Jeff Aronin’s cell and gene ther­a­py biotech Cas­tle Creek Bio­sciences has raised $112 mil­lion in eq­ui­ty, End­points News has learned.

The Ex­ton, PA, biotech se­cured the fi­nanc­ing from 54 in­vestors, ac­cord­ing to an SEC fil­ing dat­ed May 2. The late-stage start­up had last year con­sid­ered a $100 mil­lion Nas­daq de­but, but in a sign of the bear mar­ket that has plagued hun­dreds of new­ly mint­ed pub­lic biotechs, Cas­tle Creek pulled those am­bi­tions in the last few weeks of 2021.

This time around, the biotech has re­turned to pri­vate back­ing, and it comes just three months af­ter the com­pa­ny raised near­ly $12 mil­lion in debt fi­nanc­ing. Cas­tle Creek had pre­vi­ous­ly raised $25 mil­lion in debt fi­nanc­ing last year, ac­cord­ing to an SEC fil­ing, and $71.8 mil­lion from Fi­deli­ty Man­age­ment and Val­or Eq­ui­ty Part­ner in 2018.

End­points has reached out to Aronin and a Cas­tle Creek com­pa­ny spokesper­son, and will up­date this sto­ry ac­cord­ing­ly.

If Cas­tle Creek is still fol­low­ing the same strate­gic route as at the time of its S-1 fil­ing, the biotech will like­ly de­ploy the pro­ceeds on the Phase III tri­al of its ex vi­vo gene ther­a­py dabo­cema­gene aut­ofi­cel, al­so dubbed FCX-007 and D-Fi, for pa­tients with chron­ic wounds due to re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa.

The con­di­tion leads to blis­ter­ing and tear­ing of the skin due to a lack of col­la­gen pro­tein. It’s some­times been re­ferred to as a “but­ter­fly” dis­ease be­cause of how frag­ile it can make an in­fant’s skin. Oth­er biotechs ex­plor­ing the rare dis­ease in­clude Phase III-stage Abeona Ther­a­peu­tics and Eloxx Phar­ma­ceu­ti­cals.

Cas­tle Creek’s study is still re­cruit­ing and is ex­pect­ed to col­lect fi­nal pri­ma­ry out­come da­ta in April 2023, ac­cord­ing to the fed­er­al clin­i­cal tri­als data­base. When Cas­tle Creek ac­quired the drug from Fi­bro­cell in 2019, the orig­i­nal own­er said a mar­ket­ing ap­pli­ca­tion would be shipped off in 2021.

D-Fi is al­so slat­ed to en­ter a late-stage tri­al in a dom­i­nant form of the con­di­tion, ac­cord­ing to the biotech’s pipeline page on its web­site.

Cas­tle Creek’s oth­er clin­i­cal-stage ex vi­vo au­tol­o­gous gene ther­a­py, FCX-013, is in a Phase I/II study in pa­tients with mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma, which leads to hard­en­ing and tight­en­ing of the skin.

The fi­nanc­ing comes four months af­ter Cas­tle Creek bought up gene ther­a­py mak­er No­vavi­ta Thera, which adds pre­clin­i­cal as­sets tar­get­ing rare liv­er and meta­bol­ic dis­ease to the com­pa­ny’s pipeline. As part of the deal, No­vavi­ta co-founder Joseph Lil­le­gard took on the post of sci­ence chief.

Last year, when con­sid­er­ing the Wall Street en­trance, Cas­tle Creek ter­mi­nat­ed a six-year-old li­cense agree­ment with TWI Biotech­nol­o­gy last June for de­vel­op­ment of CCP-020, a com­pound known as di­ac­ere­in.

Aronin is chair of Cas­tle Creek’s orig­i­na­tor, in­vest­ment en­gine Paragon Bio­sciences, be­hind the likes of Har­mo­ny Bio­sciences and Evozyne. He’s al­so founder and chair of Chica­go health-tech in­cu­ba­tor MAT­TER and was pre­vi­ous­ly CEO of Marathon Phar­ma­ceu­ti­cals.

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

After about 15 years in an Oxford lab and three more years in the upstart world following a 2019 spinout, MiroBio is ready to enter UK clinical trials and, en route to the clinic, the biotech has picked up $97 million in Series B funds.

The £80 million financing round kicked off in earnest last September and includes a transatlantic consortium — led by Medicxi — ready to bankroll that first clinical trial, beginning “imminently,” as well as the debut study of a second program thereafter, executive chair Eliot Charles, an SR One venture partner, told Endpoints News.

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.