The C-suite mu­si­cal chairs re­ver­ber­at­ing through biotech the last few months con­tin­ued Tues­day af­ter­noon with an­oth­er small cap com­pa­ny an­nounc­ing a tran­si­tion at the top.

Long­time Aque­s­tive Ther­a­peu­tics CEO Kei­th Kendall will leave the com­pa­ny ef­fec­tive im­me­di­ate­ly, the biotech an­nounced late Tues­day, bring­ing an end to his sev­en-and-a-half year tenure. Kendall will re­main a con­sul­tant through the end of the year and be re­placed by Daniel Bar­ber, the com­pa­ny’s COO since May 2019, on a per­ma­nent ba­sis.

Aque­s­tive did not an­nounce a rea­son for the change, on­ly say­ing the move was “un­re­lat­ed to the Com­pa­ny’s strat­e­gy, op­er­a­tions, fi­nan­cial con­di­tion, re­port­ed fi­nan­cial re­sults, in­ter­nal con­trols or dis­clo­sure con­trols and pro­ce­dures.”

Much like the rest of the sec­tor, Aque­s­tive has fall­en on hard times dur­ing the cur­rent bear mar­ket, as its stock $AQST is down more than 70% since the start of 2020. It’s a slide that’s con­tin­ued for most of its pub­lic trad­ing life as well, with Aque­s­tive shares down about 90% from its IPO price back in 2018.

The biotech’s most re­cent strug­gles stem from an oft-trou­bled drug ap­pli­ca­tion for oral film to treat seizures. Orig­i­nal­ly sub­mit­ted in late 2019, the drug can­di­date was re­ject­ed in Sep­tem­ber 2020 due to what the FDA said was low­er-than-de­sired ex­po­sure lev­els in cer­tain weight groups, per Aque­s­tive’s re­count­ing.

Though the com­pa­ny re­sub­mit­ted its ap­pli­ca­tion in 2021 and re­ceived a PDU­FA date for that De­cem­ber, the FDA no­ti­fied Aque­s­tive that it could not make a fi­nal de­ci­sion at that time. Per an Aque­s­tive news re­lease, agency of­fi­cials were still “con­sid­er­ing the reg­u­la­to­ry is­sues” re­lat­ed to the drug’s ap­prov­abil­i­ty, though the com­pa­ny did not get in­to more specifics.

It’s not en­tire­ly clear whether this will amount to a sec­ond CRL or when the is­sue would be re­solved. In its first quar­ter earn­ings re­port ear­li­er this month, Aque­s­tive said fur­ther com­mu­ni­ca­tion with the agency re­vealed the de­lay stems from “or­phan-drug ex­clu­siv­i­ty is­sues re­lat­ed to” the NDA, sug­gest­ing a patent con­flict.

Aque­s­tive’s drug, brand­ed Liber­vant, is an oral for­mu­la­tion of di­azepam, self-ad­min­is­tered as a film and placed in­side the cheek.

The chal­lenge now falls on Bar­ber to try to re­solve this is­sue. He joins sev­er­al new chief ex­ec­u­tives in try­ing to right the ship at their re­spec­tive com­pa­nies with the bear mar­ket show­ing no signs of abat­ing, in­clud­ing Zen­tal­is ear­li­er this week.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Celularity has warned “a substantial portion” of its employees that layoffs could be looming in the face of a reprioritization effort. In the same breath, it touted some of its very early next-gen candidates in degenerative diseases and oncology.

“While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees,” the news release reads, in part.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.