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
Bentley Systems Announces Winners of the 2026 Year in Infrastructure Awards7.10.2026 19:55:00 CEST | Press release
New cycle of AI-enabled innovation is helping engineers solve harder problems faster (The Bentley Systems 2026 Year in Infrastructure Event) – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced the winners of the 2026 Year in Infrastructure Awards. For more than 20 years, the awards have honored the extraordinary work of infrastructure professionals and their innovative use of Bentley software to improve how infrastructure is designed, built, and operated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007964087/en/ Bentley Systems announced the winners of the 2026 Year in Infrastructure Awards on October 7, 2026 (Photo courtesy of Bentley Systems) In 2026, over 300 projects were nominated by organizations in 53 countries. Winners were selected across 12 categories spanning the infrastructure lifecycle, industries, and disciplines by a panel of independent judges
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 19:00:00 CEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 16:29:00 CEST | Press release
Each run now seals its test definition, step-by-step screenshots, console and network logs, and failure records into a single .evidence file that teams can view, share, validate, and merge. TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests,
Medisca and EUROAPI Form Strategic Partnership to Strengthen API Access for Pharmaceutical Compounding7.10.2026 16:07:00 CEST | Press release
This partnership brings together EUROAPI’s European pharmaceutical manufacturing capabilities and Medisca’s compounding expertise to expand access, strengthen its API portfolio and advance collaboration in peptides. Medisca and EUROAPI have formed a strategic partnership focused on expanding API access for pharmaceutical compounding, creating differentiated access in North America and establishing a broader framework for international growth and peptide collaboration. For more than three decades, Medisca has built its business around the evolving needs of pharmaceutical compounders. That starts with the products it chooses to bring to market but extends much further to the manufacturers behind them, the documentation and technical information supporting them, and the quality systems that carry those products through to the customer. The partnership with EUROAPI advances that approach. Under the new strategic partnership, Medisca becomes EUROAPI’s first strategic distribution partner fo
iQmetrix Launches Vendor Managed Inventory Integration with Valor Communication7.10.2026 16:00:00 CEST | Press release
The addition of Valor Communication marks another step in the rapid expansion of the iQmetrix Partner Ecosystem, bringing clients a growing network of integrated partners that work natively inside the platform they already run their business on. iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, is launching a Vendor Managed Inventory integration with Valor Communication, a factory-direct wireless accessory manufacturer and distributor serving carriers, retailers, and dealers since 1997. Built into the iQmetrix Intelligent Commerce Operating System, the integration connects Valor's assortment directly to the platform telecom retailers already run their business on – so replenishment runs on real sell-through data instead of guesswork, and approved accessories move from Valor's floor to the peg without manual reordering. The integration will be available to retailers across the iQmetrix client base. The addition of Valor Communication marks another step
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