C4 Ther­a­peu­tics bumps An­drew Phillips to CEO; Milind Desh­pande ex­its Achillion; Leena Gand­hi to head up I/O at Eli Lil­ly

An­drew Phillips has been div­ing deep in­to the biotech side of things ever since he left the acad­e­mia to join C4 Ther­a­peu­tics — he start­ed off lead­ing the sci­en­tif­ic ef­forts but soon af­ter as­sumed cor­po­rate and man­age­ment du­ties as pres­i­dent. Now, he’s tak­ing an­oth­er step up to be­come CEO of the pro­tein degra­da­tion biotech. That leaves his pre­vi­ous CSO po­si­tion avail­able for Stew­art Fish­er, for­mer­ly C4T’s head of dis­cov­ery, to fill. Like Phillips, he had a brief stint at the Broad In­sti­tute be­fore join­ing the Wa­ter­town, MA-based biotech; but un­like the new CEO, who was a pro­fes­sor at Yale, Fish­er worked at As­traZeneca for more than 10 years. To­geth­er, they are ex­pect­ed to build on the tar­get­ed pro­tein degra­da­tion plat­form and al­liances they’ve es­tab­lished to re­al­ize C4T’s po­ten­tial in ar­eas like can­cer, in­fec­tious dis­ease and au­toim­mune dis­or­ders.

Am­ber Salz­man

→ Now that it’s in clin­i­cal stage, Ad­verum Biotech­nolo­gies $AD­VM has de­cid­ed the arrange­ment where CEO Am­ber Salz­man com­mutes week­ly from the East Coast to its Men­lo Park, CA of­fices will no longer work. Salz­man, who’s al­so the pres­i­dent, is step­ping down from her roles so the board can re­cruit a full-time chief ex­ec­u­tive based out of its head­quar­ters. CFO Leone Pat­ter­son is tak­ing over her re­spon­si­bil­i­ties ad in­ter­im. Al­so head­ed out the door, but with­out an ex­pla­na­tion: CMO Athena Coun­tou­ri­o­tis, who will be re­placed by VP of clin­i­cal de­vel­op­ment Lin­da Neu­man for now.

→ As Berlin-based Ome­icos Ther­a­peu­tics moves in­to the US mar­ket, it has brought on Alexan­der Gebauer to lead clin­i­cal de­vel­op­ment for its car­dio­vas­cu­lar as­sets and dis­cov­ery ef­forts in oph­thal­mol­o­gy. Gebauer will take on two roles: man­ag­ing di­rec­tor for Ome­icos Ther­a­peu­tics, and CEO of US-based Ome­icos Oph­thalmics, which re­cent­ly formed. In the for­mer, he will over­see Ome­icos’ lead com­pound for rhythm con­trol in pa­tients with atri­al fib­ril­la­tion, steer­ing the plan­ning and tri­al de­sign for an up­com­ing Phase II. For the new ven­ture, he will head up col­lab­o­ra­tions with ex­ter­nal ex­perts in es­tab­lish­ing pre­clin­i­cal proof of con­cept for po­ten­tial drug can­di­dates. While the Ger­man ex­ec had not worked in the US since lead­ing a clin­i­cal tri­al in New Jer­sey ear­ly in his ca­reer, he had ac­crued some in­ter­na­tion­al ex­pe­ri­ence while work­ing for In­dia’s Ran­baxy Lab­o­ra­to­ries and Sun Phar­ma.

Milind Desh­pande

→ Milind Desh­pande is step­ping down from Achillion $ACHN, the biotech he’s led for the bet­ter part of the last two decades, first as CSO and then as CEO. His de­par­ture leaves the fad­ed hep C star in the hands of for­mer COO Joseph Tru­itt, who al­ready has the pres­i­dent ti­tle. Dur­ing his tenure, Desh­pande steered a pipeline re­struc­tur­ing that re­brand­ed Achillion from an in­fec­tious dis­ease play­er to a spe­cial­ist in com­ple­ment bi­ol­ogy, ax­ing staff just a few months ago. Tru­itt, who joined the com­pa­ny in 2009, emerged as a key fig­ure in that come­back nar­ra­tive. Hav­ing led com­mer­cial strat­egy and busi­ness de­vel­op­ment, he will now prep Achillion for a se­ries of read­outs from its com­ple­ment fac­tor D in­hi­bitor pro­gram in rare dis­eas­es.

→ Gre­go­ry Madi­son has re­signed from Keryx Bio­phar­ma $KERX on the same day he be­came its CEO and pres­i­dent three years ago. Jodie Mor­ri­son, a cur­rent board mem­ber and for­mer chief ex­ec­u­tive at Tokai Phar­ma, will lead the Au­ryx­ia mak­er in the in­ter­im. The Boston com­pa­ny thanked Madi­son but did not give a rea­son for Madi­son’s de­par­ture in its state­ment, choos­ing in­stead to fo­cus on its out­looks for Au­ryx­ia, its on­ly drug, cur­rent­ly ap­proved for iron de­fi­cien­cy ane­mia and hy­per­phos­phatemia in pa­tients with chron­ic kid­ney dis­ease. The ther­a­py ac­count­ed for $20 to 21 mil­lion out of $21 to $22.5 mil­lion in first quar­ter rev­enue.

→ Two weeks ago, Leena Gand­hi was in the spot­light at AACR with the lat­est land­mark da­ta on Mer­ck’s Keytru­da/chemo com­bo for front­line lung can­cer. That pack­age end­ed up out­shin­ing a ri­val play from Bris­tol-My­ers Squibb as Mer­ck con­tin­ued to con­sol­i­date its lead po­si­tion in the field. This week, we find out that Gand­hi, an in­ves­ti­ga­tor at the Perl­mut­ter Can­cer Cen­ter at NYU Lan­gone Health and a Dana-Far­ber vet, has been re­cruit­ed by none oth­er than Eli Lil­ly to head up its im­muno-on­col­ogy re­search work. Or per­haps, more to the point, the I/O work that Lil­ly plans to get start­ed on. And she’s the lat­est in a se­ries of new hires that points to Lil­ly’s brew­ing in­ter­est in forg­ing new on­col­ogy deals. As of now, Lil­ly has been large­ly by­passed on the glob­al I/O su­per high­way as it pairs up its tar­get­ed can­cer agents with the lead play­ers. But in its Q1 call a few days ago, new R&D chief Dan Skovron­sky and the ex­ec­u­tive team made it clear that the com­pa­ny is prepar­ing to hatch some I/O deals to beef up its can­cer drug pipeline. And Gand­hi is clear­ly cen­tral to that process. She ar­rives at Lil­ly June 25.

→ Fol­low­ing a brief stint at di­ag­nos­tics com­pa­ny Eu­rofins, Amit Kohli is back in the drug de­vel­op­ment busi­ness — and in his long­time home of Paris. His newest ti­tle is COO of Pharnext, a biotech fo­cused on neu­rode­gen­er­a­tive dis­eases. The Sanofi vet is ex­pect­ed to lead cor­po­rate strat­e­gy and op­er­a­tions, with a spe­cial fo­cus on cross-func­tion­al lead­er­ship as Pharnext pre­pares to re­lease Phase III da­ta on PXT3003, an or­phan drug for the treat­ment of Char­cot-Marie-Tooth dis­ease type 1A.

→ Af­ter get­ting to know CytRx $CYTR as a strate­gic con­sul­tant for the past few months, Er­ic Cur­tis has been tapped to run the com­pa­ny’s on­col­o­gy pro­grams as its pres­i­dent and COO. A sea­soned com­mer­cial­iza­tion ex­ec — with roles span­ning Glax­o­SmithK­line, Bay­er and Aege­ri­on — Cur­tis said his fo­cus will be on part­ner­ship op­por­tu­ni­ties for CytRx’s Link­er Ac­ti­vat­ed Drug Re­lease tech­nol­o­gy. Hav­ing out-li­censed its most ad­vanced drug con­ju­gate to Nant­Cell, CytRx is cur­rent­ly plan­ning INDs for sev­er­al un­named pre­clin­i­cal as­sets, to be sub­mit­ted lat­er this year, and work­ing on dis­cov­er­ing more.

→ As Log­icBio inch­es to­ward clin­i­cal de­vel­op­ment, it has re­cruit­ed COO San­dra Poole and se­nior di­rec­tor of man­u­fac­tur­ing Paul Herzich to make sure every­thing is ready. Both bring plen­ty of ex­pe­ri­ence to the high­ly tech­ni­cal genome edit­ing work that Log­icBio is do­ing on treat­ments for pe­di­atric in­di­ca­tions. Poole led bi­o­log­ics man­u­fac­tur­ing at Gen­zyme for 15 years be­fore tak­ing up a tech­ni­cal op­er­a­tions role at Im­muno­Gen. In her new po­si­tion, she will take charge of both in­ter­nal op­er­a­tions and li­ais­ing with part­ners. Herzich joins the Cam­bridge, MA-based biotech from Pfiz­er’s Bam­boo Ther­a­peu­tics, where he served as di­rec­tor of clin­i­cal gene ther­a­py man­u­fac­tur­ing.

David Thomp­son has left the helm of a biotech he co-found­ed to join In­ozyme, where he sees “com­pelling sci­ence” and ear­ly-stage re­search show­ing that its ENPP1 en­zyme re­place­ment ther­a­py has po­ten­tial in rare meta­bol­ic dis­eases. As the first CSO and SVP, Thomp­son will over­see sci­en­tif­ic and trans­la­tion­al ef­forts as In­ozyme tran­si­tions from dis­cov­ery to clin­i­cal stage. In­ozyme is cur­rent­ly ex­plor­ing lead prod­uct can­di­date in treat­ing gen­er­al­ized ar­te­r­i­al cal­ci­fi­ca­tion of in­fan­cy (GACI) and au­to­so­mal re­ces­sive hy­pophos­phatemic rick­ets type 2 (ARHR2) — both square­ly with­in Thomp­son’s ex­per­tise in min­er­al­iza­tion and bone dis­or­ders. Pri­or to found­ing Azure Biotech, he’s led pre­clin­i­cal and clin­i­cal de­vel­op­ment at Alex­ion, Pfiz­er and Mer­ck Re­search Labs.

→ South San Fran­cis­co-based Vaxart $VXRT has tapped David Tay­lor to lead its quest to de­vel­op oral re­com­bi­nant vac­cine tablets as CMO. In Tay­lor, Vaxart gets a spe­cial­ist who has ded­i­cat­ed much of his ca­reer to vac­cines, lead­ing pro­grams at Take­da, Vax­In­nate and the non­prof­it PATH. The com­pa­ny is par­tic­u­lar­ly im­pressed by his ex­pe­ri­ence in norovirus and in­fluen­za vac­cines, as it con­tin­ues on ear­ly-stage stud­ies for its own prod­ucts in those in­di­ca­tions.

Tarek Sah­moud’s decades-long in­volve­ment in on­col­o­gy drug de­vel­op­ment has tak­en him to Hu­mani­gen, the biotech that dropped its pro­gram in Cha­gas dis­ease to pur­sue CAR-T op­ti­miza­tion. Be­fore join­ing H3 Bio­med­i­cine, Sah­moud’s re­sume was es­sen­tial­ly a who’s who in big phar­ma: As­traZeneca, No­var­tis, Cel­gene and ul­ti­mate­ly Boehringer In­gel­heim. But his short run in H3 fa­mil­iar­ized him with the CMO role, which he is tak­ing at Hu­mani­gen. He will now be­come in cen­tral fig­ure in push­ing clin­i­cal work for lenzilum­ab, the mon­o­clon­al an­ti­body that Hu­mani­gen be­lieves will make CAR-T safer and bet­ter.

→ Up­ping his com­mit­ment with oph­thal­mol­o­gy biotech View­Point Ther­a­peu­tics, Robert Kim has tak­en a full-time role as CMO. Kim had served as a con­sul­tant and ad­vi­sor to the com­pa­ny while teach­ing at UCSF, and he’s been con­vinced to spear­head pre­clin­i­cal and clin­i­cal plans for VP1-001, the lead drug for age-re­lat­ed cataracts. Through­out his aca­d­e­m­ic ca­reer, Kim had as­sumed a slate of roles at first med­ical de­vice, then bio­phar­ma, com­pa­nies, with stints at Genen­tech, Al­con and most re­cent­ly Apel­lis Phar­ma­ceu­ti­cals.

→ With its promis­es of ap­ply­ing ma­chine learn­ing to drug dis­cov­ery, Re­cur­sion Phar­ma­ceu­ti­cal has wooed Kevin Lynch from Ab­b­Vie, where he’s worked for the past 22 years. There’s plen­ty for the new chief busi­ness of­fi­cer to do, says the Salt Lake City-based biotech, as its ther­a­peu­tic reach has now been ex­tend­ed in­to ar­eas like im­munol­o­gy and in­flam­ma­tion, im­muno-on­col­o­gy, and in­fec­tious dis­ease, be­yond its ini­tial fo­cus on ge­net­ic dis­ease. The next step will be to ex­pand its pre­clin­i­cal pipeline and pur­sue strate­gic part­ner­ships — some­thing that Lynch has done plen­ty of while do­ing busi­ness de­vel­op­ment at Ab­b­Vie.

→ In a sign of growth, Cari­bou Bio­sciences — the gene edit­ing com­pa­ny co-found­ed by CRISPR pi­o­neer Jen­nifer Doud­na — has cre­at­ed a new chief busi­ness of­fi­cer role and in­vit­ed a big phar­ma vet to fill it. Tim­o­thy Her­pin joins the Berke­ley, CA-based biotech from As­traZeneca, where as head of trans­ac­tions he over­saw deals with fel­low gi­ants like Mer­ck as well as biotechs like Ac­er­ta Phar­ma. A par­tic­u­lar fo­cus in his broad man­date will be to seek op­por­tu­ni­ties for Cari­bou’s off-the-shelf CAR-T can­di­dates and mi­cro­bio­me-based ther­a­pies.

Curt Her­berts has re­signed from gene edit­ing com­pa­ny Sang­amo $SG­MO to pur­sue “a lead­er­ship op­por­tu­ni­ty” with a pri­vate biotech, leav­ing with the bless­ings of ex­ecs grate­ful for the phar­ma col­lab­o­ra­tions he’s ex­e­cut­ed dur­ing his eight-year tenure. The com­pa­ny has yet to name his suc­ces­sor, but it did pro­mote Michael Holmes to chief tech­nol­o­gy of­fi­cer from VP of re­search. A long­time em­ploy­ee — he joined in 2001 — Holmes played a cru­cial role in us­ing zinc fin­ger nu­cle­as­es for gene edit­ing, a feat that the com­pa­ny is now known for.

AM­AG Phar­ma­ceu­ti­cals $AM­AG may be launch­ing sev­er­al prod­ucts this year, but it al­so wants to make sure its port­fo­lio will keep grow­ing. And it’s hired Alan Butch­er to do that as the chief busi­ness of­fi­cer. For­mer­ly of Shire, Butch­er jumps from a sim­i­lar role in li­cens­ing and busi­ness de­vel­op­ment at Pur­due Phar­ma. In ad­di­tion to scout­ing new prod­ucts, he will al­so lead an al­liance man­age­ment team and lead cor­po­rate strat­e­gy for the com­pa­ny, which is cur­rent­ly fo­cused on women’s health and can­cer care.

Jen­nifer Doud­na, one of the most promi­nent sci­en­tif­ic pi­o­neers be­hind CRISPR/Cas9 gene edit­ing tech, has qui­et­ly joined the J&J $JNJ board.

Xi­aobin Wu has jumped from Pfiz­er to BeiGene, lend­ing his Chi­na op­er­a­tions ex­per­tise to the im­muno-on­col­o­gy biotech as its gen­er­al man­ag­er and pres­i­dent. Wu, who’s worked for Wyeth and Bay­er in the coun­try, said he’s drawn to BeiGene’s “en­tre­pre­neur­ial spir­it, the qual­i­ty of its sci­ence and its em­ploy­ees, and its dri­ve to be­come a glob­al leader.”

→ Days ago, Aca­dia saw its shares slide on news that the FDA has be­gun a re­view of its an­ti-psy­chosis drug Nu­plazid fol­low­ing CNN’s re­port ques­tion­ing the safe­ty of the drug. This week, the San Diego biotech has ap­point­ed Alex­ion vet Ele­na Ridloff as its first SVP of in­vestor re­la­tions. Aca­dia ex­ecs like the fi­nan­cial com­mu­ni­ty re­la­tion­ships Ridloff has built since her hedge fund and con­sult­ing days.

Jen­nifer Du­d­i­nak is the new SVP of glob­al reg­u­la­to­ry af­fairs at Cel­gene, join­ing days be­fore the trou­bled big biotech re­as­sured in­vestors that it will re-file the block­buster hope­ful ozan­i­mod in 2019. 

→ It took a few months, but Or­biMed’s Sam Isaly has fi­nal­ly stepped down from his top post at the ven­ture firm. Late last year STAT writer Dami­an Garde out­lined charges that Isaly had ha­rassed women at the firm for years, lead­ing to a quick state­ment that he would be re­tir­ing from the com­pa­ny and his high-pro­file po­si­tion. The firm’s five oth­er part­ners — Sven Borho, Carl Gor­don, Jonathan Sil­ver­stein, Carter Neild and Ge­of­frey Hsu — will con­tin­ue their own­er­ship.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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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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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? Ac­tu­al­ly, An­nex­on was al­ready prepped and primed to toss its S-1 to Wall Street as in­vestors ral­lied

The Wall Street IPO shuffle generally calls for a little distance between the crossover ante and the Wall Street double, but with the window on the street wide open and biotech sizzling hot, who’s waiting?

The crew at Annexon didn’t leave anyone in suspense for long about their IPO plans. A day after the Bay Area biotech with clinical plans to target neurodegeneration quietly unveiled a $100 million raise, they were back with an S-1 outlining a pitch to double that — or more.

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