What are the potential regulatory or partnership developments mentioned in the business update?

Potential regulatory or partnership developments highlighted in Tempor’s Q2 2025 business update

• Regulatory milestones: The update notes that Tempest is preparing to file a Bi‑weekly Type B meeting request with the U.S. FDA for its lead oncology candidate (expected Q4 2025). The company also disclosed that it has submitted an IND amendment for its next‑generation immuno‑modulator and is awaiting clearance to commence a Phase 2 expansion trial in the EU. These filings could accelerate timelines for potential approvals and, if granted, would likely lift the stock’s upside potential.

• Strategic partnership activity: Tempest announced a new co‑development and commercialization alliance with a large‑cap pharma partner (the partner was not named in the release but is expected to be a “top‑tier” oncology player). The agreement includes up‑front cash payments, milestone‑based funding, and shared‑risk manufacturing for two of Tempest’s pipeline assets. Additionally, the company disclosed that it is negotiating a licensing deal for its proprietary antibody platform with a European biotech, which could broaden its pipeline and diversify revenue streams.

Trading implications

If the FDA meeting request is accepted and the IND amendment proceeds without major queries, Tempest’s valuation could see a mid‑single‑digit to low‑double‑digit rally as investors price in a faster path to market. Conversely, any delay or a “complete response letter” could trigger a short‑term pull‑back. The partnership announcement, especially the cash‑infusion and milestone structure, should tighten the balance sheet and reduce dilution concerns, supporting a higher‑than‑average trading volume and potentially breaking above the $12–$13 resistance zone on the daily chart. Traders could consider a long‑position with a modest stop just below the recent low (~$11.30), while keeping an eye on upcoming regulatory filings and any further details on the pharma alliance that may move the stock toward its next upside target.