A preview of the format: the nearest confirmed FDA calendar catalysts and a structural read on trials approaching data readout — sourced from public FDA-calendar disclosures and ClinicalTrials.gov, with no speculative price targets or unconfirmed figures.
Compiled as of July 12, 2026. The FDA does not publish an official forward calendar of pending decisions — the dates below are target action dates companies themselves have disclosed in press releases and SEC filings, aggregated by ORION's FDA Calendar. Target action dates can and do shift; treat day-level precision as indicative, not guaranteed.
| Target Date | Company | Drug / Application | Indication | ORION Impact Class |
|---|---|---|---|---|
| Aug 12, 2026 | Eli Lilly (LLY) | Tirzepatide (Zepbound) — sNDA | HFpEF + Obesity | VERY HIGH |
| Sep 8, 2026 | AstraZeneca / Daiichi Sankyo (AZN) | Dato-DXd (datopotamab deruxtecan) | HR+/HER2-low/neg Breast Cancer | HIGH |
| Oct 14, 2026 | Merck (MRK) | Pembrolizumab (Keytruda) — sNDA | Resectable TNBC, neoadjuvant | HIGH |
Source: ORION FDA Calendar (public, unauthenticated endpoint), company investor disclosures. Impact class reflects the size of the regulatory/clinical signal ORION's calendar schema assigns to each catalyst — not a probability of approval or a price forecast.
Public trial-design facts only. No price targets, no probability-of-approval estimate, no return forecast.
The sNDA rests on the SUMMIT trial, which carries an FDA Breakthrough Therapy designation for the HFpEF component — a structural signal of regulatory urgency around unmet need in this population, distinct from any comment on the vote itself. This is Lilly's first cardiometabolic-indication expansion for this molecule, which is why ORION's calendar classifies it at the top impact tier: a large existing franchise plus a new indication category, not a small line extension.
A Trop2-directed antibody-drug conjugate positioned against a chemotherapy comparator in a hormone-receptor-positive, HER2-low/negative population — a large, already-crowded breast cancer segment. Structurally, this places it in a more competitive category than a first-in-indication filing: even a positive outcome shares an already-served market rather than opening a new one.
An overall-survival readout supporting an sNDA in a resectable, earlier-line triple-negative breast cancer setting. Overall-survival (rather than surrogate) endpoint data is structurally a higher evidentiary bar than a response-rate-only filing — noted here as a fact about trial design, not as a signal about the outcome of this particular review.