Anorexia Nervosa3.6.2026 15:00:00 EEST | Press release
A pilot study published today in Communications Medicine demonstrates the potential of a new approach to treating anorexia nervosa — a disorder for which effective treatments have been significantly limited. The research from UC San Diego School of Medicine reports that a ketogenic nutritional intervention — a high-fat, low-carbohydrate, moderate-protein diet — was feasible and safe for patients with weight-normalized and mildly underweight anorexia nervosa. The ketogenic intervention was well-tolerated by participants, with high adherence rates and no significant weight loss observed throughout the program. Furthermore, significant improvements were observed in eating disorder symptoms, with nearly 3 in 4 of study completers in the recovered range at study end, no longer meeting criteria for an anorexia nervosa diagnosis, and all completers experiencing an improvement in depression scores. This press release features multimedia. View the full release here: https://www.businesswire.com
NetApp and Cisco Collaboration Strengthens Defense-in-Depth for Enterprise Cyber Resilience3.6.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, and Cisco (NASDAQ: CSCO), today announced an expansion of their collaboration to help customers strengthen defense-in-depth strategies for customers. Combining Intelligent Data Infrastructure with advanced analytics and observability capabilities, NetApp and Splunk have delivered deep, real-time visibility into storage and infrastructure health. Together, they are helping customers turn operational data into actionable insights that improve reliability, security, and business outcomes. By expanding their collaboration with the new NetApp Splunk Security Orchestration, Automation, and Response (SOAR) playbook, NetApp and Splunk are helping joint customers contain ransomware attacks and limit data loss at the storage layer, enhancing the containment of the blast radius of cyberattacks while increasing the speed and reducing the cost of recovery. “With AI accelerating both the speed and sophistication of cyberattacks, th
NetApp and Cisco Accelerate and Secure AI Innovation3.6.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, and Cisco (NASDAQ: CSCO) today announced that they have collaborated to offer new validated solutions for secure, scalable, and simplified AI. Expanding the proven success of FlexPod, the new solutions provide a simple, reliable path for enterprises to address the specific challenges AI workloads place on compute, network, and storage infrastructure. “As IT teams are tasked with delivering reliable, consistent performance across environments, AI workloads are placing increasing demands on their data infrastructure,” said Dallas Olson, Chief Commercial Officer at NetApp. “NetApp and Cisco’s longstanding partnership on FlexPod has already proven effective, saving customers up to 20 percent of their time in infrastructure management and maintenance. Now, we are applying our combined expertise to modern challenges to accelerate AI adoption while reducing risk with built-in security.” NetApp and Cisco are expanding FlexPod
NIQ Named 2026 Retail & Consumer Goods Snowflake Product Partner of the Year3.6.2026 14:00:00 EEST | Press release
NielsenIQ (NYSE:NIQ) today announced that it has been named the 2026 Retail & Consumer Goods Snowflake Product Partner of the Year award recipient by Snowflake, the AI Data Cloud company. NIQ was recognized for its achievements at Snowflake’s annual user conference, Snowflake Summit 26, for delivering scalable, cloud-native solutions on Snowflake that enable retailers, brands, and media partners to securely enrich data, measure performance, and unlock more precise, actionable commerce intelligence. Through Snowflake’s AI Data Cloud, NIQ helps joint customers collaborate across organizations, activate high-value data assets, and power advanced measurement while maintaining strong governance and data privacy controls. By embedding NIQ’s AI-driven data, models, and harmonization capabilities within Snowflake, customers can unify fragmented datasets into a trusted, scalable foundation for AI. This makes it easier to operationalize AI-powered decision-making and move faster from insight to
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom