NeuroDerm Ltd. (NASDAQ: NDRM) shares surged in Monday’s session following a critical update from the U.S. Food and Drug Administration (FDA). The company announced that after its End-of-Phase 2 meeting with the FDA in late October, NeuroDerm intends to pursue a comparative bioavailability regulatory path for the its lead product candidate ND0612 based on comparative pharmacokinetic (PK) data in place of data from Phase 3 clinical efficacy trials.

The FDA also reaffirmed that long-term safety data from the company’s ongoing BeyoND trial should be part of the eventual New Drug Application (NDA) submission. ND0612 is the company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson’s disease.

Following the discussions with the FDA, NeuroDerm has decided to discontinue preparations to initiate its Phase 3 clinical efficacy trial of ND0612H (trial 010) and suspend iNDiGO, its other ongoing Phase 3 trial for ND0612L. Both studies are no longer required for marketing approval and will be replaced by comparative PK studies that will be initiated in the upcoming months.

Excluding Monday’s move, NeuroDerm had actually underperformed the broad markets, with the stock down about 9% year to date.

Oded Lieberman, Ph.D., CEO of NeuroDerm, commented:

We are extremely pleased with the outcome of this FDA meeting that led us to replace two large, Phase 3 efficacy trials, with small PK trials. We are encouraged by the support that we have received from all those who care about Parkinson’s disease and share our hope that ND0612 will transform patients’ lives.  ND0612 has been designed to become the first non-surgical continuous levodopa therapy. We hope that it may offer Parkinson’s disease patients a new, effective and convenient alternative to the highly invasive treatment options available today, that are associated with potentially serious and sometimes life-threatening side effects.  We are committed to bringing this innovative therapy to market as quickly as possible, and believe that a PK-based regulatory development route in the United States charts a clear path to ND0612 NDA submission.

Shares of NeuroDerm rose about 41% to hit a new 52-week high of $21.95 Monday morning. The consensus analyst price target is $28.70, and a 52-week low is $11.76.

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