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ACER THERAPEUTICS INC.

(ACER)
  Report
Delayed Nasdaq  -  04:00:00 2023-03-21 pm EDT
0.7910 USD   -6.94%
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03/17Acer Therapeutics' ACER-801 Fails to Achieve Statistical Significance in Clinical Trial
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03/17Acer Therapeutics Inc. : Other Events, Financial Statements and Exhibits (form 8-K)
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Acer Therapeutics Inc. Announces Topline Results from Acer-801 Phase 2a Trial

03/17/2023 | 08:30am EDT

Acer Therapeutics Inc. announced that topline results from its Phase 2a proof of concept clinical trial to evaluate ACER-801 (osanetant) as a potential treatment for moderate to severe Vasomotor Symptoms (VMS) associated with menopause showed that ACER-801 was safe and well-tolerated but did not achieve statistical significance when evaluating ACER-801's ability to decrease the frequency or severity of hot flashes in postmenopausal women. As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set. Concurrently, Acer is continuing to focus on preparation for its commercial launch of OLPRUVA™ (sodium phenylbutyrate) for oral suspension for the treatment of urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS), and the ongoing pivotal Phase 3 clinical evaluation of EDSIVO™ (celiprolol) for vascular Ehlers-Danlos Syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation, subject in each instance to availability of additional capital beyond early in Second Quarter 2023.

ACER-801 (osanetant) is an investigational non-hormonal, neurokinin 3 receptor (NK3R) antagonist being studied for the potential treatment of patients with Vasomotor Symptoms (VMS), prostate cancer and post-traumatic stress disorder (PTSD). In December 2018, Acer entered into an exclusive license agreement with Sanofi to acquire worldwide rights to ACER-801 (osanetant). In the Phase 2a study, forty-nine postmenopausal women aged 40-65 who experienced moderate to severe hot flashes were randomized 1:1:1:1 and received either twice daily 50 mg, 100 mg, 200 mg of ACER-801 or placebo over a 14-day treatment period, followed by a 14-day safety follow-up assessment.

Primary endpoints were safety and pharmacokinetics, with efficacy compared to placebo as a secondary endpoint.


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All news about ACER THERAPEUTICS INC.
06:23aNorth American Morning Briefing: Stock Futures -2-
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03/17Acer Therapeutics' ACER-801 Fails to Achieve Statistical Significance in Clinical Trial
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03/17Acer Therapeutics Announces Topline Results from ACER-801 (Osanetant) Phase 2a Trial
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03/17Acer Therapeutics Inc. Announces Topline Results from Acer-801 Phase 2a Trial
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Financials (USD)
Sales 2022 - - -
Net income 2022 -23,3 M - -
Net Debt 2022 - - -
P/E ratio 2022 -0,54x
Yield 2022 -
Capitalization 16,7 M 16,7 M -
Capi. / Sales 2022 -
Capi. / Sales 2023 0,78x
Nbr of Employees 41
Free-Float 81,6%
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Mean consensus BUY
Number of Analysts 3
Last Close Price 0,79 $
Average target price 9,67 $
Spread / Average Target 1 122%
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Managers and Directors
Christopher Schelling President, Chief Executive Officer & Director
Harry S. Palmin Chief Financial Officer
Stephen J. Aselage Chairman
John M. Klopp Chief Technology Officer
Stacey Bain Vice President-Clinical Operations
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