The FDA has missed the date for Coya Therapeutics’ investigational new drug (IND) application, citing a lack of resources and its current workload as reasons for the delay, according to a legal filing from the biotech.
On July 29, the federal drug agency told Coya it would not meet the initial review goal date of July 30, according to a Securities and Exchange Commission filing from the Houston-based biotech. If approved, the IND application would allow Coya to launch a phase 2 trial for its investigational amyotrophic lateral sclerosis (ALS) treatment.
The FDA said it would deliver a decision before or by Aug. 29, according to the filing.
As of publication Thursday morning, the FDA has not responded to Fierce Biotech’s request for comment.
The delay hits the biotech in an early stage of drug development in which companies submit preclinical data to the FDA and request to move the candidate into human studies.
For Coya, the delay will stretch out the time—and the company’s cash runway—that the biotech must wait to see if it can start clinical trials for COYA 302, its lead biologic investigational product that the biotech dubs a "pipeline in a product."
The asset is a combination of Coya’s LD IL-2 candidate called COYA 301, plus a CTLA4-Ig, for the potential treatment of ALS, dementia, Parkinson’s disease and Alzheimer’s disease.
As of March 31, Coya had $35.5 million on hand, according to first-quarter earnings.
Small biotechs are typically tight on cash, with operations and funding plans tied to agency approvals and requirements.
In April, more than 200 biotech leaders penned a letter expressing concern over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards.
Under President Donald Trump, the FDA has undergone an extreme overhaul, losing at least 3,500 full-time employees and a large portion of the agency’s former leadership.
At the time of the mass layoffs, the Department of Health and Human Services said the workforce reduction “will not affect drug, medical device or food reviewers, nor will it impact inspectors.”
In June, Trump’s pick for FDA Commissioner, Marty Makary, M.D., said the agency was “on track to meet all the PDUFA targets and that morale is good and improving at the agency.”
The leader said this two days after KalVista Pharmaceuticals announced that the FDA said it would miss the biotech’s June 17 PDUFA date due to “heavy workload and limited resources.”
The Cambridge, Mass.-based biotech had been expecting the FDA to either approve or reject the company’s oral plasma kallikrein inhibitor, sebetralstat, for hereditary angioedema (HAE). But the FDA informed the company that it could have to wait up to four weeks for the agency to make the call.
On July 7, the biotech said the agency had approved its drug under the brand name Ekterly as a new, oral treatment option for acute attacks of HAE.
The newly restructured agency has also missed approval decision deadlines for GSK’s IL-5 antibody Nucala, Novavax’s protein-based COVID-19 vaccine, and Stealth BioTherapeutics’ ultrarare genetic disease candidate.