Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum hits the re­set but­ton, slic­ing away 30% of its work­force in piv­ot around 2 lead as­sets

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.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.