Medical Innovation Exchange

Reneo pulls plug on only asset after phase 2b fail, sending 70% of staff out the door and stock plummeting

Reneo Pharmaceuticals’ rare genetic disease study has missed both primary and secondary goals, prompting the California biotech to halt the development of its only asset and lay off 70% of staff.

The news, shared Thursday morning, sent the company’s stock plummeting 87%, down from $7.75 per share at market close yesterday to 98 cents as of 10:15 a.m. ET today.

The data drop comes from a phase 2b trial—dubbed STRIDE—that assessed the peroxisome proliferator-activated receptor delta (PPARδ) agonist mavodelpar among adults with primary mitochondrial myopathies, a group of genetic metabolic disorders with severity ranging from progressive weakness to death.

The study was designed to evaluate the efficacy and safety of once-daily 100 mg doses of mavodelpar over 24 weeks. The global, double-blind study failed to hit its primary efficacy endpoint—the change from baseline in distance walked during a 12-minute walk test at week 24—or secondary efficacy endpoint of the change from baseline in fatigue.

Given the results, Reneo is implementing an immediate cost-savings plan that includes a 70% workforce reduction. The layoffs are expected to be completed by Dec. 31, according to Securities and Exchange Commission filings

The biotech is also suspending development of all other mavodelpar development activities, including an open-label extension trial designed to evaluate the safety and tolerability of daily 100 mg mavodelpar doses over two years. The company was also testing out mavodelpar—the only asset listed in its pipeline—in another form of rare, genetic metabolic disorders called long-chain fatty acid oxidation disorders.  

Reneo said it currently has more than $100 million in cash, equivalents and short-term investments on hand.

https://www.fiercebiotech.com/biotech/reneo-pulls-plug-only-asset-after-phase-2b-fail-sending-70-staff-out-door-and-stock

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