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.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.