→ An­tibi­ot­ic re­sis­tance is a prob­lem of epi­dem­ic pro­por­tions that should ar­guably en­tice a swarm of R&D dol­lars, but these drugs com­mand rel­a­tive­ly cheap prices and don’t last as long as, say, can­cer drugs, which has in­cen­tivized Big Phar­ma to fo­cus their at­ten­tion else­where. How­ev­er, a hand­ful of small and big names are keep­ing the R&D en­gine hot. Vivek Ra­maswamy’s Roivant Sci­ences on Mon­day an­nounced it was tak­ing a punt on Ko­re­an biotech iN­tRON Bio, with a $667.5 mil­lion li­cens­ing agree­ment for SAL200, an ex­per­i­men­tal bi­o­log­ic for in­fec­tious dis­eases caused by an­tibi­ot­ic-re­sis­tant staphy­lo­coc­ci. Roivant plans to ini­ti­ate a Phase II tri­al test­ing the drug next year.

→ For years now, phar­ma­ceu­ti­cal com­pa­nies have looked to har­ness the pow­er the pow­er of ar­ti­fi­cial in­tel­li­gence to iden­ti­fy drug can­di­dates and con­duct re­search. Ger­many’s Evotec on Wednes­day said it had tied up with Cam­bridge, MA-based Im­muneer­ing to dis­cov­er small mol­e­cules for rare hered­i­tary meta­bol­ic dis­eases. Im­muneer­ing’s drug dis­cov­ery plat­form makes phar­ma R&D faster and more ef­fec­tive, us­ing AI and oth­er ad­vanced al­go­rithms.

→ OMass Ther­a­peu­tics, which was spun out of Ox­ford in 2016, has se­cured £14 mil­lion in a Se­ries A round of fund­ing led by Syn­cona, the life sci­ences in­vest­ment arm of the Well­come Trust that has al­so in­vest­ed in an­oth­er Ox­ford spin­out called Night­star Ther­a­peu­tics. OMass us­es mass spec­trom­e­try plat­forms to dis­cov­er and de­vel­op ther­a­peu­tics.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”