Axcella (AXLA) Up on Patent Grant for Long Covid Fatigue Drug
Axcella Therapeutics AXLA secured a methods-of-use patent from the U.S. Patent and Trademark Office for its lead pipeline candidate, AXA1125. The patent has been granted to AXA1125 for treating patients having fatigue associated with post-acute sequelae of Covid-19 or Long Covid. The patent was issued to Axcella on Aug 29, 2023 and is scheduled to expire in 2042.
AXA1125 is AXLA’s novel therapeutic composition, which is being developed using the company’s proprietary endogenous metabolic modulators (EMMs) to simultaneously support metabolic, inflammatory and fibrotic pathways associated with fatigue caused by Long Covid. We would like to remind the investors that AXA1125 has several other patents already granted with claims covering methods of use and compositions.
The previously granted patents for AXA1125 are anticipated to expire in 2037.
Shares of the company skyrocketed 298.9% during the trading session on Tuesday, followed by a 13.3% rise in stock price during the after-market hours. Year to date, shares of Axcella have shot up 37.4% against the industry’s 12.8% fall.
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Axcella’s EMMs comprise a range of meticulously engineered molecules, including amino acids that fundamentally impact and regulate human metabolism. Management believes that its EMMs are different from current targeted interventions that used to address dysregulated metabolism and have the potential to disrupt the market. The latest patent strengthens AXLA’s intellectual property rights to its novel composition of amino acids in AXA1125, while reaffirming its effectiveness in the treatment of Long Covid fatigue.
Notably, AXA1125 for Long Covid fatigue is currently Axcella’s only ongoing clinical pipeline program. The company had previously terminated the development of another EMM therapeutic candidate, AXA1665, to treat liver-related metabolic disease as well as mid-stage studies on AXA1125 to treat nonalcoholic steatohepatitis in adult and pediatric patients.
The above decisions were taken as part of the company’s restructuring and reprioritization efforts to streamline its focus on the development of AXA1125 to treat Long Covid fatigue. Earlier this year, the company reached an agreement with the FDA as well as U.K.’s regulatory authority regarding a registrational phase IIb/III study of AXA1125 in Long Covid fatigue.
The agreement was based on clinically and statistically significant improvement in mental and physical fatigue scores compared with placebo subjects in the completed phase IIa study of AXA1125.
Axcella Health Inc. Price and Consensus
Axcella Health Inc. price-consensus-chart | Axcella Health Inc. Quote
Zacks Rank & Other Stocks to Consider
Axcella currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the pharma/biotech sector worth mentioning are J&J JNJ, Corcept Therapeutics CORT and Dynavax Technologies DVAX, each carrying a Zacks Rank #2 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 J&J’s 2023 earnings per share has increased from $10.73 to $10.75. During the same period, the estimate for JNJ’s 2024 earnings per share has increased from $11.28 to $11.30. Year to date, shares of JNJ have lost 7%.
JNJ beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.58%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 62 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 61 cents to 83 cents. Year to date, shares of CORT have climbed 61.6%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 51 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 36.9%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
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