Niagen Bioscience selects Evotec to advance NB4168 for rare disease

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Reviewed by
Shriram SScanX News Team
Key Highlights

Niagen Bioscience partners with Evotec to conduct IND-enabling studies for NB4168, a novel therapy for Ataxia Telangiectasia. The deal utilizes Evotec's integrated platform to accelerate preclinical development, building on NB4168's superior bioavailability profile and existing orphan drug designations from the FDA and EMA.

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Niagen Bioscience, Inc. (NASDAQ: NAGE) has selected Evotec (NASDAQ: EVO) to lead preclinical development activities for NB4168, a proprietary oral small-molecule candidate targeting Ataxia Telangiectasia (A-T). The collaboration aims to generate the pharmacological evidence required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a critical step toward initiating human clinical trials for a rare pediatric disease with no approved therapies.

The agreement designates Evotec as a contract research organization to conduct pharmacokinetic and pharmacodynamic studies and validate bioanalytical methods for NB4168. Work will be executed in collaboration with NAD Pharmaceuticals Corp., Niagen Bioscience’s wholly owned subsidiary focused on therapies for accelerated aging and rare genetic diseases. The studies will take place at Evotec’s campus in Verona, Italy, utilizing the company’s INDiGO platform, which integrates active pharmaceutical ingredient development, drug product development, safety assessments, and regulatory services to streamline the path to clinical evaluation.

"Selecting Evotec adds streamlined drug development capabilities and executional scale to the NB4168 program," said Ozan Pamir, Chief Financial Officer of Niagen Bioscience. "This collaboration is an important step in building the pharmacological and bioanalytical evidence required to advance NB4168 toward clinical evaluation in patients with A-T."

NB4168 is designed to deliver significantly increased exposure to nicotinamide riboside (NR) compared to NR chloride, supporting its development as a more bioavailable pharmaceutical candidate. In nonclinical pharmacokinetic studies conducted to date, NB4168 demonstrated substantially higher blood exposure than NR chloride. Existing research on NR in A-T, including independent open-label clinical studies, has reported improvements in neurological measures and related biomarkers, providing a biological rationale for this approach.

Development Milestones and Regulatory Status

Niagen Bioscience has received both FDA Rare Pediatric Disease Designation and European Medicines Agency Orphan Medicinal Product Designation for NB4168 for the treatment of A-T. The company is currently advancing preclinical development activities with plans to submit an IND application to the FDA in anticipation of initiating human clinical studies.

Regulatory Designation Agency Indication
Rare Pediatric Disease U.S. Food and Drug Administration Ataxia Telangiectasia
Orphan Medicinal Product European Medicines Agency Ataxia Telangiectasia

Ataxia Telangiectasia is a rare genetic disease caused by mutations in the ATM gene, affecting roughly 1 in 40,000 people in the U.S. and 1 in 150,000 people in Europe. The condition is characterized by progressive loss of motor coordination, impaired immune function, and an elevated risk of cancer. There are currently no FDA-approved therapies for A-T, and treatment remains largely limited to supportive care.

Strategic Partnership Dynamics

Evotec brings deep drug development expertise, serving leading pharmaceutical and biotechnology companies across the life sciences industry. Dr. Ashiq Khan, Executive Vice President and Chief Commercial Officer of Evotec, stated that the collaboration demonstrates the value of Evotec’s integrated development offering in supporting innovative companies as they advance assets toward the clinic. He noted that NB4168 is a promising program supported by a defined biological rationale and a focused preclinical development plan.

The partnership allows Niagen Bioscience to leverage Evotec’s vertically integrated model, which is designed to accelerate timelines, reduce development risk, and improve cost efficiency. By consolidating ICH-directed activities required for early-phase clinical evaluation—including absorption, distribution, metabolism, excretion, and regulatory services—within a single platform, the companies aim to optimize the transition from preclinical data to first-in-human studies.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

What is the projected timeline for Niagen Bioscience to submit the IND application to the FDA following the completion of Evotec's preclinical studies?

How might the success of NB4168 in treating Ataxia Telangiectasia influence investor sentiment toward other NAD-boosting therapies in the aging and rare disease sectors?

What are the potential regulatory or commercial risks associated with relying on a contract research organization like Evotec for critical IND-enabling activities?

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Niagen Bioscience to present at Canaccord Genuity’s 46th Annual Growth Conference

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Reviewed by
Ashish TScanX News Team
Key Highlights

Niagen Bioscience executives Rob Fried and Ozan Pamir will attend Canaccord Genuity’s 46th Annual Growth Conference in Boston from August 11 to 13, 2026. CEO Rob Fried will lead a fireside chat on August 11 at 2:00 p.m. ET, with webcast registration and replay details provided. One-on-one investor meetings will also be held during the event.

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Niagen Bioscience, Inc. (NASDAQ: NAGE) announced that its senior leadership will participate in Canaccord Genuity’s 46th Annual Growth Conference, scheduled to take place in Boston from August 11 to 13, 2026. Chief Executive Officer Rob Fried and Chief Financial Officer Ozan Pamir will engage with investors during the event, highlighting the company’s position as a global authority on NAD+ (nicotinamide adenine dinucleotide) science and healthy aging. The participation aims to provide institutional investors with direct access to management insights regarding the company’s strategic direction and product portfolio, which includes the consumer supplement Tru Niagen and pharmaceutical-grade Niagen Plus.

Rob Fried is specifically scheduled to participate in a fireside chat on Tuesday, August 11, at 2:00 p.m. Eastern Time (11:00 a.m. Pacific Time). The session will be broadcast via webcast, and interested parties can register through the designated event portal. A replay of the fireside chat will be made available on the Niagen Bioscience Investor Relations website following the live event, ensuring broader accessibility for stakeholders unable to attend in person or view the stream in real time.

In addition to the public fireside chat, Mr. Fried and Mr. Pamir will hold one-on-one meetings with institutional investors throughout the conference duration. These private sessions are designed to facilitate deeper discussions on the company’s clinical advancements, patent portfolio protecting nicotinamide riboside (NR), and ongoing research into NB4168, a differentiated molecule developed under its wholly owned subsidiary, NAD Pharmaceuticals Corp. Investors seeking to arrange these meetings are instructed to contact their Canaccord Genuity representative or email the dedicated address provided by the company.

Event Detail Information
Conference Name Canaccord Genuity’s 46th Annual Growth Conference
Dates August 11 to 13, 2026
Location Boston
Key Executives Rob Fried (CEO), Ozan Pamir (CFO)
Fireside Chat Date Tuesday, August 11
Fireside Chat Time 2:00 p.m. Eastern Time

Niagen Bioscience continues to emphasize its focus on advancing healthspan through precision science. The company’s core product, Niagen, is described as the most efficient and well-researched NAD+ booster available, powering both oral supplements and intravenous/injectable products distributed through U.S. FDA-registered 503B outsourcing facilities. The firm maintains that NAD+ depletion is a key contributor to age-related health changes, positioning its solutions as critical interventions for vitality and longevity.

The company’s robust patent portfolio protects NR and other NAD+ precursors, reinforcing its competitive moat in the healthy aging sector. Niagen Bioscience collaborates with independent investigators from esteemed universities and research institutions globally to uncover the full potential of NAD+. For further information, investors and media can visit the company’s official website or contact Kendall Knysch, Senior Director of Media Relations & Partnerships, and Valter Pinto, Managing Director of KCSA Strategic Communications, who serves as the investor relations contact.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

How might the upcoming clinical data releases for NB4168 influence Niagen Bioscience's valuation relative to its consumer supplement business?

What are the potential regulatory hurdles or approval timelines for the pharmaceutical-grade Niagen Plus products distributed via 503B facilities?

Could the expansion of NAD+ research collaborations with global universities lead to new licensing revenue streams beyond the current patent portfolio?

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