BEDFORD, Mass., Ju e 26, 2026 (GLOBE NEWSWIRE) — La theus Holdi gs, I c. (“La theus” o “Compa y”) (NASDAQ: LNTH), the leadi g adiopha maceutical-focused compa y committed to e abli g cli icia s to Fi d, Fight a d Follow disease to delive bette patie t outcomes, a ou ced today that the U.S. Food a d D ug Admi ist atio (FDA) has issued a Complete Respo se Lette (CRL) ega di g its New D ug Applicatio (NDA) fo LNTH-2501 (Gallium 68 edot eotide), a PET diag ostic imagi g kit ta geti g somatostati ecepto -positive (SSTR+) eu oe doc i e tumo s (NETs).
The FDA stated that the age cy ca ot app ove the NDA by the P esc iptio D ug Use Fee Act (PDUFA) actio date of Ju e 29, 2026, due to u esolved thi d-pa ty facility ma ufactu i g- elated co ditio s. The thi d-pa ty facility is espo sible fo d ug p oduct ma ufactu i g. Satisfacto y esolutio of the u esolved facility i spectio – elated co ditio s is equi ed befo e the LNTH-2501 NDA may be app oved.
The CRL did ot ide tify a y co ce s ega di g the data submitted by La theus i suppo t of the applicatio , o did it ide tify a y issues elated to the safety o efficacy of LNTH-2501.
“We emai co fide t i LNTH-2501 a d a e committed to b i gi g this imagi g age t to NETs patie ts a d healthca e p ovide s as soo as possible,” said Ma y A e Hei o, Executive Chai pe so a d Chief Executive Office , La theus. “The feedback eceived f om the FDA elates solely to ou thi d-pa ty ma ufactu e , a d ot to the cli ical pe fo ma ce of the p oduct. We a e wo ki g closely with ou pa t e a d the Age cy to add ess these facility ma ufactu i g- elated co ditio s a d adva ce the p og am.”
About LNTH-2501 (Ga 68 edot eotide)LNTH-2501 (Kit fo P epa atio of Ga 68 edot eotide I jectio ), is a i vestigatio al adioactive diag ostic kit i dicated fo use with posit o emissio tomog aphy (PET) fo localizatio of somatostati ecepto positive eu oe doc i e tumo s (NETs) i adult a d pediat ic patie ts. LNTH-2501 is supplied as a 2-vial kit to adiopha macies which allows fo di ect p epa atio of Ga 68 edot eotide i jectio with the eluate of Gallium f om a o -site ge e ato at the adiopha macy. LNTH-2501 is ot cu e tly app oved by the FDA a d is ot yet available fo sale i the U ited States.
About La theus La theus is the leadi g adiopha maceutical-focused compa y, delive i g life-cha gi g scie ce to e able cli icia s to Fi d, Fight a d Follow disease to delive bette patie t outcomes. Headqua te ed i Massachusetts with offices i New Je sey, Ca ada, Ge ma y, Swede , Switze la d a d the U ited Ki gdom, La theus has bee p ovidi g adiopha maceutical solutio s fo 70 yea s. Fo mo e i fo matio , visit www.la theus.com.
Safe Ha bo fo Fo wa d-Looki g a d Cautio a y Stateme tsThis p ess elease may co tai “fo wa d-looki g stateme ts” withi the mea i g of the P ivate Secu ities Litigatio Refo m Act of 1995, as ame ded, that a e subject to isks a d u ce tai ties a d a e made pu sua t to the safe ha bo p ovisio s of Sectio 27A of the Secu ities Act of 1933, as ame ded, a d Sectio 21E of the Secu ities Excha ge Act of 1934, as ame ded. Reade s a e cautio ed ot to place u due elia ce o the fo wa d-looki g stateme ts co tai ed he ei , which speak o ly as of the date he eof. The Compa y u de takes o obligatio to publicly update a y fo wa d-looki g stateme t, whethe as a esult of ew i fo matio , futu e developme ts o othe wise, except as may be equi ed by law. Risks a d u ce tai ties that could cause ou actual esults to mate ially diffe f om those desc ibed i the fo wa d-looki g stateme ts i clude ou ability to wo k with ou thi d-pa ty ma ufactu i g pa t e to add ess the feedback outli ed i the CRL i o de to obtai a positive egulato y outcome f om the FDA fo LNTH-2501 a d the isks a d u ce tai ties discussed i ou fili gs with the Secu ities a d Excha ge Commissio (i cludi g those desc ibed i the Risk Facto s sectio i ou most ece tly filed A ual Repo t o Fo m 10-K a d Qua te ly Repo ts o Fo m 10-Q).
Co tacts:
La theusMa k Ki a eyVice P eside t, I vesto Relatio s978-671-8842i @la theus.com
Melissa Dow sExecutive Di ecto , Exte al Commu icatio s646-975-2533media@la theus.com
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