Amy Bur­roughs to lead Cleave Ther­a­peu­tics; Cyn­thia Collins clinch­es Ed­i­tas CEO job amid his­toric CRISPR move

Amy Bur­roughs

→ Af­ter bag­ging $12 mil­lion to ad­vance its lead drug can­di­date CB-5339 — a (VCP)/p97 in­hibitor — through ear­ly clin­i­cal de­vel­op­ment, Cleave Ther­a­peu­tics is beef­ing up its ex­ec­u­tive team. Amy Bur­roughs will be lead­ing the helm as CEO while Scott Har­ris joins as COO. Bur­roughs was an ex­ec­u­tive-in-res­i­dence at 5AM Ven­tures, which led the re­cent fi­nanc­ing, where she al­so served as a strate­gic com­mer­cial ad­vi­sor to port­fo­lio com­pa­ny Cri­net­ics Phar­ma­ceu­ti­cals. Giv­en her ear­ly ex­pe­ri­ence with the team at Genen­tech and back­ground in life sci­ences con­sult­ing, Bur­roughs brings crit­i­cal per­spec­tives on “un­der­stand­ing mar­ket needs, build­ing part­ner­ships and at­tract­ing top-notch tal­ent,” said board chair­man and for­mer Cleave CEO Lau­ra Shawver.

Har­ris most re­cent­ly served at two Bridge­Bio sub­sidiaries, in­clud­ing as ex­ec­u­tive vice pres­i­dent, cor­po­rate de­vel­op­ment and op­er­a­tions at Navire Phar­ma. He’s had a stint as ex­ec­u­tive vice pres­i­dent of reg­u­la­to­ry af­fairs and tech­ni­cal op­er­a­tions at Ad­ynxx and honed his cross-func­tion­al acu­men across Corthera, Bio­Marin Phar­ma­ceu­ti­cal, At­ten­uon, Angstrom Phar­ma­ceu­ti­cal and Biosite.

Cyn­thia Collins

Sev­en months af­ter Ka­trine Bosley abrupt­ly stepped down from Ed­i­tas, Cyn­thia Collins has been con­firmed as the of­fi­cial pres­i­dent and CEO. Collins — a board mem­ber and for­mer CEO of Hu­man Longevi­ty — has presided over the re­cent ini­ti­a­tion of Ed­i­tas’ first hu­man tri­al, and will now con­tin­ue to steer the biotech along the his­toric CRISPR move. The dos­ing of ED­IT-101 (or AGN-151587, as their part­ners at Al­ler­gan, call it) would mark the first test of in vi­vo edit­ing us­ing CRISPR/Cas9 — more specif­i­cal­ly, to a ge­net­ic mu­ta­tion that caus­es a rare form of blind­ness known as Leber con­gen­i­tal amau­ro­sis 10 (LCA10). She will al­so work on “mov­ing clos­er to the clin­ic with ED­IT-301 for the treat­ment of sick­le cell dis­ease, ex­pand­ing our port­fo­lio through strate­gic busi­ness de­vel­op­ment, and build­ing our or­ga­ni­za­tion­al ca­pa­bil­i­ties to scale for growth,” Collins added in a state­ment.

Jay Shep­ard

Ar­a­vive CEO and pres­i­dent Jay Shep­ard will be step­ping down from his roles in the com­pa­ny “for fam­i­ly med­ical rea­sons.” The com­pa­ny’s board of di­rec­tors is com­menc­ing a search for his suc­ces­sor, and in the mean­time, Shep­ard plans to serve in his cur­rent role un­til a suc­ces­sor is ap­point­ed. Shep­ard’s de­par­ture comes as the com­pa­ny has ini­ti­at­ed the Phase 1b por­tion of a Phase 1b/2 clin­i­cal tri­al for their lead drug can­di­date, AVB-500 — an affin­i­ty de­coy pro­tein that tar­gets the GAS6-AXL sig­nal­ing path­way — com­bined with stan­dard of care ther­a­pies in pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. 

→ A Phase III ready Pal­la­dio Bio­sciences — with a lead drug, lix­i­vap­tan, lined up for poly­cys­tic kid­ney dis­ease — has picked Alex Mar­tin to lead their com­pa­ny as CEO. Mar­tin had the top job at Realm Ther­a­peu­tics be­fore its ac­qui­si­tion by ES­SA Phar­ma in Ju­ly and has held the COO role at In­ter­cept Phar­ma­ceu­ti­cals. He be­gan his ca­reer at SmithK­line Beecham and lat­er be­came vice pres­i­dent, busi­ness de­vel­op­ment & li­cens­ing at No­var­tis, grad­u­al­ly build­ing a fo­cus on BD, op­er­a­tions and fundrais­ing.

Mer­ck and Il­lu­mi­na-backed Ser­im­mune has brought on Noah Nass­er to over­see the com­mer­cial­iza­tion of its “im­mune in­tel­li­gence” tech­nol­o­gy plat­form map­ping the range of anti­gens stim­u­lat­ing im­mu­ni­ty. The new CEO, who hops over from the chief com­mer­cial of­fi­cer po­si­tion at Hu­man Longevity, sees “re­mark­able op­por­tu­ni­ties” in in­fec­tious dis­ease, on­col­o­gy and au­toim­mune dis­ease. Nass­er has led sim­i­lar func­tions at mul­ti­ple ge­net­ic test­ing com­pa­nies, in­clud­ing ones that were ul­ti­mate­ly ac­quired by Myr­i­ad Ge­net­ics and Il­lu­mi­na. Ser­im­mune’s founder, Patrick Daugh­er­ty, will con­tin­ue to act as the com­pa­ny’s CSO and board mem­ber. Il­lu­mi­na Ven­tures part­ner Bill Welch is join­ing the board of di­rec­tors.

Sud­ha Para­sur­a­man

Ri­bon Ther­a­peu­tics, the biotech backed by No­var­tis, Cel­gene and J&J to go af­ter new class­es of en­zyme fam­i­lies ac­ti­vat­ed un­der cel­lu­lar stress con­di­tions, has named Sud­ha Para­sur­a­man and Ed­ward “Tad” Stew­art its first-ever CMO and CBO, re­spec­tive­ly. Well versed in hema­tol­ogy, on­col­o­gy and pe­di­atrics, Para­sur­a­man held the same role at X4 Phar­ma­ceu­ti­cals and pri­or to that was VP, glob­al med­ical af­fairs at he­mo­phil­ia play­er uniQure. Her ca­reer has al­so tak­en her to No­var­tis and Mil­len­ni­um Phar­ma­ceu­ti­cals (now Take­da On­col­o­gy), as well as Har­vard Med­ical School, Chil­dren’s Hos­pi­tal of Boston, and Dana Far­ber Can­cer In­sti­tute. Stew­art, who spent over 15 years at Mer­ri­mack Phar­ma­ceu­ti­cals, was the pres­i­dent and CEO of Com­mense and CBO of Crescen­do

Bams Abi­la

Im­mod­u­lon — a UK biotech de­vel­op­ing im­mune-mod­u­lat­ing bac­te­r­i­al add-on can­cer ther­a­pies to check­point and chemo —  has se­lect­ed phar­ma vet Bams Abi­la as their CMO. Most re­cent­ly, Abi­la served as the CMO of Cmed and as the prin­ci­pal con­sul­tant at Clin­treq. His pre­vi­ous ex­pe­ri­ences in­clude lead­er­ship roles at Aven­tis, Pfiz­er, Astel­las, As­traZeneca and GSK. Abi­la was ap­point­ed as a vis­it­ing pro­fes­sor of bi­o­log­ics and ad­vanced ther­a­py drug de­vel­op­ment to the Fac­ul­ty of Life Sci­ences & Med­i­cine at King’s Col­lege Lon­don in 2015. He is a fel­low of the Fac­ul­ty of Phar­ma­ceu­ti­cal Med­i­cine of the Roy­al Col­lege of Physi­cians in the UK. 

→ The ma­chine learn­ing-dri­ven drug dis­cov­ery spe­cial­ists at Daphne Koller’s start­up in­sitro have wel­comed Mary Rozen­man to their ranks as CFO/CBO while tap­ping Kei­th James as SVP drug dis­cov­ery. Their ap­point­ments high­light the com­pa­ny’s com­mit­ment to not just iden­ti­fy nov­el tar­gets but to achieve its re­al goal of de­vel­op­ing nov­el, bet­ter ther­a­peu­tics faster while en­vi­sion­ing new types of col­lab­o­ra­tions. Rozen­man was the SVP of cor­po­rate de­vel­op­ment at Aim­mune Ther­a­peu­tics; be­fore that she learned the ins and outs of biotech in­vest­ments and fi­nanc­ing as a VP at Lon­gi­tude Cap­i­tal and a ju­nior part­ner at McK­in­sey & Com­pa­ny. James, a Pfiz­er vet with mul­ti­ple clin­i­cal can­di­dates to his name, was the pres­i­dent of the Fer­ring Re­search In­sti­tute and a vis­it­ing in­ves­ti­ga­tor at The Scripps Re­search In­sti­tute

→ With its lead prod­uct can­di­date for re­frac­to­ry angi­na now in the clin­ic, Xy­lo­Cor Ther­a­peu­tics has re­cruit­ed Rick­ey Rein­hardt as their CMO. Hav­ing led the Eu­ro­pean ap­proval for GSK’s Strimvel­lis and di­rect­ed clin­i­cal R&D at Re­genxbio, Rein­hardt will now ap­ply his ex­per­tise in gene ther­a­py to the car­dio­vas­cu­lar niche. Most re­cent­ly he was CMO at Comet Ther­a­peu­tics, where he chan­neled his deep ex­pe­ri­ence in me­tab­o­lism.

Ajim Tam­boli Rodin

→ Synap­tic-fo­cused biotech Rodin Ther­a­peu­tics has ap­point­ed Ajim Tam­boli as CFO. A long­time health­care in­vestor, Tam­boli comes on board af­ter a stint at Asym­me­try Cap­i­tal Man­age­ment. He was an an­a­lyst at Lehman Broth­ers, Cred­it Su­isse and Lazard Fr­eres, with a num­ber of IPOs and fol­low-on of­fer­ings un­der his belt, be­fore found­ing En­durant Cap­i­tal Man­age­ment.

→ Just a few weeks af­ter tak­ing his $1.1 mil­lion sev­er­ance check from Gilead, John McHutchi­son has re-emerged as the new CEO of As­sem­bly Bio­sciences, which has seen its share price swoon as in­vestors lost con­fi­dence in its abil­i­ty to com­pete with Gilead with its ex­per­i­men­tal he­pati­tis B drug. McHutchi­son will be join­ing Steven J. Knox in the new job. Knox left as head of clin­i­cal de­vel­op­ment at Gilead, where he al­so played a big role in the de­vel­op­ment of the hep B drug Vem­lidy, to join As­sem­bly in the same role. 

Josh Bilenker didn’t just gain a per­son­al wind­fall by sell­ing Loxo to Eli Lil­ly for $8.1 bil­lion. He got a new, if tem­po­rary, job out of the deal as well. Bilenker will now head on­col­o­gy re­search and ear­ly phase de­vel­op­ment as they look for a re­place­ment for Levi Gar­raway, now head­ed off in pur­suit of “oth­er op­por­tu­ni­ties.” In ad­di­tion, Long­time BD chief Dar­ren Car­roll is head­ed to re­tire­ment af­ter 22 years at the phar­ma gi­ant. Heather Wasser­man has been pro­mot­ed to vice pres­i­dent of cor­po­rate busi­ness de­vel­op­ment, with re­spon­si­bil­i­ty for busi­ness de­vel­op­ment trans­ac­tions, emerg­ing tech­nolo­gies and in­no­va­tion, and ven­ture cap­i­tal, SVP/trea­sur­er Phil John­son will be in charge of M&A and Frank Cun­ning­ham has been pro­mot­ed to se­nior vice pres­i­dent of man­aged health­care ser­vices.

Teri Lox­am

→ Cell ther­a­py play­er SQZ Biotech has wooed se­nior Mer­ck ex­ec Teri Lox­am to be­come its CFO. The phar­ma gi­ant said that Lox­am, who’s been man­ag­ing in­vestor re­la­tions and glob­al com­mu­ni­ca­tions, “will be missed per­son­al­ly and pro­fes­sion­al­ly.” Pe­ter Dan­nen­baum has been pro­mot­ed to fill her shoes.

Ve­r­avas — a med­ical di­ag­nos­tic com­pa­ny fo­cused on bi­otin — has tapped Car­roll Street­man Jr to head the com­pa­ny as CEO. Dur­ing his 45-year ca­reer in the in­dus­try, Street­man has been in man­age­ment po­si­tions at med­ical ser­vices com­pa­ny Full Spec­trum Be­hav­ior Analy­sis, Di­a­Sorin, CSHC Con­sul­tants and HCA Health­care Cor­po­ra­tion. It was at Di­a­Sorin that he first worked with Ve­r­avas’ CSO, Josh Sol­do.

→ As Or­thofix Med­ical CEO Brad Ma­son steps in­to re­tire­ment, he’s pass­ing the ba­ton to sea­soned med­ical de­vice ex­ec Jon Ser­bousek. Aside from lead­ing the whole mus­cu­loskele­tal op­er­a­tion, Ser­bousek has al­so been named pres­i­dent of the spine unit.

Jon Ser­bousek

Aprea Ther­a­peu­tics, a can­cer biotech with head­quar­ters in both Boston and Stock­holm, has ap­point­ed Scott Coiante as the com­pa­ny’s se­nior vice pres­i­dent and CFO, join­ing from Ag­ile Ther­a­peu­tics where he held the same roles. Pri­or to his time at Ag­ile, Coiante served as the vice pres­i­dent of fi­nance and trea­sur­er at Medarex be­fore its ac­qui­si­tion in 2009 by Bris­tol My­ers Squibb.

Emalex Bio­sciences has en­list­ed At­ul Ma­h­ablesh­warkar on their mis­sion to de­vel­op ecopi­pam for pe­di­atric Tourette Syn­drome and child­hood-on­set flu­en­cy dis­or­der. As SVP of drug de­vel­op­ment, Ma­h­ablesh­warkar is tasked with every­thing from clin­i­cal af­fairs, phar­ma­covig­i­lance, reg­u­la­to­ry mat­ters to qual­i­ty as­sur­ance. The new role will draw on both his train­ing in psy­chi­a­try and years of de­vel­op­ment ex­pe­ri­ence ac­crued at Take­da, Black­Thorn and most re­cent­ly Re­vance.

No­vo Nordisk vet Lars Green is switch­ing ship af­ter 27 years to take charge of fi­nance, IT, le­gal and in­vestors re­la­tions as CFO of Novozyme — the en­zyme shop split off from the No­vo con­glom­er­ate al­most two decades ago. In his last role at the Dan­ish in­sulin mak­er, he head­ed up busi­ness ser­vices and com­pli­ance af­ter a stint lead­ing fi­nance and op­er­a­tions. In con­junc­tion with his ap­point­ment, he’s re­sign­ing from Novozyme’s board, where he’s served as a di­rec­tor since 2014.

Col­in God­dard Hi­ber­Cell

Christoph Rentsch has re­signed from the CFO post at Swiss spe­cial­ty phar­ma San­thera. Rentsch, whose ca­reer has spanned Cred­it Su­isse, Lon­za, Roche and Polyphor, was cred­it­ed for sev­er­al cor­po­rate fi­nance trans­ac­tions at San­thera, which has been on a bumpy ride with its Duchenne mus­cu­lar dy­s­tro­phy drug.

→ Lead­ing can­cer im­munother­a­py pi­o­neer Alan Ko­r­man, who is cred­it­ed for his work at BMS and Medarex that led to the de­vel­op­ment of two of the first ap­proved can­cer im­munother­a­py drugs, ip­il­i­mum­ab (an­ti-CLTA-4) and nivolum­ab (an­ti-PD-1) and their com­bi­na­tion, has joined the sci­en­tif­ic ad­vi­so­ry board of Drag­on­fly Ther­a­peu­tics

Steven Gillis Hi­ber­Cell

→ New York-based Hi­ber­Cell has ap­point­ed ex-OSI Phar­ma CEO Col­in God­dard to the board of di­rec­tors. God­dard will serve un­der new­ly mint­ed chair­man Steven Gillis, a man­ag­ing di­rec­tor at Arch who is prob­a­bly best known as founder of Im­munex.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”