Steven Lo, Zosano Pharma CEO

Af­ter fil­ing for bank­rupt­cy, re­ject­ed mi­graine drug de­vel­op­er Zosano’s val­ue more than halved

The dev­as­ta­tions of the pub­lic mar­kets and the re­peat­ed re­jec­tions hand­ed down by the FDA have added up to a dim fu­ture for Zosano Phar­ma as it ap­pears the 16-year-old biotech’s jour­ney is com­ing to an end.

The Fre­mont, CA biotech filed for bank­rupt­cy on Wednes­day and is cur­rent­ly op­er­at­ing as a “debtor-in-pos­ses­sion” and in­tends to rid it­self of “sub­stan­tial­ly all of its as­sets” over the course of the Chap­ter 11 case, Zosano said Thurs­day morn­ing.

Those as­sets in­clude a mi­graine drug that the FDA re­ject­ed in 2020, a Covid-19 vac­cine de­liv­ered via a mi­cronee­dle patch, an os­teo­poro­sis drug, can­cer vac­cines and var­i­ous oth­er pro­phy­lac­tic vac­cines for kids and adults, ac­cord­ing to Zosano’s web­site.

Zosano is one of a few biotechs to wind down op­er­a­tions dur­ing the past few months as the un­re­lent­ing pub­lic mar­kets have wiped away vast amounts of val­ue from many drug de­vel­op­ers af­ter a pan­dem­ic boom could no longer keep the in­dus­try on green­er pas­tures. Flag­ship Pi­o­neer­ing-found­ed mi­cro­bio­me biotech Kalei­do Bio­sciences shut down in April and Or­p­hazyme sold it­self through the help of the Dan­ish courts last month.

It’s been a par­tic­u­lar­ly tough few months for Zosano’s em­ploy­ees. The com­pa­ny laid off 31% of its work­force in March and then laid off an­oth­er 37% just a month lat­er, per SEC fil­ings. And, fur­ther ce­ment­ing a cloudy fu­ture for Zosano, the biotech’s clin­i­cal de­vel­op­ment and med­ical af­fairs VP Don­ald Keller­man left the com­pa­ny, ef­fec­tive June 1.

Af­ter get­ting the no-go from the FDA a few years ago for its po­ten­tial mi­graine med, Zosano at­tempt­ed to re­sub­mit, but the FDA again had dis­agree­ments over the drug. In April, the agency gave the com­pa­ny a 12-month ex­ten­sion to re­sub­mit the NDA for M207, but Zosano said that month that it would sus­pend the pro­gram to pre­serve cash.

As of April 26, Zosano had about $11.4 mil­lion in cash and cash equiv­a­lents and was work­ing with fi­nan­cial ad­vi­sor Sier­ra­Con­stel­la­tion Part­ners to fig­ure out a fu­ture for its as­sets.

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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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed 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.

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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.