RHIZEN-PHARMACEUTICALS
9.2.2021 05:47:10 CET | 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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210208005742/en/
Link:
About Business Wire
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
Xsolla Brings Direct-to-Consumer Commerce Expertise to Gamesforum Hamburg 2026 With Keynote and Panel Appearances9.6.2026 14:01:00 CEST | Press release
As An Exclusive Global Partner Of The Gamesforum Series, Xsolla Takes Two Stages In Hamburg, Headlined By A Keynote With AppsFlyer On Web Shop Attribution Xsolla, a global leader in video game commerce, today announced its participation in Gamesforum Hamburg 2026, taking place June 9–10, 2026, at NORD EVENT Panoramadeck in Hamburg, Germany. As an Exclusive Global Partner of the Gamesforum series, Xsolla will bring its direct-to-consumer commerce expertise to one of Europe's leading gatherings for mobile game growth and monetization, with Jane Startseva, Vice President of Business Development, EMEA, taking the stage across two sessions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609166526/en/ Graphic: Xsolla Xsolla's presence in Hamburg underscores its role at the center of gaming's shift toward direct-to-consumer commerce: On June 9 at 10:00 AM, Jane joined Adam Smart, Global Director of Product – Gaming at AppsFlyer,
Duetti Expands Funding Offerings for Independent Artists With Two New Programs9.6.2026 14:01:00 CEST | Press release
Master Tracks as Young as Six Months Now Eligible for Acquisition Deals; New Remix Program Expands Collaboration Opportunities Duetti Inc. (“Duetti” or the “Company”), the music company that partners with independent artists and songwriters to buy, manage, and market their catalogs, announces today a significant expansion of its funding offering. Artists can now sell their master recording tracks, or parts thereof, in as little as six months after release - substantially earlier than the company’s prior two-year threshold. Duetti is also launching its new Remix Program, which allows independent artists to create remixes, covers, and other derivative works from Duetti’s 30,000-track catalog (across both masters and compositions). In return, artists can receive upfront cash compensation, ongoing royalty % share, 0% distribution fees, and dedicated marketing support. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609063445/e
Clearlake Completes Strategic Acquisition of Pathway Capital Management9.6.2026 14:00:00 CEST | Press release
Expands Clearlake’s private markets solutions for institutional and private wealth marketsCombined platform represents over $185 billion in assets under management with more than 500 global employees Clearlake Capital Group, L.P. (“Clearlake” or the “Firm”), a global investment firm managing integrated platforms spanning private equity, liquid and private credit, and other related strategies, today announced the completion of its acquisition of Pathway Capital Management (“Pathway”), a global provider of private market solutions for institutional and wealth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609839186/en/ The strategic acquisition significantly expands Clearlake’s private markets platform, adding complementary capabilities and reinforcing its position as a leading diversified alternative asset manager. Founded in 1991, Pathway manages more than $95 billion in assets and brings a proven track record ac
Watchmaker to Unveil New Technologies Addressing NGS Workflow Bottlenecks and Sequencing Accuracy Challenges at ESHG 20269.6.2026 14:00:00 CEST | Press release
New technologies advance scalable library normalization for high-throughput genomics labs and improved amplification accuracy for oncology-focused sequencing workflows where data quality is critical Watchmaker Genomics, a leader in high-performance NGS workflow solutions, today announced it will unveil two new technologies at the European Society of Human Genetics (ESHG) 2026 conference, designed to address persistent bottlenecks in sequencing workflow scalability and amplification accuracy. The launches include the EquiPlex™ Normalization Kit, which simplifies library normalization using a novel Cas9-based approach, and Equinox® Prime Library Amplification Master Mix, engineered to improve indel accuracy in repetitive genomic regions while delivering superior amplification performance across sequencing applications. Built on Watchmaker’s expertise in protein engineering and integrated workflow design, the technologies reflect the company’s continued focus on solving real-world sequenc
The Open Group Releases OSDU® Data Platform Standard, Version 1.09.6.2026 14:00:00 CEST | Press release
The new standard provides a stable, interoperable foundation for data management across the energy ecosystem The Open Group, the global vendor‑neutral technology consortium, today announced the release of the OSDU® Data Platform Standard, Version 1.0. The new standard establishes a stable, clearly defined baseline for data platform capabilities, supporting greater interoperability, consistency, and confidence across the energy industry. The OSDU Data Platform Standard, Version 1.0 is designed to help organizations better manage, access, and use enterprise data by reducing fragmentation and breaking down data silos. It provides a common framework for organizing and accessing data securely and efficiently, supporting improved collaboration, innovation, and decision‑making. Key benefits of the standard include interoperability by design, increased stability for application development and deployment, and a clear foundation for certification. Operators benefit from greater choice and reduc
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