New Improved Drug Expected to Get FDA Approval Next Mont


May 23, 2022 ( Newswire) Greenlighting of its medication for urea cycle disorders is the first of a trio of catalysts anticipated for this U.S. pharma firm in 2022, noted a ROTH Capital Partners report. Streetwise reviews the newest updates in this drug development and the company’s stock.

Acer Therapeutics’ (ACER:NASDAQ) therapeutic for urea cycle disorders is expected to get U.S. Food and Drug Administration (FDA) approval in June 2022, reported ROTH Capital Partners analyst Jonathan Aschoff in a May 17th research note. Additional potential stock-moving events are anticipated this year as well, related to two other drug candidates, a clinical trial launch, and a data readout.

“The rest of the year will be eventful for Acer, as we expect to see important validation for ACER-001 and ACER-801,” wrote Aschoff.

Acer is developing therapies for patients with serious, rare, and life-threatening diseases. ACER-001, or sodium phenylbutyrate, is the biopharma’s therapeutic for urea cycle disorders. Patients with such an inherited disorder lack one of the six essential enzymes responsible for removing ammonia, a highly toxic substance, from the bloodstream.

ACER-001 has some advantages over the two approved competing drugs, and thus, should easily capture market share, Aschoff pointed out. Sodium phenylbutyrate has a terrible taste, which ACER-001 masks, making it a more tolerable option than Buphenyl, the same agent but without taste improvement. Also, ACER-001 will be much more affordable than Ravicti, or glycerol phenylbutyrate.

The next possible catalyst for Acer, expected later in Q2/22, is the commencement of its DISCOVER Phase 3 trial, evaluating Edsivo (celiprolol) in vascular Ehlers-Danlos Syndrome, for which no therapies currently exist, noted Aschoff. After enrollment is done, interim data are anticipated at the two-year mark followed by trial completion one and a half years later.

Finally, in H2/22, Acer’s stock could benefit from the data release from the Phase 2a trial of the company’s ACER-801 (osanetant) for hot flashes in menopausal women.

“We look forward to results in H2/22 and thus to Acer potentially broadening its clinical pipeline with another product candidate having achieved clinical proof of concept,” Aschoff wrote.

ROTH Capital Partners has a Buy rating and a $10 per share target price on Acer, the current share price of which is around $2.06.


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Disclosures for Roth Capital Partners, Acer Therapeutics, May 17, 2022

ROTH makes a market in shares of Acer Therapeutics, Inc. and as such, buys and sells from customers on a principal basis.

Shares of Acer Therapeutics, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate.

This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH. Copyright 2022. Member: FINRA/SIPC.

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