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Here's Why You Should Invest in Aquestive (AQST) Stock Now

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Aquestive Therapeutics (AQST - Free Report) makes oral products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard-of-care therapies.

Its key pipeline candidate is Anaphylm (epinephrine) Sublingual Film, which it is developing as a non-invasive oral epinephrine product candidate. It can offer greater convenience to autoinjectors such as EpiPen and Auvi-Q for the emergency treatment of severe allergic reactions, including anaphylaxis. In the fourth quarter of 2023, it initiated a pivotal phase III pharmacokinetic (PK) study for Anaphylm with top-line data targeted for first-quarter 2024. The company plans to conduct another pivotal PK study and three supportive PK studies on Anaphylm.

In clinical studies, Anaphylm has been shown to preserve an individual's mean arterial pressure or MAP in contrast to auto-injectors, which have failed to do so. Maintaining MAP supports the necessary pressure for vital organs, thereby allowing them to function normally and lowering the risk of anaphylaxis-related outcomes like losing consciousness.

Aquestive's new drug application (NDA) seeking approval of another pipeline candidate, Libervant (diazepam) Buccal Film, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity for kids aged 2-5 is under review with the FDA. The regulatory body is expected to give its decision on the NDA on Apr 28, 2024. If approved, Libervant will not face much competition as Diastat (diazepam) Rectal Gel is the only FDA-approved treatment for this patient group for the disease. Aquestive believes there is significant demand for an oral product in this space.

Libervant has been approved for patients 12 years of age and older since August 2022. However, the product has not been launched due to an orphan drug market exclusivity block until January 2027 based on an FDA-approved nasal spray product from another company.

The new year could prove to be transformational for Aquestive with the FDA’s decision on Libervant’s NDA and top-line data from the pivotal study on Anaphylm. Also, Aquestive refinanced its debt recently, resulting in approximately $28 million of cash savings through June 2025 that can support its development. This will give the company flexibility to launch or partner for both Anaphylm and Libervant, as appropriate, if approved by the FDA.

Aquestive earns royalty revenues from its five out-licensed marketed products that it supplies under license deals with partners. Aquestive is the exclusive manufacturer of these licensed products. Its revenues from these products are increasing due to strong demand trends.

Aquestive Therapeutics stock has surged 127% in the past year compared with an increase of 0.6% for the industry.

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Aquestive Therapeutics sports a Zacks Rank #1 (Strong Buy) currently. In the past 60 days, the consensus estimate for Aquestive Therapeutics’ 2024 loss has narrowed from 56 cents per share to 34 cents per share.

Aquestive Therapeutics beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 70.58%.

Other Stocks to Consider

Some other top-ranked drug/biotech companies worth considering are Novo Nordisk (NVO - Free Report) , Rigel Pharmaceuticals (RIGL - Free Report) and Puma Biotechnology (PBYI - Free Report) , each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Novo Nordisk’s 2024 earnings per share have increased from $2.99 to $3.14 over the past 60 days. NVO’s stock has surged 49% in the past year.

Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.

In the past 60 days, the loss per share estimate for Rigel Pharmaceuticals for 2024 has narrowed from 15 cents per share to 8 cents per share. RIGL’s stock has risen 5.9% in the past year.

Earnings of Rigel Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 58.14%.

In the past 60 days, the consensus estimate for Puma Biotechnology’s 2024 earnings has increased from 56 cents to 69 cents per share. PBYI’s stock has rallied 7.7% in the past year.

Puma Biotechnology beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 76.55%.

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