UCD School of Medicine

Zevra Therapeutics Reports Corporate Updates and Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
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Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026

Key Points: 
  • Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026
    Conference call and live audio webcast scheduled for today,
    CELEBRATION, Fla., Nov. 07, 2023 (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 quarter ended September 30, 2023.
  • Overview of Q3 2023 Financial Results:
    Net revenue for Q3 2023 was $2.9 million compared to prior year Q3 net revenue of $2.9 million.
  • As of September 30, 2023, these assets are included in secured corporate notes in the unaudited condensed consolidated balance sheet and totaled $42.0 million as of September 30, 2023.
  • ET, to discuss its corporate and financial results for Q3 2023.

Pheburane® (sodium phenylbutyrate) coverage to reach ~80% of commercially insured US patients by January 1st, 2024

Retrieved on: 
Thursday, October 26, 2023
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Pheburane® is not indicated for the treatment of acute hyperammonemia which can be life-threatening and requires emergency medical treatment.

Key Points: 
  • Pheburane® is not indicated for the treatment of acute hyperammonemia which can be life-threatening and requires emergency medical treatment.
  • UCDs are rare, chronic, genetic conditions that can be fatal if left untreated, and can impact children from the time of birth.
  • It does not require any mixing or oral syringes and there is no weight restriction for patients.
  • UNIK Support offers specialized services including a copay savings program, patient care liaison services, mail order pharmacy and other support services.

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023
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OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

Pheburane® (sodium phenylbutyrate) coverage rapidly expands to the benefit of Americans with certain urea cycle disorders (UCDs)

Retrieved on: 
Wednesday, August 9, 2023
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Pheburane® is also covered with preferred status at PBMs serving ~40% of covered individuals.

Key Points: 
  • Pheburane® is also covered with preferred status at PBMs serving ~40% of covered individuals.
  • It does not require any mixing or oral syringes and there is no weight restriction for patients.
  • Medunik USA has provided access to Pheburane® for Americans affected by certain UCDs since September 2022 and has since been working diligently at securing nation-wide coverage at a competitive price.
  • UNIK offers specialized services including a copay savings program, patient care liaison services, mail order pharmacy and other support services.

Acer Therapeutics Receives $1 Million Capital Infusion from Chief Executive Officer and Founder

Retrieved on: 
Monday, June 26, 2023
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NEWTON, Mass., June 26, 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 announced it has received $1,000,000 in funding in exchange for the issuance of an unsecured, subordinated promissory note for that principal amount to Christopher Schelling, the Company’s Chief Executive Officer and Founder, a member of the Company’s Board of Directors, and the beneficial owner of more than 10% of the Company’s outstanding common stock. Acer expects receipt of this funding to extend its cash runway into early Q3 2023.

Key Points: 
  • OLPRUVA™ expected to be available by prescription in the U.S. beginning July 5th
    NEWTON, Mass., June 26, 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 announced it has received $1,000,000 in funding in exchange for the issuance of an unsecured, subordinated promissory note for that principal amount to Christopher Schelling, the Company’s Chief Executive Officer and Founder, a member of the Company’s Board of Directors, and the beneficial owner of more than 10% of the Company’s outstanding common stock.
  • Acer expects receipt of this funding to extend its cash runway into early Q3 2023.
  • “This capital infusion will provide additional runway and allow us to continue to execute on our OLPRUVA™ launch and provide additional working capital for the ongoing clinical development of EDSIVO™ and other ongoing initiatives,” said Mr. Schelling.
  • “We expect OLPRUVA™ will be available by prescription beginning July 5 in the U.S. for the treatment of urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).”
    The principal amount of the promissory note will accrue interest at a rate of 6% per annum, and all principal and accrued interest will be due and payable on the maturity date on August 21, 2023.

Pheburane® Expanded Coverage with Commercial and Government (Medicaid) Payers

Retrieved on: 
Wednesday, May 17, 2023
Taste, Medicaid, Digestion, UCD, Pharmacy, Appetite, History, Tablet, PBM, WAC, UCD School of Medicine, Patient, Ammonia, CPS, OTC, DSM-IV codes, Health, Pharmaceutical industry, Sodium phenylbutyrate

Pheburane® is an innovative, palatable formulation of sodium phenylbutyrate (NaPB) with a special coating designed to mask the awful taste of NaPB.

Key Points: 
  • Pheburane® is an innovative, palatable formulation of sodium phenylbutyrate (NaPB) with a special coating designed to mask the awful taste of NaPB.
  • Pheburane® is not indicated for the treatment of acute hyperammonemia which can be life-threatening and requires emergency medical treatment.
  • Medunik USA has also worked diligently since that time to secure commercial and government reimbursement while increasing physician and patient awareness.
  • “In fact, the list price (WAC) of Pheburane® is approximately one third that of the most commonly prescribed UCD treatment.

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 Data Presented at Society for Inherited Metabolic Disorders Annual Meeting Identifying Preferred Urea Cycle Disorder Treatment Attributes

Retrieved on: 
Wednesday, March 22, 2023
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The results of the survey showed that taste and odor were the most important attributes for both prescribing and for patient adherence and compliance .

Key Points: 
  • The results of the survey showed that taste and odor were the most important attributes for both prescribing and for patient adherence and compliance .
  • “OLPRUVA™5 leverages the well-established efficacy of sodium phenylbutyrate in an innovative dual-coating formulation designed for palatability,” said Adrian Quartel, MD, FFPM, CMO of Acer.
  • ACER-001 for the treatment of certain UCDs is now marketed in the U.S. as OLPRUVA™ (sodium phenylbutyrate) following FDA approval in December 2022.
  • New FDA-Approved UCD Treatment Option: OLPRUVA™
    ACER-001 (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and is marketed under the brand name, OLPRUVA™.

Acer Therapeutics Announces Presentation of HCP Urea Cycle Disorder Treatment Preference Data at the Society for Inherited Metabolic Disorders Annual Meeting and Provides OLPRUVA™ Program Update

Retrieved on: 
Wednesday, March 15, 2023
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NEWTON, Mass., March 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 announced data will be presented from a survey designed to quantify preferences of healthcare providers for Urea Cycle Disorders (UCDs) at the upcoming 44th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD), March 18th-21st in Salt Lake City, Utah. Results from the discrete choice experiment will be available on Acer’s website following the poster presentation at SIMD on March 19 by Dr. Robert Steiner (University of Wisconsin School of Medicine and Public Health) at https://www.acertx.com/publications-and-presentations/.

Key Points: 
  • This poster summarizes results from a web-based, quantitative survey study using a discrete choice experiment (DCE) methodology.
  • “OLPRUVA™1 leverages the well-established efficacy of sodium phenylbutyrate in an innovative dual-coating formulation designed for palatability,” said Adrian Quartel, MD, FFPM, CMO of Acer.
  • ACER-001 for the treatment of UCDs is now marketed in the U.S. as OLPRUVA™ (sodium phenylbutyrate) following FDA approval in December 2022.
  • Acer is also actively engaged in negotiations regarding access for OLPRUVA™ with the major commercial payers and state Medicaid organizations.