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Axcella (AXLA) Up on Decision to Prioritize Long-COVID Program

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Axcella Therapeutics AXLA announces that it has prioritized its clinical development portfolio, following the accelerated enrollment in its mid-stage study evaluating its pipeline candidate, AXA1125, as a potential treatment for long COVID, a large and growing consequence of the pandemic.

The company has decided that it will focus on the development of AXA1125 targeting long COVID and non-alcoholic steatohepatitis (NASH). It will suspend the development of another pipeline candidate, AXA1665, as a potential treatment for overt hepatic encephalopathy (OHE) and focus resources on both the ongoing long COVID and NASH programs.

Shares of Axcella gained 16.8% on May 26, following the re-prioritization of its clinical portfolio. However, Axcella’s shares have declined 6.7% so far this year compared with the industry’s decrease of 24.3%.

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Zacks Investment Research


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Axcella believes that long COVID may provide a significant opportunity going forward as the number of patients is rising following the pandemic, which resulted in hundreds of millions of infections worldwide in the past two years. Long COVID is a post-COVID-19 condition referring to the constellation of long-term symptoms that some people experience after they have had the disease including fatigue and difficulty in breathing. Pre-clinical and clinical data demonstrated that treatment with AXA1125 may have an important impact.

Currently, Axcella is evaluating AXA1125 in a phase IIa study targeting long COVID. The company rapidly achieved its enrollment target in the study. It expects top-line data from the mid-stage study in the third quarter of 2022.

The company is also evaluating AXA1125 in a phase IIb study in NASH patients. Interim data from the study is expected during the third quarter.

Axcella decided to suspend the development of AXA1665 as a potential treatment of OHE as it faces challenges with patient enrollment due to the rarity of the disease, which can lead to a longer approval timeline. The company had initiated a mid-stage study on the candidate last year. Although Axcella decided to suspend the AXA1665 study, it still believes that the candidate is an effective therapy based on two prior clinical studies. The company is currently looking for a potential partner for the development of AXA1665 in OHE and other potential indications.

Axcella Health Inc. Price

Axcella Health Inc. Price
Axcella Health Inc. Price

Axcella Health Inc. price | Axcella Health Inc. Quote

Zacks Rank & Stocks to Consider

Axcella currently carries a Zacks Rank #3 (Hold).

Some better-ranked biotech/drug stocks are Alkermes ALKS, ProPhase Labs PRPH and Sesen Bio SESN. While ProPhase and Sesen Bio sport a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24% year to date.

Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.

Earnings estimates for ProPhase’s 2022 bottom line have improved from earnings of 27 cents per share to 55 cents per share over the past 30 days. PRPH stock is up 23.8% this year so far.

ProPhase exceeded earnings expectations in two of the last four quarters, while missing the same twice. The company has a negative four-quarter earnings surprise of 130.56%, on average.

The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 38.1% in the year-to-date period.

Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.


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