ACST stock exploded more than 30% higher in after-hours trading on December 21, 2021, after Oppenheimer initiated coverage with an eye-popping $6 target.
Oppenheimer starts Acasti Pharma with Outperform, $6 price target
Oppenheimer analyst Leland Gershell initiated coverage of Acasti Pharma with an Outperform rating and $6 price target. The company is now focused on the development of medicines for rare conditions and each of its candidates “may offer meaningful advantages over standard-of-care while mitigating development risk and cost,” Gershell tells investors in a research note. The analyst looks forward to respective entry of GTX-104 and GTX-102 into Phase 3 evaluation for subarachnoid hemorrhage and for ataxia-telangiectasia. With Acasti Pharma shares trading near cash levels Gershell recommends investors build a position.
Acasti Pharma announces interim data meets primary endpoints in PK study
On December 2, 2021, Acasti Pharma announced positive results for GTX-104 based on its interim analysis of the first 20 of 50 normal healthy subjects in its pivotal pharmacokinetic, PK, bridging study. GTX-104 met both primary endpoints for Maximum Concentration on Day 1 and Area Under the Concentration-Time Curve on Day 3, allowing the study to continue under the current infusion protocol to its completion. GTX-104 is a novel, aqueous formulation of nimodipine developed as an IV infusion for patients experiencing Subarachnoid Hemorrhage, or bleeding over the surface of the brain triggered by a ruptured aneurysm. The Company believes that the tight correlation of the primary endpoint data for the first 20 patients is a strong indication that GTX-104 could achieve comparable bioavailability with oral nimodipine in the full study cohort of 50 subjects. So far, there have been no serious adverse events observed, and only mild adverse events were reported in both groups such as headaches, that were resolved with common medications. “This interim data is very encouraging, as it suggests that our current infusion protocol is on track to meet the objectives for this pivotal PK study. As previously disclosed, we expect to report the final study results sometime in the first half of 2022. If the final study results are consistent with these interim results, we could proceed quickly to finalize the study design and protocol for the Phase 3 Safety Study of GTX-104 with the FDA, and initiate the study in the second half of 2022,” commented Jan D’Alvise, Acasti’s CEO. “Importantly, we believe the follow-up safety study has the potential to be relatively fast, low cost and low risk based on the favorable safety profile observed to date. Moreover, this clinical study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting our New Drug Application to the FDA.”
Acasti Pharma reports Q2 EPS 3c vs (52c) last year
On November 10, 2021, the company reported cash, cash equivalents and short-term investments totaled $50.8 million as of September 30, 2021, compared to $11.6 million in cash and cash equivalents as of September 30, 2020. “During the second quarter, we successfully completed a transformational merger with Grace Therapeutics, bringing to Acasti a range of new and exciting opportunities in sizable markets with substantial unmet medical needs. We have created an exciting specialty pharma company with a diverse portfolio of drug candidates focused on rare diseases,” commented, Jan D’Alvise, Chief Executive Officer of Acasti Pharma. “In the short time since completing the merger, we have made good progress regarding our clinical pipeline and business operations. We swiftly integrated the Grace team with Acasti, allowing the Company to immediately focus on advancing its clinical pipeline. Towards this end, we have commenced subject enrollment for a pivotal PK bridging study for GTX-104, which will assess its relative bioavailability compared to currently marketed oral nimodipine capsules. Based on encouraging results from an earlier safety and dose-escalation crossover study conducted by Grace, we believe that GTX-104 has the potential to provide improved bioavailability and lower intra-subject variability compared to oral capsules. This could result in better management of hypotension in patients with SAH, and potentially lead to better outcomes. We continue to anticipate reporting the results of this study during the first half of calendar 2022. If the PK study and the end of Phase 2 meeting with the FDA go as planned, we would plan to commence a Phase 3 safety study of GTX-104 in the second half of calendar 2022.”
📺 VIDEO Why Acasti (ACST) Pharma Stock Is A Buy Now
Back on June 12, 2021, Stock Adviser gave his opinion on ACST stock.
📉 ACST Stock Technical Analysis
Both the long and short term trends are negative. It is better to avoid buying stocks with negative trends. ACST is one of the lesser performing stocks in the Pharmaceuticals industry. 69% of 257 stocks in the same industry do better. ACST is currently trading near the lower end of its 52 week range, which is not a good sign. The S&P500 Index is trading in the upper part of its 52 week range, so ACST is lagging the market. There is a resistance zone ranging from 1.14 to 1.14. This zone is formed by a combination of multiple trend lines and important moving averages in the daily time frame. There is also a resistance zone ranging from 1.22 to 1.23. This zone is formed by a combination of multiple trend lines and important moving averages in the daily time frame. The technical rating of ACST is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when ACST stock is a good long entry.