Results of a third-party clinical trial of Palatin Technologies Inc. (PTN:NYSE.MKT) Vyleesi in women with hypoactive sexual desire disorder (HSDD) was just published in a Journal of Clinical Investigation peer-reviewed article, reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in an October 17, 2022 research note.
Also of note, Palatin's stock is trading at $4.51 per share, whereas H.C. Wainwright's target price on the company is dramatically higher, at $70 per share, Pantginis pointed out.
The data were positive, and the drug's effects were captured on functional magnetic resonance imaging (fMRI).
Also of note, Palatin's stock is trading at $4.51 per share, whereas H.C. Wainwright's target price on the company is dramatically higher, at $70 per share, Pantginis pointed out. This difference, "driven by the new very low share count," implies a large potential return for Palatin investors.
The newly published study of Palatin's Vyleesi showed on fMR that it enhanced sexual brain function. Effects included a statistically significant increase in sexual desire and processing that lasted up to 24 hours, compared to placebo (p≤0.01), Pantginis relayed.
Palatin's Vyleesi (bremelanotide injection) is the first and only p.r.n. treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with HSDD.
"These data are tied to fMRI data for the first time on women with HSDD using a melanocortin-4 receptor (MCR4) agonism approach," Pantginis wrote.
He noted that H.C. Wainwright is waiting to hear about a commercialization plan for Vyleesi, possibly involving a partnership, before including the drug in its valuation of Palatin. Even though the biopharma is not marketing Vyleesi, sales of it are increasing. For instance, noted Pantginis, sales in the recent quarter were up 17% over the previous quarter, and more than half of the prescriptions were refills.
Meanwhile, Palatin continues advancing the other drug candidates in its pipeline.
"There has been a significant increase by New Jersey-based Palatin to advance the novel approaches and robustness of the melanocortin receptor [agonist] (MCR) platform for the treatment of inflammation across several indications," Pantginis wrote.
As for the next viable candidate from the platform, PL9643, a Phase 3 clinical trial in 350 patients with dry eye disease, is moving forward. The primary endpoints for MELODY-1 include inferior corneal fluorescein staining, total conjunctival lissamine green staining, and ocular discomfort. Topline results are expected in Q2/23.
"We continue to believe, along with company management, that the trial's adaptive design allows for key derisking and increases its chances of achieving primary endpoints," wrote Pantginis.
As for another of Palatin's pipeline treatments, PL8177, a melanocortin-1 receptor agonist, recruitment has started for a Phase 2 study in ulcerative colitis. Up to 28 patients at about 22 sites are expected to be enrolled. The trial's primary endpoint includes the Mayo endoscopic subscore that evaluates patients' stages of the disease. Interim study results are expected in Q1/23, with topline data following in Q2/23.
H.C. Wainwright rates Palatin Buy.
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Disclosures For H.C.Wainwright & Co., Palatin Technologies Inc., October 17, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Joseph Pantginis, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
The covering research analyst and/or the research analyst’s household has a financial interest in and own the securities of Palatin Technologies, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Palatin Technologies, Inc..
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