Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Wednesday, Stifel analysts adjusted their outlook on Ionis Pharmaceuticals (NASDAQ:IONS) shares by reducing the price target from the previous $45.00 to $38.00, while maintaining a Hold rating on the stock. Currently trading at $31.56, near its 52-week low of $30.23, the stock has seen a 32.9% decline over the past six months. The adjustment follows the company’s fourth-quarter earnings, which were reported to be consistent with analysts’ expectations. InvestingPro analysis shows several headwinds, including weak gross profit margins and anticipated sales decline for the current year.
Ionis reported that Wainua royalty revenues for the quarter met projections, with earnings of $10 million compared to the anticipated $12 million. With a market capitalization of $4.98 billion, the company currently operates with negative gross profit margins of -14.3% and faces profitability challenges. According to InvestingPro’s Fair Value analysis, the stock appears to be overvalued at current levels. Analysts at Stifel noted the importance of the ongoing phase 3 study of TTR-CM, with results expected in the second half of 2026. They also mentioned the commencement of the Tryngolza launch for the treatment of Familial Chylomicronemia Syndrome (FCS). Despite it being the initial phase of the launch, management has expressed satisfaction with the market’s response and the diversity of prescribing doctors.
The analysts’ report indicated that while the Tryngolza launch is projected to be gradual, the investor focus is largely on the development of treatments for severe hypertriglyceridemia (sHTG), which is seen as a more substantial market opportunity. For deeper insights into Ionis’s pipeline potential and financial health, InvestingPro subscribers can access the comprehensive Pro Research Report, which provides detailed analysis of the company’s growth prospects and market position among 1,400+ top US stocks. Phase 3 data for sHTG treatments are expected in the second half of 2025, with a potential market introduction in 2026.
Furthermore, Ionis is advancing its wholly-owned pipeline, including the phase 3 trial of a drug for Angelman Syndrome, which is scheduled to commence in the first half of 2025. Additionally, the company is preparing for the launch of donidalorsen, pending approval by the FDA by the Prescription Drug User Fee Act (PDUFA) date on August 21, 2025.
The revised price target of $38.00 is primarily attributed to increased assumptions about the company’s spending, as outlined by the Stifel analysts in their commentary. Ionis Pharmaceuticals continues to progress in its various developmental stages, with multiple significant milestones anticipated in the coming years.
In other recent news, Ionis Pharmaceuticals reported a notable performance for the fourth quarter of 2024, exceeding earnings and revenue expectations. The company achieved an earnings per share (EPS) of -0.66, surpassing the anticipated -1.11, while revenue reached $227 million, significantly higher than the forecasted $135.58 million. Ionis Pharmaceuticals highlighted strong growth in key product revenues, including SPINRAZA royalties and WAYNEUWA sales, which contributed to the overall financial success. The company has also been advancing its product pipeline with the recent FDA approval of TRINGOLZA, marking its first independent product launch. Looking forward, Ionis Pharmaceuticals projects revenue of over $600 million for 2025, with plans for multiple product launches and strategic partnerships to drive growth. The firm maintains a strong cash position, forecasting approximately $1.7 billion in cash and investments by the end of 2025. Additionally, Ionis Pharmaceuticals has been actively preparing for the launch of new products, including Donadolorsen for hereditary angioedema and olexarsen for severe hypertriglyceridemia. The company is also in discussions to secure commercial partnerships outside the U.S. for its products.
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