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GRACE THERAPEUTICS INC

2.17

-0.0259-1.18%

Volume:68.33K

Turnover:148.29K

Market Cap:45.73M

PE:-1.81

High:2.23

Open:2.23

Low:2.13

Close:2.20

52wk High:5.18

52wk Low:1.79

Shares:21.04M

Float Shares:15.51M

Volume Ratio:1.04

T/O Rate:0.44%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-1.2003

EPS(LYR):-0.7916

ROE:-36.19%

ROA:-10.81%

PB:0.95

PE(LYR):-2.75

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Overview Company News Filings

Grace Therapeutics publishes corporate presentation on GTx-104 IV nimodipine for aSAH

Grace Therapeutics Shares Fall After FDA Flags Issues in Aneurysm Treatment Application

Grace Therapeutics issued Complete Response Letter from FDA

US FDA declines to approve Grace Therapeutics' drug for a type of stroke

Grace Therapeutics, Inc - FDA Issues Complete Response Letter for Gtx-104 Nda

THOMSON REUTERS

Grace Therapeutics, Inc - Cited Items Include Leachables Data, Toxicology Assessments, Manufacturing Deficiencies for Gtx-104

THOMSON REUTERS

Grace Therapeutics Provides Regulatory Update on New Drug Application for Gtx-104

THOMSON REUTERS

Grace Therapeutics, Inc: Company Intends to Resubmit Application Following Resolution of Cited Items

THOMSON REUTERS

FDA issues complete response letter for Grace Therapeutics’ GTx-104 NDA

Grace Therapeutics, Inc trading halted, news pending

NASDAQ TRADE HALT HALT NEWS PENDING AT 12:27 PM

BUZZ-U.S. STOCKS ON THE MOVE-Tesla, Nano-X, Travere

BUZZ-Grace Therapeutics rises after late‑stage win for brain bleeding drug

Grace Therapeutics to present Phase 3 STRIVE-ON GTX-104 safety trial results at AAN 2026

Grace Therapeutics Announces Abstract Highlighting Strive-on Phase 3 Trial Results Accepted for Presentation at Aan 2026

THOMSON REUTERS

Grace Therapeutics to present GTx-104 aSAH data at two medical conferences

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Therapeutics publishes corporate presentation on GTx-104 IV nimodipine for aSAH","url":"https://stock-news.laohu8.com/highlight/detail?id=2630337399","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630337399?lang=en_us&edition=fundamental","pubTime":"2026-04-27 20:15","pubTimestamp":1777292121,"startTime":"0","endTime":"0","summary":"Grace Therapeutics highlighted FDA complete response letter for GTx-104, an intravenous nimodipine candidate for aneurysmal subarachnoid hemorrhage.Company framed letter as driven by CMC package completeness and manufacturing readiness, citing no clinical deficiencies.Grace plans to resubmit NDA once cited items are resolved, with work focused on leachable data, nonclinical assessment tied to that dataset, and CDMO remediation.Phase 3 STRIVE-ON trial met primary safety endpoint, with clinically significant hypotension in 28% of GTx-104 patients versus 35% on oral nimodipine.Presentation also cited 90-day outcomes, including a 29% relative increase in good recovery and 54% of GTx-104 patients achieving at least 95% relative dose intensity versus 8% for oral nimodipine.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purpos","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260427:nNDL3h64Wc:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["GRCE","BK4007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629585227","title":"Grace Therapeutics Shares Fall After FDA Flags Issues in Aneurysm Treatment Application","url":"https://stock-news.laohu8.com/highlight/detail?id=2629585227","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629585227?lang=en_us&edition=fundamental","pubTime":"2026-04-24 02:56","pubTimestamp":1776970560,"startTime":"0","endTime":"0","summary":"Grace Therapeutics shares tumbled after regulators told the company that the application for its aneurysm treatment could not be approved in its current form.The stock slid nearly 50%, to $2.21. Shares at one point during Thursday's session touched a 52-week low of $1.79. Year to date, shares have lost 40% of their value.The Food and Drug Administration sent the biopharma company a Complete Response Letter for its GTx-104 treatment, which is designed to address medical needs in aneurysmal subarachnoid hemorrhage, a brain injury with a high death rate.The FDA referenced certain items in the chemistry, manufacturing and controls, and non-clinical sections of the drug application that still need work. Grace said it believes it can address the issues in a resubmission of the application.The flagged issues are related to leachables data for product packaging, non-clinical product toxicology risk assessments and product manufacturing deficiencies at the company's manufacturing site, the comp","market":"other","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","BK4585","GRCE","LENZ","BK4139","BK4539","BK4588","LABU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629851715","title":"Grace Therapeutics issued Complete Response Letter from FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2629851715","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629851715?lang=en_us&edition=fundamental","pubTime":"2026-04-24 01:21","pubTimestamp":1776964886,"startTime":"0","endTime":"0","summary":"Grace Therapeutics (GRCE) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company’s New Drug App...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/grace-therapeutics-issued-complete-response-letter-from-fda-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/grace-therapeutics-issued-complete-response-letter-from-fda-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["GRCE","BK4539","LENZ","BK4585","LABU","BK4588","BK4007","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629276851","title":"US FDA declines to approve Grace Therapeutics' drug for a type of stroke","url":"https://stock-news.laohu8.com/highlight/detail?id=2629276851","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629276851?lang=en_us&edition=fundamental","pubTime":"2026-04-24 01:19","pubTimestamp":1776964775,"startTime":"0","endTime":"0","summary":"US FDA declines to approve Grace Therapeutics' drug for a type of strokeApril 23  - Grace Therapeutics GRCE.O said on Thursday the U.S. Food and Drug Administration declined to approve its drug for a rare type of stroke.  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to seek regulatory approval and will present full data at a neurology conference later this month** As of last close, stock up ~8% YTD  ","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260414:nL4N40X19G:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","GRCE"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2627451774","title":"Grace Therapeutics to present Phase 3 STRIVE-ON GTX-104 safety trial results at AAN 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While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Grace Therapeutics Inc. published the original content used to generate this news brief on March 19, 2026, and is solely responsible for the information contained therein.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260319:nNDL55h2sS:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["GRCE","BK4007"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":2,"pageCount":2,"totalSize":36,"code":"91000000","status":"200"}]}}