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ACER

Acer Therapeutics

$3.72

-0.04 (-1.06%)

08:32
07/05/19
07/05
08:32
07/05/19
08:32

Acer Therapeutics says pre-commercial activities of EDSIVO have been halted

Acer Therapeutics announced a corporate restructuring and update on its pipeline programs. Acer's headcount has been reduced from 48 to 19 employees and pre-commercial activities of EDSIVO have been halted. The restructuring is expected to provide the resources needed for Acer to conduct its planned business operations through 2020. Acer intends to pursue discussions with the U.S. Food and Drug Administration regarding its previously announced Complete Response Letter for Acer's New Drug Application for EDSIVO for the treatment of vascular Ehlers-Danlos syndrome, and to continue the development of Acer's additional pipeline programs, including ACER-001 and osanetant. "While we are disappointed by the CRL, we intend to continue our dialogue with the FDA to fully understand its response and work toward our goal of approval of EDSIVO for confirmed COL3A1+ vEDS patients, who currently have no approved treatment options," said Chris Schelling, CEO and Founder of Acer. "Nevertheless, in light of the CRL it was necessary to reduce our expenses, extend our cash runway, and focus our resources on a potential path forward for EDSIVO as well as continued development of our other pipeline opportunities."

ACER Acer Therapeutics
$3.72

-0.04 (-1.06%)

06/25/19
RAJA
06/25/19
DOWNGRADE
RAJA
Market Perform
Acer Therapeutics downgraded to Market Perform from Outperform at Raymond James
06/25/19
RAJA
06/25/19
DOWNGRADE
RAJA
Market Perform
Raymond James doesn't see path forward for Edsivo, cuts Acer to Market Perform
As previously reported, Raymond James analyst Steven Seedhouse downgraded Acer Therapeutics to Market Perform from Outperform following the company's announcement this morning of the receipt of a complete response letter from the FDA for Edsivo. The analyst, who said he doesn't see a path forward for the drug in vascular Ehlers-Danlos Syndrome as he does not think conducting the required study is a viable option, removed Edsivo from his estimates and reduced his view of the probability of success for Acer's other programs.
06/25/19
ROTH
06/25/19
NO CHANGE
Target $9
ROTH
Buy
Acer Therapeutics price target lowered to $9 from $66 at Roth Capital
Roth Capital analyst Yasmeen Rahimi lowered her price target for Acer Therapeutics to $9 from $66 following the company's CRL letter from the FDA requesting a well-controlled trial, which stems from FDA's issue with the way BBEST was stopped early, despite lengthy discussions with regulators about this dating back to EDSIVO IND filing and agreement on how to treat stats from ultra-orphan data. With minimal clarity as to the future of EDSIVO, the analyst is removing EDSIVO from her valuation to focus on ACER-001. Rahimi reiterates a Buy rating on the shares.
06/26/19
HCWC
06/26/19
NO CHANGE
Target $10
HCWC
Buy
Acer Therapeutics price target lowered to $10 from $55 at H.C. Wainwright
After Acer announced that lead product candidate Edsivo received a Complete Response Letter from the FDA, H.C. Wainwright analyst Raghuram Selvaraju called the action "surprising," noting that vascular Ehlers-Danlos Syndrome is an ultra-rare disease without any approved treatment and "it was agency reviewers who encouraged Acer to submit the drug for approval in the first place." The FDA trial request may take several years to fulfill and may not be practical to achieve given the rarity of the condition, said Selvaraju, who removed Edsivo from his projection and cut his price target on the stock to $10 from $55. He keeps a Buy rating on Acer shares, noting that its cash runway "remains relatively lengthy" and he expects Acer to now pivot to clinical development of ACER-001, a taste-masked, immediate-release formulation of sodium phenylbutyrate for treatment of urea cycle disorders and maple syrup urine disease.

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