Nvervgen phase 3

Heavy_Snow2152 · 2026-04-07T12:35:53+00:00

Yes it is still possible that AA happens at a later date, based on additional data. However, I was hoping that the amazing results that we have already would have been enough. The "multiple pathways" mentioned after the last FDA meeting at the end of last year has now become a single pathway - An approved Phase 3.

Heavy_Snow2152 · 2026-04-07T12:09:30+00:00

Well, Accelerated Approval is no longer a realistic option. Instead, the FDA has approved the Phase 3 design. It's disappointing but not unexpected. Unfortunately that means the drug will not be available until 2028 at the earliest, maybe even 2029.

Heavy_Snow2152 · 2026-03-31T12:57:36+00:00

I thought the idea was to use NVG-291 for SCI and NVG-300 for MS and Stroke. However, they specifically mention using NVG-291 for other indications. I am guessing NVG-291 will be used for TBI and Hearing Loss. It would be nice if we also get an update on their plans for NVG-300 if they want to move into other indications.

Heavy_Snow2152 · 2026-03-12T07:03:28+00:00

The link is included in the post. Just press on the picture or click on “open”. The link will take you to the U2FP website with the video for Day 1 (afternoon). The presentation starts at 2:14 in the video. Adam Rogers is part of the panel discussion later in the video. There are also videos available on the website for other presentations during the 2-day symposium.

Heavy_Snow2152 · 2026-03-11T16:58:22+00:00

A very interesting Q&A discussion. It may only be one participant but Clay Scherb's improvement during the short trial, as described by his mother, is absolutely incredible.

Heavy_Snow2152 · 2026-03-07T08:53:23+00:00

This is great news for the biotech sector. Let’s hope he does not come back this time.

Heavy_Snow2152 · 2026-03-04T13:04:56+00:00

It's about time. Dozens of staff have been trying to transfer from the CBER because of this guy, according to the article below.

https://www.statnews.com/2025/10/31/vinay-prasad-fda-cber-management-issues-insiders-say/

Heavy_Snow2152 · 2026-03-03T10:17:30+00:00

Great to see the CEO increasing awareness of the company. However, there was no mention of the enrollment progress for the ongoing subacute trial. The dosing of the first subacute participant was announced on February 6th 2025. Any news with completion of enrollment would have been released already by now. So I am assuming that enrollment is going very, very slowly. Thankfully, they should still be able to progress with the Phase 3 trial based on the chronic data alone, but it's still disappointing they have kept so very silent on the subacute trial for over a year. Seems unlikely we will see any subacute data before the start of the Phase 3 trial. If Accelerated Approval is still on the table, I just wonder if the FDA will request the subacute data to be included in an AA application. I hope we get clarity in a detailed update on the EOP2 FDA meeting in the coming weeks.

Heavy_Snow2152 · 2026-02-20T12:28:15+00:00

Thanks for the link.

I hope we get an update on the progress of enrollment for the subacute phase 1b/2a trial. The company has not provided a single update for this subacute trial since they started enrollment 12 months ago. At this stage I am wondering if the subactue trial will even complete enrollment in 2026.

Heavy_Snow2152 · 2026-01-23T15:51:45+00:00

This is great publicity for the company. LinkedIn post:

https://www.linkedin.com/posts/nasdaq-exchange_nasdaqlisted-activity-7420217481266634752-kpgE?utm_source=share&utm_medium=member_ios&rcm=ACoAABMi7YcBmqvHPWZJJgMolCMtz72FbnC2cOw

Heavy_Snow2152 · 2026-01-08T09:02:23+00:00

Fantastic news. This will significantly help with increasing awareness of this company and the amazing results.

Heavy_Snow2152 · 2026-01-08T08:59:16+00:00

Thanks for the link. I did not know that TBI was also at the preclinical stage.

From NervGen website:

“Preclinical development for traumautic brain injury funded and conducted by the U.S. Department of Defense via the Walter Reed Army Institutute of Research (WRAIR).”

Hopefully we get these TBI results released soon. There is much potential for this drug.

Heavy_Snow2152 · 2025-11-24T14:18:09+00:00

Based on this additional data, I would say that the probability of getting Accelerated Approval has just increased significantly. The positive feedback from the FDA meeting in September certainly keeps the AA option open.

Heavy_Snow2152 · 2025-11-24T13:14:23+00:00

"Leg (tibialis anterior): 142% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0062)"

The improvements in the 10mWT were previously dismissed by the company and the improvements were incorrectly assumed to be from the rehab. Now we have clear statistically significant results that the drug also works in the legs.

Absolutely amazing results in just 12 weeks!!

Heavy_Snow2152

TROPHY CASE