Taysha Gene Therapies Inc (TSHA)

Taysha Advances Rett Syndrome Programme as Pivotal Trial Enrollment Completes (TSHA)June 22, 2026 8:56 AM
IH Market News Taysha Gene Therapies Inc (NASDAQ:TSHA) shares rose 3.6% in premarket trading on Monday after the company announced the completion of patient dosing in its pivotal Rett syndrome study and released updated long-term clinical data for its lead gene therapy candidate, TSHA-102. The biotechnology company said the latest results continue to support the therapy’s safety profile and demonstrate sustained functional improvements in treated patients. Pivotal REVEAL Trial Reaches Key Milestone Taysha confirmed that all 17 patients enrolled in the pivotal portion of its REVEAL study have now received treatment with TSHA-102. The trial is evaluating the gene therapy as a treatment for Rett syndrome, a rare neurodevelopmental disorder. The company expects to report topline findings from a six-month interim analysis during the first half of 2027 and anticipates receiving feedback from the U.S. Food and Drug Administration regarding the Biologics License Application (BLA) pathway during the same period. Safety Profile Remains Encouraging As of the June 2026 data cutoff, TSHA-102 continued to demonstrate a favourable safety profile across both the Phase 1/2 and pivotal portions of the REVEAL programme. The company reported no treatment-related serious adverse events and no dose-limiting toxicities among the 29 patients treated to date. Management said the results reinforce confidence in the therapy as development progresses toward potential regulatory submission. Patients Show Meaningful Functional Improvements Data from the REVEAL Part A study showed that all patients aged between six and 21 years either gained or regained at least one developmental milestone within 12 months of treatment. Across the 12 patients followed for at least one year, researchers recorded a total of 310 functional improvements, averaging approximately 26 gains per patient. These included 31 developmental milestones as well as 279 additional improvements in skills and day-to-day functioning. Benefits Continue to Deepen Over Time According to the company, longer-term follow-up suggests that the treatment effect continues to strengthen beyond the initial months following administration. Functional gains accumulated across multiple core disease areas, with developmental milestone improvements increasing by 69% between six and 12 months after treatment and by 94% between six months and the longest follow-up periods reported. The findings suggest TSHA-102 may deliver durable benefits that continue to evolve over time. Additional Trial Progress Supports Regulatory Plans Taysha also announced progress in its ASPIRE study, which enrolled four patients aged between two and five years and exceeded its original enrollment target. The company expects to complete dosing in the ASPIRE trial during July 2026. In addition, Taysha anticipates completing the Process Performance Qualification campaign required to support a future BLA submission for TSHA-102 in the fourth quarter of 2026. The milestones are expected to support the company’s broader regulatory strategy as it advances the programme toward potential approval. The post Taysha Advances Rett Syndrome Programme as Pivotal Trial Enrollment Completes (TSHA) appeared first on US Editors. Original: Taysha Advances Rett Syndrome Programme as Pivotal Trial Enrollment Completes (TSHA)

TSHA...............................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

At least someone payed attention

At least someone payed attention

You are the one that got me intrigued by it, its never too late to improve your skill esp when trading is self taught, you need every edge you can get.. thanks

Never heard ya talk about weekly’s until I brought the importance of that time frame. Nobody on this site even heard of the cloud until I started talking.
Carry on!!!

Never heard ya talk about weekly’s until I brought the importance of that time frame. Nobody on this site even heard of the cloud until I started talking.
Carry on!!!

Hey T, I have always been a successful chartist for just over a decade now but I first discovered incorporating Ichimoku, w/the Tenkan-Sen conversion, Kijun-Sen base, Senkou Span A, Senkou Span B, and Chikou lagging Span when you posted about it. I decided to research it and hone my skill further, esp because it was Japanese, the Japanese are pioneers in many things

This was one of the key tutorials I used and started with a few years ago

Where did ya learn those skills. Remember when you nothing about charts

THSA great news this morning and very explosive monthly break out chart full weekly breakout over the cloud plus the largest daily volume in the stocks history already $TSHA $9.00 This is the PT esp on that FDA news today - this is there Baby/bread & butter
Piper Sandler Maintains a Buy on (TSHA), Sets a PT of $9 - Huge break out on the monthly chart!! Shorts WILL get decimated her if they dont cover https://t.co/mcShEKOpt7 pic.twitter.com/v7Qyq6bl83— TheTradingLounge (@ThePennyLounge) October 2, 2025

TSHA..........................................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome
Breakthrough Therapy designation granted based on FDA’s review of available clinical evidence of safety and efficacy from all 12 patients treated in Part A of the REVEAL Phase 1/2 trials

Finalized FDA alignment on REVEAL pivotal trial protocol and SAP following resolution of remaining clinical and statistical queries to IND application amendment; on track to begin patient enrollment in Q4 2025

Key pivotal trial design elements remain unchanged, including 6-month interim analysis to potentially expedite BLA submission based on the rigorous developmental milestone evaluation in Part A showing an unprecedented response rate at 6 months post-TSHA-102 that deepened over time

DALLAS, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TSHA-102, an intrathecally delivered AAV9 gene therapy with disease modifying potential, for the treatment of Rett syndrome. Additionally, the Company announced that it has finalized alignment with the FDA on the REVEAL pivotal trial protocol and statistical analysis plan (SAP) that are intended to support the planned Biologics License Application (BLA) submission for TSHA-102, following the resolution of remaining clinical and statistical queries.

Breakthrough Therapy designation and finalized FDA alignment on the pivotal trial protocol and SAP were based on the FDA’s review of positive clinical evidence from Part A of the REVEAL Phase 1/2 adolescent/adult and pediatric trials.

Breakthrough Therapy Designation Granted by FDA for TSHA-102 in Rett Syndrome

The FDA grants Breakthrough Therapy designation to expedite the development and regulatory review of an investigational therapy intended to treat a serious condition. A drug is eligible for this designation if it demonstrates preliminary clinical evidence of substantial improvement over available treatments in one or more clinically significant endpoints.

Clinical evidence supporting Breakthrough Therapy designation for TSHA-102 included previously disclosed Part A REVEAL clinical data demonstrating a generally well-tolerated safety profile and a 100% response rate post-TSHA-102 (May 2025 data cutoff) for the pivotal trial primary endpoint of the gain/regain of ≥ one defined developmental milestone, with

So strong 🎅

TSHA...........................................p/m

TSHA...........................................a/h

TSHA........................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA...............................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

tsha................................................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA...$1.53... 🥳... https://finviz.com/insidertrading.ashx?oc=1494695&tc=7 ...Bullish Harami Cross Reversal Pattern...

tsha..........................https://stockcharts.com/h-sc/ui?s=tsha&p=W&b=5&g=0&id=p86431144783

TSHA, under $2

TSHA.....................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA..............https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA...$2.58...Off the $2.10 Alert...🥳

georgie18

Member Level
Re: georgie18 post# 85

Tuesday, November 12, 2024 3:56:56 PM

Post#
89
of 90
TSHA...$2.41...🥳...on the $2.10 gapper alert...All out for now...will revisit...

georgie18

Member Level
Re: None

Monday, November 11, 2024 5:18:23 PM

Post#
664504
of 664675
TSHA...$2.10... https://schrts.co/KsMDABsM ...Psar flipped Bullish...🥳Should be a gapper in the morning...

TSHA............................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA...$2.41...🥳...on the $2.10 gapper alert...All out for now...will revisit...

georgie18

Member Level
Re: None

Monday, November 11, 2024 5:18:23 PM

Post#
664504
of 664675
TSHA...$2.10... https://schrts.co/KsMDABsM ...Psar flipped Bullish...🥳Should be a gapper in the morning...

restart soon

TSHA....................................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA.................https://stockcharts.com/h-sc/ui?s=TSHA&p=W&b=5&g=0&id=p86431144783

TSHA...$2.10... https://schrts.co/KsMDABsM ...Psar flipped Bullish...🥳Should be a gapper in the morning...

I sent an email to TSHA IR on 11/5 asking if they could explain the sharp drop (at that time) and high volume in the stock. I did not receive an answer.

Premiums were high all last week and today on TSHA call options. Volume in the common has been high as well.

I was thinking the same thing, it started to pop in the afternoon and now it took off after hours

What is going on with TSHA in the AH today? Up sharply - now 2.10

TSHA under $3

TSHA under $3

Started buying shares last year at .77 Riding the houses money now and sold three quarters of my shares at $4.00 range when I saw the double top formation come into play I can see this going to $8.00-$10.00 only on a buyout in the next year. Risky with only a handful of patients dosed and the competition for Rhett but a cunning bet with the management at TSHA. now.
CEO and CMO are best in class. Not a core position but glad I'm in with a few. I hope they have a remedy for these poor kids with Rhett.

$TSHA

If these are senior people in prominent management or technical roles it is pretty standard for them to be granted options as part of their compensation package. They vest over 4 years, so it is not an outright giveaway.

Additionally, since these are NEW employees, by definition they have not manipulated the stock down to get a lower option strike price.

I am fine with this very normal comp package.

I'm sorry but granting options to NEW employees is absurd - they shouldn't be entitled to stock options UNTIL their one year on the job.

No wonder why this has trouble making gains for shareholders whom the employees actually work for.

Weird. Both TSHA and NGNE have gene therapy candidates for Rett and both of them tanked today, despite sharing strong interim results. There's an International Rett Syndrome Foundation meeting today and tomorrow, so I wonder if something happened there to take the wind out of the gene therapy treatment class. Anyone have any knowledge here?

Diluted on news

Ouch - what happen?

TSHA...GAPPING

Yes, no sorry, didn’t mean to imply that. I was asking if you have other bio names you have on your radar (obviously know about this and Huma). Thanks

chart has nothing to do with what sector!!

You have the bios nailed down! Any I should put on my radar? As always, thank you as I sincerely appreciate your help and knowledge. Thanks!

TSHA BREAK OUT

TSHA new 52 week high

TSHA...HERES 4 DOLLA

TSHA...READY FOR 4