Acer Therapeutics (ACER)
The next biopharma with an advanced drug candidate well into the regulatory process is Acer Therapeutics. The company’s research is focused on serious metabolic diseases that are also exceedingly rare, and lack effective medical treatments. The company’s pipeline currently features three research tracks, with the leading drug candidate, ACER-001, being the farthest along.
ACER-001 is underdevelopment as a treatment for serious ‘inborn errors of metabolism,’ including urea cycle disorders, UCDs, and maple syrup urine disease (MSUD). Acer resubmitted the new drug application (NDA) on -001 to the FDA in July of this year, and is looking at a PDUFA date from the regulatory agency of January 15, 2023.
In June 2022, the FDA already turned down Acer’s application to get ACER-001 approved for the treatment of UCDs. The Complete Response Letter (CRL) stated that the FDA field investigator “could not complete inspection” of ACER’s third party contract packaging manufacturing location because “the facility was not ready for inspection.” The FDA also had one comment in the CRL that was “not an approvability issue” pertaining to a request for additional nonclinical information.
On the insider front, we see a clear case of confidence ahead of the upcoming PDUFA date. First, CEO Steven Lisi laid down $1 million for a bloc of 819,672 shares in his company. The second large buy was from Chairman Steve Aselage who’s 409,836 share purchase cost $500,000.
5-star analyst Vernon Bernardino, covering Acer for H.C. Wainwright, doesn’t hide his optimism for the stock as well. Bernardino is clear on why Acer has sound prospects ahead, and lays it out in unambiguous prose.
“With no further approvability concerns, we are positive on ACER-001’s prospects for FDA approval on or before January 15, 2023. Thus, we look for ACER-001 to achieve commercial success, and estimate ACER-001 can achieve approximately $750M in annual sales as a treatment for UCDs by 2028. We believe Acer’s accomplishments in meeting the challenges of advancing its NDA, and the potential for ACER-001 to achieve near-term commercial success, are underappreciated,” Bernardino wrote.
Going forward from these comments, Bernardino gives ACER shares a Buy rating, and his $12 price target implies a hefty upside of 664% for the coming year. (To watch Bernardino’s track record, click here)
Turning now to the rest of the Street, other analysts are on the same page. With 3 Buys and no Holds or Sells, the word on the Street is that ACER is a Strong Buy. The stock has a $9.67 average price target and a share price of $1.57, for a one-year upside potential of ~516%. (See ACER stock forecast on TipRanks)
