RGNX News - Candlesense

Regenx Provides Bi-Weekly Update on Status of Management Cease Trade Order

Regenx confirms audit underway, filings expected Sept 29, 2025; no material changes or financial concerns to report.

2 days ago

REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approved Commercial launch pla...

What are the risks to the commercial launch timeline and reimbursement landscape if the BLA is not approved on the first submission? What is the potential market size and pricing power for a one‑time gene therapy for Hunter syndrome compared to existing treatments and pipeline competitors? How will the FDA review extension and upcoming data presentation affect RGNX's short‑term price volatility?

Clinical trials

4 days ago

Regenx Provides Bi-Weekly Update on Status of Management Cease Trade Order

Regenx provides bi-weekly update on MCTO status; expects to file 2025 Annual Filings by September 29. No material changes or defaults reported.

What are the broader regulatory implications if the 2025 Annual Filings are delayed beyond the September 29 deadline? Is there any historical precedent for how RGNX’s stock has responded to previous MCTO status updates? What market participants (e.g., institutional investors, short‑sellers) are likely to react to this filing timeline and status report?

Regulation

15 days ago

REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE® trial data demonstrate a durable safety and effic...

What are the potential upside and downside scenarios for RGNX based on the upcoming pivotal trial outcomes? How does the suprachoroidal delivery platform differentiate RGNX from other gene‑therapy companies pursuing ocular indications? What is the likely impact on RGNX's valuation multiples (e.g., EV/Revenue, P/E) if the trial meets its primary endpoints?

Clinical trials

16 days ago