Fortress Biotech, the in­cu­ba­tor at the cen­ter of a stock mar­ket scan­dal two sum­mers ago, is tak­ing out a loan to re­fi­nance ex­ist­ing debt.

The com­pa­ny is bor­row­ing $60 mil­lion through Oak­tree Cap­i­tal Man­age­ment, with the loan ex­pect­ed to ma­ture in five years. Fortress will pay back the loan first with quar­ter­ly in­stall­ments of 11% in­ter­est un­til 2025, and then with the en­tire prin­ci­pal amount on the loan’s five-year an­niver­sary, ac­cord­ing to the SEC fil­ing.

Fortress can al­so re­pay Oak­tree be­fore the loan ma­tures at any time, with a pre­pay­ment fee re­quired with­in the first four years.

Back in Au­gust 2018, Reuters dropped a bomb­shell re­port about how Fortress bought and used a bro­ker­age firm, Na­tion­al Hold­ings, to tout its own star­tups with­out dis­clos­ing the con­nec­tion be­tween the two com­pa­nies un­til re­porters start­ed ask­ing about it. That in­clud­ed not in­form­ing in­vestors in an­a­lyst notes about po­ten­tial con­flicts of in­ter­est.

Fortress end­ed up sell­ing its 56.1% stake in Na­tion­al a few months lat­er to B. Ri­ley Fi­nan­cial.

Al­so on Fri­day, Fortress an­nounced that a Menkes dis­ease pro­gram from one of its part­ner com­pa­nies, Cypri­um Ther­a­peu­tics, had met its pri­ma­ry end­point of over­all sur­vival from birth. The av­er­age sur­vival was 14.8 years com­pared to 1.3 years in an un­treat­ed his­tor­i­cal con­trol group. — Max Gel­man

En­ta­sis pulls in $25 mil­lion pri­vate place­ment for PhI­II tri­al 

As­traZeneca spin­out En­ta­sis Ther­a­peu­tics is ex­pect­ed to close on a $25 mil­lion pri­vate place­ment with In­no­vi­va and oth­er in­vestors on Sept. 1.

The com­pa­ny plans to sell 9,345,794 shares at $2.675 apiece. The an­nounce­ment comes two years af­ter En­ta­sis’ $ET­TX Nas­daq de­but. In Sep­tem­ber 2018, the Waltham, MA-based com­pa­ny priced shares at $15 apiece, be­low a set range of $16 to $18.

En­ta­sis plans on us­ing pro­ceeds to con­tin­ue a Phase III tri­al of its sul­bac­tam-dur­lobac­tam, used to treat pneu­mo­nia and blood­stream in­fec­tions caused by car­bapen­em-re­sis­tant Acine­to­bac­ter bau­man­nii. The drug, an in­hibitor of Class A, C, and D β-lac­ta­mases, has been grant­ed FDA fast-track des­ig­na­tion. — Nicole De­Feud­is 

Virios files for a $35 mil­lion IPO to de­vel­op fi­bromyal­gia drug

Al­pharet­ta, GA-based Virios Ther­a­peu­tics $VIRI an­nounced on Fri­day that it’s look­ing to go pub­lic. The biotech filed for a $35 mil­lion raise, which it plans on us­ing to push its fi­bromyal­gia drug to Phase III.

The num­ber of biotech de­buts this year have al­ready sur­passed that of 2019. Com­pa­nies prof­it­ing from the boom have raised more than $11 bil­lion com­bined.

Virios, found­ed in 2012, says it will use IPO funds to com­plete a Phase IIb tri­al and chron­ic tox­i­col­o­gy stud­ies of its lead can­di­date, IMC-1. The an­tivi­ral ther­a­py is de­signed to sup­press her­pes sim­plex virus-1 ac­ti­va­tion and repli­ca­tion. Virios ex­pects to read out topline da­ta from the IIb in ear­ly 2022. — Nicole De­Feud­is 

Pfiz­er ex­tends an­oth­er CRO, this time with Parex­el

The big CRO Parex­el an­nounced a new con­tract with Pfiz­er to pro­vide clin­i­cal de­vel­op­ment ser­vices.

Parex­el will work with the Big Phar­ma for the next three years with an op­tion to ex­tend the part­ner­ship for an­oth­er two. The com­pa­nies have col­lab­o­rat­ed for the last decade, Parex­el said in a state­ment.

The ser­vices will be ad­min­is­tered across all of Pfiz­er’s ther­a­peu­tic ar­eas, in­clud­ing rare dis­eases, on­col­o­gy, in­flam­ma­tion and im­munol­o­gy and in­ter­nal and hos­pi­tal-based med­i­cines.

This marks the fourth CRO agree­ment Pfiz­er has agreed to over the last few months, adding the Parex­el deal to oth­ers with Icon, Sy­neos Health and the PPD. — Max Gel­man

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.