Pe­di­atric can­cer biotech Day One Phar­ma­ceu­ti­cals is head­ed for Nas­daq, in a move that comes less than three months af­ter their work on a brain can­cer treat­ment led to a nine-fig­ure crossover round backed by some blue-chip in­vestors.

The South San Fran­cis­co-based com­pa­ny is pen­cil­ing in $100 mil­lion as their ini­tial IPO tar­get, though the ul­ti­mate raise will like­ly be high­er. Tues­day’s fil­ing comes af­ter RA Cap­i­tal led a $130 mil­lion B round for the com­pa­ny in Feb­ru­ary, fol­low­ing what CEO Je­re­my Ben­der said at the time was “rapid” progress of their lead pro­gram.

When Day One prices in a few weeks, it will trade un­der the tick­er $DAWN.

As the phar­ma in­dus­try con­tin­ues de­vel­op­ing and push­ing for­ward can­cer treat­ments, Day One ex­ecs ar­gue that the main­stream play­ers left pe­di­atric can­cer be­hind. Adult pa­tients make up a sig­nif­i­cant­ly big­ger por­tion of the mar­ket, the com­pa­ny said, and there have been lags in un­der­stand­ing pe­di­atric bi­ol­o­gy prop­er­ly.

Day One’s mis­sion, then, is to try to fill that gap by de­vel­op­ing tar­get­ed ther­a­pies aimed specif­i­cal­ly at chil­dren. Their pro­posed treat­ments are en­tire­ly new ef­forts rather than re­for­mu­lat­ing adult treat­ments that come with heavy side ef­fects, like ra­di­a­tion ther­a­py and chemo.

Their lead pro­gram is a for­mer Take­da pro­gram called DAY101, an oral pan-RAF in­hibitor that can cross the blood-brain bar­ri­er and block mu­ta­tions in gliomas. As such, Day One is aim­ing for an in­di­ca­tion to treat pe­di­atric low-grade gliomas, the most com­mon form of brain tu­mors in chil­dren. The cur­rent stan­dard of care is plat­inum-based chemo, with no clear fa­vorite be­yond that, Ben­der told End­points News in Feb­ru­ary.

The biotech re­cent­ly launched a Phase II study for the ex­per­i­men­tal drug, with the goal of read­ing out top-line re­sults in the first half of 2022. Day One plans to ul­ti­mate­ly en­roll 60 pa­tients in the sin­gle-arm, open-la­bel study and hopes it can form the ba­sis of an ap­proval pack­age.

With­in its S-1, Day One plans to fun­nel its cash not on­ly to­ward this Phase II tri­al, but al­so launch a new Phase III study for the front­line treat­ment of pe­di­atric low grade gliomas next year. Its goals al­so in­clude a Phase II tri­al for RAF-al­tered sol­id tu­mors in pa­tients old­er than 12, as well as a Phase Ib/II study com­bin­ing DAY101 with Mer­ck Kg­GA’s MEK in­hibitor pi­masert­ib to treat adult MAPK-al­tered sol­id tu­mors.

The S-1 al­so pro­vid­ed some de­tails re­gard­ing that deal with Take­da and the com­pa­ny’s eq­ui­ty. Day One on­ly paid $1 mil­lion for the DAY101 can­di­date and at the time of the agree­ment, De­cem­ber 2019, of­fered a Take­da sub­sidiary about a 12% stake in the com­pa­ny. The sub­sidiary, Mil­len­ni­um Phar­ma­ceu­ti­cals, will con­tin­ue to own that stake when Day One goes pub­lic.

Ben­der for his part, owns a 3% stake, while CMO and founder Sam Black­man has a 4.6% stake. The biggest stake­hold­er is Canaan Part­ners at 21.9%, fol­lowed up by the At­las Ven­ture Fund at 16.9%.

Day One al­so not­ed that Derek DiRoc­co, the RA Cap­i­tal part­ner who joined the board with Feb­ru­ary’s raise, will be leav­ing the com­pa­ny af­ter a very short stint once the biotech be­gins trad­ing pub­licly.

Biotech IPOs con­tin­ue to boom as 2021 march­es for­ward, with more than 50 com­pa­nies hav­ing ei­ther filed or priced their IPOs so far this year. For the year, the com­bined biotech raise is ap­proach­ing $6.5 bil­lion, and is ex­pect­ed to reach near­ly $7 bil­lion lat­er this week when four more com­pa­nies make their Nas­daq de­buts.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.