Syndax Pharmaceuticals

UCB’s Bimzelx approved for hidradenitis suppurativa; FDA approves Emrosi for rosacea, Danziten for CML without fasting, Aucatzyl for ALL, Kebilidi for AADC deficiency, Revuforj for acute leukemia, Ziihera for HER2-positive BTC, Attruby for ATTR-CM, Imkeldi for leukemia, and Rapiblyk for SVT, marking significant advancements in treatment options.

Qurient's Adrixetinib, targeting cGVHD, received FDA phase 1b IND approval. The trial will assess its safety and efficacy in 18 patients. Adrixetinib, a triple kinase inhibitor, shows promise in treating cGVHD and leukemia, offering advantages over existing treatments. Qurient aims for global pharmaceutical interest.

Syndax Pharmaceuticals presents positive data on Revuforj (revumenib) in acute leukemias at the 66th ASH Annual Meeting, showing high efficacy and tolerability as both a single-agent and in combination with standard care agents.

Syndax Pharmaceuticals presented positive data on Revuforj (revumenib) in R/R AML and KMT2Ar acute leukemia at the 66th ASH Annual Meeting, showing high ORR and CR/CRh rates, rapid and durable responses, and favorable tolerability.

The FDA approved Revuforj (revumenib), a menin inhibitor, for relapsed or refractory acute leukemia with KMT2A gene translocation. Results from the AUGMENT-101 trial showed significant efficacy, with nearly two-thirds of patients achieving complete or partial remission. Revuforj is generally safe, with manageable side effects, and is now available at a cost of $39,500 per month.

Novartis acquires Kate Therapeutics for $1.1B, Barclays predicts challenging 2025 for European pharma, Trump picks surgeon Martin Makary to lead FDA, Novartis partners with Ratio Therapeutics for up to $745M, Kyowa Kirin pays Kura Oncology $330M upfront for leukemia drug rights, global measles cases rise 20% to 10.3 million, Brookfield considers €7B bid for Grifols, Bavarian Nordic's 2025 order book reaches €320M, FDA supports REGENXBIO's Duchenne muscular dystrophy gene therapy, Merck's subcutaneous Keytruda matches infused version, Syndax Pharmaceuticals secures FDA approval for Revuforj, Aclaris Therapeutics licenses 2 antibodies from Biosion for over $40M upfront, Sandoz to cut 10% of workforce in France, Incyte halts testing and discontinues drugs, Sage Therapeutics discontinues dalzanemdor, Johnson & Johnson and Merck announce job cuts in China, Samsung Biologics signs $668M contracts, FDA grants accelerated approval to Jazz Pharmaceuticals' Ziihera, Lexicon Pharmaceuticals cuts 60% of workforce, Halozyme withdraws €2B bid for Evotec, mpox epidemic overwhelms hospitals in Kinshasa.

Kura Oncology secures $330 million from Kyowa Kirin for ziftomenib, a menin inhibitor targeting KMT2A-mutated leukemia, with plans for FDA submission in 2025. The collaboration aims to develop ziftomenib across leukemias and solid tumors, with potential milestone payments up to $1.2 billion.

Incyte pauses Phase 2 study of INCB000262 due to toxicology findings, and scraps INCB000547 after Phase 2 results. These setbacks impact Incyte's diversification efforts from Jakafi, which faces competition and patent issues. Investors focus shifts to povorcitinib's Phase 3 readout for hidradenitis suppurativa.

Syndax Pharmaceuticals announced FDA approval of Revuforj (revumenib) for relapsed or refractory acute leukemia in patients with KMT2A translocation. Revuforj, the first FDA-approved menin inhibitor, targets KMT2A gene rearrangements. It showed 21% complete remission in AUGMENT-101 trial, with common adverse reactions including infection and hemorrhage. The drug will be available in 110 mg and 160 mg tablets, priced at $39,500 for a 30-day supply.