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top stories
1. Apple Tree files for bankruptcy as it seeks funds from Russian billionaire backer
2. Investors buy up stocks in biggest follow-on offering day in biotech history
3. US manufacturer scores sped-up approval for amoxicillin thanks to Makary’s voucher
4. Adare Pharma shutters Philadelphia site and lays off over 100 staffers
5. In a first, FDA approves a gene therapy from a nonprofit
6. Roche’s breast cancer pill cuts post-surgery disease recurrence risk by 30%
7. D3 Bio raises $108M to take next-gen KRAS G12C drug into Phase 3
more stories
 
Drew Armstrong
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We told you biotech investors wanted more stock. After Kyle LaHucik's report yesterday on a boom in follow-on offerings, almost all of the companies we mentioned upsized their sales, making for a record-setting day. It's another facet of rising investor enthusiasm for the sector.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
1
by Kyle LaHucik

VC firm Ap­ple Tree Part­ners filed for vol­un­tary Chap­ter 11 re­lief in US bank­rupt­cy court on Wednes­day, seek­ing to re­struc­ture and keep its port­fo­lio afloat as it con­tin­ues an ef­fort to get its main in­vestor to hand over tens of mil­lions of dol­lars.

The bank­rupt­cy fil­ing fol­lows a rul­ing from Fri­day, in which a Delaware court chan­cel­lor ruled that Ap­ple Tree's main fun­der Rigmo­ra Hold­ings must pay about $97 mil­lion of the ap­prox­i­mate­ly $102 mil­lion that Ap­ple Tree re­quest­ed from the in­vestor in May.

Rigmo­ra is an in­vest­ment ve­hi­cle con­trolled by Russ­ian bil­lion­aire Dmit­ry Ry­bolovlev. It is es­sen­tial­ly Ap­ple Tree's sole backer, mak­ing up about 98% of the VC fir­m's funds over the past decade. The two sides are al­so in­volved in a sep­a­rate case in the Cay­man Is­lands.

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2
by Kyle LaHucik

A record-set­ting $3.2 bil­lion in biotech fol­low-on stock of­fer­ings were sold over the last 24 hours, an­oth­er in­di­ca­tion of pub­lic in­vestors’ ap­petite for the sec­tor.

From late Tues­day evening in­to Wednes­day morn­ing, eight biotechs priced sales of new stocks, and sev­en of those com­pa­nies in­creased their of­fer­ing sizes to meet de­mand, with Struc­ture Ther­a­peu­tics, Terns Phar­ma­ceu­ti­cals and Kymera Ther­a­peu­tics each rais­ing more than $600 mil­lion.

“$3.2bn of biotech eq­ui­ty is­suance makes yes­ter­day the busiest day ever,” said Jack Ban­nis­ter, Leerink’s se­nior man­ag­ing di­rec­tor in eq­ui­ty cap­i­tal mar­kets, who tracks com­pa­ny of­fer­ings. “There have been busier weeks than this week, but yes­ter­day was the busiest day ever,” Ban­nis­ter said by email.

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3
by Zachary Brennan

US­An­tibi­otics on Tues­day won ap­proval for its Amer­i­can-made ver­sion of ex­tend­ed-re­lease amox­i­cillin, about two months faster than nor­mal.

It is the first prod­uct to win ap­proval as part of FDA Com­mis­sion­er Mar­ty Makary’s Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er pi­lot pro­gram, which aims to speed cer­tain tar­get­ed ap­provals.

The FDA said it ap­proved the an­tibi­ot­ic just two months fol­low­ing sub­mis­sion. A typ­i­cal FDA re­view for a sup­ple­men­tal ap­pli­ca­tion takes about four months. The pi­lot ini­tial­ly se­lect­ed eight oth­er prod­ucts al­so seek­ing to speed ap­provals.

A US­An­tibi­otics spokesper­son said the "in­tense back and forth" re­quired the com­pa­ny to re­spond to the FDA's ques­tions "with­in a mat­ter of days" as part of the pi­lot. The com­pa­ny said it cur­rent­ly man­u­fac­tures about 5% of the amox­i­cillin US pa­tients use.

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4
by Anna Brown

CD­MO Adare Phar­ma So­lu­tions is clos­ing a fa­cil­i­ty in Philadel­phia and let­ting go of 137 work­ers, a lit­tle over a year af­ter re­lo­cat­ing its head­quar­ters to Penn­syl­va­nia.

The 128,000 square foot site will close be­tween March 1 and June 30, ac­cord­ing to a De­cem­ber WARN no­tice.

The site hous­es com­mer­cial man­u­fac­tur­ing for tablets and cap­sules, a qual­i­ty con­trol lab, and re­search and de­vel­op­ment ser­vices, ac­cord­ing to the com­pa­ny's web­site. Adare Phar­ma did­n't re­ply to a ques­tion from End­points News about why it was mak­ing the cuts.

The site clo­sure comes af­ter the CD­MO in­vest­ed $16.8 mil­lion to move its head­quar­ters to Penn­syl­va­nia from New Jer­sey last year. As part of the re­lo­ca­tion, Adare Phar­ma said it planned to cre­ate around 115 new jobs.

The CD­MO al­so has an­oth­er 175,000 square foot pack­ag­ing and ware­house fa­cil­i­ty in Philadel­phia.

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5
by Lei Lei Wu

The FDA on Tues­day ap­proved a gene ther­a­py for a rare im­mune dis­ease called Wiskott-Aldrich syn­drome, for which pa­tients have lit­tle op­tions be­sides a bone mar­row trans­plant.

The gene ther­a­py will be mar­ket­ed as Waskyra, and was de­vel­oped by Fon­dazione Telethon, an Ital­ian char­i­ty fo­cused on rare dis­ease re­search. It marks the first ap­proved cell and gene ther­a­py from a non­prof­it ap­pli­cant, ac­cord­ing to FDA.

The gene ther­a­py was pre­vi­ous­ly li­censed by Or­chard Ther­a­peu­tics, which stopped work on the treat­ment in 2022 in an ef­fort to save cash amid lay­offs. It’s one of the many gene ther­a­pies aban­doned by in­dus­try even with promis­ing clin­i­cal da­ta be­cause they may not be prof­itable.

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