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ChromaDex (CDXC) Up as Ataxia Candidate Gets Orphan Drug Tag
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ChromaDex’s (CDXC - Free Report) shares jumped 11.9% on Jun 7 after the company announced that the FDA has granted the Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to its investigational candidate, nicotinamide riboside chloride (NRC), to treat ataxia telangiectasia (AT).
The company is currently gearing up to file an investigational new drug (IND) application for NRC with the FDA to treat AT. Subject to IND clearance, ChromaDex will begin evaluating the candidate in human clinical studies.
The FDA grants the ODD to support the development of medicines for rare disorders that affect a few patients in the United States. The ODD will grant CDXC market exclusivity for NRC in the treatment of AT for a predefined time period, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval.
Per ChromaDex, the ODD grant reaffirms the potential of NRX to treat a rare, neurodegenerative disease like AT that causes severe disability (premature aging).
Currently, there is no cure or FDA-approved treatment to slow the progression of AT. The average life expectancy is around 25 years for those diagnosed in childhood, representing a serious unmet medical need.
Per the FDA’s RPD program, companies are awarded a Priority Review Voucher when their pediatric disease product applications meet certain criteria. The purpose of the program is to encourage companies to develop new drugs that prevent or treat rare pediatric diseases. When awarded, a company holds the option to either redeem the voucher to receive a priority review of a subsequent marketing application or sell/transfer the same.
Year to date, shares of ChromaDex have skyrocketed 123.8% against the industry’s 5.3% decline.
Image Source: Zacks Investment Research
It is important to note that this commercial-stage company operates in a niche market space. It is pioneering research on nicotinamide adenine dinucleotide (NAD+), an essential coenzyme that is a key regulator of cellular metabolism and is found in every cell of the human body.
ChromaDex claims that NAD+ levels in humans have shown to decline by up to 65% between the age group of 30 and 70, which may be increased with NAD+ boosters, calorie restriction and moderate exercise.
The company currently markets the Niagen (nicotinamide riboside, or NR) as the most efficient and superior-quality NAD+ booster, which is available in several countries, including the United States. ChromaDex delivers Niagen as the sole active ingredient in its dietary supplement consumer product, Tru Niagen.
However, in the first quarter of 2024, the company recorded net sales of $22.2 million, down 2% from the prior-year quarter. The decline in total Tru Niagen sales was primarily due to decreased sales through distributor partners.
Despite the unfavorable first-quarter sales figure, ChromaDex expects its total revenues from Tru Niagen to grow 16% year over year in 2024. The guidance assumes continued revenue growth through its e-commerce business as well as established partnerships and assumes upside from opportunities with new partnerships, channels and products.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have plunged 39.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $2.93 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.83 to $1.95. Year to date, shares of ANVS have plunged 67%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have gained 6.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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ChromaDex (CDXC) Up as Ataxia Candidate Gets Orphan Drug Tag
ChromaDex’s (CDXC - Free Report) shares jumped 11.9% on Jun 7 after the company announced that the FDA has granted the Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to its investigational candidate, nicotinamide riboside chloride (NRC), to treat ataxia telangiectasia (AT).
The company is currently gearing up to file an investigational new drug (IND) application for NRC with the FDA to treat AT. Subject to IND clearance, ChromaDex will begin evaluating the candidate in human clinical studies.
The FDA grants the ODD to support the development of medicines for rare disorders that affect a few patients in the United States. The ODD will grant CDXC market exclusivity for NRC in the treatment of AT for a predefined time period, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval.
Per ChromaDex, the ODD grant reaffirms the potential of NRX to treat a rare, neurodegenerative disease like AT that causes severe disability (premature aging).
Currently, there is no cure or FDA-approved treatment to slow the progression of AT. The average life expectancy is around 25 years for those diagnosed in childhood, representing a serious unmet medical need.
Per the FDA’s RPD program, companies are awarded a Priority Review Voucher when their pediatric disease product applications meet certain criteria. The purpose of the program is to encourage companies to develop new drugs that prevent or treat rare pediatric diseases. When awarded, a company holds the option to either redeem the voucher to receive a priority review of a subsequent marketing application or sell/transfer the same.
Year to date, shares of ChromaDex have skyrocketed 123.8% against the industry’s 5.3% decline.
Image Source: Zacks Investment Research
It is important to note that this commercial-stage company operates in a niche market space. It is pioneering research on nicotinamide adenine dinucleotide (NAD+), an essential coenzyme that is a key regulator of cellular metabolism and is found in every cell of the human body.
ChromaDex claims that NAD+ levels in humans have shown to decline by up to 65% between the age group of 30 and 70, which may be increased with NAD+ boosters, calorie restriction and moderate exercise.
The company currently markets the Niagen (nicotinamide riboside, or NR) as the most efficient and superior-quality NAD+ booster, which is available in several countries, including the United States. ChromaDex delivers Niagen as the sole active ingredient in its dietary supplement consumer product, Tru Niagen.
However, in the first quarter of 2024, the company recorded net sales of $22.2 million, down 2% from the prior-year quarter. The decline in total Tru Niagen sales was primarily due to decreased sales through distributor partners.
Despite the unfavorable first-quarter sales figure, ChromaDex expects its total revenues from Tru Niagen to grow 16% year over year in 2024. The guidance assumes continued revenue growth through its e-commerce business as well as established partnerships and assumes upside from opportunities with new partnerships, channels and products.
ChromaDex Corporation Price and Consensus
ChromaDex Corporation price-consensus-chart | ChromaDex Corporation Quote
Zacks Rank and Stocks to Consider
ChromaDex currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have plunged 39.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $2.93 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.83 to $1.95. Year to date, shares of ANVS have plunged 67%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have gained 6.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.