Apolipoprotein

NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter 2023 Financial Highlights

Retrieved on: 
Monday, November 13, 2023
Apolipoprotein, Risk, AHA, Apolipoprotein B, Cardiovascular disease, History, Patient, American Heart Association, Dyslipidemia, Children of General Hospital, Apolipoprotein E, CETP, ASCVD, Mutation, Moyamoya disease, NAMS, Pharmaceutical industry, Management, MIAMI

NAARDEN, The Netherlands and MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided a corporate update and announced financial highlights for the quarter ended September 30, 2023.

Key Points: 
  • “We experienced strong momentum in the third quarter, continuing the foundational work required to scale NewAmsterdam into a robust clinical and commercial organization,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
  • “We recently expanded our leadership team with appointments of BJ Jones as Chief Commercial Officer and Ian Somaiya as Chief Financial Officer.
  • In October 2023, NewAmsterdam appointed Ian Somaiya as Chief Financial Officer.
  • Live webcasts of both fireside chats will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com .

Verve Therapeutics Highlights Recent Company Progress and Reports Third Quarter 2023 Financial Results

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Tuesday, November 7, 2023
Science, Apolipoprotein, Primate, FDA, Gene editing, Lilly, United Kingdom, IND, Beam Therapeutics, RNA, Moyamoya disease, Vertex Pharmaceuticals, Frederick, American Heart Association, Host, G&A, Beam, Research and development, Research, R, Mouse, Medicine, Low-density lipoprotein, PCSK9, Blood, General Administration of Sport of China, Safety, ANGPTL3, AHA, Therapy, Administration, ASCVD, Cardiovascular disease, Pharmaceutical industry, Vaccine, Patient, Vertex, Webcast, Verve

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported recent company progress and financial results for the third quarter of 2023.

Key Points: 
  • ET
    BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported recent company progress and financial results for the third quarter of 2023.
  • Verve plans to participate in fireside chats during the following upcoming investor events:
    Cash Position: Verve ended the third quarter of 2023 with $485.2 million in cash, cash equivalents, and marketable securities.
  • Research & Development (R&D) Expenses: R&D expenses were $43.8 million for the third quarter of 2023, compared to $35.2 million for the third quarter of 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $11.7 million for the third quarter of 2023, compared to $9.6 million for the third quarter of 2022.

NewAmsterdam Pharma Announces Appointment of Ian Somaiya as Chief Financial Officer

Retrieved on: 
Monday, October 23, 2023
Apolipoprotein, Nomura Securities, Morgan Stanley, Neuroscience, NAMS, BMO Capital Markets, Biotechnology, CETP, Head, Research, Thomas Weisel Partners, The Wall Street Journal, Wall Street, Health, CFO, Therapy, Patient, Dyslipidemia, Cardiovascular disease, Prudential Securities, Pharmaceutical industry, Biology, New York University

Mr. Somaiya is an established healthcare executive with extensive financial and operational expertise, including over two decades of experience on Wall Street as a prominent biotechnology research analyst.

Key Points: 
  • Mr. Somaiya is an established healthcare executive with extensive financial and operational expertise, including over two decades of experience on Wall Street as a prominent biotechnology research analyst.
  • Ian is a proven leader, who possesses a breadth of industry experience, as well as deep relationships within the financial community,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
  • We look forward to his many contributions.”
    Mr. Somaiya joins NewAmsterdam Pharma with over twenty-five years’ experience in senior leadership roles in the biopharmaceutical industry.
  • Prior to joining TCR2, Mr. Somaiya was managing director and head of biotechnology research at BMO Capital Markets.

A Quarter Century of Disease-Focused Neuroscience

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Tuesday, October 3, 2023
Epilepsy, San Francisco, Huntington's disease, Central nervous system, Therapy, Prevalence, Stanford University, Apolipoprotein, Biogen, Biotechnology, University of California, San Francisco, Brain, Research, DSM-IV codes, Multiple sclerosis, Fairmont San Francisco, AstraZeneca, Eli Lilly, Neuroscience, Amyloid, Parkinson's disease, UC, Myenteric plexus, Patient, Tau, Trustee, SAN, Gladstone Institutes, Spectrum, Blood, Weill Cornell Medicine, Sanofi, BMS, Merck, Takeda Pharmaceutical Company, Disease, Pharmaceutical industry, Vaccine, Nursing, Lundbeck, Alzheimer's disease, Genentech, MD, William Ewart Gladstone

SAN FRANCISCO, Oct. 3, 2023 /PRNewswire/ -- A quarter century ago, in September 1998, Gladstone Institutes launched the Gladstone Institute of Neurological Disease. In 2023, it brought together investigators and alumni to celebrate the institute's 25th anniversary, reflect on landmark scientific achievements, and look ahead at the future of disease-focused neuroscience.

Key Points: 
  • SAN FRANCISCO, Oct. 3, 2023 /PRNewswire/ -- A quarter century ago, in September 1998, Gladstone Institutes launched the Gladstone Institute of Neurological Disease.
  • In 2023, it brought together investigators and alumni to celebrate the institute's 25th anniversary, reflect on landmark scientific achievements, and look ahead at the future of disease-focused neuroscience.
  • As populations around the world are living longer, aging-related neurodegenerative disorders have been rising in prevalence at an unprecedented pace.
  • These landmark discoveries, and many others, were presented on September 15, 2023, as part of the symposium "Disease-Focused Neuroscience: From Discovery to Translation."

NewAmsterdam Pharma Announces Initial Data from Phase 2a Clinical Trial Evaluating Obicetrapib in Patients with Early Alzheimer’s Disease Who Carry an ApoE4 Mutation

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Thursday, September 21, 2023
Cognition, Oxysterol, University, Cardiovascular disease, Pathology, Pharmacokinetics, NAMS, Brain, Apolipoprotein, Biomarker, Cerebrospinal fluid, Disability, Reno 1868 FC, Plasma, Patient, CETP, Risk, Lipid metabolism, CSF, AD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Food, FESC, Neuroinflammation, Disease, Pharmaceutical industry, Medical imaging, Apolipoprotein E

NAARDEN, The Netherlands and MIAMI, Sept. 21, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced initial data from its Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease (“AD”) and at least one copy of the apolipoprotein E4 mutation (“ApoE4”).

Key Points: 
  • This Phase 2a trial was designed to explore the effects of obicetrapib on lipid metabolism in the brains of early AD patients who are ApoE4 carriers.
  • As such, NewAmsterdam believes reductions of 24- and 27-hydroxycholesterol in the CSF may indicate improved cholesterol metabolism in the brain and may lead to improved cognitive function.
  • NewAmsterdam observed reductions in the levels of 24- and 27-hydroxycholestrol of 11% and 12%, respectively, in the CSF.
  • In addition, an increase of 8% in the Aβ42/40 ratio in patient’s plasma was observed and pTau181 levels were observed to be stable.

NewAmsterdam Pharma to Present at 2023 Cantor Fitzgerald Global Healthcare Conference

Retrieved on: 
Wednesday, September 20, 2023
Cardiovascular disease, NAMS, Apolipoprotein, Patient, Conference, Pharmaceutical industry, Broadcasting

NAARDEN, The Netherlands and MIAMI, Sept. 20, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma, will participate in a fireside chat at the 2023 Cantor Fitzgerald Global Healthcare Conference on Wednesday, September 27, 2023 at 1:50 p.m.

Key Points: 
  • NAARDEN, The Netherlands and MIAMI, Sept. 20, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma, will participate in a fireside chat at the 2023 Cantor Fitzgerald Global Healthcare Conference on Wednesday, September 27, 2023 at 1:50 p.m.
  • ET.
  • A live webcast of the fireside chat will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com .
  • Following the live webcast, an archived replay will be available on the Company’s website.

NewAmsterdam Pharma Announces Appointment of William “BJ” Jones, formerly of Biohaven Pharmaceuticals, as Chief Commercial Officer

Retrieved on: 
Monday, August 14, 2023
Industrial engineering, Dyslipidemia, Marketing, Texas A&M University, Cardiovascular disease, Business, NAMS, Apolipoprotein, Bristol Myers Squibb, CCO, AstraZeneca, Boehringer Ingelheim, Migraine, Patient, CETP, M.B.A, Stanford Graduate School of Business, Pfizer, Takeda Pharmaceutical Company, Common, Pharmaceutical industry, Nitrome

Mr. Jones brings 30 years of commercial and launch experience in the U.S. and globally, with particular experience in driving mass market product launch strategies for industry-leading brands.

Key Points: 
  • Mr. Jones brings 30 years of commercial and launch experience in the U.S. and globally, with particular experience in driving mass market product launch strategies for industry-leading brands.
  • At NewAmsterdam, he will build and lead all commercial functions, including marketing, market access, sales, medical science engagement and commercial operations.
  • Most recently, he served as CCO, Migraine & Common Diseases at Biohaven Pharmaceuticals, which was acquired by Pfizer for $11.6B.
  • During his tenure, Mr. Jones led the commercial enterprise that launched Biohaven’s Nurtec® ODT.

NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROADWAY Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia and/or Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Tuesday, July 25, 2023
Food, Dyslipidemia, Myocardial infarction, Triglyceride, Cardiovascular disease, NAMS, Apolipoprotein, Patient, CETP, Physician, Risk, LDL, Cerebral infarction, ASCVD, Moyamoya disease, Safety, FESC, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or established atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally. NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.

Key Points: 
  • The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally.
  • NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.
  • The mean baseline LDL-C for enrolled patients is approximately 100 mg/dL despite high intensity statin use reported by greater than 60% of patients during screening.
  • “It has become increasingly clear that lower levels of LDL-C are directly correlated with a reduced risk for major adverse cardiovascular events.

NewAmsterdam Pharma Announces Positive Topline Results from Phase 2b Dose-Finding Trial Evaluating Obicetrapib in Japanese Patients

Retrieved on: 
Monday, June 5, 2023
Dyslipidemia, Public, Cardiovascular disease, National Lipid Association, NAMS, Apolipoprotein, Osaka Medical and Pharmaceutical University, Ongo, Patient, China Pharmaceutical University, Moyamoya disease, Conference, Safety, Pharmaceutical industry

-- Management to Host Conference Call Today at 8:00 a.m. E.T. --

Key Points: 
  • Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan.
  • The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients.
  • NewAmsterdam anticipates sharing full data from this Phase 2b clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.
  • ET to review these data, as well as the full data from the Phase 2 ROSE2 clinical trial, which were presented on Saturday.

NewAmsterdam Pharma Presents Full Data from Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy at NLA Scientific Sessions 2023

Retrieved on: 
Saturday, June 3, 2023
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ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed.

Key Points: 
  • ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed.
  • In addition, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo.
  • “The data presented today are highly encouraging, showing that the combination of obicetrapib and ezetimibe delivers robust impacts on multiple atherogenic lipid parameters.
  • The table below shows the median percent change from baseline in patients receiving the combination of obicetrapib and ezetimibe, obicetrapib monotherapy and placebo.