Ian Mortimer, Xenon Pharmaceuticals CEO

Xenon jumps on pos­i­tive da­ta-to-im­me­di­ate pub­lic of­fer­ing train to bankroll PhI­II epilep­sy study

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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.