Tony Kings­ley takes over the reins at Schol­ar Rock; Idor­sia taps phar­ma vet Pa­tri­cia Torr for new US ops

Tony Kings­ley

Schol­ar Rock — which part­nered with Gilead back in 2018 for a dis­cov­ery pact for fi­brot­ic dis­eases — has passed the CEO and pres­i­dent ba­ton down to Tony Kings­ley, who is tak­ing over from Nagesh Ma­han­thap­pa. Kings­ley joined the com­pa­ny’s board of di­rec­tors in May. Pri­or to his new role, Kings­ley was CEO and pres­i­dent of Taris Bio (ac­quired by Janssen Phar­ma­ceu­ti­cals). In ad­di­tion, he served as pres­i­dent and COO of The Med­i­cines Com­pa­ny and held po­si­tions at Bio­gen and McK­in­sey & Com­pa­ny among oth­ers.

In ad­di­tion, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny has named Ed­ward (Ted) Myles as CFO and head of busi­ness op­er­a­tions. Myles has been a mem­ber of Schol­ar Rock’s board of di­rec­tors and will be step­ping down from that po­si­tion with his new ap­point­ment. Most re­cent­ly, Myles served as CFO and COO of AM­AG Phar­ma­ceu­ti­cals and has pre­vi­ous­ly held roles at Primer­aDX and EMD Phar­ma­ceu­ti­cals (now EMD Serono).

Jean-Paul Clozel’s start­up Idor­sia has ex­pand­ed its reach in the US by es­tab­lish­ing com­mer­cial op­er­a­tions in the Philadel­phia sub­urb of Rad­nor, PA. Pa­tri­cia Torr is tak­ing the reins as pres­i­dent and GM of Idor­sia Phar­ma­ceu­ti­cals US and has been lin­ing up lead­er­ship for the en­deav­or. Torr was pre­vi­ous­ly VP, glob­al com­mer­cial strat­e­gy for throm­bo­sis and he­mo­sta­sis at CSL Behring; EVP, head of US hema­tol­ogy for Shire; and VP, US sales at J&J.

Join­ing Torr will be the fol­low­ing: Scot­ty Bow­man, VP, head of US mar­ket ac­cess; William Gileza, VP, head of US fi­nance and in­fra­struc­tures; Frances Lil­lo, se­nior di­rec­tor, head of US hu­man re­sources; Michael Moye, VP, head of US mar­ket­ing; Er­ic Siegel, VP, head of US com­pli­ance; and Paul Var­ki, VP, US gen­er­al coun­sel, head of le­gal.

Jen­nifer Simp­son

→ Min­neso­ta-based Sun Bio­Phar­ma, cen­tered on pan­cre­at­ic can­cer, has made Jen­nifer Simp­son their pres­i­dent and CEO. Michael Cullen, who helmed Sun Bio­Phar­ma since Oc­to­ber 2018, will re­main as ex­ec­u­tive chair­man of their board of di­rec­tors. Simp­son start­ed at Del­cath Sys­tems in 2012 as EVP, glob­al mar­ket­ing, and with­in three years, she be­came the com­pa­ny’s pres­i­dent and CEO. From 2008-12, she was VP, glob­al mar­ket­ing, on­col­o­gy brand lead at Im­Clone Sys­tems.

→ Li­cens­ing its pre­clin­i­cal K-NK004 pro­gram to Sanofi last week in a $19.7 mil­lion col­lab­o­ra­tion with al­most a bil­lion dol­lars in mile­stones, nat­ur­al killer bio­phar­ma Kiadis al­so has new faces on their lead­er­ship team, bring­ing in Cru­cell Vac­cines vets Ray Bar­low and Govert Schouten as CBO and head of in­no­va­tion, re­spec­tive­ly. At Cru­cell (ac­quired by J&J), Bar­low was se­nior di­rec­tor of busi­ness de­vel­op­ment, while Schouten was VP of busi­ness de­vel­op­ment.

Bar­low is a for­mer ex­ec­u­tive di­rec­tor, cor­po­rate de­vel­op­ment at Am­gen who al­so spent a decade at As­traZeneca. Schouten comes to Dutch-based Kiadis af­ter found­ing Id­mon Con­sult­ing. Ad­di­tion­al­ly, Kiadis an­nounced that SVP of cor­po­rate de­vel­op­ment Mar­cel Zwaal has hit the ex­it “to pur­sue oth­er op­por­tu­ni­ties.”

Christo­pher Sla­pak

→ Af­ter haul­ing in $110 mil­lion from its Se­ries B last week, Vor Bio­phar­ma has locked in their in­ter­im CMO Christo­pher Sla­pak in­to a per­ma­nent po­si­tion with the com­pa­ny. Sla­pak has served in the po­si­tion since Ju­ly 2019 and hopped aboard the com­pa­ny af­ter a more than 20 year-stint at Eli Lil­ly— serv­ing as in var­i­ous roles, in­clud­ing VP, ear­ly phase re­search.

Daniel­la Beck­man

One oth­er Vor note: Tan­go Ther­a­peu­tics CFO Daniel­la Beck­man has been added to the board of di­rec­tors. She’s al­so been on Trans­late Bio’s board since the fall of 2017.

→ French mi­cro­bio­me biotech MaaT Phar­ma has added some new faces to its ranks. The Ly­on, France-based com­pa­ny has bagged John Wein­berg as CMO and Servi­er ex­ec, Claude Bertrand, as an in­de­pen­dent mem­ber of the com­pa­ny’s board of di­rec­tors. Pri­or to his new role, Wein­berg served as CMO of 4D Phar­ma and has held pre­vi­ous role at Velox­is Phar­ma­ceu­ti­cals, No­var­tis and En­zon Phar­ma­ceu­ti­cals. At Servi­er, Bertrand serves as CSO and EVP of R&D. In ad­di­tion, Bertrand brings ex­pe­ri­ence from his times at Ipsen, As­traZeneca, No­var­tis, Roche and Pfiz­er.

Joyson Karakun­nel

Pierre Do­di­on is re­tir­ing af­ter 6 years as CMO of French on­col­o­gy-fo­cused biotech In­nate Phar­ma — which had a par­tial hold on la­cu­tam­ab lift­ed by the FDA in June — and Joyson Karakun­nel has an­swered the bell to re­place him. Karakun­nel comes from a CMO stint at Tizona Ther­a­peu­tics and al­so spent some time at Ar­cus Bio­sciences as VP and head of clin­i­cal de­vel­op­ment, reg­u­la­to­ry and safe­ty.

Vi­jay Mod­ur

Sanofi Gen­zyme vet Vi­jay Mod­ur is tak­ing on the role of chief sci­en­tif­ic and med­ical of­fi­cer at Zikani Ther­a­peu­tics, which is de­vel­op­ing nov­el ri­bo­some mod­u­lat­ing agents (RMAs) to treat rare, non­sense mu­ta­tion-dri­ven dis­eases through its Tur­bo-XM plat­form. Mod­ur was Sanofi Gen­zyme’s glob­al project head in rare dis­ease clin­i­cal de­vel­op­ment and he al­so held po­si­tions at No­var­tis and Mer­ck.

My­ron Czucz­man is head­ed to New Jer­sey-based Citius Phar­ma­ceu­ti­cals, which fo­cus­es on the de­vel­op­ment of an­ti-in­fec­tive and can­cer care prod­ucts, as their CMO and EVP. Pri­or to Citius, Czucz­man was Cel­gene’s ther­a­peu­tic area head, VP, clin­i­cal R&D, glob­al lym­phoma/CLL pro­gram.

Brit­tany Bradrick

→ Di­a­betes-fo­cused stem cell play­er Vi­a­Cyte has en­list­ed Brit­tany Bradrick as CFO. Bradrick hails from In­sulet, where she was VP, strat­e­gy and cor­po­rate de­vel­op­ment. Pri­or to that, she was at Ab­bott Di­a­betes Care and served as di­rec­tor, busi­ness de­vel­op­ment and al­liance man­age­ment as well as held roles at Cred­it Su­isse and Piper Jaf­fray.

→ ARCH-backed Au­to­bahn Ther­a­peu­tics, which emerged in June with a $76 mil­lion round to fight CNS dis­or­ders such as MS, has wel­comed Scott For­rest as their CBO. For­rest was most re­cent­ly at In­cep­tion Ther­a­peu­tics, where was chief op­er­at­ing of­fi­cer. He al­so co-found­ed Black­Thorn Ther­a­peu­tics and was their VP, op­er­a­tions and cor­po­rate de­vel­op­ment.

→ Pro­tein degra­da­tion play­er C4 Ther­a­peu­tics, which an­nounced in June that they had scored $170 mil­lion in fi­nanc­ing, has brought on two new ex­ecs. William Mc­K­ee, cur­rent­ly CEO of MB­JC As­so­ci­ates, is now C4’s CFO. The long­time EVP and CFO of Barr Phar­ma­ceu­ti­cals be­fore its ac­qui­si­tion by Te­va Phar­ma­ceu­ti­cals in 2008, Mc­K­ee held the COO and CFO roles at EKR Ther­a­peu­tics from 2010-12. Af­ter lead­ing the sale of Neon Ther­a­peu­tics to BioN­Tech in May as Neon’s VP, gen­er­al coun­sel, Jolie Siegel has joined C4 as their chief le­gal of­fi­cer.

Er­ic Loumeau

Anap­tys­Bio, which just se­cured or­phan drug des­ig­na­tion from the FDA for im­si­dolimab to treat pa­tients with gen­er­al­ized pus­tu­lar pso­ri­a­sis (GPP), has shak­en up its lead­er­ship team with Den­nis Mul­roy com­ing in as CFO and Er­ic Loumeau mov­ing in­to a new role at the com­pa­ny as chief op­er­at­ing of­fi­cer. Mul­roy has been the top fi­nance ex­ec at a host of biotechs, most re­cent­ly La­Jol­la Phar­ma­ceu­ti­cal, where he held the post for 5 years. Loumeau served as Anap­tys­Bio’s in­ter­im CFO since Au­gust, join­ing the com­pa­ny in Au­gust 2018 as their gen­er­al coun­sel; from 2011-13, he was CFO at Rem­pex Phar­ma­ceu­ti­cals.

→ Gas­troin­testi­nal dis­ease-fo­cused Phath­om Phar­ma­ceu­ti­cals has se­lect­ed Al­ler­gan vet Todd Bran­ning as their CFO, suc­ceed­ing in­ter­im CFO David Sacks, who will con­tin­ue at the New Jer­sey com­pa­ny as a board mem­ber and a strate­gic ad­vi­sor. Bran­ning had spent the last year as CFO at Am­neal Phar­ma­ceu­ti­cals and from 2016-18 was CFO, glob­al gener­ic med­i­cines di­vi­sion at Te­va Phar­ma­ceu­ti­cals. Be­fore Te­va, he was VP of fi­nance at Al­ler­gan.

→ With its lead can­di­date EYP-1901 in de­vel­op­ment for wet AMD, Eye­point Phar­ma­ceu­ti­cals has snagged Jay Duk­er as their chief strate­gic sci­en­tif­ic of­fi­cer, step­ping down from the board of di­rec­tors to fill the new­ly-cre­at­ed role. Duk­er has been chair­man of oph­thal­mol­o­gy at Tufts Med­ical Cen­ter for the past 19 years and is the di­rec­tor of the New Eng­land Eye Cen­ter. He al­so chairs the board at Sesen Bio.

Mor­rey Atkin­son

→ With its ex­per­i­men­tal drug CTX001 show­ing demon­stra­ble ef­fi­ca­cy in treat­ing be­ta tha­lassemia and sick­le cell dis­ease in da­ta pre­sent­ed along­side part­ner CRISPR Ther­a­peu­tics, Ver­tex tells Peer Re­view that Mor­rey Atkin­son has been named SVP, head of com­mer­cial man­u­fac­tur­ing and sup­ply chain. Atkin­son is com­ing off 8 years at Bris­tol My­ers Squibb, where he was SVP, glob­al man­u­fac­tur­ing op­er­a­tions. He was al­so at Eli Lil­ly for 9 years, no­tably as the Big Phar­ma’s head of biotech­nol­o­gy (man­u­fac­tur­ing sci­ences and tech­nol­o­gy).

→ Al­lied with Gilead and Sanofi while scor­ing $120 mil­lion of its own in March, pro­tein degra­da­tion play­er Nurix Ther­a­peu­tics has tapped Ja­son Kan­tor as SVP, fi­nance and in­vest­ment strat­e­gy. Kan­tor comes to San Fran­cis­co-based Nurix from Ar­ti­san Part­ners, where he was a se­nior bio­phar­ma an­a­lyst. He’s pre­vi­ous­ly been a man­ag­ing di­rec­tor, biotech­nol­o­gy an­a­lyst for Cred­it Su­isse and RBC Cap­i­tal Mar­kets.

→ Re­veal­ing en­cour­ag­ing da­ta a month ago in their Phase IIa and IIb stud­ies for TP-03, a nov­el top­i­cal oph­thalmic drug to treat De­mod­ex ble­phar­i­tis, Irvine, CA-based Tar­sus Phar­ma­ceu­ti­cals has two new ex­ecs on board with Se­sha Neer­van­nan as chief op­er­at­ing of­fi­cer and Leo Green­stein as CFO. Neer­van­nan heads to Tar­sus from Al­ler­gan, where he was SVP of glob­al phar­ma­ceu­ti­cal de­vel­op­ment. Green­stein is for­mer­ly the SVP of fi­nance & cor­po­rate con­troller for Spec­trum Phar­ma­ceu­ti­cals.

An­drew Par­tridge

→ Can­cer-fo­cused Turn­ing Point Ther­a­peu­tics, which just signed a deal with Zai Lab to sell re­potrec­tinib in Greater Chi­na, has turned to An­drew Par­tridge to take over as EVP and chief com­mer­cial of­fi­cer. Be­fore his ar­rival at Turn­ing Point, Par­tridge held the CCO and COO posts at Cen­trex­ion Ther­a­peu­tics. A Scher­ing-Plough, Roche and Am­gen vet, Par­tridge spent 5 years at Ver­tex, where he even­tu­al­ly be­came SVP and head of North Amer­i­can com­mer­cial op­er­a­tions.

→ Af­ter nam­ing Yuk Chun Chiu VP of man­u­fac­tur­ing op­er­a­tions last week, Ok­la­homa City CD­MO Cy­to­vance Bi­o­log­ics has pro­mot­ed John Mott to VP of de­vel­op­ment. A long­time Up­john and Pfiz­er vet, Mott has been a “close ad­vi­sor to the com­pa­ny” the last 4 years, Cy­to­vance CEO Jesse Mc­Cool says, and was VP of lab­o­ra­to­ry ser­vices for Ara­gen Bio­science be­fore his as­so­ci­a­tion with Cy­to­vance.

Ken­neth Hut­tner has made his way to New York-based Neu­ro­gene, which cen­ters on rare neu­ro­log­i­cal dis­eases, to be their SVP of clin­i­cal de­vel­op­ment. Lead­ing up to his ap­point­ment at Neu­ro­gene, Hut­tner was a se­nior trans­la­tion­al med­i­cine ex­pert at No­var­tis be­fore be­com­ing a clin­i­cal de­vel­op­ment ex­ec at Biover­a­tiv and Log­icBio Ther­a­peu­tics.

Dirk Hoen­e­mann

→ Shang­hai-based An­ten­gene has called up­on Dirk Hoen­e­mann to be their VP, head of med­ical af­fairs for the Asia Pa­cif­ic Re­gion (APAC) and ear­ly clin­i­cal de­vel­op­ment. Pri­or to An­ten­gene, which gar­nered ap­proval from the FDA last month for Xpovio (se­linex­or) in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B cell lym­phoma (DL­B­CL), Hoen­e­mann led ear­ly clin­i­cal de­vel­op­ment pro­grams at Cel­gene.

Erik Spek is jump­ing to Michael Gilman’s team at RNA-fo­cused Ar­rakis Ther­a­peu­tics as their VP, le­gal and in­tel­lec­tu­al prop­er­ty. Spek held sev­er­al roles at Vedan­ta Bio­sciences, in­clud­ing SVP and head of le­gal af­fairs and in­tel­lec­tu­al prop­er­ty, and was al­so di­rec­tor of in­tel­lec­tu­al prop­er­ty for Epizyme.

→ Tee­ing up a $150 mil­lion IPO ear­li­er this month, No­var­tis-backed Po­sei­da Ther­a­peu­tics is bring­ing in Har­ry Leon­hardt as gen­er­al coun­sel and gen­er­al com­pli­ance of­fi­cer. Be­fore mak­ing it to Po­sei­da, Leon­hardt was SVP, gen­er­al coun­sel, chief com­pli­ance of­fi­cer and cor­po­rate sec­re­tary, and a mem­ber of the ex­ec­u­tive com­mit­tee at Halozyme Ther­a­peu­tics.

→ Cal­i­for­nia genome se­quenc­ing play­er Per­son­alis is shoring up its lead­er­ship team with Leslie Grab as VP of in­tel­lec­tu­al prop­er­ty and John Lyle as VP of as­say R&D. Be­fore Per­son­alis, Grab was se­nior coun­sel, patent and em­ploy­ment at Google spin­out Ver­i­ly Life Sci­ences. Lyle hails from Pa­cif­ic Bio­sciences, where he spent 14 years in var­i­ous re­spon­si­bil­i­ties, cul­mi­nat­ing in his role as se­nior di­rec­tor, sin­gle mol­e­cule se­quenc­ing.

Jodie Mor­ri­son

Ca­dent Ther­a­peu­tics CEO Jodie Mor­ri­son is now chair­ing the board at on­col­o­gy biotech Ri­bon Ther­a­peu­tics, which tar­gets monoPARPs that reg­u­late stress re­spons­es. She’s al­so a mem­ber of the board of di­rec­tors at Aileron Ther­a­peu­tics.

El­liott Si­gal has added an­oth­er di­rec­tor­ship to his quiver, this time jump­ing on the board of di­rec­tors at George Scan­gos’ im­munol­o­gy play­er Vir Biotech­nol­o­gy. Si­gal, the for­mer EVP, CSO and pres­i­dent of Bris­tol My­ers Squibb, joined Affinia Ther­a­peu­tics’ board in June.

Alan Dun­ton

Rec­ce Phar­ma — fo­cused on the de­vel­op­ment of syn­thet­ic an­ti-in­fec­tives — has ap­point­ed for­mer J&J ex­ec Alan Dun­ton to its board of di­rec­tors as an in­de­pen­dent non-ex­ec­u­tive di­rec­tor. In the past, Dun­ton served as pres­i­dent and CEO of Pana­cos Phar­ma­ceu­ti­cals and Metaphore Phar­ma­ceu­ti­cals.

→ South San Fran­cis­co-based Calithera Bio­sciences fo­cused on treat­ing can­cer with the de­vel­op­ment of nov­el small mol­e­cule drugs, has cho­sen Scott Gar­land to be on their board of di­rec­tors. The cur­rent pres­i­dent and CEO of Por­to­la Phar­ma­ceu­ti­cals, Gar­land is al­so a board mem­ber at Karyopharm.

→ Lon­don-based VC shop 4BIO Cap­i­tal, which re­cent­ly had Ky­owa Kirin back its new fund, has tapped Kenya Hon­da for its sci­en­tif­ic ad­vi­so­ry board. Hon­da is a pro­fes­sor in the de­part­ment of mi­cro­bi­ol­o­gy and im­munol­o­gy at Keio Uni­ver­si­ty School of Med­i­cine, Tokyo, Japan. Hon­da’s work is fo­cused on the treat­ment of IBD, au­toim­mu­ni­ty, al­ler­gies and can­cer.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.