With its one and on­ly can­cer drug poised to start a Phase III study some­time lat­er this year, Sel­l­as is get­ting in­to the pub­lic mar­ket game by ex­e­cut­ing a re­verse merg­er with a post-im­plo­sion Gale­na $GALE.

Just a few weeks ago Gale­na ad­mit­ted what quite a few in­vestors had long ex­pect­ed. Its can­cer vac­cine Neu­Vax was fail­ing to help breast can­cer vic­tims and re­searchers had to wrap up ear­ly, leav­ing the biotech strug­gling with a pen­ny stock that had al­ready been pumped up last fall in a 1-for-20 split.

An­ge­los Ster­giou

Now Sel­l­as is tak­ing over the com­pa­ny, as well as its pipeline, and re­vers­ing its way on­to the pub­lic mar­ket with its WT1-tar­get­ing drug gal­in­pepimut-S, which the com­pa­ny plans to study in a long list of can­cers. New York-based Sel­l­as has tout­ed Phase II re­sults for their drug, which was in-li­censed from Memo­r­i­al Sloan Ket­ter­ing.

“This trans­ac­tion with Gale­na is an im­por­tant step for SEL­L­AS and the ad­vance­ment of our lead prod­uct can­di­date, GPS, through im­por­tant de­vel­op­ment mile­stones,” said Sel­l­as CEO An­ge­los Ster­giou in a state­ment. “We be­lieve GPS has the po­ten­tial to ben­e­fit a wide range of can­cer pa­tients and be­come an im­por­tant piece of the can­cer im­munother­a­py treat­ment land­scape as both a monother­a­py and in com­bi­na­tion with oth­er agents, par­tic­u­lar­ly check­point in­hibitors. Neu­Vax strength­ens our plat­form and may pro­vide im­por­tant val­ue in­flec­tions as the clin­i­cal tri­als progress. The com­bined pipeline, with sig­nif­i­cant near term mile­stones, cre­ates mul­ti­ple de­vel­op­ment and part­ner­ing op­por­tu­ni­ties to cre­ate val­ue as these pro­grams evolve.”

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.”

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.”

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.

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.