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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a leading late-stage biopharmaceutical company headquartered in the Netherlands, dedicated to revolutionizing patient care for metabolic diseases. The company focuses on populations where existing therapies are insufficient or poorly tolerated. Central to NewAmsterdam's innovation is obicetrapib, a next-generation, oral, low-dose CETP inhibitor designed to address limitations of current LDL-C lowering treatments.
As of 2024, NewAmsterdam is at the forefront of clinical development, with multiple pivotal Phase 3 trials underway. The company is optimistic about its potential to transform cardiovascular disease (CVD) treatment. Recent milestones include the enrollment completion of the BROOKLYN and BROADWAY Phase 3 trials, both aimed at evaluating obicetrapib’s efficacy as an adjunct to maximally tolerated statin therapy. Additionally, the company's PREVAIL cardiovascular outcomes trial and the newly initiated TANDEM Phase 3 trial are progressing, assessing obicetrapib's combination with ezetimibe for patients with elevated LDL-C levels.
In 2023, NewAmsterdam reported promising outcomes from its Phase 2 trials, including the ROSE2 trial, which combined obicetrapib with ezetimibe, demonstrating a significant 63% reduction in LDL-C levels. The company's robust clinical pipeline showcases obicetrapib’s strong tolerability profile, having tested the drug in over 800 patients with elevated lipid levels and observing statistically significant results without severe adverse events.
Looking to the future, NewAmsterdam is well-positioned financially, forecasting sufficient cash runway through 2026 to support its ambitious development plans. The company is also actively preparing for the global launch of obicetrapib, pending necessary regulatory approvals. This includes strategic investments in its commercial organization to ensure comprehensive market readiness.
NewAmsterdam’s commitment to innovation is further reinforced by strong intellectual property protection for obicetrapib, with patents extending until July 2043. This robust IP portfolio underscores the company's dedication to maintaining a competitive edge in the biopharmaceutical industry.
For more information, visit NewAmsterdam Pharma Company’s investor relations page or contact their media and investor relations teams for the latest updates.
Menarini Group announced positive topline data from two Phase 3 trials evaluating Obicetrapib. The BROADWAY trial showed Obicetrapib achieved a 33% LDL-C reduction compared to placebo (p<0.0001), with 50% of patients reaching LDL-C levels below 55 mg/dL. A 21% reduction in major adverse cardiovascular events was observed at one year.
The TANDEM trial, testing a fixed-dose combination of Obicetrapib with Ezetimibe, demonstrated a 48.6% LDL-C reduction (p<0.0001), with over 70% of patients achieving target LDL-C levels. Both treatments were well-tolerated with safety profiles comparable to placebo. These trials are part of a larger Phase 3 program including over 12,250 patients across four studies.
NewAmsterdam Pharma (NAMS) has successfully closed its upsized public offering, raising $479.0 million through the sale of securities. The offering included 14,667,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The underwriters fully exercised their option to purchase an additional 2,550,000 ordinary shares.
After deducting underwriting discounts, commissions, and estimated offering expenses, the company received net proceeds of approximately $452.6 million. The offering was conducted through multiple joint book-running managers, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair.
NewAmsterdam Pharma (NAMS) has announced the pricing of its upsized public offering, consisting of 12,117,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The offering is expected to generate approximately $416.5 million in proceeds before deducting expenses.
The company has granted underwriters a 30-day option to purchase up to an additional 2,550,000 ordinary shares. The offering is expected to close around December 13, 2024. Multiple investment banks, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair, are acting as joint book-running managers.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced the commencement of a $300 million public offering of ordinary shares and pre-funded warrants. The company is offering investors the choice between ordinary shares and pre-funded warrants to purchase ordinary shares. Additionally, underwriters will receive a 30-day option to purchase up to an additional $45 million of ordinary shares.
The offering will be conducted through multiple joint book-running managers including Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair. The offering will be made pursuant to a registration statement on Form S-3 that was declared effective by the SEC on July 12, 2024.
NewAmsterdam Pharma announced positive topline data from its Phase 3 BROADWAY clinical trial evaluating obicetrapib in patients with cardiovascular disease and heterozygous familial hypercholesterolemia. The trial achieved its primary endpoint with a statistically significant 33% reduction in LDL-C compared to placebo (p<0.0001).
Key findings include a 21% reduction in major adverse cardiovascular events favoring obicetrapib at one year. The drug demonstrated favorable safety results comparable to placebo, with treatment discontinuation rates of 11.1% for obicetrapib versus 12.4% for placebo. The trial involved 2,530 patients randomized 2:1 to receive 10mg obicetrapib or placebo daily for 52 weeks.
NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee approved inducement share options for 79,000 ordinary shares to two non-executive new hires. The options, granted under the 2024 Inducement Plan and compliant with Nasdaq Rule 5635(c)(4), have an exercise price of $19.64 per share, based on the December 2, 2024 closing price. The shares will vest over four years, with 25% vesting after one year and the remaining vesting monthly over 36 months, contingent on continued employment.
NewAmsterdam Pharma (NAMS) announced positive topline data from its Phase 3 TANDEM clinical trial evaluating a fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg. The trial met all co-primary endpoints, demonstrating a significant 48.6% LDL-C reduction compared to placebo at day 84 (p<0.0001). Over 70% of patients achieved LDL-C levels below 55 mg/dL. The drug combination was well-tolerated with safety results consistent with previous studies. The trial included 407 patients with HeFH and/or ASCVD or ASCVD risk factors, with results supporting global regulatory filings for the fixed-dose combination therapy.
Frazier Life Sciences (FLS) has appointed John Smither and Jim Williams as Senior Advisors. Smither brings over 25 years of biopharmaceutical financial experience, having served as CFO at companies including Arcutis Biotherapeutics, where he led their IPO and follow-on financings. He currently serves on the boards of NewAmsterdam Pharma (NAMS) and Genlux Williams contributes 35 years of investment strategy expertise, previously serving as Chief Investment Officer for the J. Paul Getty Trust and President of Harbor Capital Advisors. Both advisors will support FLS's private and public investment strategies in innovative therapeutics.
NewAmsterdam Pharma announced additional results from its Phase 3 BROOKLYN trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia. The trial met its primary endpoint with LDL-C mean reduction of 36.3% at day 84 and 41.5% at day 365 versus placebo. Secondary endpoints showed significant improvements, including Lp(a) reduction of 45.9% at day 84 and 54.3% at day 365, and total LDL-P reduction of 52.5% at day 180. The drug demonstrated a favorable safety profile comparable to placebo, with a lower discontinuation rate (7.6%) compared to placebo (14.4%). The study involved 354 patients randomized 2:1 to receive 10 mg obicetrapib or placebo.
NewAmsterdam Pharma (NAMS) reported Q3 2024 financial results and corporate updates. The company expects topline data from the pivotal Phase 3 TANDEM trial in Q4 2024, earlier than planned due to faster enrollment. Cash position strengthened to $422.7 million as of September 30, 2024. Q3 revenue increased to $29.1 million, up from $2.9 million in Q3 2023. R&D expenses decreased to $35.7 million from $43.4 million year-over-year, while SG&A expenses increased to $18.4 million from $9.1 million. Net loss improved to $16.6 million compared to $47.1 million in Q3 2023.
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