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
Brenus Pharma Welcomes New European and Asia-Pacific Life Sciences Investors in Series A Extension20.7.2026 22:00:00 CEST | Press release
Brenus Pharma today announced an €11 million ($12.6M) extension to its Series A round, bringing total capital raised since inception to €38 million ($43.5M). This funding reflects strong execution across clinical, regulatory, and business development milestones, de-risking STC-1010 (NCT06934538): lead clinical-stage in-vivo immunotherapy for MSS mCRC, while positioning the company’s proprietary platform for multi-asset expansion. The round was supported by strong follow-on participation from existing investors, including Angelor, UI Investissement (managing FRAI), Crédit Agricole (CACE Création, CACF Capital Innovation), Noshaq, Orsa (formerly Investsud), BIO JAG, and Bpifrance (through non-dilutive funding). This round also welcomes two new international investors: Sambrinvest, strengthening the company’s European shareholder base, and Korea Omega Investment Corp, marking its first institutional investment from the Asia-Pacific region. "We couldn't be more confident in our first inves
Hollywood Chamber of Commerce Expands Into Luxury Hospitality20.7.2026 18:30:00 CEST | Press release
Hollywood Hotels & Residences to Bring the Spirit of Hollywood to Luxury Destinations Worldwide The Hollywood Chamber of Commerce, known for the iconic Hollywood Sign® and Hollywood Walk of Fame®, is expanding into luxury hospitality through a strategic partnership with The Scene Hotels & Resorts to launch Hollywood Hotels & Residences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720026178/en/ The Scene Hotels & Resorts, with 40+ years of combined expertise in hospitality, travel, and brand development, will lead the brand’s development and management. The partnership will bring the Hollywood lifestyle to luxury hotels and branded residences around the world, creating immersive destinations inspired by the world's entertainment capital. "This partnership represents far more than an expansion of the Hollywood brand—it reflects our vision of Hollywood as the world's premier hub for entertainment, creativity, and commerce
Andersen Consulting udvider med samarbejdsfirmaet Smartbridge20.7.2026 17:54:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Smartbridge, et Texas-baseret firma, der tilbyder digitale løsninger og AI-teknologi, og forbedrer dermed sine kapaciteter inden for data og analyse samt digitale transformationstjenester. Smartbridge blev grundlagt i 2003 og hjælper organisationer med at accelerere deres digitale transformation og modernisere driften gennem digital innovation, AI, data og analyse samt applikationsmoderniseringstjenester. Firmaet arbejder med kunder inden for olie- og gas-, medtech- og restaurationsbranchen og kombinerer rådgivnings- og teknologitjenester for at muliggøre erhvervsvirksomheders transformation og vækst. Ved at udnytte strategiske relationer med førende teknologileverandører hjælper Smartbridge organisationer med at forbinde data, forbedre beslutningstagning og accelerere forretningsresultater. "I dag ønsker organisationer at accelerere deres digitale omstilling og AI-transformation og søger praktiske måder at omsætte innovation til m
Epic Flight Academy Agrees to Purchase up to 50 Pipistrel Voyager Aircraft, Supplementing Its Fleet of Trainers as It Supports Continued Pilot Training20.7.2026 17:38:00 CEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today announced Epic Flight Academy as the launch customer for the Pipistrel Voyager during Textron Aviation’s press conference at EAA AirVenture 2026. The company has signed a purchase agreement for up to 50 Voyager aircraft, with an order for 10 initial deliveries beginning in 2027, and options for up to 20 additional aircraft in 2028 and 20 in 2029, supporting the continued expansion of its training fleet and growing demand for pilot training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720003143/en/ Epic Flight Academy agrees to purchase up to 50 Pipistrel Voyager aircraft, supplementing its fleet of trainers as it supports continued pilot training (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) Epic Flight Academy is a Florida-based flight training provider offering FAA Part 141 and
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 15:00:00 CEST | Press release
Debuting at EAA AirVenture 2026 in Oshkosh, the world’s largest aviation gathering Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. c
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