Palatin Technologies, Inc. (NYSEMKT:PTN) shares were down 7.06% on Tuesday to $0.483 then surged 57.25% in after-hours trading to $0.760. Share prices have been trading in a 52-week range of $0.36 to $0.86. The company has a market cap of $42.81 million at 85.93 million shares outstanding.
Palatin Technologies is a biopharmaceutical company that is engaged in developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. The company’s programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. Its primary product in clinical development is bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder or a type of female sexual dysfunction defined as low desire with associated distress.
In yesterday’s press release, Palatin Technologies announced positive, statistically significant top-line results fromits Phase 3 clinical trial program of lead drug candidate bremelanotide. The Reconnect Studies investigates bremelanotide as an on-demand treatment for premenopausal women and has met the pre-specified co-primary efficacy endpoints in both Phase 3 clinical trials. These co-primary endpoints for the Phase 3 clinical trials were the Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO), with the clinical significance of the results evaluated by an independent committee using multiple anchors of patient assessment of benefit, consistent with discussions with the FDA and guidance documents.
We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results. Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis,” said Carl Spana, Ph.D., CEO and President of Palatin Technologies.
Chief Medical Officer of Palatin Johna Lucas added that bremelanotide was used as a single dose self-administered in anticipation of sexual activity by premenopausal women, and that the studies demonstrated that bremelanotide provided a meaningful benefit for those patients who responded to the drug candidate. Palatin Technologies is scheduled to have a conference call and audio webcast on Wednesday, November 2, 2016 at 9:00 a.m. Eastern Time, during which they might announce more details into the study or what the company has lined up next.
On the daily chart of Palatin Technologies shares, it can be seen that volume has significantly picked up since September and has carried on for the first half of October. Price has bounced off the support at the $0.5 mark and onto the $0.7 levels, lending more potential upside to the next highs at $0.85. The company is targeting a New Drug Application with the FDA for the second half of 2017, which would open up plenty of revenue opportunities for bremelanotide and therefore more potential upside for Palatin Technologies shares.
Hypoactive sexual desire disorder is the most prevalent form of female sexual dysfunction,” said Sheryl A. Kingsberg, Ph.D., Professor of Reproductive Biology at Case Western Reserve University School of Medicine. “The distress component of HSDD reflects the profound negative impact that this condition can have on women’s self-image, relationships and quality of life well outside the bedroom. In the Phase 3 trials we saw significant reduction in distress with use of bremelanotide.”
The company is still continuing its Reconnect Studies and monitoring results, possibly providing more data in the coming weeks to support the drug’s availability in the market by next year. These results could also be disclosed in future sexual medicine and women’s health conferences and in peer reviewed journal publications.
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