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.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Arndt Rolfs steps aside as Cen­to­gene CEO, with An­drin Os­wald named as his suc­ces­sor; João Sif­fert lands an­oth­er CEO post at De­sign Ther­a­peu­tics

→ There’s a change at the top at German rare disease biotech Centogene. Arndt Rolfs decided to step down as CEO, effective Tuesday, and Big Pharma vet Andrin Oswald will replace him starting Dec. 1. Oswald, the delegate for Covid-19 vaccines and immunotherapies for the federal government of Switzerland, recently spent 4 years with the Bill & Melinda Gates Foundation as director of life science industry engagement and partnerships. He was also a business integration exec at GSK and division head of vaccines & diagnostics at Novartis.

Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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