SYNDAX PHARMACEU.DL-,0001

At the H.C. Wainwright conference, Syndax presents a business model that already generates significant revenues but needs clinical data for further growth. Revuforj and Niktimvo each reach more than $200 million annually and drive growth, with Revuforj increasingly generating recurring revenue as a maintenance therapy after stem cell transplants. Near-term catalysts are expected data from axatilimab studies (IPF and frontline cGVHD) in the fourth quarter; the pipeline includes several oncology and rare-disease programs with clinical starts planned through 2027. Management expects expansion of the maintenance indication to be the dominant long-term revenue driver but sees a need for additional data to support that growth. » Więcej na de.investing.com

Syndax reports that Revuforj is achieving an annualized revenue well over $200 million in its second year on the market and generated $55 million in the last quarter; market share is around 85% in relapsed/refractory AML with KMT2A and NPM1 mutations. Two approval-relevant phase III first-line studies (EVOLVE-2 for unfit patients, REVEAL for fit patients) are progressing well, while the company plans further label expansions and combination tests. In parallel, Syndax is advancing development of Niktimvo in IPF and cGvHD and new programs in lung cancer and myelofibrosis, with initial clinical starts for two projects planned for 2027. » Więcej na de.investing.com

Syndax reported Q2 revenue of $73 million and a loss of $0.55 per share, missing both revenue and earnings expectations. Revenue grew 92% year‑over‑year, driven by Revuforj (net revenue $54.7 million) and Niktimvo (collaboration revenue $18.1 million), and management expects projected annual revenues for both products to be well over $200 million. The company ended the quarter with $575 million in cash, reiterated its operating cost guidance for 2026, and cited several clinical data catalysts for the second half of the year; the stock fell after hours following the missed metrics. » Więcej na de.investing.com