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GRACE THERAPEUTICS INC

2.22

-0.0400-1.77%

Post-market: 2.220.00000.00%19:30 EDT

Volume:716.52K

Turnover:1.68M

Market Cap:46.70M

PE:-1.85

High:2.46

Open:2.29

Low:2.20

Close:2.26

52wk High:5.18

52wk Low:1.79

Shares:21.04M

Float Shares:15.51M

Volume Ratio:3.18

T/O Rate:4.62%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-1.2003

EPS(LYR):-0.7916

ROE:-36.19%

ROA:-10.81%

PB:0.97

PE(LYR):-2.80

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Overview Company News Filings

Grace Therapeutics posts corporate presentation highlighting IV nimodipine candidate GTx-104 for aneurysmal subarachnoid hemorrhage

Press Release: Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update

Grace Therapeutics FY26 net loss narrows 18.55% to $7.79 million

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 posts corporate presentation highlighting IV nimodipine candidate GTx-104 for aneurysmal subarachnoid hemorrhage","url":"https://stock-news.laohu8.com/highlight/detail?id=2644859450","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644859450?lang=en_us&edition=fundamental","pubTime":"2026-06-18 20:43","pubTimestamp":1781786631,"startTime":"0","endTime":"0","summary":"Grace Therapeutics posts corporate presentation highlighting IV nimodipine candidate GTx-104 for aneurysmal subarachnoid hemorrhage. Grace Therapeutics highlighted GTx-104, an intravenous nimodipine candidate for aneurysmal subarachnoid hemorrhage, positioning it as a potential alternative to oral nimodipine.Phase 3 STRIVE-ON safety trial met its primary endpoint, showing 28% clinically significant hypotension with GTx-104 versus 35% with oral capsules.Trial data showed 54% of GTx-104 patients received at least 95% of prescribed dose intensity versus 8% for oral capsules.90-day outcomes showed a 29% relative increase in good recovery versus oral capsules; trial was not powered for statistical comparisons.FDA issued a Complete Response Letter in April 2026 citing CMC and manufacturing readiness; no clinical deficiencies identified; company plans an NDA resubmission.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strive","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:20260618:nNDL4wvMbX: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":"2644208337","title":"Press Release: Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update","url":"https://stock-news.laohu8.com/highlight/detail?id=2644208337","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644208337?lang=en_us&edition=fundamental","pubTime":"2026-06-18 20:00","pubTimestamp":1781784000,"startTime":"0","endTime":"0","summary":"Type A Meeting Scheduled with FDA to Potentially Clarify Path to GTx-104 NDA Resubmission. Phase 3 STRIVE-ON Safety Trial Data Presented at Multiple Medical Conferences. Company Continues Disciplined Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA. \"Since receipt of the U.S. Food and Drug Administration's  Complete Response Letter  in April 2026, we have been working diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission,\" said Prashant Kohli, CEO of Grace Therapeutics. \"FDA approval of our New Drug Application  for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard of care for these patients in more than 40 years. As evidenced by the response among researchers, practitioners and industry leaders to the presentation of our Phase 3 STRIVE-ON trial results at major medical conferences throughout the fiscal year, we believe the","market":"nz","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["RDI","CMC","BK4121","LU2746668974.SGD","IE00B1BXHZ80.USD","LU0149725797.USD","IE00BFMHRM44.USD","LU2237443549.SGD","LU2237443895.HKD","BK4588","LU0170899867.USD","BK4139","LABU","LU2237443622.USD","BK4585","IE00BZ1G4Q59.USD","LU0971096721.USD","LU0128526141.USD","IE00BKVL7J92.USD","BK4006","LU2237443382.USD","LU0882574139.USD","ICU","LU2237443978.SGD","BK4530","LU0757428866.USD","BK4082","LU0390134368.USD","BK4007","LU1815336091.USD","BK4108","CRL","BK4539","LU2746668461.USD","LU0029874061.USD","LENZ","LU0267386448.USD","LU1363072403.SGD","LU2237443465.HKD","GRCE","IE00BFXG1179.USD","IE00BHPRN162.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644408850","title":"Grace Therapeutics FY26 net loss narrows 18.55% to $7.79 million","url":"https://stock-news.laohu8.com/highlight/detail?id=2644408850","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644408850?lang=en_us&edition=fundamental","pubTime":"2026-06-18 19:32","pubTimestamp":1781782379,"startTime":"0","endTime":"0","summary":"Grace Therapeutics posted a fiscal 2026 net loss of USD 7.79 million, narrowing from the prior year; loss per share improved to USD 0.47.Research and development expense fell to USD 2.41 million from USD 9.51 million, while general and administrative expense rose to USD 8.67 million.Cash and cash equivalents ended March 31, 2026 at USD 16.98 million, down from USD 22.13 million a year earlier.The board decided not to resume internal funding for GTx-102 or GTx-101; it expects USD 9.2 million and USD 4.3 million impairment charges in fiscal 2027 Q1.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 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 via EDGAR, the Electronic Data Gathering, Analysis, and ","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:20260618:nNDL85QL6Q: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":"2630337399","title":"Grace 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":"nz","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":["BK4007","GRCE"],"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":["BK4588","LABU","BK4539","GRCE","BK4585","BK4007","BK4139","LENZ"],"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":["BK4588","LENZ","LABU","GRCE","BK4539","BK4139","BK4007","BK4585"],"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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