Newamsterdam Pharma Co NV

NewAmsterdam Pharma Co. NV is a clinical-stage biopharmaceutical company, which engages in the development of oral, non-statin medicine for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol. Its lead product candidate, Obicetrapib, is a next-generation, oral, low-dose cholesteryl ester transfer protein inhibitor, which will be used to prevent major adverse cardiovascular events. The company was founded on June 10, 2022 and is headquartered in Naarden, the Netherlands.

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Enrollment to continue to the end of April to accommodate strong patient and site interest Enrollment to continue to the end of April to accommodate strong patient and site interest

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

RICHMOND, Calif.--(BUSINESS WIRE)-- #aging--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. "His expertise as a physician and researcher in the field of cardiometa.

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

NAARDEN, the Netherlands and MIAMI, April 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 (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the appointment of Juliette Audet as Chief Business Officer (“CBO”), and her simultaneous resignation from the Company's Board of Directors, both effective April 1, 2024.

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

NAARDEN, the Netherlands and MIAMI, March 25, 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 that it will present additional data from the Phase 2 ROSE2 clinical trial at the 2024 American College of Cardiology Congress (“ACC”) in Atlanta, Georgia, being held April 6-8. 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 Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress

NewAmsterdam (NAMS) gains on the initiation of a phase III study evaluating fixed-dose combination of obicetrapib and ezetimibe in patients with HeFH and/or ASCVD.

NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up

-- TANDEM is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (“FDC”) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with HeFH, ASCVD or ASCVD risk equivalents requiring additional lowering of low-density lipoprotein cholesterol (“LDL-C”) -- -- Company expects to report topline data in the first quarter of 2025 -- -- TANDEM is being conducted in parallel with BROOKLYN, BROADWAY and PREVAIL pivotal Phase 3 studies; data from BROOKLYN and BROADWAY expected in 3Q and 4Q 2024, respectively -- 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.

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

-- On-track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3 BROADWAY trial in ASCVD in 4Q 2024 -- -- Plan to initiate TANDEM, pivotal Phase 3 trial evaluating obicetrapib and ezetimibe fixed-dose combination, in 1Q 2024; topline data expected in 1Q 2025 --

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

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 pricing of the previously announced underwritten public offering of (i) 4,488,159 of the Company's ordinary shares, with a nominal value of €0.12 per share (“Ordinary Shares,”) at a public offering price of $19.00 per share and (ii) to certain investors that so choose in lieu of Ordinary Shares, pre-funded warrants to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such pre-funded warrant (“Pre-Funded Warrants,” such offering, the “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. 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.

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

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. The proposed Offering is subject to market and other conditions and there can be no assurance as to whether or when the proposed Offering may be completed, or as to the actual size or terms of the proposed Offering.

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

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.

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

-- Positioned for three Phase 3 trial readouts over the next 18 months -- -- Topline data expected from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and BROADWAY trial in ASCVD in 4Q 2024 --

NewAmsterdam Pharma Announces 2024 Strategic Priorities

-- BROADWAY Phase 3 trial enrollment completed; on-track to report topline data for Phase 3 BROOKLYN and BROADWAY trials in 2H 2024 –

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

NAARDEN, the Netherlands and MIAMI, Oct. 23, 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 the appointment of Ian Somaiya as Chief Financial Officer (“CFO”). 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.

NewAmsterdam Pharma Announces Appointment of Ian Somaiya as Chief Financial Officer

Replimune Group Inc

The company aims to become a global leader in precision oncology by redefining Synthetic Lethality to treat large, currently unserved patient populations Lead program targets Alternative Lengthening of Telomeres (ALT) through the FANCM protein complex Company backed by leading venture firms, BioGeneration Ventures (BGV) and Forbion World-class leadership team with proven experience as entrepreneurs and deep expertise in drug discovery and precision oncology AMSTERDAM and LONDON, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Tessellate BIO, a preclinical stage biotechnology company with a focus on novel Synthetic Lethality approaches, has today emerged from stealth, with an initial €8m in seed funding backed by two leading European venture capital firms, BioGeneration Ventures (BGV) and Forbion. Its lead program targets the DNA damage response (DDR) and in particular cancers that depend on Alternative Lengthening of Telomeres (ALT).

Tessellate BIO Emerges from Stealth

New clinical data shows the potential of obicetrapib in treating early Alzheimer's disease in patients with the ApoE4 mutation. The Phase IIa trial demonstrated positive biomarker indications and good safety profiles for obicetrapib. NewAmsterdam Pharma's venture into Alzheimer's research could be an undervalued growth avenue, but there are risks and the investment balance between cardiovascular studies and Alzheimer's research is crucial.

NewAmsterdam Pharma's Pioneering Pulse On Alzheimer's Breakthroughs

-- Observed reductions of 11% and 12% in 24- and 27-hydroxycholesterol in cerebrospinal fluid (“CSF”), respectively, indicating potential improvement of cholesterol metabolism in the brain -- -- Observed 8% increase in Aβ42/40 ratio, a key biomarker of AD risk, suggesting improvement in disease pathology -- 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”).

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

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.

NewAmsterdam Pharma to Present at 2023 Cantor Fitzgerald Global Healthcare Conference

NewAmsterdam Pharma showcased positive trajectory in Q2 2023 financial report, with over-enrollment in obicetrapib's Ph.3 BROADWAY trial indicating robust global demand. Lead asset obicetrapib is set to present top-line data in 2H24, with potential approval by 2025-2026. Obicetrapib is a novel oral LDL-c lowering treatment that can be taken with statins and ezetimibe, which we believe to have a peak sales of ~$2bn.

NewAmsterdam Pharma: Best Cardiovascular Biotech In 2023

NAARDEN, The Netherlands and MIAMI, Aug. 14, 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 the appointment of William “BJ” Jones as the Company's first Chief Commercial Officer (“CCO”), effective August 14, 2023. 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.

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

-- Announced full data from ROSE2 Phase 2 clinical trial evaluating combination of obicetrapib and ezetimibe, which met the primary endpoint with 63.4% median reduction in LDL-C (p

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

-- Exceeded Target Enrollment; Expect to Randomize More Than 2,500 Patients -- -- Topline Results Expected in 2H 2024 –

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

NAARDEN, The Netherlands and MIAMI, June 09, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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, for whom existing therapies are not sufficiently effective or well-tolerated, today announced the closing of the previously announced underwritten public offering of 15,787,695 of the Company's ordinary shares, with a nominal value of €0.12 per share (“Ordinary Shares,” such offering, the “Offering”) by certain of the Company's existing shareholders, including affiliates of Forbion (collectively, the “Selling Shareholders”), at a public offering price of $11.50 per share, which included a partial exercise of the underwriters' option to purchase additional Ordinary Shares, granted to the underwriters by certain of the Selling Shareholders. The Company did not receive any proceeds from the Offering.

NewAmsterdam Pharma Announces Closing of Upsized Secondary Offering of Ordinary Shares

NewAmsterdam Pharma Company N.V. (NAMS) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it.

After Plunging -16.36% in 4 Weeks, Here's Why the Trend Might Reverse for NewAmsterdam Pharma Company N.V. (NAMS)

NewAmsterdam is a clinical-stage biopharmaceutical company with a lead therapy candidate that lowers cholesterol levels. The company is examining the therapy to treat high cholesterol levels on patients with cardiovascular disease as well as on Alzheimer's patients.

Why Shares of NewAmsterdam Pharma Were Plummeting on Wednesday

NAARDEN, The Netherlands and MIAMI, June 06, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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, for whom existing therapies are not sufficiently effective or well-tolerated, today announced the pricing of the previously announced underwritten public offering of 13,857,415 shares of the Company's ordinary shares, with a nominal value of €0.12 per share (“Ordinary Shares,” such offering, the “Offering”) by certain of the Company's existing shareholders, including affiliates of Forbion Capital Partners (collectively, the “Selling Shareholders”), at a public offering price of $11.50 per share. In connection with the Offering, certain of the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 2,078,612 Ordinary Shares at the public offering price, less the underwriting discount. The Offering is expected to close on or about June 9, 2023, subject to customary closing conditions. The Company will not receive any proceeds from the Offering.

News for Newamsterdam Pharma Co NV Stock (NAMS)