Celiprolol

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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Thursday, March 28, 2024
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CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

Acer Therapeutics Reports Q1 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, May 15, 2023
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NEWTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • NEWTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.
  • “As a result, we are now ahead of our anticipated launch schedule with drug-in-channel expected in mid-June 2023.
  • As a result, we anticipate enrollment in this trial to be completed by the end of this year.
  • Cash and cash equivalents were $6.4 million as of March 31, 2023, compared to $2.3 million as of December 31, 2022.

Acer Therapeutics Reports Q4 and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, March 27, 2023
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OLPRUVA™ is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment.

Key Points: 
  • OLPRUVA™ is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment.
  • As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set
    Ended Q4 2022 with $2.3 million in cash and cash equivalents.
  • Cash and cash equivalents were $2.3 million as of December 31, 2022, compared to $12.7 million as of December 31, 2021.
  • For additional information, please see Acer’s Annual Report on Form 10-K filed today with the SEC.

Acer Therapeutics Announces Topline Results from ACER-801 (Osanetant) Phase 2a Trial

Retrieved on: 
Friday, March 17, 2023
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As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set.

Key Points: 
  • As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set.
  • “We are surprised and disappointed the Phase 2a trial did not meet its efficacy objectives in treating VMS given the extensive body of non-clinical and clinical evidence previously generated,” stated Chris Schelling, CEO and Founder of Acer.
  • “We intend to conduct a comprehensive analysis of the totality of the clinical trial data – including the pharmacokinetic data, which has not yet been analyzed – which will inform our path forward for the program, including our collaborations for prostate cancer and post-traumatic stress disorder (PTSD).
  • We wish to thank the patients, investigators and partners who participated in this clinical trial.

Acer Therapeutics Highlights Key 2022 Achievements and Pipeline Advancements, and Provides Anticipated 2023 Milestones

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Monday, January 9, 2023
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NEWTON, MA – January 09, 2023 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced a corporate update and provided anticipated key development milestones for 2023.

Key Points: 
  • NEWTON, MA – January 09, 2023 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced a corporate update and provided anticipated key development milestones for 2023.
  • “Our commitment to patients is the cornerstone of our mission, and we are proud to have secured our first FDA approval.
  • We are eager to report the topline results from our ongoing Phase 2a trial of ACER-801 in moderate to severe VMS in post-menopausal women in Q1 of 2023.
  • These trial results will provide important insight into ACER-801’s therapeutic potential in induced VMS (iVMS).

Acer Therapeutics Announces $1.5M Private Placement

Retrieved on: 
Wednesday, November 30, 2022
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The investors are Chris Schelling, CEO and Founder of Acer, and Steve Aselage, Chairman of Acers Board of Directors.

Key Points: 
  • The investors are Chris Schelling, CEO and Founder of Acer, and Steve Aselage, Chairman of Acers Board of Directors.
  • The private placement is scheduled to close on or about December 2, 2022, subject to the satisfaction or waiver of customary closing conditions.
  • The proceeds from the private placement will be used by Acer for working capital and general corporate purposes and, together with Acers existing cash and cash equivalents, are expected to be sufficient to fund the Companys anticipated operating and capital requirements through the fourth quarter of 2022.
  • Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs.

Acer Therapeutics to Participate in August and September 2022 Investor Conferences

Retrieved on: 
Tuesday, August 23, 2022
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Date and Time: On-demand corporate presentation available beginning at 7 am ET, September 12, 2022

Key Points: 
  • Date and Time: On-demand corporate presentation available beginning at 7 am ET, September 12, 2022
    Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs.
  • Acers pipeline includes four investigational programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of viruses, including cytomegalovirus, Zika, dengue, Ebola and COVID-19.
  • For more information, visit www.acertx.com .

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs

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Thursday, July 28, 2022
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The FDA designated the NDA as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2023.

Key Points: 
  • The FDA designated the NDA as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2023.
  • We are very pleased to receive confirmation that the FDA is commencing its review of our NDA resubmission, said Chris Schelling, Founder & Chief Executive Officer of Acer.
  • These efforts reinforce our ongoing commitment to developing new and differentiated treatment options for those affected by rare diseases.
  • Acer notified the FDA in the NDA resubmission that the third-party contract packaging manufacturer is ready for inspection.

Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs

Retrieved on: 
Monday, July 18, 2022
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Acer believes the resubmission addresses in full the items raised by the FDA in the Complete Response Letter (CRL).

Key Points: 
  • Acer believes the resubmission addresses in full the items raised by the FDA in the Complete Response Letter (CRL).
  • Acer notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection.
  • Our team did an outstanding job resubmitting the NDA one month after we received the CRL, said Chris Schelling, Founder & Chief Executive Officer of Acer.
  • ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD).

Acer Therapeutics and Relief Therapeutics Announce That the China National Intellectual Property Administration (CNIPA) Issued Utility Model Patent 11,202,767 Covering ACER-001 Dosage Form

Retrieved on: 
Friday, July 8, 2022
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and GENEVA, July 08, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced that the China National Intellectual Property Administration (CNIPA) issued Electronic Patent Certificate ZL202122004991.9 on May 24, 2022, for Utility Model directed to ACER-001 (sodium phenylbutyrate).

Key Points: 
  • and GENEVA, July 08, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced that the China National Intellectual Property Administration (CNIPA) issued Electronic Patent Certificate ZL202122004991.9 on May 24, 2022, for Utility Model directed to ACER-001 (sodium phenylbutyrate).
  • Specifically, the newly issued patent covers dosage form claims related to ACER-001s polymer coated formulation for oral administration as a potential treatment for urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
  • The issuance of this patent also marks an important step in our pursuit of possible ACER-001 commercialization in China.
  • ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD).