CRLs. 483s. CBER, CDER and RWE. For bio­phar­ma pro­fes­sion­als, these acronyms com­mand at­ten­tion be­cause of the fun­da­men­tal role FDA plays in drug de­vel­op­ment. Now End­points is dou­bling down on reg­u­la­to­ry cov­er­age, and launch­ing a week­ly re­port fo­cus­ing on de­vel­op­ments out of White Oak, with analy­sis and in­sight in­to what it all means.

Zachary Bren­nan

Cov­er­age will be led by our new se­nior ed­i­tor, Zachary Bren­nan. He joins End­points from POLITI­CO, where he cov­ered phar­ma. Pri­or to that he was the man­ag­ing ed­i­tor for Reg­u­la­to­ry Fo­cus, a news pub­li­ca­tion from the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety.

This new reg­u­la­to­ry beat is part of our com­mit­ment to go­ing deep­er and broad­er in 2021. The main End­points News web­site and dai­ly news re­port cov­ers the en­tire wa­ter­shed of bio­phar­ma from drug dis­cov­ery to ap­provals, with a laser fo­cus on clin­i­cal R&D. Back in Jan­u­ary we launched End­points Man­u­fac­tur­ing, which you can sign up for here for a deep­er ex­plo­ration in­to sup­ply chains and bio­man­u­fac­tur­ing.

End­points FDA+ will fo­cus on FDA but we’ll al­so look at con­se­quen­tial de­vel­op­ments com­ing out of oth­er ma­jor reg­u­la­to­ry au­thor­i­ties like EMA and Chi­na FDA. We’ll give you the news, the con­text around it, what it means for bio­phar­ma and who it im­pacts.

For pre­mi­um sub­scribers on ei­ther an En­ter­prise or In­sid­er plan, there’s no ad­di­tion­al charge to ac­cess End­points FDA+ sto­ries or to sign up for the week­ly email re­port, which launch­es in April.

Zachary Bren­nan starts at End­points on Mon­day, March 8. Please give him a warm wel­come, you can con­tact him at: zachary@end­pointsnews.com.

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.