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PRINCETON, N.J. - Acasti Pharma (NASDAQ:ACST) Inc., a biopharmaceutical company focusing on rare diseases, has announced a corporate rebranding and will now operate under the name Grace Therapeutics, Inc. Starting October 28, 2024, the company will trade on the Nasdaq stock market under the new ticker symbol GRCE.
The rebranding marks a return to the company's original identity prior to its 2021 merger with Acasti. Grace Therapeutics is known for its work on GTx-104, an injectable treatment for aneurysmal subarachnoid hemorrhage (aSAH), a rare and severe medical condition. The company's CEO, Prashant Kohli, stated that the name change "reconnects us to our roots that are steeped in scientific innovation" and reflects the company's transformation and progress in drug development.
Grace Therapeutics has reported the completion of enrollment for the STRIVE-ON trial of GTx-104 and anticipates a data readout in early 2025, with plans to submit a New Drug Application to the U.S. Food and Drug Administration in the first half of the same year.
In addition to GTx-104, the company's portfolio includes other drug candidates, such as GTx-102 and GTx-101, although their development has been deprioritized to focus on GTx-104. There is a possibility that Grace Therapeutics may license or sell these assets in the future.
Grace Therapeutics will host a virtual Key Opinion Leader event on November 20, 2024, to discuss GTx-104 and its potential impact on the treatment of aSAH.
This announcement is based on a press release statement from Acasti Pharma, Inc. The company's forward-looking statements involve risks and uncertainties, and there is no guarantee that the anticipated results and developments will be realized or, if realized, will have the expected effects on Grace Therapeutics.
In other recent news, Acasti Pharma has undergone significant corporate changes and has been the focus of positive analyst attention. The pharmaceutical company has confirmed the election of its board of directors and the approval of the Acasti Pharma Inc. 2024 Equity Incentive Plan. The company's strategic efforts to align its corporate structure with its operational needs and long-term objectives have led to a significant corporate restructuring.
Acasti Pharma's lead drug candidate, GTX-104, has prompted Craig-Hallum and H.C. Wainwright to maintain a Buy rating and raise their price targets for the company. Craig-Hallum has increased its price target from $6.00 to $8.00, reflecting the potential of GTX-104, which is aimed at treating a subset of stroke patients. H.C. Wainwright has set a price target of $12.00, with potential FDA approval for GTX-104 by April 2026 and projected peak sales exceeding $130 million.
Furthermore, Acasti Pharma has completed enrollment for its STRIVE-ON trial for GTX-104, an intravenous nimodipine formulation. This trial focuses on the safety of GTX-104 in treating aneurysmal subarachnoid hemorrhage (aSAH), with approximately 100 participants enrolled. These recent developments are crucial for investors as they indicate the company's progress and potential future growth.
InvestingPro Insights
As Grace Therapeutics, Inc. (formerly Acasti Pharma) embarks on its rebranding journey, InvestingPro data provides additional context to the company's financial position and market performance. The company's market capitalization stands at $34.48 million, reflecting its status as a small-cap biopharmaceutical firm focused on rare diseases.
InvestingPro Tips highlight that Grace Therapeutics holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing clinical trials and potential FDA submission for GTx-104. This strong liquidity position is further supported by the fact that the company's liquid assets exceed its short-term obligations.
The stock has shown impressive momentum, with a 43.46% price return over the past year and a 20.14% return in the last three months. This performance aligns with the company's progress in its STRIVE-ON trial and the anticipated data readout in early 2025. Currently trading near its 52-week high at 94.44% of that level, the stock's performance may reflect investor optimism about the company's future prospects.
However, it's important to note that Grace Therapeutics is not currently profitable, with an adjusted operating income of -$13.27 million over the last twelve months. This is typical for biopharmaceutical companies in the development stage, and investors should be aware that the company is quickly burning through cash as it advances its clinical programs.
Analysts are optimistic about the company's future, predicting profitability this year. This expectation may be tied to the potential success of GTx-104 and the company's focused strategy on this lead candidate.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Grace Therapeutics, providing a deeper understanding of the company's financial health and market position as it enters this new phase under its rebranded identity.
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