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Better Therapeutics' (BTTX) CBT Gains FDA's Breakthrough Status

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Better Therapeutics (BTTX - Free Report) recently announced that its innovative Cognitive Behavioral Therapy (CBT) platform has received Breakthrough Device Designation from the FDA to treat people with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.

The breakthrough status is significant for the company as technologies achieving Breakthrough Device Designation show promise for outperforming the existing standard of care for patients with severe or life-threatening diseases.

Price Performance

For the past six months, BTTX’s shares have lost 73.9% against the industry’s rise of 5.8%. The S&P 500 increased 12.8% in the same time frame.

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More on MASH

MASH is an advanced stage of the disease related to the rising rates of diabetes and obesity. However, 16.5 million persons in America have been diagnosed with serious liver problems, including MASH. It is believed that one in four adults in the country suffer from MASLD1.

MASH is a major contributor to liver-related mortality and a growing global burden on healthcare systems. Patients with MASH are also more likely to experience unfavorable cardiovascular events, as well as higher rates of morbidity and death. This is particularly true for those with more advanced metabolic risk factors, such as concurrent type 2 diabetes and hypertension.

More on the CBT Platform

The innovative CBT offered by Better Therapeutics targets lifestyle choices that are known to initiate and worsen metabolic illnesses.

The CBT platform was created to fill the current void in widely available, standardized intensive behavioral therapies that facilitate the successful application of current treatment guidelines that emphasize behavior modification as the foundation of care.

AspyreRx, the first prescription digital therapy to administer cognitive behavioral therapy as a treatment for type 2 diabetes (T2D), was authorized by the FDA in 2023 because of the company's CBT platform demonstrating clinically relevant effects in T2D cases.

Presently, the company has received the designation of a breakthrough device, and it is likely to move more quickly to obtain marketing authorization for a possible second indication of MASH. Better Therapeutics is also actively looking for strategic partnerships to help them develop and commercialize CBT more quickly for the millions of patients who suffer from advanced liver disease.

Industry Prospects

Per a report by Data Bridge Market Research, the global fatty liver disease treatment market size was valued at $9.1 billion in 2022 and is expected to grow at 15% to reach up to $28 billion by 2030.

The increasing prevalence of people with an overdose of alcohol worldwide is majorly responsible for boosting growth of the global fatty liver disease treatment market.

With the given market potential for the treatment of fatty liver diseases, the attainment of the breakthrough status for Better Therapeutics’ CBT platform is likely to prove beneficial for its business and generate additional revenues.

Zacks Rank & Stocks to Consider

BTTX carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space that have announced quarterly results are Cencora, Inc. (COR - Free Report) , Elevance Health, Inc. (ELV - Free Report) and Cardinal Health, Inc. (CAH - Free Report) .

Cencora, carrying a Zacks Rank of 2 (Buy), reported first-quarter fiscal 2024 adjusted earnings per share (EPS) of $3.28, beating the Zacks Consensus Estimate by 14.7%. Revenues of $72.25 billion outpaced the consensus mark by 5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cencora has a long-term estimated growth rate of 8.6%. COR’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 6.7%.

Elevance Health reported fourth-quarter 2023 adjusted EPS of $5.62, beating the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%. It currently carries a Zacks Rank #2.

Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 3.1%.

Cardinal Health reported second-quarter fiscal 2024 adjusted EPS of $1.82, beating the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion surpassed the Zacks Consensus Estimate by 1.1%. It currently carries a Zacks Rank #2.

Cardinal Health has a long-term estimated growth rate of 15.9%. CAH’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 15.6%.

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