$OCGN

For the first time in its history, after breaking EMA21 it did a retest and bounced back. Again for the first time in its history, it may be able to clear Supertrend (black sell). It made an early breakout by getting above the red line. Next up is pushing through to trigger a BoS breakout and clear supertrend. It broke a small cup + handle at the bottom

There’s progress in Ocugen’s critical Phase 2/3 GARDian3 study for OCU410ST gene therapy for Stargardt disease. GARDian3 has a Phase 2/3 design that the FDA has accepted as a confirmatory “pivotal” study. The study plans to enroll a total of 51 patients, randomized 2:1 to a single subretinal injection arm of OCU410ST versus an untreated arm. The primary endpoint evaluates the change in lesion area at 12 months using fundus autofluorescence measurements.

Enrollment is targeted to be completed in Q1 2026, and an interim analysis is expected around mid-2026 once 50% of participants have completed at least 8 months of treatment.

If the interim data comes in positive, the possibility of a BLA filing for OCU410ST in 2027 comes onto the table.

On the Europe side, it’s noted that the EMA’s CHMP committee indicated that a single U.S. study could be sufficient for an MAA filing for the Stargardt indication.

For the GA (Geographic Atrophy) indication, full data from the mid-stage study for the OCU410 program is also expected to be announced in Q1 2026.

On the financial side, as of September 30, 2025, the company has $32.9 million in cash. In addition, $20 million was raised through a registered direct offering, and there is potential for an additional $30 million in gross proceeds if the warrants are exercised.

It’s stated that the company burns about $19.36 million in cash per quarter, the warrants have a $1.50 exercise price with a 2-year term, and it’s also noted that for OCU400’s Phase 3 program in retinitis pigmentosa, a rolling BLA process is planned in the first half of 2026, with top-line data targets in Q4 2026.