FDA Issues Complete Response Letter for GTx-104 Application

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: 2 days ago

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GRCE-45.48%

Should l Buy GRCE?

Source: Newsfilter

FDA Response Letter: The FDA issued a Complete Response Letter for Grace Therapeutics' GTx-104 New Drug Application, citing issues in Chemistry, Manufacturing, and Controls (CMC) and non-clinical information, although no additional clinical data was requested, indicating the rigor of regulatory scrutiny.
Company's Action Plan: Grace Therapeutics intends to resubmit its application after addressing the cited issues and plans to request a Type A meeting with the FDA to clarify the path forward, demonstrating the company's ongoing commitment to product approval.
Clinical Trial Results: In the STRIVE-ON trial, GTx-104 showed a 19% improvement in reducing clinically significant hypotension events compared to oral nimodipine's 28%, supporting the clinical efficacy of GTx-104 and potentially changing the standard of care for aSAH patients.
Market Potential: Potential FDA approval of GTx-104 would represent the first significant innovation in aSAH treatment in over 40 years, which could provide substantial market opportunities and competitive advantages for the company by addressing significant unmet medical needs.

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About GRCE

Grace Therapeutics, Inc. is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Its novel drug delivery technologies have the potential to improve the performance of marketed drugs by achieving faster onset of action, and reduced side effects. Its lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. The nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. Its other pipeline includes GTX-102, which is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (AT) in a pediatric population and GTx-101, which is a topical administration via a bioadhesive, film-forming polymer, for the treatment of pain associated with postherpetic neuralgia.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Grace's Drug FDA Rejection Leads to Stock Plunge

1 day agostocktwits

FDA Rejection: Grace Therapeutics' application for GTx-104 to treat aneurysmal subarachnoid hemorrhage was rejected by the FDA due to issues in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, resulting in a 49% drop in stock price this week, marking its worst performance since September 2020.
Analyst Downgrades: Craig-Hallum cut its price target for Grace from $11 to $4 while maintaining a 'Buy' rating, believing the company has enough runway to address the FDA's deficiencies, although shares are unlikely to recover until more visibility is provided.
Management's Response: CEO Prashant Kohli expressed confidence in the robust data package supporting their NDA submission and stated that the CMC issues identified by the FDA can be successfully addressed in a resubmission, with plans to meet with the FDA to clarify resubmission timelines.
Retail Investor Sentiment: Despite the stock's decline, retail sentiment on Stocktwits remained 'bullish', with users highlighting that the FDA's cited issues are fixable and expecting a rebound, indicating market confidence in the company's future prospects.

Grace Therapeutics Faces FDA Rejection for New Drug Application

1 day agoNASDAQ.COM

FDA Complete Response Letter: Grace Therapeutics' New Drug Application for GTx-104 was rejected by the FDA due to issues in chemistry, manufacturing, and controls (CMC) and non-clinical sections, hindering progress in treating aneurysmal Subarachnoid Hemorrhage (aSAH).
Clinical Trial Data: GTx-104 demonstrated clinical benefits in the Phase 3 STRIVE-ON trial, showing a 19% reduction in the incidence of clinically significant hypotension compared to oral Nimodipine, providing supportive data for future applications.
Death Event Analysis: The GTx-104 group reported 8 deaths compared to 4 in the oral Nimodipine group, with all deaths attributed to the severity of underlying conditions, which may still impact the FDA's safety assessment of the drug.
Next Steps: The company intends to resubmit the application after addressing the FDA's concerns and plans to request a Type A meeting with the FDA to clarify the path forward, demonstrating its ongoing commitment to drug development.

FDA Rejects Grace Therapeutics Drug Application

1 day agostocktwits

FDA Rejection: The U.S. FDA rejected Grace Therapeutics' drug application for GTx-104, citing issues in Chemistry, Manufacturing, and Controls (CMC) and non-clinical sections, resulting in a 45% drop in the company's stock on Thursday.
No Additional Clinical Data Required: Although the FDA issued a complete response letter highlighting concerns over leachables data and manufacturing deficiencies, it did not request additional clinical data, indicating that the results from the Phase 3 trial remain recognized.
Positive Market Reaction: On Stocktwits, retail sentiment around GRCE stock shifted from 'neutral' to 'bullish' in the past 24 hours, with message volume increasing from 'normal' to 'high', reflecting investor confidence in the company's future.
CEO's Optimistic Outlook: CEO Prashant Kohli expressed confidence in the robust data package supporting the NDA submission and believes that the identified CMC issues can be successfully addressed in a resubmission, with plans to meet with the FDA to determine next steps.