Af­ter woo­ing in­vestors last Oc­to­ber with a suc­cess­ful Phase IIb, Xenon Phar­ma­ceu­ti­cals is back with more da­ta on an ex­pan­sion study for its dai­ly epilep­sy pill, and the biotech im­me­di­ate­ly went to the pub­lic mar­kets to drum up the cash need­ed for a Phase III that it hopes will gar­ner an FDA nod.

The Phase III tri­al of XEN1101 is slat­ed to be­gin in the sec­ond half of this year and will set the grounds, along with the Phase IIb da­ta, for a reg­u­la­to­ry fil­ing, the com­pa­ny said. To bankroll that work and oth­er stud­ies of the drug, the British Co­lum­bia-based biotech laid out plans Wednes­day night for a $250 mil­lion pub­lic of­fer­ing that is ex­pect­ed to close Mon­day.

Xenon’s stock $XENE dropped about 11.5% short­ly af­ter the open­ing bell Thurs­day to ap­proach the of­fer­ing price of $30.50 per share.

The biotech’s drug re­duced fo­cal on­set seizure (FOS) with­in one week for all three dos­es com­pared to place­bo, Xenon said. A whop­ping 96% of pa­tients, or 275 peo­ple, in the ran­dom­ized por­tion of the Phase IIb X-TOLE study moved in­to the open-la­bel ex­pan­sion phase, with 54 of them so far go­ing at least two years on treat­ment.

That fast on­set pro­vides a boon for the drug’s po­ten­tial go­ing for­ward, with Jef­feries an­a­lysts not­ing XEN1101 might beat out al­ready ap­proved com­peti­tors and the new da­ta “in­cre­men­tal­ly sup­ports our view the drug will be used in ear­li­er set­tings.” With ef­fi­ca­cy hap­pen­ing as ear­ly as week 1, Jef­feries an­a­lysts not­ed oth­er drugs can take mul­ti­ple weeks, in­clud­ing Xco­pri, GSK’s Lam­ic­tal and UCB’s Vim­pat.

Pa­tients in the open-la­bel ex­pan­sion had at least a 70% re­duc­tion in me­di­an month­ly seizure fre­quen­cy af­ter three months and greater than 80% re­duc­tion af­ter 12 months, the com­pa­ny said. Fur­ther yet, Xenon said the drug led to at least six con­sec­u­tive months of seizure free­dom in 19.6% of pa­tients in the open-la­bel ex­ten­sion and more than 12 months in 9.5% of pa­tients.

“A ‘time course to ef­fi­ca­cy’ analy­sis shows that all dos­es of XEN1101 rapid­ly re­duced the fre­quen­cy of fo­cal on­set seizures with­in one week com­pared to place­bo, sug­gest­ing that XEN1101 may of­fer a com­pelling and dif­fer­en­ti­at­ed op­tion for pa­tients seek­ing to quick­ly re­duce seizure fre­quen­cy,” CEO Ian Mor­timer said in a state­ment.

With the da­ta and at the re­quest of study in­ves­ti­ga­tors, Xenon will ex­tend the open-la­bel ex­pan­sion from three to five years, CMO Christo­pher Ken­ney said in a state­ment.

Com­ment­ing on Wednes­day’s new da­ta, William Blair an­a­lysts said they be­lieve the drug’s case for a high­ly dif­fer­en­ti­at­ed pro­file is bol­stered go­ing in­to the Phase III tri­al.

The com­pa­ny is al­so test­ing the drug in mid-stage stud­ies in pri­ma­ry gen­er­al­ized ton­ic-clonic seizures and ma­jor de­pres­sive dis­or­der. Jef­feries an­a­lysts pro­ject­ed XEN1101’s sales, if ap­proved, could reach $1 bil­lion in epilep­sy, more than $1 bil­lion for MDD and eclipse $400 mil­lion in PGTCS.

Xenon had $537.9 mil­lion in cash as of March 31, which was enough in the bank to last “at least” in­to 2024, Xenon said last month.

The biotech’s quick da­ta drop to im­me­di­ate pub­lic of­fer­ing fol­lows the suit of mul­ti­ple drug de­vel­op­ers this year, all try­ing to raise cap­i­tal on the back of pos­i­tive da­ta amid a tu­mul­tuous bear mar­ket.

Day One Bio­phar­ma­ceu­ti­cals did so last week af­ter pos­i­tive da­ta on its pe­di­atric brain can­cer drug. That fol­lowed the tra­jec­to­ry of oth­ers, like Phath­om Phar­ma­ceu­ti­cals, Re­zo­lute, Tar­sus, As­cendis Phar­ma, ar­genx and Apel­lis Phar­ma­ceu­ti­cals.

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.”