Two years af­ter go­ing pub­lic on the promise of a new ap­proach to fight re­cur­rent brain can­cer, Toca­gen has hit the wall.

The biotech blunt­ly re­port­ed the fail­ure of their piv­otal Phase III study of a 2-part drug — To­ca 511 & To­ca FC —  for high-grade glioma. Part 1 us­es a vec­tor to at­tack can­cer cells in the brain and de­liv­er a gene for an en­zyme, while part 2 is a pro­drug — 5-flu­o­ro­cy­to­sine (5-FC) — that con­verts in­to the an­ti-can­cer ther­a­py 5-FU.

It didn’t work. 

Re­searchers at the San Diego-based biotech re­port­ed that they hit a haz­ard ra­tio of 1.06, re­flect­ing an in­creased risk to pa­tients, with a dis­as­trous p-val­ue of 0.6154. The over­all sur­vival rate for the drug arm hit 11.1 months com­pared to 12.2 months for con­trol.

The com­pa­ny says it will now thor­ough­ly an­a­lyze the da­ta, but in­vestors weren’t wait­ing around. The stock $TO­CA for the mi­cro-cap biotech was blitzed, nose-div­ing 81% ahead of the bell.

Brain can­cer has been one of the tough­est fields in on­col­o­gy, with a slew of fail­ures re­port­ed out. Toca­gen has two oth­er pro­grams un­der­way for the same tech, but they are both very ear­ly stage stud­ies.

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.

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.”