KemPharm, Inc. KMPH was up 7.27% on Sep 28 after the company announced top-line data from its phase I study evaluating serdexmethylphenidate (SDX) for cardiovascular safety.
SDX is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH).
KemPharm initiated the phase I study in the first quarter of 2022, evaluating SDX in comparison to Ritalin (racemic methylphenidate), a commonly prescribed CNS stimulant. In the data reported from this study, the company confirmed the relative cardiovascular effects and pharmacokinetics of serdexmethylphenidate (SDX) compared to Ritalin.
The initial data from phase I of the SDX study exhibited a potential for higher doses (80mg and 200mg) of SDX to be completely safe and well-tolerated in subjects compared to two doses of 40 mg of Ritalin. The tolerability of higher doses of SDX is expected to result in improved efficacy of the prodrug candidate, KP1077, in KemPharm’s portfolio.
The pharmacokinetic and pharmacodynamic data from the study confirmed that the doses of SDX released d-MPH as designed and in a manner that is expected to be well-suited for treating idiopathic hypersomnia (IH).
Based on the phase I SDX study data, KemPharm anticipates initiating a phase II study of KP1077 in patients with IH in the fourth quarter of 2022. Pursuant to the phase I data, KemPharm believes that the initial dosing strengths of KP1077 in the phase II study will be well tolerated among participants compared to other methylphenidate products that are used for the treatment of IH.
The company also intends to initiate a phase II study evaluating KP1077 in patients with narcolepsy in 2023.
Shares of KemPharm declined 28.8% in the year-to-date period, compared to the industry’s fall of 29.3%.
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KemPharm is a biopharma company focused on developing treatments for CNS disorders and rare diseases.
Apart from KP1077, the company has yet another prodrug product candidate, KP879, being evaluated for treating stimulant use disorder (“SUD”).
KemPharm, Inc. Price
KemPharm, Inc. price | KemPharm, Inc. Quote
Zacks Rank and Stocks to Consider
KemPharm currently has a Zacks Rank #3 (Hold).
Some better-ranked stock in the same sector is Acer Therapeutics ACER, Aerie Pharmaceuticals AERI and Soleno Therapeutics SLNO, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acer Therapeutics’ loss per share estimates for 2022 remained steady at $2.47 in the past 30 days. The same for 2023 has remained steady at $1.07 during the same time frame.
Earnings of Acer missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average negative earnings surprise for ACER is 106.16%.
Aerie Therapeutics’ loss per share estimates for 2022 have remained steady at $1.82 over the past 30 days. The same for 2023 has remained steady at 96 cents over the same time frame.
Earnings of Aerie beat estimates in three of the trailing four quarters and missed the same in the remaining occasion. The average earnings surprise for AERI is 70.27%.
Soleno Therapeutics’ loss per share estimates for 2022 have remained steady at $4.05 over the past 30 days. The same for 2023 has remained steady at $2.10 in the same time frame.
Earnings of Soleno missed estimates in three of the trailing four quarters and were in line on the remaining occasion. The average earnings surprise for SLNO is 11.40%.
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