Earlier this month, Altimmune said the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for pemvidutide for the treatment of patients with metabolic dysfunction-associated steatohepatitis.
- The BTD designation was granted on the basis of data from a mid-stage trial in which pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis.
- The company is now looking forward to initiating a late-stage trial evaluating multiple pemvidutide doses over a 52-week treatment period in MASH.
Shares of Altimmune (ALT) rallied nearly 4% on Thursday in a move hailed by investors as a sign of building trust in the company.
“To me the last couple of days are a sign the market is building trust in ALT again,” a Stocktwits user said, while adding that buyers are now acting on revised fundamentals and not hype.
Another opined that Altimmune is currently financially well-positioned to run its clinical trials by itself while it also has the option to enter into profitable collaboration deals or buyout agreements valuing the company at a premium.
Overall, retail sentiment around ALT stock on Stocktwits rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company developing therapies for liver diseases. Its lead candidate called pemvidutide is an investigational drug in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).
Earlier this month, Altimmune said the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for pemvidutide for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease marked by fat accumulation, inflammation, and fibrosis in the liver. The designation from FDA is meant to speed up the development and review of medicines that are intended to treat a serious or life-threatening condition.
The designation was granted on the basis of data from a mid-stage trial in which pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis. The study also showed early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation.
Looking Ahead
The company is now looking forward to initiating a late-stage trial evaluating multiple pemvidutide doses over a 52-week treatment period in MASH.
Altimmune said earlier this month that it is seeking scientific advice from European regulators which will be considered when finalising the protocol of the upcoming trial.
ALT stock has fallen 31% over the past 12 months.
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