Syndax's Revuforj Approved for Leukemia, Biosion Inks $940M Antibody Deal with Aclaris
Key Insights
Syndax Pharmaceuticals' Revuforj (revumenib) received FDA approval as the first menin inhibitor for relapsed or refractory acute leukemia (search) with specific genetic translocations.
Biosion (search) granted Aclaris Therapeutics (search) exclusive global rights to develop two antibodies, including BSI-045B (anti-TSLP (search)) and BSI-502 (bispecific TSLP/IL4R (search)), for up to $940 million.
Novartis expanded its radiopharma portfolio, licensing a somatostatin receptor 2 (search) radiotherapeutic candidate from Ratio Therapeutics (search) for cancer (search), potentially worth $745 million plus royalties.
Syndax Pharmaceuticals Inc. has secured FDA approval for Revuforj (revumenib), marking it as the first and only menin inhibitor available for patients with relapsed or refractory acute leukemia (search) who have a lysine methyltransferase 2A (KMT2A) gene translocation. This approval, granted ahead of its December 26 PDUFA date, offers a new treatment option for both adult and pediatric patients (one year and older) facing this aggressive form of leukemia.
The FDA had previously recognized Revuforj as a breakthrough therapy and granted it fast track designation and priority review. The approval was facilitated through the FDA's Real Time Oncology Review program. Syndax Pharmaceuticals, based in Waltham, Mass., saw its shares rise following the announcement.
Aclaris Acquires Antibody Rights from Biosion in $940M Deal
In other news, Biosion (search) Inc. has entered into an agreement with Aclaris Therapeutics (search) Inc., granting Aclaris the global rights (excluding China) to develop two of its antibodies. The deal includes an upfront payment of over $40 million to Biosion, with the potential for an additional $900 million in regulatory and sales milestone payments.
The assets involved are BSI-045B, a high-affinity and high-potency anti-TSLP (search) monoclonal antibody, and BSI-502, a bispecific antibody targeting both TSLP and IL4R (search). BSI-045B recently completed a phase IIa proof-of-concept study in patients with moderate to severe atopic dermatitis (search). Aclaris Therapeutics (search)' stock experienced a significant boost following the announcement of the deal.
Novartis Expands Radiopharma Pipeline with Ratio Therapeutics Collaboration
Novartis AG continues to invest in radiopharmaceutical therapies, entering into an exclusive worldwide license and collaboration agreement with Ratio Therapeutics (search) Inc. to develop a somatostatin receptor 2 (search) (SSTR2) radiotherapeutic candidate for cancer (search). Ratio Therapeutics is eligible for upfront and potential milestone payments totaling $745 million, in addition to royalties. This deal marks another collaboration for Ratio, which has existing diagnostic-focused agreements with Lantheus Holdings Inc. and Merck & Co. Inc.