De­spite win­ning an ap­proval back in 2016, Aca­dia’s Nu­plazid has not had the eas­i­est of paths in its jour­ney to ex­pand in­to new ar­eas. And late Thurs­day night, the com­pa­ny put out a press re­lease say­ing it re­ceived more bad news from the FDA.

Reg­u­la­tors re­ject­ed Aca­dia’s ap­pli­ca­tion to ex­pand Nu­plazid cov­er­age in­to Alzheimer’s-re­lat­ed psy­chosis, the biotech said, turn­ing away its sup­ple­men­tal NDA with a CRL. The re­jec­tion let­ter in­di­cat­ed the FDA al­so rec­om­mend­ed that Aca­dia con­duct an ad­di­tion­al tri­al in ADP, Aca­dia said.

Ac­cord­ing to Aca­dia, while the FDA stat­ed its study did demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant treat­ment ef­fect on its pri­ma­ry end­point, lim­i­ta­tions re­main re­gard­ing its ef­fec­tive­ness.

The FDA added that al­though there was pos­i­tive treat­ment ef­fect of the drug on de­men­tia-re­lat­ed psy­chosis in Aca­dia’s HAR­MO­NY study, it ap­peared to be dri­ven pri­mar­i­ly by pa­tients with Parkin­son’s dis­ease de­men­tia — a con­di­tion the FDA stat­ed in­clud­ed Nu­plazid’s ap­proval for pa­tients with Parkin­son’s dis­ease psy­chosis.

“We are dis­ap­point­ed with this out­come. The treat­ment of Alzheimer’s dis­ease psy­chosis con­tin­ues to be an area of high un­met need, for which there is no ap­proved ther­a­py. We want to ex­press our grat­i­tude to all of the pa­tients, their fam­i­lies and in­ves­ti­ga­tors who have par­tic­i­pat­ed in our clin­i­cal tri­als,” Aca­dia CEO Steve Davis said in a state­ment.

The com­pa­ny did not re­spond to in­quiries from End­points News. Aca­dia shares $ACAD are down 35% since Jan­u­ary but re­mained flat in Fri­day morn­ing trad­ing.

Thurs­day’s news is just the lat­est in a string of is­sues that Nu­plazid has faced. In 2018, the drug first came un­der fire af­ter a re­port ques­tioned its safe­ty of the drug, but the FDA even­tu­al­ly gave an all-clear for its safe­ty.

Amidst the push to have the drug treat de­men­tia-re­lat­ed psy­chosis and with the FDA be­ing at­ten­tive af­ter the Aduhelm ap­proval, the drug has not been win­ning fa­vor with the FDA.

Af­ter a CRL in 2021, due to a “lack of sub­stan­tial ev­i­dence of ef­fec­tive­ness” in a Phase III tri­al, the com­pa­ny re­turned to the FDA on­ly to re­ceive more bad news. In June, a pan­el of the FDA’s out­side ex­perts vot­ed 9-3 stat­ing that the drug did not ap­pear to be ef­fec­tive at treat­ing pa­tients with Alzheimer’s-re­lat­ed psy­chosis.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.