Car­dio­vas­cu­lar dis­ease is hav­ing some­what of a re­vival in re­cent years, with a spate of next-gen­er­a­tion heart drugs crack­ing open ma­jor in­di­ca­tions. But for at least one drug’s R&D jour­ney, As­traZeneca has de­cid­ed to give up the reins rather than ride it out.

As­traZeneca has grant­ed ex­clu­sive de­vel­op­ment and com­mer­cial rights to Re­gio Bio­sciences for REG-101, a car­dio­vas­cu­lar drug ex­pect­ed to en­ter Phase IIa tri­als for pe­riph­er­al artery dis­ease (PAD) in the sec­ond half, the com­pa­nies said Thurs­day.

Re­gio will take on all R&D and mar­ket­ing costs for REG-101, pre­vi­ous­ly known as ME­DI5884, with fi­nan­cial back­ing from Hi­bis­cus Cap­i­tal Man­age­ment and In­no­force. As the drug’s pri­or name im­plies, the mol­e­cule cane from Med­im­mune, a for­mer­ly sep­a­rate di­vi­sion As­traZeneca bought for $15.6 bil­lion way back in 2007.

Rakesh Dix­it

The drug pur­port­ed­ly works by tar­get­ing en­dothe­lial li­pase to cut plaque lev­els in pa­tients with PAD and oth­er CV dis­eases, and Re­gio — which has no oth­er drugs in the pipeline — hopes this can­di­date will even­tu­al­ly prove a win­ner.

“Pe­riph­er­al artery dis­ease cur­rent­ly has few phar­ma­ceu­ti­cal op­tions, and with­out ap­pro­pri­ate treat­ment, symp­toms of PAD can progress from pain while walk­ing to gan­grene and limb loss,” Re­gio CSO Rakesh Dix­it said in a state­ment. “We be­lieve re­duc­ing the size of cho­les­terol-rich plaque with­in pe­riph­er­al ar­ter­ies us­ing REG-101 has the po­ten­tial to di­rect­ly and pos­i­tive­ly ad­dress the un­der­ly­ing patho­phys­i­ol­o­gy of PAD.”

Re­gio was found­ed in 2020 and is based out of Rockville, MD. Along with the Phase IIa study in PAD, the biotech is al­so pur­su­ing mid-stage stud­ies for REG-101 in coro­nary artery dis­ease.

The PAD mar­ket is packed with ap­proved drugs, in­clud­ing Pfiz­er and J&J’s trou­bled blood thin­ner ri­varox­a­ban, but Re­gio thinks tar­get­ing plaque could help carve out a path to pa­tients. Pa­tients with PAD, char­ac­ter­ized by the nar­row­ing of blood ves­sels, are of­ten treat­ed with LDL-low­er­ing cho­les­terol drugs, which Re­gio says doesn’t ad­dress the plaque prob­lem.

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.

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.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.