Pipeline Alert: enGene’s New CMO Means Big Regulatory Deals

🚀 Battle Card: enGene Holdings Inc.

• Hussein Sweiti, M.D., MSc, Chief Medical Officer · 🔗 [LinkedIn](https://www.linkedin.com/company/engene)

• With BLA submission for detalimogene slated 2H 2026, the new CMO must hit the ground running on FDA strategy and urologic oncology outreach → Source

• Urgent need for seasoned regulatory affairs expertise to lock in BLA timelines

• Demand for proven clinical trial partners to streamline LEGEND trial milestones

• Primary: Regulatory Strategy Suite → Mitigate FDA filing risks and accelerate approval

• Expansion: Clinical Development Platform → Boost trial enrollment speed and data quality

• HQ: Boston, MA & Montreal, QC

• Employees: ≈ 50

• Rev: ≈ $10 M

• Website: [engene.com](https://engene.com)

🤼 Competitive Intel

• [IQVIA](https://www.iqvia.com) — Clinical Development Outsourcing

• [Parexel](https://www.parexel.com) — Regulatory Affairs & Trials

• [ICON](https://www.iconplc.com) — ICH-GCP Compliant Trials

• [Covance](https://www.covance.com) — Early-Phase R&D Services

• [Korn Ferry](https://www.kornferry.com) — Executive Search

• [Russell Reynolds](https://www.russellreynolds.com) — Leadership Hiring

• [Spencer Stuart](https://www.spencerstuart.com) — Life Sciences Recruitment

✅ Do-Now Checklist

🧠 Copy My Prompt for Personalized Cold Outreach

────────────────────────────
✏️ YOUR COMPANY
────────────────────────────
OUR_COMPANY   = ❑❑
OFFER_BRIEF   = ❑Regulatory Strategy Suite❑
PROOF_METRIC  = ❑secured FDA approval❑
CTA_STYLE     = ❑quick_call❑
TONE          = ❑friendly❑

────────────────────────────
📌 TARGET COMPANY
────────────────────────────
NAME        = Hussein
COMPANY     = enGene Holdings Inc.
DEPT        = Medical
SIZE        = ≈3
BOTTLENECK  = regulatory bottleneck
EVENT       = new CMO appointment
DETAIL      = CMO appointment
PAIN        = need for regulatory and trial partners
SRC         = http://cts.businesswire.com/ct/CT?id=ftfLlWd9aZbF2NXfwppam3Bd664=&newsLang=en&newsId=20250930030471&div=41152219
SIM_CO      = J&J
WIN_METRIC  = FDA approval
NEXT_SIZE   = ≈5
EMP_EST     = ≈50
REV_EST     = ≈10M

────────────────────────
TASK FOR CHATGPT
────────────────────────
Role: “NewsletterForLeads SDR-Assist”.

Validate any ≈ guesses via SRC.

EMAIL  (keep breaks):
Subject: ≈3-person Medical

Hussein—noticed your Medical team is ≈3.

That’s when regulatory bottleneck slows growth.

We helped J&J fix this with Regulatory Strategy Suite.

Result: FDA approval.  
Quick call?

PS—next bottleneck hits ≈5.

DM ≤45 words, TONE:
Saw your post about CMO appointment — need for regulatory and trial partners.  
Regulatory Strategy Suite. secured FDA approval.  
Quick chat?