Covid-19 has been a rough go for many drug­mak­ers, but few more so than Spec­trum Phar­ma­ceu­ti­cals, which has seen in­spec­tion de­lays and un­want­ed CRLs haunt its chance at a first ap­proval. Feel­ing the sting, Spec­trum will now down­size to keep the lights on through the year.

Spec­trum will cut 30% of its work­force and piv­ot its R&D ef­forts around its two fur­thest-along drugs as part of a re­struc­tur­ing ef­fort that will pave the com­pa­ny’s cash run­way out in­to next year, it an­nounced Wednes­day.

In Au­gust 2021, the FDA hand­ed Spec­trum a CRL for a neu­trope­nia drug set to be mar­ket­ed as Rolon­tis, cit­ing man­u­fac­tur­ing is­sues in the drug’s ap­pli­ca­tion. The FDA or­dered a re-in­spec­tion at the drug’s man­u­fac­tur­ing site in South Ko­rea — this af­ter Covid-19 re­lat­ed trav­el re­stric­tions for FDA in­spec­tors pushed off Rolon­tis’ ear­ly re­view date by the agency.

Spec­trum said it would pri­or­i­tize its R&D ef­forts around get­ting Rolon­tis across the fin­ish line as well as dri­ving ahead on pozi­o­tinib, a TKI in­hibitor can­di­date for HER2 ex­on 20-mu­tant non-small cell lung can­cer.

Spec­trum CEO Tom Riga had this to say in a state­ment:

The de­ci­sion to re­struc­ture the or­ga­ni­za­tion is nec­es­sary to fo­cus on our ad­vanced clin­i­cal pro­grams that will dri­ve our fu­ture growth. I would like to ex­press my ap­pre­ci­a­tion to our col­leagues who are af­fect­ed by this de­ci­sion and are leav­ing Spec­trum. We are grate­ful for their ded­i­ca­tion and their con­tri­bu­tions to ad­vanc­ing our mis­sion. The changes we are im­ple­ment­ing are ex­pect­ed to re­sult in a re­duc­tion in op­er­at­ing ex­pens­es and the ex­ten­sion of the com­pa­ny’s cash run­way in­to 2023.

As Rolon­tis and pozi­o­tinib get the up­vote, Spec­trum said it will “de­pri­or­i­tize” de­vel­op­ment of its ear­ly-stage pipeline, which in­cludes its FIT Pro­gram (IGN 002) and IL-12. Mean­while, the com­pa­ny plans to “sig­nif­i­cant­ly re­duce” its foot­print at se­lect­ed fa­cil­i­ties this year amid the cost-cut­ting ef­forts.

In all, the cuts will re­duce Spec­trum’s burn rate by about 20-25%, which the com­pa­ny ex­pects will save enough cash to get it in­to 2023.

Shares in $SP­PI, al­ready well in pen­ny stock ter­ri­to­ry, were trad­ing down around 4% on the news Wednes­day.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.