ACER

Acer Therapeutics Announces $1.5M Private Placement

Retrieved on: 
Wednesday, November 30, 2022
COVID-19, Vipul Ved Prakash, MSUD, Fever Dream, III, Emetine, Acquisition, ACER, Therapy, Patient, Annual report, Security (finance), Maple syrup urine disease, Cytomegalovirus, Sale, Virus, COL3A1, Post-traumatic stress disorder, PTSD, Microdeletion syndrome, IVMS, Celiprolol, RCSI & UCD Malaysia Campus, Safety, Metabolism, Pharmaceutical industry, Bank, Acer

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.

Highlights - 2021 Discharge: Hearing with Agencies - Committee on Budgetary Control

Retrieved on: 
Tuesday, November 29, 2022
EUROJUST, European Medicines Agency, ECHA, ENISA, ESMA, ECDC, European Agency for Special Needs and Inclusive Education, EEA, Hearing, EASA, EMA, Director, CDT, ETF, EMSA, ACER, EIOPA, ERA, Area of freedom, security and justice, Strategic autonomy, European Operations Management Association, ELA, European Parliament Committee on Budgetary Control, Security, EFCA, EUROPOL, Committee, European Union Agency for the Space Programme, Eu-LISA, EMCDDA, ECA, CEPOL, Justice, EBA, EUSPA, Area, ESA, EIT, BEREC, FRA, EFSA, EU, Renewable energy

2021 Discharge: Hearing with Agencies

Key Points: 
  • 2021 Discharge: Hearing with Agencies
    29-11-2022 - 12:18
    On 30 November 2022, in the framework of the 2021 discharge cycle, the Committee on Budgetary Control will hold a hearing with the Chair of the EU Agencies Network and three decentralised European Agencies (eu-LISA, EUAA, and EMA).
  • The CONT Committee will hold a hearing with Hans Bruyninckx, outgoing Chair of the EU Agencies Network, as well as with the Executive Directors of the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), the European Union Agency for Asylum (EUAA), and the European Medicines Agency (EMA).
  • The hearing will be held in the presence of the ECA reporting member Mihails Kozlovs.
  • - Rapporteur Agencies: Gilles Boyer (Renew) for EIOPA, ESMA
    - Rapporteur: Olivier Chastel (Renew) for CdT, Cedefop, EASA, EIGE, ERA, Eurofound, Horizontal Report
    - Rapporteur Agencies: Katalin Cseh (Renew) for ACER, BEREC, ECDC, ECHA, EEA, EFSA, EIT, EMA, ENISA, ESA, EUSPA
    - Rapporteur Agencies: Pierre Karleskind (Renew) for EFCA, EMSA
    - Rapporteur Agencies: Alin Mitua (Renew) for EBA, ELA, ETF, EU-OSHA
    - Rapporteur Agencies: Ramona Strugariu (Renew) for CEPOL, EMCDDA, EUAA, eu-LISA, EUROJUST, EUROPOL, FRA, Frontex
    - 2021 Agencies Discharge

ICE to Launch European LNG Futures for North-West and South-West Europe and Three Supporting French, German and Italian Natural Gas Futures

Retrieved on: 
Thursday, October 27, 2022
Finance, Oil, Gas, Banking, Energy, Professional Services, Carbon, Technology, New, NYSE, NBP, Private Securities Litigation Reform Act, Agency for the Cooperation of Energy Regulators, ACER, Annual report, Intercontinental Exchange, JKM, PSV, Coal, KIDS, EU, PEG, New York Stock Exchange, U.S. Securities and Exchange Commission, Mission statement, Cyprus Securities and Exchange Commission, Prandtl number, ICE, Risk, Council of European Energy Regulators, SEC, WIM, Strategic autonomy, Contract, Henry Hub, Intercontinental, THE, USD, Risk management, Natural gas, TTF, Security (finance), Oil, LNG, Electricity

Intercontinental Exchange, Inc. (NYSE: ICE), a leading global provider of data, technology, and market infrastructure, today announced plans to launch two liquid natural gas (LNG) futures contracts for North-West Europe and South-West Europe.

Key Points: 
  • Intercontinental Exchange, Inc. (NYSE: ICE), a leading global provider of data, technology, and market infrastructure, today announced plans to launch two liquid natural gas (LNG) futures contracts for North-West Europe and South-West Europe.
  • The price of natural gas in Europe remains high because of an imbalance between supply and demand, caused by the significant reduction in the supply of natural gas into Europe from Russia and the downstream impact of physical capacity constraints across the European natural gas network.
  • Additionally, ICE plans to launch three supporting French PEG, German THE and Italian PSV Natural Gas 1st Line contracts on December 5, subject to regulatory approval.
  • Trademarks of ICE and/or its affiliates include Intercontinental Exchange, ICE, ICE block design, NYSE and New York Stock Exchange.

Harvard Astrophysicist Searching for Extraterrestrial Life to Keynote 2022 International Forum on Consciousness in Madison, WI September 29-30

Retrieved on: 
Thursday, September 22, 2022
Professional Services, Pharmaceutical, Thought Leadership, Consumer, Mental Health, Other Education, University, Education, Science, Biotechnology, Religion, Health, Other Science, People, Newton, Philosophy, International Forum on Energy Security for the Future, Time, Forum, Department, Cell biology, Dean (education), ACER, Humanities, Center, University of Wisconsin–Madison, Knowledge, Industry, Environment, Harvard University, Government, As Above..., Technology, Perception, Founder, Consciousness, Drug development, Rice University, RNA, Solar System, DNA, Research, Multimedia, Awareness, University, Promega, Public relations, Retail, Management, Amazon rainforest

Thought leaders from around the world, including Avi Loeb, the Harvard astrophysicist in search of extraterrestrial life, and Rosalind Watts, named among the 50 Most Influential People in Psychedelics, will gather in Madison, WI on September 29-30 for the 2022 International Forum on Consciousness .

Key Points: 
  • Thought leaders from around the world, including Avi Loeb, the Harvard astrophysicist in search of extraterrestrial life, and Rosalind Watts, named among the 50 Most Influential People in Psychedelics, will gather in Madison, WI on September 29-30 for the 2022 International Forum on Consciousness .
  • View the full release here: https://www.businesswire.com/news/home/20220922005745/en/
    The 2022 International Forum on Consciousness will be held in Madison, WI on September 29-30.
  • Avi Loeb, the Harvard astrophysicist searching for extraterrestrial life, will keynote.
  • The International Forum on Consciousness is a yearly event dedicated to information-sharing and discussion regarding importantand often challengingtopics related to the exploration of consciousness.

As Above, So Below: 2022 International Forum on Consciousness Explores How Expansive Macro–Micro View Can Transform Awareness of Self

Retrieved on: 
Thursday, August 4, 2022
Alternative Medicine, Mental Health, Health, Other Health, General Health, Pharmaceutical, Biotechnology, People, Newton, Multimedia, Philosophy, Dean (education), Industry, ACER, Technology, Solar System, Harvard University, Consciousness, Knowledge, Environment, Research, Department, Government, Perception, Promega, Founder, University of Wisconsin–Madison, DNA, Center, BTC, Cell biology, RNA, Awareness, Drug development, Forum, University, International Forum on Energy Security for the Future, Time, Rice University, Humanities, Public relations, Management, Amazon rainforest

This years forum As Above, So Below explores how expanded understanding of both the universe and micro unseen worlds can transform awareness of self amid time, space, matter and energy.

Key Points: 
  • This years forum As Above, So Below explores how expanded understanding of both the universe and micro unseen worlds can transform awareness of self amid time, space, matter and energy.
  • View the full release here: https://www.businesswire.com/news/home/20220804005879/en/
    The 2022 International Forum on Consciousness returns fully in-person in Madison, WI September 29-30.
  • This years topic As Above, So Below gathers a diverse group of thought leaders to explore how a macro-micro understanding of the universe transforms awareness.
  • The Forum is a yearly event dedicated to information-sharing and discussion regarding importantand often challengingtopics related to the exploration of consciousness.

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

Retrieved on: 
Thursday, July 28, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Emetine, MSUD, Degenerative disease, RLF, File, Microdeletion syndrome, Safety, New Drug Application, Lung, Review, Security (finance), LinkedIn, OTC, UCD School of Medicine, Acquisition, Maple syrup urine disease, ACER, APR, U.S. Securities and Exchange Commission, EMA, SA, CPS, Metabolism, Cytomegalovirus, Maple syrup, SIX Swiss Exchange, IVMS, Communication, PDUFA, Virus, III, GLOBE, Food, COVID-19, Endpoint security, CRL, COL3A1, European Medicines Agency, FDA, Nasdaq, OTCQB, Annual report, Celiprolol, Ved Prakash Airy, Fever Dream, History, Private Securities Litigation Reform Act, NDA, Therapy, Relief, Prescription Drug User Fee Act, Drug development, Patient, Pharmaceutical industry, Acer

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
III, PDUFA, Acquisition, Patient, Security (finance), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nasdaq, U.S. Securities and Exchange Commission, Microdeletion syndrome, Ved Prakash Airy, Safety, Review, European Medicines Agency, GLOBE, Private Securities Litigation Reform Act, Food, Emetine, Endpoint security, CRL, Metabolism, Classification, EMA, Drug development, Celiprolol, ACER, COVID-19, NDA, CPS, Maple syrup urine disease, IVMS, Cytomegalovirus, Annual report, OTC, Therapy, Fever Dream, FDA, Virus, Agency, Calendar, UCD School of Medicine, MSUD, COL3A1, Pharmaceutical industry, Risk management, Medical device, Acer

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
COL3A1, Patient, European Medicines Agency, GLOBE, Marketing, COVID-19, U.S. Securities and Exchange Commission, Cytomegalovirus, EMA, Vipul Ved Prakash, Communication, UCD School of Medicine, Patent, Drug development, Therapy, Security (finance), NDA, Maple syrup urine disease, FDA, OTCQB, Emetine, Celiprolol, Utility model, Acquisition, OTC, III, LinkedIn, Maple syrup, SIX, ACER, SIX Swiss Exchange, Private Securities Litigation Reform Act, MSUD, Lung, Nasdaq, Virus, Fever Dream, CPS, China National Intellectual Property Administration, APR, RLF, Review, Annual report, IVMS, Trial of the century, Metabolism, History, Clinical trial, CNIPA, Microdeletion syndrome, Safety, Acer, Pharmaceutical industry, Relief

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).

Acer Therapeutics Announces Promotion of Tanya Hayden to Chief Operating Officer

Retrieved on: 
Tuesday, June 21, 2022
Review, Security (finance), Drug development, COVID-19, Emetine, Microdeletion syndrome, Safety, Annual report, III, CEO, COL3A1, U.S. Securities and Exchange Commission, Cytomegalovirus, Founder, Leadership, Virus, Trial of the century, Private Securities Litigation Reform Act, ACER, Growth, Clinical trial, Marketing, GLOBE, Vipul Ved Prakash, Acquisition, Nasdaq, Fever Dream, Metabolism, IVMS, COO, Patient, MSUD, Maple syrup urine disease, Therapy, Gonzaga University, Celiprolol, Pharmaceutical industry, UCD School of Medicine, Acer, Chemistry, Program

NEWTON, Mass., June 21, 2022 (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 the promotion of Tanya Hayden to Chief Operating Officer (COO).

Key Points: 
  • NEWTON, Mass., June 21, 2022 (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 the promotion of Tanya Hayden to Chief Operating Officer (COO).
  • Harry S. Palmin, who had been serving as the Companys Chief Operating Officer as well as its Chief Financial Officer, will continue to serve as the Companys Chief Financial Officer.
  • Ms. Hayden will continue to oversee program and strategic alliance management responsibilities in her new role as COO.
  • Prior to joining Acer, Ms. Hayden spent 20-years at Lonza (formerly Bend Research/Capsugel) and was responsible for business unit planning, operational excellence, clinical and commercial contract manufacturing, and program management.

Acer Therapeutics and Relief Therapeutics Announce Update on U.S. FDA Review of New Drug Application (NDA) for ACER-001

Retrieved on: 
Tuesday, June 21, 2022
Security (finance), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Endpoint security, European Medicines Agency, LinkedIn, SIX Swiss Exchange, OTCQB, Clinical trial, Marketing, Fever Dream, MSUD, U.S. Securities and Exchange Commission, Communication, Therapy, GLOBE, Comment, File, Review, NDA, Microdeletion syndrome, Annual report, CEO, OTC, Cytomegalovirus, Founder, Private Securities Litigation Reform Act, ACER, APR, Maple syrup, Lung, Nasdaq, Metabolism, Maple syrup urine disease, Celiprolol, FDA, CPS, Drug development, COVID-19, III, COL3A1, CRL, Virus, RLF, History, IVMS, Patient, Relief, Emetine, Safety, New Drug Application, UCD School of Medicine, Trial of the century, SA, Ved Prakash Airy, Acquisition, Food, EMA, Dietary supplement, Pharmaceutical industry, Medical device, Acer

NEWTON, Mass. and GENEVA, June 21, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs).

Key Points: 
  • The CRL indicates that the FDA cannot approve the NDA in its current form.
  • The FDA did not cite any other approvability issues in the CRL pertaining to the NDA, nor request any additional clinical or pharmacokinetic studies be conducted prior to FDA approval.
  • We should be able to resubmit the NDA relatively quickly, said Chris Schelling, CEO and Founder of Acer.
  • This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses.