Trou­bled poop-test­ing start­up uBio­me an­nounces plans for liq­ui­da­tion

Your fa­vorite, fun-lov­ing, poop-test­ing, bac­te­ria-div­ing, un­der fed­er­al in­ves­ti­ga­tion, bank­rupt start­up with the pos­si­bly fun­da­men­tal­ly flawed sci­ence is — alas — shut­ting down.

uBio­me has filed to con­vert its Chap­ter 11 bank­rupt­cy in­to a Chap­ter 7 liq­ui­da­tion, all but spelling the end for a once soar­ing com­pa­ny that part­nered with re­searchers at Har­vard and Stan­ford and wooed Sil­i­con Val­ley in­vestors, but ul­ti­mate­ly found it­self ow­ing po­ten­tial­ly hun­dreds of mil­lions to health­care com­pa­nies, lay­ing off half of its staff and un­der fed­er­al in­ves­ti­ga­tion for its billing prac­tices.

The news comes bare­ly a year af­ter the com­pa­ny an­nounced an $83 mil­lion fund­ing round and the hir­ing of for­mer No­var­tis CEO Joe Jimenez to head a new R&D arm in Cam­bridge, MA.

What went wrong?

From their 2012 crowd-sourced found­ing un­til the first lay­offs came this Jan­u­ary, it seemed Ubio­me could do no wrong. They were 23andMe for your gut, a young com­pa­ny with young, telegenic founders of­fer­ing a warm face to a hot new sci­ence. They promised to map your mi­cro­bio­me, the 3-pound bac­te­r­i­al ecosys­tem sci­en­tists on­ly re­cent­ly dis­cov­ered had wide im­pacts on your health, from di­ges­tion to men­tal health. Their web­site home page sent “A warm wel­come to you. And your 39 tril­lion bac­te­ria.”

Their pre­mier ser­vice was Ex­plor­er. Orig­i­nal­ly priced at $400, it of­fered to test your stool sam­ple and give back all sorts of health-re­lat­ed ad­vice. Since then, they’ve widened their fo­cus to in­clude vagi­nal health and STDs women face.

But while their blog of­fered fun tips about di­et, sleep and “could your sum­mer fling change your mi­cro­bio­me?” some re­searchers were sound­ing alarms. They of­fered the same warn­ing re­searchers gave about 23andMe’s first for­ays in­to health-re­lat­ed ad­vice: It’s too soon and the sci­ence isn’t there. (23andMe has since gained FDA ap­proval for sev­er­al health-re­lat­ed ser­vices).

Ian Lip­kin Co­lum­bia

“I don’t think we know enough yet about the mi­cro­bio­me to be able to ad­vice peo­ple as to how they should mod­i­fy their di­et or change their lifestyles based on a kit of this sort,” Co­lum­bia epi­demi­ol­o­gist Ian Lip­kin told The At­lantic’s James Ham­blin in a 2016 video, of­fer­ing a 10-year time­frame for when the sci­ence will be ready.

In that video, uBio­me told the quite svelte Ham­blin that based on his test that he had the mi­cro­bio­me of an over­weight, de­pressed man. He did not con­firm the de­pres­sion sug­ges­tion.

The first sign of trou­ble came in Jan­u­ary, when the start­up cut 55 jobs out of its 300-per­son work­force, re­port­ed­ly to fo­cus on drugs and part­ner­ships. In May, founders Jes­si­ca Rich­man and Zac Apte were placed on leave as the FBI be­gan an in­quiry in­to the com­pa­ny’s billing process. This sum­mer, Busi­ness In­sid­er re­port­ed the com­pa­ny had laid off half its staff and that its sci­ence may have been flawed from the start.

They filled for Chap­ter 11 at the be­gin­ning of Sep­tem­ber. Court doc­u­ments re­vealed they may owe hun­dreds of mil­lions to health­care com­pa­nies, BI re­port­ed.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; 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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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