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
Lattice to Showcase Industry-Leading FPGA Innovations at FPGA Conference Europe 202616.6.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming FPGA Conference Europe. Lattice will participate in various speaker sessions to showcase how low power FPGAs are driving innovation across multiple sectors. The company will also demonstrate its latest FPGA technology advancements in physical AI, advanced connectivity, security, and more. Who: Lattice Semiconductor What / When (GMT+2): June 30 – July 2: Lattice Presentations & Demo Showcase Speaker sessions: Day 1 – 3 Speaker Sessions: Lattice FPGA deep dive sessions spanning physical AI, advanced connectivity, security, and design tools Date Time Session June 30 9:45 a.m. FPGA Verification and Testing by Arrow 11:15 a.m. Trusted Resilience Edge: Unified FPGA-TPM for Post-Quantum Cryptography RED & Cyber Resilience Act 12 p.m. SIPHashIP for Embedded Security: Enabling RED Compliance and CRA Readiness in Smart AR/VR Systems 2:15 p.m. Foundations of FPGA Security
IQM Deploys Its First U.S. Quantum Computer at Oak Ridge National Laboratory16.6.2026 20:53:00 CEST | Press release
Pathfinder, a 20-qubit IQM Radiance system, is now operational at the home of Frontier, the world's most powerful supercomputer for open science. It’s ORNL's first commercially procured quantum computer and IQM's first system on U.S. soil. It will be connected to high-performance computing systems in the National Center for Computational Sciences Technology Integration Group's test bed. ORNL owns and operates the system on its own campus. IQM's deployment model gives customers direct ownership and control of their quantum infrastructure, including the IP. IQM has sold 23 full-stack quantum systems worldwide, more on-premises systems than any other manufacturer. The deployment expands IQM's commercial presence in the United States ahead of its planned Nasdaq listing through its merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). The Department of Energy's Oak Ridge National Laboratory (ORNL) today launched Pathfinder, the first commercially procured quantum computer at ORNL, built
Hologic Secures Significant Patent Victory Against Siemens Over Breast Cancer Detection Technology16.6.2026 19:00:00 CEST | Press release
Court orders Siemens to halt production and recall and destroy products across Germany, France and the Netherlands Hologic, Inc. today announced a significant and far-reaching victory in the Unified Patent Court (UPC) in Germany, which ruled that Siemens* infringed upon a critical Hologic mammography technology patent in Siemens’ latest mammography system. The court imposed a sweeping injunction, immediately prohibiting Siemens from making, offering, placing on the market, using or importing or storing for those purposes its MAMMOMAT B.brilliant systems across Germany, France and the Netherlands, as well as monetary damages and penalties for non-compliance. The court also required Siemens to execute a mandatory recall and destruction of all affected systems in those countries. On June 10, 2026, the UPC determined that Siemens infringed upon European Patent EP 2 352 431, Hologic’s Focusing Technology on the Envision™ Platform, the first FDA-approved mammography innovation of its kind.1
RealTime Reservation Acquires STAY to Create Leading Global Guest Experience Platform Serving 2,000+ Properties Across 75+ Countries16.6.2026 18:30:00 CEST | Press release
Wavecrest Growth Partners invests to enable combination and support growth of the combined company RealTime Reservation (RTR), the industry leader in dynamic hospitality booking technology for onsite activities, amenities, and ancillary revenue management, today announced its acquisition of STAY, creating a global end-to-end guest experience platform for the hospitality industry. The combined company will serve more than 2,000 hospitality properties across 75+ countries throughout North America, Europe, Latin America and the Caribbean. The combination significantly expands RTR's international footprint and strengthens its position as a leading provider of guest engagement, ancillary revenue, and guest experience technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260616258776/en/ Pictured: RealTime Reservation's dynamic booking interface allows hotel guests to select and reserve pool and beach amenities by location, d
Happy Holidays S.A. and JTA Investment Holding Announce €65 Million Investment for SARTIMARE Tourism Development in Greece16.6.2026 17:42:00 CEST | Press release
Happy Holidays S.A. today announced the signing of an Investment Agreement with Qatar-based JTA Investment Holding for the development of the sustainable SARTIMARE Beach Resort & Spa project in Sarti, Halkidiki, Greece. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260616892834/en/ Dr. Amir Ali Salemi Zadeh, CEO of JTA Investment Holding and Georgios Iosifidis, Founder & Owner of Happy Holidays S.A. Under the agreement, JTA Investment Holding will invest €65 million into the development. The project will be built on a site of approximately 120,900 square meters, with construction scheduled between 2027 and 2030. Designed with a strong commitment to environmental responsibility, the SARTIMARE project will feature luxury hospitality facilities, premium residences and villas, wellness amenities, retail, food & beverage outlets, and marina infrastructure. The project's valuation is expected to exceed €100 million as key develop
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