FDA

SteadyMed shares slammed as FDA tosses its NDA for PAH drug-device

When SteadyMed $STDY outlined its IPO plans in early 2015, the biotech assured would-be investors that it could be ready to file an application for its drug-device therapeutic Trevyent a year later.

Things haven’t worked out as planned for the biotech, though. The NDA arrived at the agency in June of this year, and has now been handed back as incomplete.

This morning the biotech reported that the FDA has issued a refuse-to-file letter on Trevyent — the FDA’s second RTF this week — which uses a pump to deliver a reformulated version of United Therapeutics’ mainstay drug Remodulin for pulmonary arterial hypertension.

That’s not the news investors were looking for. Its shares plunged 44%, taking a big bite out of its micro market cap.

The active ingredient in United’s Remodulin is treprostinil, and SteadyMed — based in San Ramon, CA with R&D in Israel — has been fighting to cancel United’s patents on that drug. It has some immediate concerns to deal with at the FDA, though.

According to the biotech:

FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. Within the next 30 days, the Company will request a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The Company will provide further guidance after the anticipated meeting with FDA.

Jonathan Rigby

The FDA also issued a rare RTF earlier in the week to Acorda, which has been attempting a high wire act to hustle CVT-301 to the FDA as it looks to replace Ampyra as generic competition looms.

As for SteadyMed, the company plans to regroup and get back in front of regulators.

“We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application,” said SteadyMed CEO Jonathan Rigby. “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.”


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