Alk­er­mes has had a rough go in the past few years, mak­ing the de­ci­sion to slice away a healthy por­tion of its R&D work­force last year af­ter a ma­jor set­back in de­pres­sion. The drug­mak­er placed a lot of hope in an­tipsy­chot­ic drug ALKS 3831 to turn things around, and af­ter a win­ning ad­comm late last year that bet is fi­nal­ly pay­ing off.

The FDA on Tues­day ap­proved Alk­er­mes’ Ly­balvi (olan­za­p­ine and sami­dor­phan) to treat schiz­o­phre­nia and bipo­lar 1 dis­or­der, the com­pa­ny said in a re­lease.

The drug was ap­proved as a main­te­nance monother­a­py, or for the acute treat­ment of man­ic or mixed episodes as a monother­a­py or ad­junct to lithi­um or val­proate, Alk­er­mes said. Ly­balvi is a com­bi­na­tion of nov­el chem­i­cal sami­dor­phan and an­tipsy­chot­ic olan­za­p­ine, an ag­ing an­tipsy­chot­ic con­sid­ered one of the field’s most ef­fec­tive de­spite pre­vi­ous red flags over pa­tients’ weight gain.

But with the new for­mu­la­tion, Alk­er­mes thinks it has cracked the code on those pri­or olan­za­p­ine is­sues. The agency based its re­view on ex­pan­sive da­ta from Alk­er­mes’ EN­LIGHT­EN pro­gram, which in­clud­ed 27 clin­i­cal stud­ies, in­clud­ing 18 stud­ies test­ing Ly­balvi and nine study­ing sami­dor­phan alone, the com­pa­ny said. Among those, EN­LIGHT­EN-2 churned out da­ta show­ing schiz­o­phre­nia pa­tients on Ly­balvi post­ed sig­nif­i­cant­ly less weight gain than pa­tients tak­ing olan­za­p­ine alone.

Alk­er­mes $ALKS shares were trad­ing up about 6% be­fore the bell Tues­day.

Ly­balvi will come with a black box warn­ing for in­creased risk of mor­tal­i­ty in el­der­ly pa­tients with de­men­tia-re­lat­ed psy­chosis, ac­cord­ing to its la­bel. That warn­ing is tied to re­port­ed cas­es of cere­brovas­cu­lar side ef­fects in clin­i­cal tri­als, in­clud­ing stroke and tran­sient is­chemic at­tack. The drug will come with con­traindi­ca­tions for pa­tients tak­ing opi­oids or who are un­der­go­ing acute opi­oid with­draw­al.

The drug­mak­er ex­pects Ly­balvi to hit the mar­ket in the Oc­to­ber/No­vem­ber time­frame and plans to lean on its ex­ist­ing com­mer­cial in­fra­struc­ture from mar­ket­ed an­tipsy­chot­ic Aris­ta­da to grease the wheels for the new drug’s suc­cess­ful launch, ac­cord­ing to a re­lease. The team will add 50 sales reps to that Aris­ta­da “core,” CCO Todd Nichols said on a Tues­day morn­ing call with in­vestors, as it works to ramp up com­mer­cial man­u­fac­tur­ing and fi­nal­ize its pro­mo­tion­al claims pri­or to a full roll­out at launch.

Alk­er­mes didn’t re­lease the list price, say­ing it was wait­ing on pay­er ne­go­ti­a­tions pri­or to launch.

An­tipsy­chotics is an un­usu­al mar­ket, with most first-line scripts dom­i­nat­ed by gener­ics al­though a pro­por­tion of pa­tients even­tu­al­ly cy­cle through those ear­ly drugs. That means the po­ten­tial mar­ket for Ly­balvi will like­ly take a while to de­vel­op, with Alk­er­mes pre­dict­ing around $10 mil­lion in sales by the end of the year.

“We have es­tab­lished a pro­file that there will be a path­way to ac­cess at launch, but it will de­vel­op over time,” Nichols said. “They’re most like­ly go­ing to have to step through one or two gener­ics be­fore ac­cess, and we’re pre­pared for that.”

Ly­balvi, for­mer­ly dubbed ALKS 3831, faced an FDA ad­vi­so­ry com­mit­tee in Oc­to­ber dur­ing which the ques­tion of a po­ten­tial REMS was pro­posed for the drug. The com­mit­tee vot­ed 11-6 that po­ten­tial la­bel­ing was enough to mit­i­gate risk, a big draw for Alk­er­mes in the heav­i­ly reg­u­lat­ed an­tipsy­chot­ic space.

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.”

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.

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:

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.