Dikaia Regulatory Briefing
47 binary catalysts. 91 days. Six agencies. This is every regulatory date in Q2 2026 that creates a definitive before and after.
This is my first calendar. I track the machinery of governance that moves markets — the precise dates when decisions become facts. No analysis. No predictions. Just the when, the who, and the what's at stake.
Q2 2026 is unusually dense. The tariff architecture is in transition. The FDA pipeline is loaded. A spectrum auction returns after a four-year gap. And the Hormuz crisis has injected geopolitical binaries into every sector.
This Week: March 31 – April 6
Orforglipron — Eli Lilly ($LLY)
First oral GLP-1 receptor agonist for obesity. If approved, it breaks Novo Nordisk's injectable monopoly. The biggest pharma binary of Q2. Peak sales estimates: $25B+.
Orca-T — Orca Bio
Allogeneic cell therapy for AML, ALL, MDS. Significant survival data vs. conventional transplant. Private company — watch for IPO filing on approval.
Trump Hormuz Deadline for Iran
Administration deadline for Iran to reopen Strait. WSJ reports Trump may accept closed Hormuz; social media threatens infrastructure destruction. Compound binary with NFP reaction (market closed Apr 4, reopens Apr 7). Brent at $112.
The Full Q2 Calendar
Every confirmed date, organized by week. Dates marked ● are high-impact binaries. Dates marked ● are standard catalysts.
April 2026
| Date | Agency | Event | Tickers |
|---|---|---|---|
| ● Apr 1 | FDA | Orforglipron NDA — oral GLP-1 for obesity | LLY, NVO |
| ● Apr 6 | FDA | Orca-T BLA — allo cell therapy (AML/ALL/MDS) | ORCA (pvt) |
| ● Apr 6 | Geopolitical | Trump Hormuz deadline — Iran reopen or escalation | XOM, CVX, COP |
| ● Apr 8 | FCC | AWS-3 spectrum auction — upfront payments due | T, TMUS, VZ |
| ● Apr 9 | FDA | RVT-2001 NDA — Alzheimer's disease | ROIV |
| ● Apr 10 | EPA | RMP rollback comment period closes | Chemical sector |
| ● Apr 11 | FDA | AQST-109 NDA — epinephrine oral film | AQST |
| ● Apr 13 | FDA | Sparsentan sNDA — FSGS (rare kidney) | TVTX |
| ● Apr 15 | USTR | Section 301 written comments deadline — industrial overcapacity + forced labor | Broad imports |
| ● Apr 23 | FDA | GTx-104 NDA — IV nimodipine for aSAH | GRCE |
| ● ~Late Apr | CBP/CIT | CAPE tariff refund system launch — $166B IEEPA refund begins | All importers |
| ● Apr 28 | FDA | Doravirine/Islatravir NDA — HIV (Merck) | MRK |
| ● Apr 30 | FDA/ODAC | Camizestrant AdCom — HR+/HER2– breast cancer (morning) + Capivasertib AdCom — mHSPC (afternoon) | AZN |
| ● Apr 30 | FDA | AXS-05 sNDA — Alzheimer's agitation | AXSM |
| ● ~Apr 30 | USTR | Special 301 Report — annual IP enforcement review | IP-intensive |
May 2026
| Date | Agency | Event | Tickers |
|---|---|---|---|
| ● May 5–8 | USTR/ITC | Section 301 public hearings — industrial overcapacity (16 countries) | Broad industrials |
| ● May 9 | FDA | ATA188 BLA — progressive multiple sclerosis | ATRA |
| ● May 15 | SEC | 13F filing deadline — Q1 2026 institutional holdings disclosed | All institutional |
| ● May 15 | FDA | Avutometinib NDA — low-grade serous ovarian cancer | VSTM |
| ● May 24 | FDA | Leqembi SC sBLA — subcutaneous Alzheimer's starting dose | BIIB, ESALY |
| ● May 29 | FDA | Afrezza pediatric sNDA — inhaled insulin | MNKD |
June 2026
| Date | Agency | Event | Tickers |
|---|---|---|---|
| ● Jun 2 | FCC | AWS-3 spectrum auction opens — first FCC auction since 2022 | T, TMUS, VZ |
| ● Jun 5 | FDA | Vepdegestrant NDA — ER+/HER2– breast cancer (protein degrader) | ARVN, PFE |
| ● Jun 10 | FDA | Camizestrant NDA — HR+/HER2– breast cancer | AZN |
| ● Jun 12 | FDA | Tipifarnib NDA — HRAS-mutant HNSCC (Breakthrough Therapy) | KURA |
| ● Jun 18 | FDA | Tebipenem PDUFA — first oral carbapenem antibiotic | SPRO |
| ● Jun 20 | FDA | Cytisinicline NDA — first new smoking cessation drug in 20 years | ACHV |
| ● Jun 26 | FCC | AWS-3 statutory hard deadline (One Big Beautiful Bill Act) | T, TMUS, VZ |
| ● ~Jun | EPA | PFAS Reporting Rule final rule expected | MMM, chemicals |
The Three Structural Binaries
Three events in Q2 don't just move prices — they change the rules.
Trade Architecture
The $166B IEEPA Refund
The Supreme Court ruled IEEPA doesn't authorize tariffs. CBP's CAPE system launches ~late April to process $166 billion in refunds to 330,000+ importers. Every public company that passed tariff costs through to consumers now faces class action exposure. Morgan Lewis reports plaintiff demand letters already circulating.
Spectrum
AWS-3: First Auction in Four Years
The FCC returns to spectrum auctions on June 2 after a four-year hiatus. 200 AWS-3 licenses. The licenses were returned by EchoStar after an improper bidding credits finding. AT&T, T-Mobile, and Verizon are the probable bidders. Statutory deadline: June 26.
Pharma
The 2026 Patent Cliff
$21B+ in annual revenue faces generic entry this year. Eliquis ($11B, BMS/Pfizer), Januvia ($3.7B, Merck), Xarelto ($4B, J&J/Bayer), Xeljanz ($2B, Pfizer). The steepest single-year patent cliff in pharmaceutical history. Generic entry dates land throughout Q2–Q3.
The Tariff Transition Timeline
The U.S. tariff regime is in an unprecedented legal and procedural transition. Here are the hard dates:
What I'm Watching
Five items I'll track closely and update as they develop:
- Iran's Hormuz Management Plan implementation date. Parliament's Security Committee approved it March 30. The full vote and effective date will be a hard binary for every energy-exposed name.
- CAPE system go-live. The $166B IEEPA refund process. Currently targeted for ~45 days after the March 6 CIT order. The class action exposure for pass-through importers is the hidden second-order catalyst.
- Orforglipron PDUFA outcome. An oral GLP-1 approval restructures the entire obesity therapeutics market. Rejection or CRL would be the biggest biotech catalyst of the year.
- Section 301 remedy determinations (~July 24). The replacement tariff architecture. What comes after Section 122 determines the trade regime for the rest of this administration.
- AWS-3 auction dynamics. Who bids, how aggressively, and whether the statutory deadline creates pricing pressure. The first spectrum auction in four years will signal the telecom capex cycle.
This calendar will be updated as dates are confirmed, postponed, or resolved. Dates sourced from FDA.gov, USTR.gov, FCC.gov, EPA.gov, SEC.gov, company press releases, and CIT filings. Cross-referenced with ChrysosAI network research.