Syndax: Execution Meets Expansion

Two differentiated launches, disciplined fiscal guidance, and a clear path to profitability put this mid-cap biotech firmly on investors’ radar.

Syndax Pharmaceuticals (NASDAQ: SNDX) has transitioned into a commercial-stage biotech with two differentiated therapies: Revuforj (revumenib), a first-in-class menin inhibitor for KMT2A-rearranged AML, and Niktimvo (axatilimab), partnered with Incyte, approved for chronic GVHD. Both launches are exceeding early expectations, with Revuforj generating $28.6 million in Q2 2025 revenue and Niktimvo contributing $36.2M in gross sales, translating into $9.4M collaboration revenue for Syndax.

The near-term catalyst is the October 25, 2025 PDUFA decision for mNPM1 AML, where Revuforj has shown compelling response rates in Phase 2. Uptake is also shifting earlier in AML treatment, with potential to expand into maintenance post-transplant. For Niktimvo, demand has been broad across transplant centers, and label expansion into idiopathic pulmonary fibrosis underscores its franchise potential.

Financially, Syndax is guiding to flat OPEX for the next 2–3 years, aiming for profitability without new capital raises. Bloomberg consensus models $900M revenue and $2.31 EPS by 2029, though we see upside if costs remain disciplined. Analysts remain constructive, highlighting strong execution, robust cash (~$600M), and high-margin economics. Taken together, Syndax represents one of the rare mid-cap biotechs with credible near-term profitability.

Risks To Watch

Key risks include: regulatory delays for Revuforj’s mNPM1 approval; variability in AML launch momentum; dependence on Incyte’s execution for Niktimvo; expense creep versus management guidance; and financing risk if launches underperform. Consensus may be conservative, but sentiment could turn quickly if commercial execution falters.

Barcelona, Spain. Hartaj Singh, Spring 2022.

Coming Up on The Biotech Capital Compass

September 2025 – Understanding mRNA as a Therapeutic Platform

mRNA (messenger ribonucleic acid) first gained broad recognition during the COVID-19 pandemic, when vaccines were developed and deployed at unprecedented speed with critical governmental support. Beyond that historic moment, mRNA has established itself as a versatile therapeutic modality—one with the potential to become a true platform technology, much like small molecules and antibodies before it.

In an upcoming Biotech Capital Compass video, I’ll be joined by Katerina from The Biotech Blueprint to examine the scientific and clinical features that make mRNA well-suited for broad application. We’ll discuss how its modular design, rapid manufacturing, and flexible delivery approaches are shaping early development in infectious diseases, oncology, and other therapeutic areas.

Stay tuned…

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Biotech Capital Compass: September Newsletter

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About the Author

Hartaj Singh brings over 30 years of experience in drug development, corporate strategy, hedge fund management, and biotech analysis. With a career spanning top investment banks, Hartaj has been a highly ranked analyst, known for providing astute guidance on biotech investments for over a decade. His deep sector knowledge, honed through years of navigating the biotech landscape, is now being put to use to help investors capitalize on biotech opportunities.