Genen­tech gains clin­i­cal de­vel­op­ment ex­ec by ap­point­ing Lil­li Petruzzel­li; Paul Sekhri caps event­ful week, nam­ing Sap­na Sri­vas­ta­va CFO of eGe­n­e­sis

Lil­li Petruzzel­li

→ A spokesper­son for Genen­tech tells End­points News that Lil­li Petruzzel­li has forged a new path this week as SVP, ear­ly clin­i­cal de­vel­op­ment at Genen­tech’s Re­search and Ear­ly De­vel­op­ment or­ga­ni­za­tion (gRED). Petruzzel­li just spent two years as In­cyte’s group VP, ear­ly clin­i­cal de­vel­op­ment, and pri­or to In­cyte, she was glob­al head, trans­la­tion­al clin­i­cal on­col­o­gy at the No­var­tis In­sti­tutes of Bio­med­ical Re­search.

“Lil­li Petruzzel­li has a re­mark­able track record of part­ner­ing close­ly with dis­cov­ery teams to ad­vance in­no­v­a­tive mol­e­cules from re­search in­to first-in-hu­man stud­ies and through proof-of-con­cept,” Genen­tech’s head of gRED Aviv Regev said in a state­ment.

Sap­na Sri­vas­ta­va

→ Just a cou­ple days af­ter their Se­ries C haul, Paul Sekhri-led eGe­n­e­sis has a new CFO in place with Sap­na Sri­vas­ta­va. She’s pre­vi­ous­ly been chief fi­nan­cial and strat­e­gy of­fi­cer at Abide Ther­a­peu­tics, which Lund­beck ac­quired in the spring of 2019 in a $250 mil­lion deal. The ex-Mor­gan Stan­ley and Gold­man Sachs biotech an­a­lyst was al­so chief fi­nan­cial and strat­e­gy of­fi­cer at In­tel­lia Ther­a­peu­tics. Since its de­but three years ago this month, eGe­n­e­sis — which has been ge­net­i­cal­ly al­ter­ing pigs for the pur­pose of or­gan trans­plan­ta­tion in hu­mans — has to­taled more than $263 mil­lion in fund­ing, with al­most half ($125 mil­lion) com­ing in this week’s megaround.

→ While you or some­one you know have re­ceived their mR­NA vac­cine, Mod­er­na is fill­ing out lead­er­ship po­si­tions re­lat­ed to oth­er tar­gets, with Jonathan Hog­gatt locked in as di­rec­tor of hema­tol­ogy. Hog­gatt is a prin­ci­pal fac­ul­ty mem­ber at the Har­vard Stem Cell In­sti­tute and runs the Hog­gatt Lab, which con­cen­trates on tis­sue re­gen­er­a­tion and stem cell bi­ol­o­gy. He’s al­so a sci­en­tif­ic co-founder of Ma­gen­ta Ther­a­peu­tics.

Christophe Bour­don

Or­p­hazyme had been bask­ing in the glow of the FDA ac­cept­ing its NDA a few months ear­li­er for ari­mo­clo­mol in Nie­mann-Pick dis­ease type C pa­tients, and now Christophe Bour­don is helm­ing the Dan­ish biotech af­ter Kim Strat­ton de­cid­ed to re­sign Dec. 20. Bour­don takes con­trol at the Copen­hagen com­pa­ny af­ter his sec­ond stint at Am­gen, where he was SVP and GM of the US on­col­o­gy busi­ness. The Sanofi vet was Alex­ion’s SVP of Eu­rope, Mid­dle East, Africa, and Cana­da (EMEAC) in a two-year stay that was sand­wiched in be­tween his time at Am­gen.

Mark Sten­house

Pen­cil­ing in a $125 mil­lion IPO last month af­ter scor­ing $130 mil­lion in fund­ing back in No­vem­ber, Mark McKen­na-led Prometheus Bio­sciences is hand­ing the role of COO to Mark Sten­house. He’s an Ab­b­Vie vet of al­most 30 years (1990-2018) who was the phar­ma gi­ant’s VP of US im­munol­o­gy and, be­fore that, VP and GM of the gas­troen­terol­o­gy fran­chise. In all, he spent 10 years with Ab­b­Vie in IBD, which is San Diego-based Prometheus’ fo­cus. Af­ter Ab­b­Vie, Sten­house was GM, screen­ing busi­ness at Ex­act Sci­ences, lead­ing com­mer­cial du­ties with the col­orec­tal can­cer de­tec­tion test Co­lo­guard.

Joel Schnei­der

Sol­id Bio’s clin­i­cal hold for its Duchenne mus­cu­lar dy­s­tro­phy drug lift­ed last Oc­to­ber, fend­ing off re­peat­ed slings and ar­rows from the FDA. Now Sol­id has pro­mot­ed Joel Schnei­der to COO and Erin Pow­ers Bren­nan is on board as chief le­gal of­fi­cer. Schnei­der — who was chief tech­ni­cal of­fi­cer and head of ex­plorato­ry R&D be­fore set­tling in his new gig on Tues­day — has spent sev­en years at Sol­id over­all, while Bren­nan leaves Cov­etrus, where she was SVP, gen­er­al coun­sel & sec­re­tary. Else­where at Sol­id, for­mer Glax­o­smithK­line and Pfiz­er reg­u­la­to­ry ex­ec Clare Kahn and ex-Take­da COO of R&D Geor­gia Ker­esty have been waved in to the Cam­bridge biotech’s board of di­rec­tors.

Si­mon Coop­er has suc­ceed­ed John Ryan as CMO of Kad­mon as Ryan piv­ots to the new role of ex­ec­u­tive med­ical di­rec­tor, clin­i­cal and reg­u­la­to­ry de­vel­op­ment. Coop­er has cer­tain­ly made the Big Phar­ma rounds as a clin­i­cal sci­ence leader at Roche, a glob­al pro­gram di­rec­tor at No­var­tis, the glob­al project head for im­munol­o­gy and in­flam­ma­tion at Sanofi, and as­set strat­e­gy di­rec­tor for Skyrizi with Ab­b­Vie. Af­ter his work with those heavy hit­ters, Coop­er took his first CMO gig with Anokion in 2019 be­fore of­fi­cial­ly start­ing at Kad­mon on Mon­day.

Sean Zhang

→ Bei­jing-based can­cer biotech In­no­Care, which racked up $289 mil­lion in its Hong Kong IPO in March 2020, has brought on Sean Zhang as CMO, leav­ing his CEO post at Hen­grui Ther­a­peu­tics. Be­fore get­ting pro­mot­ed to the top spot, Zhang was Hen­grui’s CMO and a board mem­ber. He too has hop­scotched around Big Phar­ma most of his ca­reer, first as a re­search sci­en­tist in Mer­ck and then as a clin­i­cal leader at J&J. He al­so spent four years in dis­cov­ery med­i­cine and clin­i­cal phar­ma­col­o­gy at Bris­tol My­ers Squibb and an­oth­er three years in clin­i­cal de­vel­op­ment at Glax­o­SmithK­line.

Aa­van­tiBioBo Cum­bo’s post-Sarep­ta gene ther­a­py en­deav­or — has en­trust­ed the CFO and trea­sur­er du­ties to Dou­glas Swirsky sev­er­al months af­ter tak­ing the tarp off with a meaty $107 mil­lion launch round. Swirsky, who had been in a con­sult­ing role at Aa­van­tiBio since Feb­ru­ary, helmed Rex­ahn Phar­ma­ceu­ti­cals for two years and has al­so been pres­i­dent and CEO of Gen­Vec. He al­so chairs the board of di­rec­tors at Cel­lec­tar Bio­sciences and Neu­roBo Phar­ma­ceu­ti­cals.

Wildon Far­well

→ With its oligonu­cleotide ther­a­py pipeline for rare mus­cle dis­eases in de­vel­op­ment, 2020 IPO boom par­tic­i­pant Dyne Ther­a­peu­tics has cor­ralled Wildon Far­well as CMO soon af­ter Ash Dugar was ap­point­ed glob­al head of med­ical af­fairs. Far­well spent a decade at Bio­gen, lead­ing the de­vel­op­ment of oligonu­cleotide Spin­raza and hold­ing nu­mer­ous posts that cul­mi­nat­ed in his role as VP, glob­al head of neu­ro­mus­cu­lar dis­eases, med­ical af­fairs.

Jes­si­ca Stitt

→ Fresh off sparkling da­ta for AMD gene ther­a­py GT005, Lon­don-based Gy­ro­scope Ther­a­peu­tics has wel­comed Jes­si­ca Stitt as CFO. Stitt, who’s al­so held fi­nance po­si­tions at Alk­er­mes and Ther­a­vance, was pre­vi­ous­ly VP of fi­nance and op­er­a­tions at MyoKar­dia, which Bris­tol My­ers Squibb swooped in to buy for more than $13 bil­lion back in Oc­to­ber.

→ New York-based An­ti­body Ra­di­a­tion-Con­ju­gate (ARC) phar­ma Ac­tini­um ap­point­ed two clin­i­cal de­vel­op­ment ex­ecs (Avinash De­sai and Mary Mei Chen) in a two-week span late last fall, and now Mark Ku­bik has ac­cept­ed the role of Ac­tini­um’s CBO. A for­mer busi­ness de­vel­op­ment di­rec­tor at such biotechs as Macro­Gen­ics and Seat­tle Ge­net­ics (now Seagen), Ku­bik makes the tran­si­tion to Ac­tini­um af­ter a brief stay as CBO at On­coIm­mune, which Mer­ck bought for $425 mil­lion in a deal that was bro­kered by then-Op­er­a­tion Warp Speed chief Mon­cef Slaoui.

Mary Kay Fen­ton

→ Long­time Achillion CFO Mary Kay Fen­ton will take on the same re­spon­si­bil­i­ty at Ta­laris Ther­a­peu­tics, which land­ed a $115 mil­lion Se­ries B in its quest to help make or­gan trans­plan­ta­tion safer for pa­tients. Fen­ton was VP of strate­gic op­er­a­tions at Ver­tex’s cell and ge­net­ic ther­a­pies unit, and had been Sem­ma’s CFO and COO be­fore Ver­tex bought the com­pa­ny for $950 mil­lion in 2019.

→ Six months af­ter Sven Rohmann grabbed hold of the reins as CEO, Swedish can­cer biotech Im­mu­nicum AB has tapped Jeroen Rovers to be CMO. Rovers hails from DCprime, an­oth­er den­drit­ic cell ther­a­py out­fit which merged with Im­mu­nicum to­ward the end of last year, where he had been CMO since 2018. The ex-CMO at Kiadis and Ceron­co Bio­sciences re­places Pe­ter Sue­naert, who sticks with Im­mu­nicum as a clin­i­cal ad­vi­sor. Rovers’ ap­point­ment fol­lows that of Lot­ta Ferm as in­ter­im CFO and comes af­ter Im­mu­nicum’s or­phan drug des­ig­na­tion for il­ix­aden­cel to treat he­pa­to­cel­lu­lar car­ci­no­ma.

Al­i­son Schecter

Flag­ship-backed Ax­cel­la, which has lead drug can­di­dates for NASH and he­pat­ic en­cephalopa­thy in its pipeline, has made Al­i­son Schecter pres­i­dent of R&D af­ter com­plet­ing a year as CMO of Se­lec­ta Bio­sciences. Just be­fore that, Schecter was Sanofi Gen­zyme’s glob­al project head, rare dis­eases and the glob­al pro­gram head for he­mo­phil­ia at Bax­al­ta. She al­so brings ex­pe­ri­ence from the North­east J&J In­no­va­tion Cen­ter and the No­var­tis In­sti­tutes of Bio­med­ical Re­search.

Schond Green­way is jump­ing on board as CFO of Cere­cor, suc­ceed­ing Chris Sul­li­van, who had been in the in­ter­im CFO slot for a year and will now be­come the Mary­land phar­ma’s chief ac­count­ing of­fi­cer. Green­way had pre­vi­ous­ly been Mesoblast’s VP, in­vestor re­la­tions and was al­so an ex­ec­u­tive di­rec­tor in in­vestor re­la­tions at Halozyme.

→ Strik­ing up a $10 mil­lion up­front pact with Sarep­ta last sum­mer to de­vel­op im­li­fi­dase as a pre-treat­ment for DMD and LGMD pa­tients, Hansa Bio­phar­ma out of Swe­den has giv­en the nod to Mag­nus Ko­rs­gren to be head of R&D. An As­traZeneca and No­var­tis vet, Ko­rs­gren has de­vot­ed the last six years to Fer­ring Phar­ma­ceu­ti­cals, more re­cent­ly as VP, head of trans­la­tion­al med­i­cine.

Ger­ald Cox

→ Ex-Ed­i­tas Med­i­cine CMO Ger­ald Cox has been named act­ing CMO at Gainesville, FL biotech Cy­clo Ther­a­peu­tics, which is work­ing on cy­clodex­trin-based drugs that tar­get Nie­mann-Pick dis­ease type C and Alzheimer’s. Cox, a long­time staff physi­cian at Boston Chil­dren’s Hos­pi­tal, had spent more than 15 years at Gen­zyme, leav­ing as VP of rare dis­ease clin­i­cal de­vel­op­ment be­fore his two years at Ed­i­tas.

Gary Sender has re­tired as CFO of Dublin-based Nabri­va Ther­a­peu­tics, and start­ing March 12, Daniel Dolan will take his place. The 12-year Shire vet had been Ra­dius Health’s VP of fi­nan­cial plan­ning & analy­sis since 2017. Nabri­va got side­tracked with a CRL in June 2020 for its an­tibi­ot­ic Con­tepo, with man­u­fac­tur­ing is­sues at Nabri­va’s Eu­ro­pean CMO site as the main cul­prit. Nabri­va pinned the lack of re­sponse to the FDA’s con­cerns on trav­el re­stric­tions.

Leonard Pao­lil­lo

→ Seat­tle-based Im­pel Neu­roPhar­ma, with its pri­ma­ry fo­cus on CNS dis­eases, has a pair of new faces with Leonard Pao­lil­lo as chief com­mer­cial of­fi­cer and Ger­ald Penn as VP, mar­ket ac­cess & trade. Pao­lil­lo makes the leap from Ky­owa Kirin’s North Amer­i­can af­fil­i­ate, where he was EVP and CCO, while Penn just held the same ti­tle at Es­pe­ri­on that he does at Im­pel Neu­roPhar­ma. The new lead­er­ship comes af­ter Im­pel Neu­roPhar­ma brought Amarin alum Rigo Canal in­to the fold as VP, com­mer­cial op­er­a­tions and an­a­lyt­ics.

→ British biotech 4D phar­ma got in on the SPAC ac­tion, merg­ing with blank check com­pa­ny Longevi­ty back in Oc­to­ber, and in an­tic­i­pa­tion of break­ing through on Nas­daq, the mi­cro­bio­me play­er has re­cruit­ed John Beck as CFO. Beck’s most re­cent CFO ex­pe­ri­ence was a two-year run at Rit­ter Phar­ma­ceu­ti­cals from 2018-20. Else­where at 4D phar­ma, ex-Lig­and and Se­quenom CFO Paul Maier has climbed on to the board as a non-ex­ec­u­tive di­rec­tor.

Nicholas Hols­man

→ Ire­land’s Shorla Phar­ma, which pulled in $8.3 mil­lion in a mod­est Se­ries A in June 2020, has en­list­ed Nicholas Hols­man as chief com­mer­cial of­fi­cer. Be­fore tran­si­tion­ing to the on­col­o­gy play­er, Hols­man had led com­mer­cial op­er­a­tions since the sum­mer of 2019 at On­copep­tides, now helmed by for­mer Toca­gen CEO Mar­ty Du­vall.

→ With pro­grams in se­vere in­flam­ma­to­ry dis­eases (ABX464) and he­pa­to­cel­lu­lar car­ci­no­ma (ABX196), Paris-based Abi­vax has se­lect­ed So­phie Biguenet as CMO, re­plac­ing the re­tir­ing Jean-Marc Steens. Biguenet’s Big Phar­ma ex­pe­ri­ence traces back to Bio­gen and Bris­tol My­ers Squibb and she’s been Ab­b­Vie’s med­ical di­rec­tor and pe­di­atric lead for HCV, RSV and HIV glob­al pe­di­atric clin­i­cal de­vel­op­ment. Biguenet joins Abi­vax af­ter hold­ing her first CMO post at Swiss biotech Ver­san­tis.

→ Ich­nos Sci­ences has re­cruit­ed Michael D Price as CFO. Price for­mer­ly served as VP and CFO of Akcea Ther­a­peu­tics and held po­si­tions at Novleion Ther­a­peu­tics, Noven Phar­ma­ceu­ti­cals and Bent­ley Phar­ma­ceu­ti­cals.

Byung Ha Lee

T-cell-fo­cused NeoIm­muneTech has pro­mot­ed Byung Ha Lee to the po­si­tion of CSO. Lee joined the com­pa­ny in 2016 as prin­ci­pal sci­en­tist be­fore be­ing named di­rec­tor of R&D in 2019. Pri­or to his roles at NeoIm­muneTech, Lee was at Sam­sung Bio­med­ical Re­search In­sti­tute and at Genex­ine.

→ A fa­mil­iar face and a new staffer have shored up the C-suite at Bay Area biotech Cor­cept Ther­a­peu­tics, with Atabak Mokari as CFO and his pre­de­ces­sor Charles Robb step­ping in as CBO. Mokari was pre­vi­ous­ly the CFO for Bel­licum, while Robb slides in­to the CBO po­si­tion af­ter nine years as Cor­cept’s CFO. Cor­cept’s drug Ko­r­lym was ap­proved in 2012 for en­doge­nous Cush­ing’s syn­drome.

Richard Pye

Sen­syne Health has named Richard Pye as CFO and ex­ec­u­tive di­rec­tor. Pye pre­vi­ous­ly served as chief in­vest­ment of­fi­cer for the com­pa­ny and hopped aboard from Sum­mit Ther­a­peu­tics. In ad­di­tion, the com­pa­ny’s in­ter­im CFO Michael Nor­ris and Ge­off Race are join­ing the board of di­rec­tors as non-ex­ec­u­tive di­rec­tors. Nor­ris is cur­rent­ly di­rec­tor and CFO of Beck­ley Psytech, while Race is the co-founder, EVP, CFO and CBO of Min­er­va Neu­ro­sciences.

ERS Ge­nomics has ap­point­ed Jon Kra­tochvil as VP for busi­ness de­vel­op­ment & li­cens­ing for North Amer­i­ca. Kra­tochvil hops aboard from Mil­l­li­pore­Sig­ma, where he was di­rec­tor of busi­ness de­vel­op­ment and li­cens­ing. His oth­er roles in­clude stints at Wash­ing­ton Uni­ver­si­ty and Ab­bott Lab­o­ra­to­ries.

eTh­eR­NA has reeled in David Rick­etts as con­sul­tant di­rec­tor of busi­ness de­vel­op­ment for man­u­fac­tur­ing ser­vices. Rick­etts comes aboard with ex­pe­ri­ence as CEO of Phar­ma­Di­ag­nos­tics and Link Tech­nolo­gies.

Mar­tin Chavez

Mar­tin Chavez has been elect­ed chair­man of the board at Chris Gib­son-helmed Re­cur­sion, the Salt Lake City drug de­vel­op­er that raised a hefty $239 mil­lion Se­ries D last Sep­tem­ber and is part­ner­ing with Bay­er on fi­brot­ic dis­eases. Chavez, a mem­ber of Re­cur­sion’s board for al­most a year, was with Gold­man Sachs from 2005-20 in a num­ber of ca­pac­i­ties such as chief in­for­ma­tion of­fi­cer, CFO and glob­al co-head of the Se­cu­ri­ties Di­vi­sion.

→ Plant-based tech com­pa­ny Ca­lyxt has pulled Yves Ribeill as ex­ec­u­tive chair of the board of di­rec­tors as the com­pa­ny ini­ti­ates a search for a new CEO to suc­ceed ex­it­ing Jim Blome, who is pur­su­ing oth­er op­por­tu­ni­ties. Ribeill has served on the board of di­rec­tors for Ca­lyxt since Ju­ly 2018 and for a time served as the com­pa­ny’s in­ter­im CEO from Au­gust 2018 to Oc­to­ber 2018. Ribeill is the CEO of Ri­bo­gen­ics and a founder and for­mer CEO of Scynex­is. Pri­or to these roles, he served at Rhône-Poulenc and Aven­tis in France and the UK.

Don­nie Mc­Grath

→ Along with this week’s news of Ar­ti­zan Bio­sciences’ $11 mil­lion Se­ries A-2 round and a part­ner­ship with Bio­haven, New Haven, CT-based Ar­ti­zan Bio­sciences is al­so adding Don­nie Mc­Grath and Seth Rud­nick to the board of di­rec­tors. A Bris­tol My­ers Squibb alum, Mc­Grath is Bio­haven’s chief of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment, and ex-Canaan part­ner Rud­nick was chair­man and CEO of Cy­toTher­a­peu­tics.

Robert Gagnon has joined the board of di­rec­tors at Is­raeli on­col­o­gy out­fit Pur­ple Biotech. The Bio­gen alum has been Ve­rastem’s chief busi­ness and fi­nan­cial of­fi­cer since 2018.

June Bray

BioX­cel has re­served a seat for Al­ler­gan vet June Bray on its board of di­rec­tors. Bray, who’s served as Al­ler­gan’s SVP, glob­al reg­u­la­to­ry af­fairs and med­ical writ­ing, has al­so been a reg­u­la­to­ry ex­ec at Organon.

→ Red­wood City, Cal­i­for­nia-based Am­Max Bio has en­list­ed John Var­i­an for its board of di­rec­tors as an in­de­pen­dent board mem­ber. Var­i­an joins with ex­pe­ri­ence from his time as CEO and di­rec­tor of XO­MA. Pri­or to XO­MA, Var­i­an was COO of Aryx Phar­ma­ceu­ti­cals and CFO of An­er­gen, Genset and Neurex. Var­i­an al­so sits on the board of Stel­las Life Sci­ences.

→ Gas­troen­terol­o­gy com­pa­ny 9 Me­ters Bio­phar­ma has reeled in Michael Rice to its board of di­rec­tors. Rice is the co-founder and pres­i­dent of LifeSci Ad­vi­sors and the co-founder of LifeSci Cap­i­tal. Rice’s oth­er stints in­clude roles at Canac­cord Adams, ThinkE­quity, Bank of Amer­i­ca and JP­Mor­gan/Ham­brecht & Quist.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

You may start to notice more stories exclusively available to Premium subscribers. This week alone, paid subscribers can read our in-depth reporting on Alzheimer’s data, digital therapeutics and Allogene’s cell therapy for solid tumors, as well as scoops on Twitter ads and Catalent. With your support, we can keep growing our team and spend more time on quality work. We have both individual and company plans available — check them out to unlock the full Endpoints experience.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.