In­vestor suit fu­eled by news ar­ti­cles over failed can­cer drug ends in $24M set­tle­ment

Once rid­ing high with a mar­ket val­ue close to $1 bil­lion, Geron on Tues­day said it set­tled an in­vestor law­suit for $24 mil­lion.

Stock­hold­ers claimed the com­pa­ny wrong­ly tout­ed ear­ly da­ta for a Janssen-part­nered can­cer drug can­di­date and failed to re­veal the ac­tu­al dis­ap­point­ing pri­ma­ry end­point re­sults.

Back in 2018, the com­pa­ny tout­ed the fa­vor­able sur­vival rate of the can­di­date known as ime­tel­stat, say­ing it helps pa­tients live longer with a type of bone mar­row dis­or­der, and the com­pa­ny com­pared the re­sults to oth­er clin­i­cal tri­als, the in­vestors claimed, stat­ing “that mul­ti­ple out­come mea­sures sug­gest­ed clin­i­cal ben­e­fit from the use of ime­tel­stat.”

But the in­vestors cit­ed 2018 news re­ports from Stat News‘ Adam Feuer­stein, who called on Geron to “dis­close the base­line dis­ease char­ac­ter­is­tics of the 100 myelofi­bro­sis pa­tients en­rolled in their Phase 2 study” and “to ex­plain why they’ve de­layed by al­most one year the dis­clo­sure of pri­ma­ry end­point re­sults from the Phase 2 study that would show, de­fin­i­tive­ly, if myelofi­bro­sis pa­tients re­spond to treat­ment with ime­tel­stat,” both of which the com­pa­ny de­clined to do.

Sev­er­al months lat­er, Geron stock shares plunged by more than 25% af­ter it “con­firmed the jour­nal­ist’s sus­pi­cions by re­veal­ing that the IM­bark study failed to meet its pri­ma­ry ef­fi­ca­cy end­points. Ad­di­tion­al­ly, Janssen ter­mi­nat­ed its col­lab­o­ra­tion agree­ment to de­vel­op ime­tel­stat,” the suit notes.

That col­lab­o­ra­tion, which still brought Geron $35 mil­lion up­front, once had J&J promis­ing to pay up to $935 mil­lion in fees and mile­stones.

While Geron did not ad­mit any guilt in the set­tle­ment with in­vestors, and its stock price rose by 3%, the com­pa­ny and Janssen ap­peared to have in­ten­tion­al­ly slowed the suit, ac­cord­ing to court fil­ings.

“The sole rea­son that the tri­al had to be post­poned was be­cause Janssen dragged its feet and had tak­en so long to pro­duce the rel­e­vant doc­u­ments,” Judge William Al­sup of the US Dis­trict Court for the North­ern Dis­trict of Cal­i­for­nia, wrote in an or­der filed in Ju­ly. He said that Janssen took a to­tal of 104 days to pro­duce cer­tain re­quest­ed records.

“If this caus­es ad­di­tion­al ex­pense, Janssen has no one to blame but it­self and its lawyers. It is im­por­tant to the Court that coun­sel be here in per­son to dis­cuss these is­sues. (More­over, it is im­prop­er to make a tele­phone re­quest like Janssen’s coun­sel have made),” he added.

Janssen’s lawyer George Mc­Clel­lan told the court a month ear­li­er that the de­lay was due to the vol­ume of the records col­lect­ed, and “some un­ex­pect­ed tech­ni­cal dif­fi­cul­ties in pro­cess­ing the da­ta.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

SPACs might be slowly creeping back.

Monday evening, Estrella Biopharma said it was going public via a SPAC deal with TradeUP Acquisition Corp. The deal is set to close in the first half of 2023, and if all goes as planned, the public version of Estrella — dubbed Estrella Immunopharma — will be worth around $398.5 million.

The Bay Area biotech will also get around $45.4 million in cash, and TradeUp stockholders will get around 15% stock in the public biotech.

Al Sandrock, Voyager Therapeutics CEO

Af­ter 12 months of dig­ging, Pfiz­er opts for one of two Voy­ager cap­sids for gene ther­a­py

The path at Voyager Therapeutics keeps winding, and at the 12-month deadline, Pfizer has elected to only move forward with one of two capsids out of the preclinical biotech for the Big Pharma’s AAV gene therapies.

Last October, the Big Pharma and biotech linked arms on a deal that gave Pfizer the ability to hit the gas pedal on two capsids: one for a cardiac target and the other for a rare neurologic disease target.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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