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Maroc Maroc - ZACKS.COM - All Stories - 28/Aug 14:25

Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review

SLNO stock gains 6.3% as FDA accepts regulatory filing for lead candidate, DCCR, to treat hyperphagia associated with PWS under Priority Review.

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FDA Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up

zacks.com - 05/Sep 15:35

The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

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Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug

zacks.com - 11/Sep 14:47

CRVS stock gains 14% on initiating a registrational study on its lead candidate, soquelitinib, to treat relapsed/refractory peripheral T-cell...

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ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

zacks.com - 11/Sep 16:04

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

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Hoth Stock Up as Lead Drug Heals Skin Toxicities in Cancer Patient

zacks.com - 06/Sep 14:43

HOTH stock soars on superior efficacy data from the first patient treated with the lead candidate, HT-001, suffering from EGFRI-related skin...

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Hoth Stock Up as Lead Drug Heals Skin Toxicities in Cancer Patient

zacks.com - 06/Sep 14:43

HOTH stock soars on superior efficacy data from the first patient treated with the lead candidate, HT-001, suffering from EGFRI-related skin...

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Aura Stock Up as Lead Drug Shows Superior Efficacy in Eye Cancer Study

zacks.com - 13/Sep 13:30

AURA stock up as lead candidate shows tumor control and visual acuity preservation abilities in eye cancer patients over 12 months of treatment.

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Praxis Stock Up as Epilepsy Candidate Shows Reduction in Seizures

zacks.com - 04/Sep 14:34

Shares of PRAX gains on positive efficacy data from the mid-stage study of its investigational candidate, relutrigine, for two epilepsy indications.

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Praxis Stock Up as Epilepsy Candidate Shows Reduction in Seizures

zacks.com - 04/Sep 14:34

Shares of PRAX gains on positive efficacy data from the mid-stage study of its investigational candidate, relutrigine, for two epilepsy indications.

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RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study

zacks.com - 10/Sep 14:44

The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.

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RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study

zacks.com - 10/Sep 14:44

The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.