NAMS

NewAmsterdam Pharma Enrolls Over 9,000 Patients in Pivotal Phase 3 PREVAIL Global Cardiovascular Outcome Trial Evaluating the Effect of Obicetrapib in Patients with Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Tuesday, April 9, 2024
Disability, Cardiovascular disease, Myocardial infarction, CVD, Risk, Patient, Stroke, NAMS, History, Mortality, Death, FESC, Moyamoya disease, Phase 3, Monash University, MACE, ASCVD, Hypercholesterolemia, Pharmaceutical industry

Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.

Key Points: 
  • Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.
  • “PREVAIL, our pivotal CVOT, will potentially demonstrate that obicetrapib’s lowering of LDL-C will reduce major adverse cardiac events (“MACE”).
  • The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.
  • “Despite widespread availability of statin therapies, CVD-related deaths are on the rise, and many patients are not at their risk-based LDL-C goals.

NewAmsterdam Pharma Announces the Appointment of Juliette Audet as Chief Business Officer

Retrieved on: 
Monday, April 1, 2024
Novartis, Cardiovascular disease, Science, EPFL, Risk, Patient, NAMS, Harvard Business School, CBO, Partner, McKinsey & Company

“We are privileged to welcome Juliette to our management team as CBO,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.

Key Points: 
  • “We are privileged to welcome Juliette to our management team as CBO,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
  • Prior to joining Forbion, Ms. Audet was a principal at the Novartis Venture Fund based in Cambridge, MA.
  • She also worked at Novartis AG for their commercial division and at McKinsey and Company focusing on Pharma and Biotech.
  • She earned her M.B.A. with distinction from Harvard Business School and her M.Sc.

BioAge Appoints Renowned Cardiologist and Biopharma Entrepreneur Michael H. Davidson, MD, to its Board of Directors

Retrieved on: 
Tuesday, April 9, 2024
Research, FDA, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Internal medicine, Incretin, Obesity, AstraZeneca, Novo Nordisk, Cardiology, University college, Patient, DSM-IV codes, Weight loss, NAMS, Doctor of Philosophy, MD, Biology, PPD, Inc., Book, Ageing, Pharmaceutical industry

BioAge Labs, Inc., ("BioAge"), a clinical-stage biotechnology company developing novel therapies for obesity and metabolic diseases by harnessing the biology of aging, today announced the appointment of Michael Davidson, MD to the company's board of directors.

Key Points: 
  • BioAge Labs, Inc., ("BioAge"), a clinical-stage biotechnology company developing novel therapies for obesity and metabolic diseases by harnessing the biology of aging, today announced the appointment of Michael Davidson, MD to the company's board of directors.
  • "We are delighted to welcome Michael to BioAge's board of directors," said Kristen Fortney, PhD, CEO and co-founder of BioAge Labs.
  • "I'm excited to join the board of BioAge at this pivotal juncture, as the company progresses azelaprag into Phase 2 trials in obesity," said Davidson.
  • I look forward to working with the team to bring this promising therapy to patients in need."

NewAmsterdam Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress

Retrieved on: 
Monday, March 25, 2024
Moyamoya disease, Cardiovascular disease, Congress, Risk, Patient, NAMS, American College, Ezetimibe, Clinical trial, FDC, ACC, ASCVD

ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.

Key Points: 
  • ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.
  • At ACC, NewAmsterdam will share new data demonstrating obicetrapib and ezetimibe’s impact on small dense LDL-C, a robust predictor of residual risk of future cardiovascular events.
  • NewAmsterdam recently initiated TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC (‘fixed-dose combination”) in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.
  • Details of the presentation are as follows:
    Presentation at the 2024 American College of Cardiology (ACC) Congress:

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
Tuesday, March 12, 2024
Consensus, Moyamoya disease, Cardiovascular disease, Myocardial infarction, Dyslipidemia, CVD, Cardiology, Risk, Patient, Apolipoprotein B, Consensus decision-making, Stroke, NAMS, ASCVD, Plaque, Artery, Diet, Cleveland Clinic, Ezetimibe, Clinical trial, Safety, FDC, Apolipoprotein, Genetic disorder, Physician, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

NewAmsterdam Pharma Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 28, 2024
Research, Ezetimibe, Cardiovascular disease, Growth, Research and development, Drug discovery, Exercise, CVD, ASCVD, Risk, Phase 3, NAMS, History, Administration, FDC, Patient, Clinical trial, Moyamoya disease, Insurance, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, Feb. 28, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • "2023 was a year of remarkable progress for NewAmsterdam, marked by consistent clinical execution and substantial corporate development.
  • NewAmsterdam completed enrollment of over 350 patients in April 2023 and expects to report topline data in the third quarter of 2024.
  • NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024.
  • Cash Position: As of December 31, 2023, NewAmsterdam recorded cash of $340.5 million, compared to $467.7 million as of December 31, 2022.

NewAmsterdam Pharma to Participate in Upcoming Investor Conferences in March

Retrieved on: 
Monday, February 26, 2024
Cardiovascular disease, Risk, Conference, NAMS, Patient

Michael Davidson, Chief Executive Officer, and Ian Somaiya, Chief Financial Officer, will present a corporate overview at 2:10 p.m.

Key Points: 
  • Michael Davidson, Chief Executive Officer, and Ian Somaiya, Chief Financial Officer, will present a corporate overview at 2:10 p.m.
  • Leerink Global Biopharma Conference in Miami, FL on Monday, March 11, 2024.
  • Michael Davidson, M.D., Chief Executive Officer, will present a corporate overview at 4:00 p.m.
  • Live webcasts of both the Cowen and Leerink presentations will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com .

NewAmsterdam Pharma Announces Pricing of $175.3 Million Public Offering of Ordinary Shares and Pre-Funded Warrants

Retrieved on: 
Wednesday, February 14, 2024
Attention, Jefferies Group, Prospectus, Telephone, Cardiovascular disease, RBC Capital Markets, EDGAR, Sale, Equity capital markets, Form, Nicollet Mall, Risk, NAMS, State Street, SVB Securities, Madison Avenue, Patient, Common stock, Vesey Street, Offering

The proceeds to the Company from the Offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, are expected to be approximately $175.3 million.

Key Points: 
  • The proceeds to the Company from the Offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, are expected to be approximately $175.3 million.
  • In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 1,383,750 Ordinary Shares at the public offering price, less underwriting discounts and commissions.
  • The Offering is expected to close on or about February 16, 2024, subject to satisfaction of customary closing conditions.
  • Jefferies, Leerink Partners, Piper Sandler, and RBC Capital Markets are acting as joint book-running managers for the Offering.

NewAmsterdam Pharma Announces Commencement of Public Offering of Ordinary Shares and Pre-Funded Warrants

Retrieved on: 
Tuesday, February 13, 2024
Attention, Jefferies Group, Prospectus, Telephone, Cardiovascular disease, RBC Capital Markets, Sale, Equity capital markets, Form, Nicollet Mall, Risk, NAMS, State Street, SVB Securities, Madison Avenue, Patient, Common stock, Vesey Street

NAARDEN, The Netherlands and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the commencement of an underwritten public offering of the Company’s ordinary shares, with a nominal value of €0.12 per share (“Ordinary Shares,”) and, to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase Ordinary Shares (“Pre-Funded Warrants,” such offering, the “Offering”).

Key Points: 
  • NAARDEN, The Netherlands and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the commencement of an underwritten public offering of the Company’s ordinary shares, with a nominal value of €0.12 per share (“Ordinary Shares,”) and, to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase Ordinary Shares (“Pre-Funded Warrants,” such offering, the “Offering”).
  • All Ordinary Shares and Pre-Funded Warrants to be sold in the proposed Offering will be sold by the Company.
  • In addition, the Company expects to grant the underwriters a 30-day option to purchase a number of additional shares not to exceed 15% of the securities sold in the proposed Offering.
  • Jefferies, Leerink Partners, Piper Sandler, and RBC Capital Markets are acting as joint book-running managers for the proposed Offering.

NewAmsterdam Pharma to Present at Guggenheim Healthcare Talks 6th Annual Biotechnology Conference

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Cardiovascular disease, Patient, NAMS, Conference, Risk

NAARDEN, the Netherlands and MIAMI, Feb. 01, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated 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 and Ian Somaiya, chief financial officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 1:00 p.m.

Key Points: 
  • NAARDEN, the Netherlands and MIAMI, Feb. 01, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated 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 and Ian Somaiya, chief financial officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 1:00 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.