Tricida CEO Gerrit Klaerner

Go­ing for broke, Tri­ci­da is slam­ming the brakes on a piv­otal tri­al ear­ly while plan­ning a run at the FDA

Two years af­ter a bit­ter set­back at the FDA, with its cash re­serves ebbing away, Tri­ci­da is ex­e­cut­ing a high-stakes gam­ble on win­ning a swift ap­proval at the FDA. A win would put them back in play with a new drug to com­mer­cial­ize. A loss, as one Wall Street an­a­lyst re­cent­ly as­sessed, would take the stock to ze­ro.

To­day Tri­ci­da $TC­DA an­nounced an “ad­min­is­tra­tive stop” for its VAL­OR-CKD tri­al af­ter watch­ing 237 pa­tients reach a pri­ma­ry end­point event — re­nal death, end-stage re­nal dis­ease, or greater than or equal to 40% re­duc­tion in es­ti­mat­ed glomeru­lar fil­tra­tion rate — in the re­nal out­comes study for their meta­bol­ic aci­do­sis and CKD drug vev­er­imer. They’ll con­tin­ue to track events in­to Q3 as they look for a top-line read­out in the near term.

When they start­ed out in the fourth quar­ter of 2018, Tri­ci­da re­searchers had set a tar­get for 511 events, which the biotech says would stretch the study in­to 2024. But op­er­at­ing cap­i­tal will be ef­fec­tive­ly tapped out by the ear­ly part of Q2 2023.

Ex­ecs say they got the FDA to sign off on the ear­ly tri­al stop af­ter re­view­ing their fi­nan­cial sit­u­a­tion with reg­u­la­tors along with study close-out pro­ce­dures.

Phil Nadeau at Cowen re­cent­ly as­sessed their chances, not­ing:

As­sum­ing a true haz­ard ra­tio (HR) of 0.70, the tri­al would be 78% pow­ered at 250 events. Switch­ing from pow­er to ob­served HR, VAL­OR-CKD could be suc­cess­ful at 250 events if the ob­served HR is 0.78. There is on­ly a mod­est in­crease to 0.79 ob­served HR should 300 events be in the fi­nal analy­sis. This cal­cu­la­tion on the ob­served HR re­quired for sig­nif­i­cance is based on 300 sim­u­la­tions on tri­al out­comes.

A win, he added, wold spur a big ral­ly — pre­sum­ably set­ting up a raise — while a fail would amount to an ex­tinc­tion lev­el event.

None of this will come as a big sur­prise to the biotech’s in­vestors, as Tri­ci­da ex­ecs have been painful­ly clear about what they’re do­ing and why. CEO Ger­rit Klaern­er was equal­ly trans­par­ent back in the sum­mer of 2020, as reg­u­la­tors wound up to de­liv­er a CRL for the drug.

This year, though, the in­dus­try has been roiled by a sav­age bear mar­ket for biotech stocks, and Tri­ci­da wants a few months of op­er­at­ing rev­enue in the bank when the biotech will make a fresh pitch.

“With re­gards to tim­ing over­all to­wards po­ten­tial com­mer­cial launch, pre­sum­ing we have the an­nounce­ment of the VAL­OR study ear­ly in Q4, we would an­tic­i­pate fil­ing or re­sub­mit­ting the NDA in Q2 of ‘23 and have a po­ten­tial PDU­FA date in Q4 of 2023,” Tri­ci­da CFO Ge­off Park­er said dur­ing their Q1 call a few days ago. “That’s a six-month re­view for a re­sub­mis­sion. And then rough­ly speak­ing, we would have a launch in Q1 of 2024. So pre­sum­ing pos­i­tive da­ta on VAL­OR-CKD, we will put those plans in­to mo­tion lat­er this year.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

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On­corus lays off most of its re­main­ing team, warns of wind-down as it takes one last shot at deal­mak­ing

Despite cutting its headcount, pipeline and lease late last year, Oncorus is still struggling to stay afloat and is now on the brink of bankruptcy or dissolution, the company revealed late Thursday.

The Andover, MA-based biotech is letting “substantially all of Oncorus’ workforce” go, after the board of directors approved the layoffs. CEO Ted Ashburn, COO/chief of staff Stephen Harbin and CMO John Goldberg are among the 55 to depart.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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