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Palatin (PTN) Up 15% on Results From Dry Eye Disease Study
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Shares of Palatin Technologies (PTN - Free Report) rose 14.8% on Monday after management announced encouraging results from the pivotal phase III MELODY-1 study on its investigational dry eye disease (DED) drug PL9643. These results were presented at the American Society of Cataract and Refractive Surgery (ASCRS) last week.
As previously reported in February, data from the MELODY-1 study showed that treatment with PL9643 over a 12-week period exhibited clinically meaningful and statistically significant improvements in the co-primary symptom endpoint of pain. The study did not achieve statistical significance in the other co-primary endpoint of clinical sign (conjunctival lissamine green staining).
Palatin reported additional data from the study that showed that treatment with the Palatin drug provided clinical benefit in seven out of 11 exploratory secondary symptom endpoints, including eye dryness. Treatment with PL9643 was also well tolerated by study participants.
Management stated that a ‘substantial patient population’ achieved statistically significant efficacy results after two weeks of treatment with PL9643 across multiple sign endpoints, including all four fluorescein staining endpoints. A clinical benefit across these endpoints suggests that treatment with the drug improves ocular surface disorders and facilitates the identification and treatment of epithelial damage and corneal injuries.
Based on these results, Palatin intends to hold a meeting with the FDA later this quarter to discuss the regulatory pathway for approval of PL9643 in DED. If successful, a regulatory filing is expected in early 2025. Likewise, management continues to advance discussions with potential collaboration partners. These factors were likely to have been responsible for the rise in share price.
Palatin estimates the DED market size in 2024 to be around $6.1 billion, which will reach nearly $7.5 billion by 2029. Per management, there is a significant unmet need for DED therapies, as existing therapies are generally regarded as inadequate by physicians and patients.
Year to date, Palatin’s shares have plunged 49.3% compared with the industry’s 5.7% fall.
Image Source: Zacks Investment Research
Last December, Palatin completed the asset sale for its sole marketed drug, Vyleesi, to Cosette Pharmaceuticals for up to $171 million (including $159 million in milestone payments). The drug is approved for hypoactive sexual desire disorder (HSDD) in females.
As a result, the company is devoid of a marketed drug in its portfolio and entirely dependent on its pipeline for growth. A successful development of its pipeline candidates will boost Palatin’s growth prospects.
Apart from PL9643, Palatin is developing first-in-class medications, which include anti-inflammatory and metabolic programs. These include PL8177, which is being evaluated in the mid-stage study for ulcerative colitis (UC). Despite selling Vyleesi, Palatin still retains the rights to develop the drug for obesity and male erectile dysfunction indications. Management is currently conducting mid-stage studies evaluating the drug in both these indications. Palatin expects data readouts from all these studies throughout this year.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 37.6%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 22.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Ligand Pharmaceuticals’ earnings estimates per share for 2024 have increased from $4.42 to $4.56. During the same period, earnings estimates for 2025 have risen from $5.11 to $5.27. Year to date, shares of Ligand have gained 11.5 %.
Ligand Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters. On average, LGND’s four-quarter earnings surprise was 84.81%.
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Palatin (PTN) Up 15% on Results From Dry Eye Disease Study
Shares of Palatin Technologies (PTN - Free Report) rose 14.8% on Monday after management announced encouraging results from the pivotal phase III MELODY-1 study on its investigational dry eye disease (DED) drug PL9643. These results were presented at the American Society of Cataract and Refractive Surgery (ASCRS) last week.
As previously reported in February, data from the MELODY-1 study showed that treatment with PL9643 over a 12-week period exhibited clinically meaningful and statistically significant improvements in the co-primary symptom endpoint of pain. The study did not achieve statistical significance in the other co-primary endpoint of clinical sign (conjunctival lissamine green staining).
Palatin reported additional data from the study that showed that treatment with the Palatin drug provided clinical benefit in seven out of 11 exploratory secondary symptom endpoints, including eye dryness. Treatment with PL9643 was also well tolerated by study participants.
Management stated that a ‘substantial patient population’ achieved statistically significant efficacy results after two weeks of treatment with PL9643 across multiple sign endpoints, including all four fluorescein staining endpoints. A clinical benefit across these endpoints suggests that treatment with the drug improves ocular surface disorders and facilitates the identification and treatment of epithelial damage and corneal injuries.
Based on these results, Palatin intends to hold a meeting with the FDA later this quarter to discuss the regulatory pathway for approval of PL9643 in DED. If successful, a regulatory filing is expected in early 2025. Likewise, management continues to advance discussions with potential collaboration partners. These factors were likely to have been responsible for the rise in share price.
Palatin estimates the DED market size in 2024 to be around $6.1 billion, which will reach nearly $7.5 billion by 2029. Per management, there is a significant unmet need for DED therapies, as existing therapies are generally regarded as inadequate by physicians and patients.
Year to date, Palatin’s shares have plunged 49.3% compared with the industry’s 5.7% fall.
Image Source: Zacks Investment Research
Last December, Palatin completed the asset sale for its sole marketed drug, Vyleesi, to Cosette Pharmaceuticals for up to $171 million (including $159 million in milestone payments). The drug is approved for hypoactive sexual desire disorder (HSDD) in females.
As a result, the company is devoid of a marketed drug in its portfolio and entirely dependent on its pipeline for growth. A successful development of its pipeline candidates will boost Palatin’s growth prospects.
Apart from PL9643, Palatin is developing first-in-class medications, which include anti-inflammatory and metabolic programs. These include PL8177, which is being evaluated in the mid-stage study for ulcerative colitis (UC). Despite selling Vyleesi, Palatin still retains the rights to develop the drug for obesity and male erectile dysfunction indications. Management is currently conducting mid-stage studies evaluating the drug in both these indications. Palatin expects data readouts from all these studies throughout this year.
Palatin Technologies, Inc. Price
Palatin Technologies, Inc. price | Palatin Technologies, Inc. Quote
Zacks Rank & Key Picks
Palatin currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) ,each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 37.6%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 22.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Ligand Pharmaceuticals’ earnings estimates per share for 2024 have increased from $4.42 to $4.56. During the same period, earnings estimates for 2025 have risen from $5.11 to $5.27. Year to date, shares of Ligand have gained 11.5 %.
Ligand Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters. On average, LGND’s four-quarter earnings surprise was 84.81%.