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
Acceleronix, IDEMIA Secure Transactions and Orange Announce Flexible, Single-SKU Manufacturing with Quantum-Safe IFPP4.11.2026 16:44:00 CET | Press release
One SKU. Every market. Connectivity decided at the end of production. Live at electronica 2026. Orange, one of the world’s leading telecom operators, has joined the global quantum-safe In-Factory Profile Provisioning (IFPP) program, jointly launched by Acceleronix and IDEMIA Secure Transactions at MWC Barcelona in February. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104070181/en/ Acceleronix, IDEMIA Secure Transactions and Orange announce flexible, single-SKU manufacturing with quantum-safe IFPP The program enables device makers to build a single product for every market and connect it to the Orange network before it leaves the factory. Acceleronix and IDEMIA Secure Transactions will demonstrate the solution live at electronica 2026, the international electronics trade fair, at Messe München, Hall C2, Stand 601, from 10 to 13 November. Most connected devices share the same weak spot: provisioning and testing on the pr
U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma4.11.2026 15:13:00 CET | Press release
If approved, BRUKINSA plus rituximab would be the first and only chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphomaApplication supported by Phase 3 MANGROVE data, showing a 43% reduction in the risk of progression or death versus bendamustine plus rituximabFull MANGROVE results to be presented during the Plenary Scientific Session at the 68th American Society of Hematology Annual Meeting BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for BRUKINSA® (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The application is supported by data from the pivotal Phase 3 MANGROVE study, in which this chemotherapy-free regimen significantly reduced the risk of dis
Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement4.11.2026 15:00:00 CET | Press release
This framework agreement provides all entities subject to the French Public Procurement Code with simplified access to a support alternative enabling them to control their costs, preserve their freedom of technological choice and free themselves from vendor-imposed upgrade cycles Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that it had been selected as the awardee of the third-party support service lots (TMA) by CANUT, the French public purchasing center specializing in digital technology and telecommunications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104431817/en/ Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement Eligible public organizations subject to the French Public Procurement Code can now benefit from Rimini Street services for their Oracle, SAP, VMw
Incyte to Present New Data Highlighting Progress Across its Hematology Portfolio at ASH 20264.11.2026 15:00:00 CET | Press release
New data in myeloproliferative neoplasms (MPNs) will include INCA033989, Incyte’s first-in-class, mutant calreticulin (mutCALR)-targeted monoclonal antibody, in first-line myelofibrosis (MF); and preclinical findings for Incyte’s next-generation mutCALR- and JAK2V617F-targeted compoundsUpdated results for INCA033989 in second-line MF and second-line essential thrombocythemia (ET) will build on previously presented datasetsLong-term Phase 1/2 data further characterize the potential of latarcibart (VGA039), an investigational Protein S-targeting antibody, as prophylaxis in adolescents and adults with von Willebrand disease (VWD)More than 30 abstracts will highlight progress across Incyte’s broader hematology portfolioIncyte will host an investor event and webcast on Saturday, December 12, 2026 from 7:30 – 9:00 p.m. CT (8:30 – 10:00 p.m. ET) Incyte (Nasdaq:INCY) today announced that new data highlighting progress across its hematology portfolio will be presented across more than 30 abstra
Zenitar Announces Initiation of International Randomized Study of Flonoltinib Maleate in Patients with Myelofibrosis and Related American Society of Hematology 2026 Meeting Presentations4.11.2026 15:00:00 CET | Press release
Chengdu Zenitar Biomedical Technology Co., Ltd. (Zenitar) is developing flonoltinib maleate (FM), a first-in-class oral JAK2/FLT3/CDK6 inhibitor for myeloproliferative neoplasms (MPNs), including myelofibrosis (MF) and polycythemia vera (PV). Zenitar launched randomized Phase 2 FM-MF-02 (NCT07750574) in the US, Canada and Brazil to select Phase 3 dose for JAKi-naïve and refractory MF. Randomized FMF-02 (NCT06457425) met its week-24 endpoints: superior SVR35 and TSS50 with FM 50/100mg versus ruxolitinib; previous data presented orally at ASH24 (#486) and ASH25 (#908). ASH 2026 presence covers FMF-02 long-term follow-up (oral presentation, #411, December 12, 4:30pm) and refractory PV Phase 2 data (poster, #3765, December 13, 6pm), both in Session 634. “Over the 15 years since the initial FDA approval of Ruxolitinib, JAKi have markedly improved the prognosis of many patients with MF. The long-term data show significant room for improvement for this key therapeutic class in terms of both e
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