→ These days, there’s vir­tu­al­ly no raise too big for biotech. Case in point: 2 loom­ing IPOs where the ex­ec­u­tive team is sketch­ing out some mega-mon­ey that can fu­el their op­er­a­tions for some time. Avid­i­ty Bio­sciences, which has a pre­clin­i­cal pro­gram for my­oton­ic dy­s­tro­phy type 1, be­lieves it can gin up to $248 mil­lion or more now, based on the high end of their range. They’re look­ing for a mar­ket cap of around $619 mil­lion. Ge­off Mc­Do­nough at Gen­er­a­tion Bio, mean­while, has his eyes set on $218 mil­lion-plus with a top-end range of $19 a share. Gen­er­a­tion is al­so pre­clin­i­cal, some­thing that would have scared off in­vestors ear­li­er. To­day, that pro­file can be worth more than $880 mil­lion in mar­ket val­ue.

→ Plano, TX-based Rea­ta $RE­TA is get­ting a ma­jor league as­sist from the Black­stone Life Sci­ences group to get its drug bar­dox­olone over the line at the FDA and in­to the mar­ket. A busy Black­stone Life Sci­ences chief Nicholas Galakatos has inked a $350 mil­lion roy­al­ty and eq­ui­ty deal with Rea­ta on its CKD drug in Al­port syn­drome, au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease and oth­er con­di­tions. “Bring­ing the first po­ten­tial ther­a­py to Al­port syn­drome pa­tients, a dev­as­tat­ing ge­net­ic con­di­tion with no ap­proved treat­ments, is very mo­ti­vat­ing,” said Paris Panayiotopou­los, Black­stone Life Sci­ences se­nior man­ag­ing di­rec­tor.

→ Texas biotech CNS Phar­ma­ceu­ti­cals has se­cured the FDA’s or­phan drug des­ig­na­tion for its lead ex­per­i­men­tal drug, beru­bicin, for the treat­ment of ma­lig­nant gliomas, a type of brain tu­mor. Brain can­cer is no­to­ri­ous­ly dif­fi­cult to treat, giv­en that for treat­ments to work they must sur­mount a for­mi­da­ble ob­sta­cle — the blood-brain bar­ri­er.

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.