Shares of INmune Bio, Inc. INMB were down 24.6% on Tuesday after the company reported that it has received an email from the FDA on May 20, stating that the regulatory body has placed a clinical hold on the investigational new drug application to begin a phase II study evaluating XPro1595 (XPro) in patients with Alzheimer’s disease (“AD”).
Via the email, the FDA requested additional information about Chemistry Manufacturing and Controls related to the newly-manufactured XPro1595, a next-generation tumor necrosis factor (TNF) inhibitor candidate.
An official clinical hold letter from the FDA is expected within 30 days.
Meanwhile, a phase II study of XPro continues to enroll patients in Australia.
Shares of INmune Bio have plunged 46.3% this year compared with the industry’s decline of 23.5%.
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In April 2022, INmune Bio dosed the first patient in a phase II study investigating XPro to treat cognition and function in patients with mild AD and biomarkers of inflammation.
INMB also plans to start another phase II study in patients with mild cognitive impairment. Top-line data from both these studies are expected in 2023.
We note that the Biogen’s BIIB Alzheimer’s drug, Aduhelm, has spotlighted the AD market since its controversial FDA approval in June 2021.
In April 2022, the final national coverage determination released by the Centers for Medicare & Medicaid Services (“CMS”) for amyloid-beta targeting therapies to treat AD effectively denied all Medicare beneficiaries access to Aduhelm.
Biogen has now decided to substantially eliminate its infrastructure supporting the commercialization of Aduhelm, retaining minimal resources.
Aduhelm generated sales of $2.8 million in the first quarter of 2022 compared with $1 million in the fourth quarter of 2021. Sales of the drug are likely to be minimal as BIIB significantly reduces commercial infrastructure.
Zacks Rank & Other Stocks to Consider
INmune Bio currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks worth considering in the biotech sector are Leap Therapeutics, Inc. LPTX and Aeglea BioTherapeutics, Inc. AGLE, both carrying Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
AegleaBio Therapeutics’ loss per share estimates narrowed 23.2% for 2022 and 30.6% for 2023 in the past 60 days.
Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
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