It’s nev­er fun to re­ceive a CRL, but per­haps even less so when the re­jec­tion has to do with man­u­fac­tur­ing rather than the drug.

Rare dis­ease play­er Ac­er, along with Gene­va-based part­ner Re­lief Ther­a­peu­tics, un­veiled Tues­day that the FDA had is­sued the two a CRL for AC­ER-001, a drug can­di­date to treat urea cy­cle dis­or­ders. From the CRL, as re­port­ed by the com­pa­nies:

[The FDA’s] field in­ves­ti­ga­tor could not com­plete in­spec­tion of [Ac­er’s third-par­ty con­tract pack­ag­ing man­u­fac­tur­er], be­cause the fa­cil­i­ty was not ready for in­spec­tion. Sat­is­fac­to­ry in­spec­tion is re­quired be­fore [the NDA] may be ap­proved. Please no­ti­fy us in writ­ing when this fa­cil­i­ty is ready for in­spec­tion.

Ac­er not­ed that the FDA did not cite any oth­er ap­prov­abil­i­ty is­sues in the CRL re­lat­ing to the NDA. How­ev­er, the FDA did re­quest “ad­di­tion­al ex­ist­ing non­clin­i­cal in­for­ma­tion to be pro­vid­ed in the re­sub­mis­sion of the NDA.” Ac­er added that the re­quest for ad­di­tion­al da­ta was “not an ap­prov­abil­i­ty is­sue.”

Be­yond Ac­er “ac­tive­ly col­lab­o­rat­ing” with its un­named con­tract pack­ag­ing man­u­fac­tur­er and co­op­er­at­ing with the FDA, the biotech added that it plans to re­sub­mit the NDA for AC­ER-001, al­so known as sodi­um phenyl­bu­tyrate, to the fed­er­al reg­u­la­tors next quar­ter.

So far, in­vestors are not buy­ing Ac­er’s state­ment as shares $AC­ER dropped more than 10% to $1.58 each — a far cry from its once $18 share price.

Ac­er CEO Chris Schelling said in a state­ment: “While the out­come of the NDA re­view was not what we had hoped for, mul­ti­ple rounds of la­bel­ing ne­go­ti­a­tions have al­ready been con­duct­ed to date and we be­lieve the rec­om­men­da­tions raised by FDA can be ap­pro­pri­ate­ly ad­dressed. We should be able to re­sub­mit the NDA rel­a­tive­ly quick­ly.”

He added, “We re­main com­mit­ted to bring­ing a new treat­ment op­tion to pa­tients in the U.S. with UCDs.”

End­points News has reached out to Ac­er and will up­date this sto­ry ac­cord­ing­ly.

This is not Ac­er’s first time around the CRL block. The biotech got a CRL for celipro­lol, al­so known as Ed­si­vo, for vas­cu­lar Ehlers-Dan­los syn­drome back in 2019. At the time, the fed­er­al agency was re­quest­ing an “ad­e­quate and well-con­trolled tri­al” as shares plum­met­ed 77%. And so far, that drug can­di­date has not been ap­proved.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.