WILMINGTON, Del. and WALTHAM, Mass. - Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (NASDAQ:SNDX) announced today the recent approval of Niktimvo™ (axatilimab-csfr) by the U.S. Food and Drug Administration (FDA) for the treatment of chronic graft-versus-host disease (GVHD) after the failure of two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. This announcement follows the publication of the Phase 2 AGAVE-201 trial results in The New England Journal of Medicine, demonstrating the efficacy of Niktimvo in patients with recurrent or refractory chronic GVHD.
The AGAVE-201 trial, which spanned 121 sites in 16 countries, enrolled 241 patients who had received at least two prior systemic therapies, with 74% previously treated with ruxolitinib. The trial met its primary endpoint, with 74% of patients in the 0.3 mg/kg every two weeks cohort achieving a complete or partial response within the first six months of treatment. The median time to response was 1.7 months, and approximately 60% of responders maintained their response at 12 months.
Patients in the trial experienced clinically meaningful reductions in symptoms, with 60% reporting a greater than five-point reduction in the modified Lee Symptom Scale. Organ-specific responses were observed across all organs studied, including those with fibrosis, such as the esophagus and lungs.
The most common treatment-emergent adverse events (TEAEs) were consistent with the known effects of CSF-1R inhibition and included laboratory abnormalities and symptoms like fatigue and infections. In the 0.3 mg/kg cohort, 49% of patients experienced grade 3 or higher adverse events, with 6% discontinuing treatment due to TEAEs.
Niktimvo has also been included in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A recommendation for chronic GVHD treatment after two failed systemic therapies. The U.S. commercial launch of Niktimvo is anticipated no later than early first quarter 2025, with Incyte holding exclusive commercialization rights outside of the U.S.
This news is based on a press release statement, which highlights the potential of Niktimvo to provide a new treatment option for patients with chronic GVHD who have exhausted other therapies.
In other recent news, Incyte Corporation has been the subject of several significant developments. The biopharmaceutical company's second quarter 2024 revenues reached $1.4 billion, a 9% increase from the previous year, primarily driven by key products, Jakafi and Opzelura. Truist Securities downgraded Incyte's stock from Buy to Hold, citing concerns over the approaching patent expiration for Jakafi. However, TD Cowen and BofA Securities maintained their Buy and Neutral ratings respectively, following positive data from the European Society for Medical Oncology conference.
Incyte's drug '667, a CDK2 inhibitor, showed increased response rates in patients with advanced solid tumors, reinforcing TD Cowen's confidence in the drug's potential. Goldman Sachs also reiterated a Neutral rating on Incyte's stock, highlighting the encouraging trial results. In addition, the company reported positive outcomes from its Phase 3 inMIND trial, evaluating the effectiveness of the drug tafasitamab in patients with relapsed or refractory follicular lymphoma.
Following the FDA approval of Incyte's drug axatilimab, now branded as Niktimvo, RBC Capital Markets and BMO Capital Markets updated their ratings on Incyte's shares. JMP Securities maintained a Market Perform rating on Incyte, expressing the view that the stock is currently fairly valued. These are recent developments in Incyte's trajectory.
InvestingPro Insights
As Incyte (NASDAQ:INCY) celebrates the FDA approval of Niktimvo™, a closer look at the company's financial health and market performance through InvestingPro's lens offers additional insights. Incyte boasts a strong balance sheet, as highlighted by an InvestingPro Tip that points out the company holds more cash than debt. This financial stability could be a significant factor in supporting the commercialization efforts for Niktimvo.
Moreover, Incyte's management has demonstrated confidence in the company's future, with an aggressive share buyback strategy, another InvestingPro Tip. Share buybacks can often signal management's belief in the company's undervalued stock and its long-term growth prospects.
On the data front, Incyte's market capitalization stands at an impressive $12.57B USD. However, the company's P/E ratio is notably high at 150.02, suggesting a premium valuation by the market, which may reflect the anticipated growth from new product launches like Niktimvo. The revenue growth over the last twelve months, as of Q1 2023, was 9.78%, indicating a solid upward trajectory in sales, an essential factor for investors considering the stock's future potential.
For those seeking a more in-depth analysis, InvestingPro offers a total of 12 additional InvestingPro Tips for Incyte, providing a comprehensive view of the company's financials and market position. These tips, along with real-time metrics, can be found at https://www.investing.com/pro/INCY, offering valuable information for investors and analysts following Incyte's journey in the biopharmaceutical industry.
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