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Trevena Scores NIH Grant For Research In Major Depression

This article was originally published in The Pink Sheet Daily

Executive Summary

The biotech has forged a partnership with NIH to discover and begin development of a biased ligand to the delta opioid receptor for the treatment of MDD.

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Forest Takes Option On Trevena’s Heart Failure Drug, And Some Equity

Already strong in both CNS and cardiovascular drugs, Forest obtained an option to license the Pennsylvania start-up’s lead program in acute heart failure. In the process, Forest took a stake in Trevena as the young company shifts its focus toward pain drugs based on Nobel Prize-winning research.

Launching Ampyra: The Long Road To Approval

The January 2010 approval for Acorda Therapeutics Inc.'s oral multiple sclerosis therapy Ampyra (dalfampridine) is an impressive accomplishment - by any account. The company took a drug that failed one development program and resurrected it so that it ultimately won FDA approval and is fast becoming a commercial success. Every drug and indication has its challenges, and gaining FDA approval is never simple. But Acorda's challenges were greater than most. MS causes demyelination, which leads to slower nerve conduction; gait problems are one of its most common symptoms. Acorda was first to tackle the walking problem, and it faced the challenge of proving a novel benefit in a disease that is highly debilitating, progressive, and variable. Patients can feel better one day, worse another, for reasons no one entirely understands, making it difficult to discern a drug's impact. Along the way, Acorda also had to contend with the usual complications: development setbacks, edgy investors and negotiations with FDA. To demonstrate that its new drug for walking impairment was efficacious, Acorda devised an innovative responder rate analysis, which used a novel endpoint and an unusual statistical analysis to identify subsets of responders.

With $35 Million B Round, Trevena to Push GPCR-Targeted Program into Phase II for Acute Heart Failure

Four investors returned to back the Duke University spinout, which is developing biased ligand small molecules.


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