A week af­ter New York-based Ax­some Ther­a­peu­tics said it ex­pect­ed a CRL for its mi­graine drug, the biotech re­port­ed Mon­day that the FDA has fol­lowed through.

The prin­ci­pal rea­sons giv­en in the CRL are re­lat­ed to chem­istry, man­u­fac­tur­ing and con­trols (CMC) con­sid­er­a­tions, Ax­some re­it­er­at­ed Mon­day. The let­ter iden­ti­fied the need for some ad­di­tion­al CMC da­ta about the drug prod­uct it­self as well as the man­u­fac­tur­ing process, ac­cord­ing to Ax­some. The biotech be­lieves the is­sues raised can be ad­dressed and in­tends to pro­vide po­ten­tial tim­ing for a re­sub­mis­sion fol­low­ing con­sul­ta­tion with the FDA. The let­ter did not raise any ef­fi­ca­cy is­sues, Ax­some said.

“It is our goal to work with the FDA to ful­ly un­der­stand and ad­e­quate­ly ad­dress their com­ments so that we can make this im­por­tant new med­i­cine avail­able to pa­tients with mi­graine as quick­ly as pos­si­ble,” said Ax­some CEO Her­riot Tabuteau in a state­ment. “The ap­proval of AXS-07 would of­fer a much-need­ed new mul­ti-mech­a­nis­tic treat­ment op­tion for the mil­lions of peo­ple liv­ing with this de­bil­i­tat­ing neu­ro­log­i­cal con­di­tion.”

Though the drug re­ceived a re­jec­tion, the biotech’s stock price $AXSM stayed pos­i­tive with a rough­ly 3% in­crease in ear­ly Mon­day trad­ing, but it re­mains down about 16% from last week.

Per pre­vi­ous re­port­ing on the AXS-07 saga, Ax­some said the NDA is to be de­layed by about a year, with six months to cor­rect the is­sues and six months for FDA to re-re­view, ac­cord­ing to in­vest­ment an­a­lysts at William Blair. An­a­lysts at Cowen said that the drug, dubbed AXS-07, has gen­er­at­ed two pos­i­tive piv­otal stud­ies in the treat­ment of acute mi­graines in ad­di­tion to a long-term fol­low-up tri­al with pa­tients see­ing rapid and sus­tained pain re­lief.

They al­so be­lieve that if Ax­some gets over the hill on the FDA front, the med­i­cine could serve as a vi­able ther­a­py and a po­ten­tial mon­ey­mak­er.

The ther­a­py it­self is an oral med­i­cine for the acute treat­ment of mi­graines and con­sists of the com­pa­ny’s Mo­SE­IC tech­nol­o­gy as well as meloxi­cam and riza­trip­tan.

Ax­some is no stranger to go­ing back to the draw­ing board with the FDA. Back in 2020, af­ter clear­ing a late-stage study, Ax­some’s AXS-05 ther­a­py, meant to treat ma­jor de­pres­sive dis­or­der, al­so faced sev­er­al chal­lenges. The drug then failed to meet its main goal for the AXS-05 pill, de­lay­ing any fur­ther ac­tion.

In 2021, the FDA laid out its con­cerns with AXS-05 in a let­ter, out­lin­ing how FDA had iden­ti­fied de­fi­cien­cies that pre­clude la­bel­ing dis­cus­sions with Ax­some. Af­ter the biotech re-sub­mit­ted its ap­pli­ca­tion,  the drug ap­pears to be back on the cusp of ap­proval again.

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.

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.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.