Praxis (PRAX) Surges on Positive Epilepsy Study Results
Praxis Precision Medicines, Inc. PRAX shares surged 23.1% after the clinical-stage biopharmaceutical company reported positive results from its mid-stage study evaluating PRAX-628 in epilepsy patients with photo paroxysmal response (PPR).
PRAX-628 is a next-generation, functionally selective small molecule targeting the hyperexcitable state of sodium channels in the brain. It is currently being developed as a once-daily oral treatment for adult focal onset epilepsy.
PPR studies measure electroencephalogram signatures after intermittent photic stimulation and are used as an indicator of anti-seizure efficacy. Two doses were evaluated in the phase IIa proof of concept study.
A total of six patients were baselined in the 15 mg cohort, of whom five were evaluable. One patient in the 15 mg cohort did not present adequate PPR at the baseline to be evaluated. Four patients were baselined in the 45 mg cohort, of whom three were evaluable. One patient in the 45 mg cohort was not evaluable due to lack of eligibility. Three patients from the 15mg cohort participated in the 45mg cohort after a washout period of greater than 100 days. Three patients were on background anti-seizure medications.
100% of patients achieved a complete response in the 45 mg cohort. 80% of patients achieved a complete response, and 20% achieved a partial response in the 15 mg cohort. The safety was consistent with prior dose escalation studies, and pharmacokinetic analysis confirmed therapeutic exposures.
Per management, the strength and consistency of response across both study arms, combined with a continued positive tolerability and safety profile, reinforces the potential of PRAX-628 to be the first precision sodium channel modulator for focal epilepsy patients.
Consequently, Praxis plans to initiate an efficacy study in focal onset epilepsy on PRAX-628 in the second half of 2024.
Praxis stock has soared 360.8% in the past year against the industry’s decline of 8.3%.
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Praxis is focused on the development of therapies for central nervous system (CNS) disorders through two proprietary platforms — Cerebrum and Solidus. The company has established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy.
Cerebrum has generated three clinical-stage product candidates — ulixacaltamide (formerly known as PRAX-944), PRAX-562 and PRAX-628. Ulixacaltamide is being developed in essential tremor in a phase III study. PRAX-562 is being evaluated in the phase II EMBOLD study, and the company expects to announce top-line results for both cohorts (SCN2ADEE and SCN8A-DEE) in mid-2024.
The successful development and commercialization of any of the candidates will be a significant boost for Praxis.
Zacks Rank & Stocks to Consider
Praxis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are ADMA Biologics, Inc. ADMA, Galapagos GLPG and ANI Pharmaceuticals, Inc. ANIP, 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 have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 95.7%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, estimates for GLPG’s loss have narrowed from $1.68 per share to 39 cents. Galapagos beat on earnings in three of the trailing four quarters and missed once, delivering an average surprise of 92.4%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. In the past year, shares of ANIP have surged 81.%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.
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