Steven Lo, CEO of Zosano Pharma

Af­ter culling work­force, mi­graine biotech Zosano drops lead — and sole — pro­gram

It ap­pears Zosano may not have much left in the tank.

In April, the mi­graine-fo­cused biotech an­nounced that it would cull about a third of its work­force — less than a month af­ter the FDA re­fused to re­view the com­pa­ny’s re­sub­mis­sion for its mi­graine treat­ment patch known as M207. The agency said that the com­pa­ny didn’t ad­e­quate­ly re­spond to the de­fi­cien­cies iden­ti­fied in the FDA’s ini­tial, 2020 CRL.

At the time, Zosano pres­i­dent and CEO Steven Lo said that “We are in dis­cus­sions with the FDA to de­ter­mine if there is a vi­able op­tion to pur­sue ap­proval of M207 us­ing the cur­rent­ly avail­able clin­i­cal da­ta. In ad­di­tion, we are ac­tive­ly eval­u­at­ing fi­nan­cial and strate­gic al­ter­na­tives in col­lab­o­ra­tion with ex­ter­nal ad­vi­sors, with a goal of max­i­miz­ing val­ue.”

But now, the com­pa­ny has a new up­date. Zosano an­nounced on Fri­day that it is sus­pend­ing the M207 pro­gram in what ap­pears to be one of the com­pa­ny’s fi­nal at­tempts at stay­ing open. The de­ci­sion comes just over two weeks af­ter the FDA gave the biotech a 12-month ex­ten­sion to re­sub­mit its NDA for the pro­gram. Zosano al­so not­ed that it has an on­go­ing fea­si­bil­i­ty study with an un­named phar­ma­ceu­ti­cal part­ner, ex­pect­ed to con­clude by the end of the quar­ter.

End­points News has reached out to Zosano for com­ment and will up­date ac­cord­ing­ly.

The biotech said that in the weeks af­ter fir­ing ap­prox­i­mate­ly 40% of its em­ploy­ees, a slight hunger jump from the ap­prox­i­mate­ly 33% an­nounced in March, it had al­so sus­pend­ed GMP man­u­fac­tur­ing op­er­a­tions at its Fre­mont, CA fa­cil­i­ty, sus­pend­ed ac­tiv­i­ties at its third-par­ty CROs and is cur­rent­ly eval­u­at­ing its “long-lived as­sets” for the “im­pair­ment re­lat­ed to these ac­tions.”

As of April 26, the com­pa­ny had ap­prox­i­mate­ly $11.4 mil­lion in com­bined cash and cash equiv­a­lents.

Chris­tine Matthews

Zosano had em­ployed a 35-to-1 re­verse stock split on April 8, boost­ing its stock price to over a dol­lar per share af­ter it had been un­der 20 cents apiece. The biotech’s stock $ZSAN fell more than 25% in post-mar­ket trad­ing Fri­day.

Zosano bled cash in 2021, los­ing $7 mil­lion in Q4 and just shy of $30 mil­lion over the course of the en­tire year. The biotech al­so said in its 10-K from March that it will need “sub­stan­tial ad­di­tion­al fund­ing to fund our op­er­a­tions, and we will not be able to con­tin­ue as a go­ing con­cern if we are un­able to do so.”

At the same time, CEO Steven Lo and CFO Chris­tine Matthews re­ceived bonus­es un­der Zosano’s “re­ten­tion bonus pro­gram,” with Lo re­ceiv­ing $178,500 and Matthews re­ceiv­ing $98,333 on March 31.

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:

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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.

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

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.

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.

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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?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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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.