$2.120
-0.039 (-1.85%)At close
GRCE News
GRCE Events
Selling Stockholders Plan to Sell 4.76M Shares of Common Stock
This filing relates to the offer and sale from time to time by the selling stockholders of up to 4.76M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
Company Initiates Dual-Source Manufacturing Strategy for GTx-104
In parallel, the company has initiated a dual-source manufacturing strategy for GTx-104 to mitigate potential remediation issues from the company's current contract manufacturer and provide flexibility. As such, a technology transfer to a second, U.S.-based contract manufacturer is already underway. The timing of new drug application, or NDA, resubmission will reflect the manufacturing pathway that reaches readiness first: either the U.S.-based facility, which would require completion of a full chemistry, manufacturing, and controls package supported by 12 months of stability data following the technology transfer; or the company's current contract manufacturer, if it successfully remediates its FDA compliance issues and is able to support the NDA sooner. The company is also advancing efforts to address the remaining CMC and non-clinical items identified in FDA's Complete Response Letter to the NDA, though the company expects that manufacturing readiness, rather than these items, will be the key driver of NDA resubmission timing.
Grace Therapeutics Completes $10M Private Placement Financing
Grace Therapeutics announced that it has entered into a securities purchase agreement for a private placement financing with new and existing fundamental investors. The financing is expected to result in aggregate gross proceeds to the company of approximately $10M, before deducting placement agent fees and other offering expenses. The company intends to use the net proceeds from the financing to support the manufacturing and regulatory work needed to advance GTx-104. Pursuant to the terms of the securities purchase agreement, Grace Therapeutics will issue an aggregate of 4.762M shares of common stock at a price of at $2.10 per share. The private placement is being priced at-the-market under the rules of the Nasdaq Stock Market. The financing is expected to close on August 6, subject to the satisfaction of customary closing conditions. The company expects the net proceeds from the private placement, together with existing cash and cash equivalents, to extend the company's cash runway to the end of calendar 2028. Craig-Hallum is acting as the sole placement agent for the private placement.
Grace Therapeutics Receives FDA Meeting Minutes
Grace Therapeutics announced receipt of the FDA meeting minutes from a Type A meeting held with the FDA to discuss the complete response letter, or CRL, issued on April 23. The minutes constitute the official record of the Type A meeting. As previously disclosed, the CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The items cited by the FDA relate to the current good manufacturing practice compliance status of the Company's contract manufacturing organization - a facility-level matter, and not a GTx-104 product-specific quality finding - together with additional leachables data time points and excipient toxicology risk assessments. The company intends to address each of the CRL items in its planned resubmission, including completing the required non-clinical studies. As part of that plan, the company is pursuing a dual-source manufacturing strategy. Its current contract manufacturer is responsible for remediating the cGMP matters identified at its facility and demonstrating inspection readiness, which would ultimately need to be verified through an FDA reinspection. In parallel, the company is advancing technology transfer to a second-source contract manufacturer located in the United States. This approach gives GTx-104 more than one route to a compliant registration site and reduces reliance on any single manufacturing source. The company has not designated a single path to resubmission; a resubmission may be supported by either contract manufacturer, or both."
Major Averages Rebound, Nasdaq Gains 1.91%
The major averages closed broadly higher in a rebound from the prior session's selloff after the Federal Reserve held rates steady but signaled that a rate hike later this year remains possible. Meanwhile, oil prices declined after President Donald Trump signed a memorandum of understanding with Iran's President Masoud Pezeshkian to end the war and open the Straight of Hormuz.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:President Trump said Applehaswith Intelto design chipsApple CEO Tim Cookthe company will raise prices on its products to offset increasing memory and storage costsAccenturereportedand narrowed its FY26 earnings guidanceKrogerreportedand reaffirmed its FY26 outlookRumbleannounced a2. WALL STREET CALLS:Aretecoverage of SpaceXwith a Buy rating and Street-high $401 price targetSalesforceto Buy at Monness CrespiIntuitto Hold at StifelenGeneto Underweight at Morgan StanleyBarclaysEnphaseto Equal Weight on data center opportunity3. AROUND THE WEB:SpaceXbankers are preparing a $20B bond offering, Bloomberg reportsVail Resortsis working with takeover-defense bankers, Semafor saysSamsungis seeing a rise in advanced chip production requests from BYD, Google, AMD, Tesla, and other companies as AI demand strains TSMC'scapacity, Nikkei Asia reportsThe U.S. Federal Trade Commission, FTC, has drafted a potential complaint against Amazonover claims the company misled advertisers, Bloomberg reportsCME Groupsued the Commodity Futures Trading Commission over the regulator allowing perpetual futures tied to the price of cryptocurrencies, Bloomberg says4. MOVERS:Butterfly Networkgained after commenting on Midjourney'sSmith & Wesson Brandswas higher afterMarvellwas up after announcing it has shipped overwith Tower SemiconductorNovocurewas lower in New York after announcing its Phase 3 TRIDENT trialLegend Biotechfell after announcing a5. EARNINGS/GUIDANCE:Deluxereaffirmed itsGrace TherapeuticsreportedSagtecprovidedSteel DynamicsprovidedNucorprovided itsINDEXES:The Dow rose 72.15, or 0.14%, to 51,564.70, the Nasdaq gained 496.28, or 1.91%, to 26,517.93, and the S&P 500 advanced 80.48, or 1.08%, to 7,500.58.
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