Shares of Monopar Therapeutics MNPR, a clinical-stage biotech, skyrocketed 383.5% in the past three months fueled by a licensing agreement with AstraZeneca AZN, which granted MNPR an exclusive worldwide license to ALXN-1840 (bis-choline tetrathiomolybdate). ALXN-1840 is an investigational once-daily, oral medicine, which is being developed for treating Wilson disease, a rare and progressive genetic disease.

AstraZeneca had earlier announced that a pivotal phase III study evaluating the candidate for the above indication had met its primary endpoint. Although AZN terminated the ALXN-1840 program in 2023, Monopar took up the candidate upon the request of the Wilson Disease Association. AstraZeneca’s termination of the ALXN-1840 program was based on the review of results from phase II mechanistic studies and discussions with regulatory authorities.

In the past six months, shares of Monopar have rallied 525.5% against the industry’s 4.8% decline.

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More on the Licensing Deal Between MNPR and AZN

The licensing agreement with AstraZeneca added a late-stage candidate to Monopar’s early-stage pipeline. This has brought MNPR significantly close to becoming a commercial-stage company.

Following the deal, Monopar has assumed responsibilities for all future global development and commercialization activities related to ALXN-1840 to treat Wilson disease. Management believes that the company’s expertise in rare disease drug development and commercialization will catapult ALXN-1840 into a successful product for the above indication.

Under the terms of the transaction, Monopar is liable to make an undisclosed upfront cash payment to AstraZeneca, along with a stake in its equity, in consideration of the global rights to ALXN-1840. The company shall also be liable to make additional payments to AZN based on the achievement of certain pre-determined regulatory and sales milestones. AstraZeneca is also eligible to receive tiered royalties on net sales from Monopar if ALXN-1840 is approved and launched.

Per MNPR, ALXN-1840 has significant market opportunity as one in 30,000 live births in the United States are affected by Wilson disease.

Monopar will initially be focusing on developing ALXN-1840 for patients with more severe Wilson disease symptoms. It is gearing up to hold discussions with the FDA to figure out a path forward for the candidate.

Apart from ALXN-1840, the company is currently evaluating several other candidates for various oncology indications in separate early-stage studies.

Monopar Therapeutics Inc. Price and Consensus

Monopar Therapeutics Inc. price-consensus-chart | Monopar Therapeutics Inc. Quote

MNPR’s Zacks Rank & Other Stocks to Consider

Monopar currently sports a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks from the sector are Castle Biosciences CSTL and Spero Therapeutics SPRO, each presently sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 6.2%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 20.2%.

SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.

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