Vanda's Approval, OSS's Pivot, and 3 Biotech Catalysts to Watch

The FDA's approval of tradipitant (Nereus) on December 30 marks a historic milestone, delivering the first new treatment for motion sickness in over four decades. The drug, an oral neurokinin-1 receptor antagonist, was approved for the prevention of vomiting induced by motion. This validation caps a decade-long pipeline effort and provides a crucial regulatory win for Vanda Pharmaceuticals. The approval was based on robust data from pivotal trials, showing the drug significantly reduced vomiting rates by over 50-70% compared to placebo.

Yet, for investors, this binary event has already priced in its success. The stock has rallied about 62% since mid-November, erasing the year's losses and positioning the share price at a level that reflects the approval's impact. The approval date itself acted as the key catalyst, with the market's strong reaction indicating that the win was anticipated and discounted. This leaves limited near-term upside from the news alone.

The commercial opportunity, while meaningful, is also a constraint. The total addressable market for motion sickness is estimated at $670 million in 2025, a figure that is expected to grow at a modest 3.1% annual rate. For a company with a market cap in the hundreds of millions, this represents a niche but not transformative market. The approval validates the drug's science and mechanism, but the financial scale of the initial indication caps the immediate revenue potential.

The bottom line is that Vanda's story has shifted. The FDA win is a necessary step, but it is no longer the primary driver. The stock's recent surge has already captured the event's value. The next phase will depend on execution-launch timing, market penetration, and the company's ability to leverage its NK-1 receptor platform into other indications like GLP-1-induced nausea. For now, the binary event is over, and the stock trades on the next chapter.

One Stop Systems: A Strategic Pivot Creates a Cash-Rich, Focused Play

One Stop Systems has executed a decisive tactical shift, selling its European subsidiary Bressner Technology GmbH for $22.4 million. This move, which closed on December 30, 2025, is a classic example of a company pruning a mature asset to fuel a sharper focus on its high-growth core. The transaction is expected to generate a pre-tax gain of approximately $7.4 million for the 2025 fourth quarter, delivering a meaningful, one-time boost to earnings.

The strategic rationale is clear. OSS acquired Bressner for about $5.6 million in October 2018, and the subsidiary grew sales to nearly $33 million on a trailing basis by September 2025. While this represents solid execution, the company now sees greater opportunity in its own AI, machine learning, and rugged edge computing markets. The divestiture allows OSS to reinvest capital in its higher-growth segments and streamline its operations. Management expects this focus to result in a significant cash position, no debt, strong year-over-year sales growth, and higher gross margin by year-end.

Financially, the pivot is already reshaping the outlook. With Bressner classified as a discontinued operation, OSS has updated its full-year 2025 revenue guidance to $30 million to $32 million. This reflects the company's core business performance and marks year-over-year growth of 22% to 30%. More importantly, it sets a foundation for multi-year organic growth, with management targeting over 20% annual expansion in its core markets. The sale provides the balance sheet strength to pursue that growth, whether organically or through targeted acquisitions in its chosen fields.

The bottom line is that this transaction transforms OSS from a diversified hardware player into a leaner, cash-rich specialist. The immediate gain and balance sheet improvement are tangible wins. The longer-term bet is on the company's ability to compound its core AI and edge computing business at a high rate. For investors, it's a tactical reset that removes a distraction and funds a clearer path forward.

Beyond the Headlines: 3 Biotech Catalysts to Watch in 2026

The biotech sector's strong momentum in 2025, fueled by a steady stream of approvals and renewed investor enthusiasm, sets the stage for a year of high-stakes regulatory decisions. While the industry's overall health is positive, the real catalysts for individual stocks often lie in specific, near-term events. Three companies stand out for their potential to unlock significant shareholder value in 2026 through pivotal FDA actions.

First, Denali Therapeutics faces a critical decision point for its lead asset. The company's BLA for tividenofuspalfa, an enzyme replacement therapy for Hunter syndrome, has a new target action date of April 5, 2026. The timeline extension, requested by the FDA for updated clinical pharmacology information, does not signal safety or efficacy concerns but adds a layer of near-term uncertainty. A successful approval would be transformative for Denali, validating its Enzyme Transport Vehicle platform and providing a commercial foothold for a rare disease with significant unmet need.

Second, Nuvalent is advancing a promising oncology candidate with a clear regulatory path. Its NDA for zidesamtinib, a novel ROS1-selective inhibitor for non-small cell lung cancer, has been accepted by the FDA with a target action date of September 18, 2026. The drug holds Breakthrough Therapy designation, reflecting its potential to address treatment resistance and brain metastases-a major clinical challenge. Positive data from its pivotal trial, combined with this accelerated review pathway, makes this a high-impact event to watch for the second half of the year.

Finally, Vanda Pharmaceuticals is seeking a fast track for its rare disease drug. The company recently submitted a BLA for imsidolimab to treat generalized pustular psoriasis and has requested priority review. If granted, this would establish a six-month review cycle, with a potential approval as early as mid-2026. The therapy's strong Phase 3 data, showing rapid and sustained disease clearance, supports the request. A priority review would significantly de-risk the approval timeline, a crucial step for a company building its commercial presence in rare orphan disorders.

These three catalysts represent a concentrated set of near-term events that could dramatically alter the investment thesis for each company. They highlight how, even within a sector experiencing broad-based momentum, the most significant moves are often driven by discrete regulatory milestones.