News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

Lon­don Stock Ex­change-list­ed PureTech Health an­nounced Wednes­day that it’s look­ing to ex­tend to Nas­daq. But due to its “strong cash po­si­tion,” the biotech says it isn’t is­su­ing any new shares in the po­ten­tial sec­ondary list­ing.

The com­pa­ny’s shares closed at £256.50 Tues­day on the Lon­don Stock Ex­change. Its can­di­date LYT-100 is cur­rent­ly in Phase I de­vel­op­ment for var­i­ous in­di­ca­tions, in­clud­ing lym­phat­ic flow dis­or­ders and fi­brot­ic and in­flam­ma­to­ry dis­or­ders. PureTech is ex­pect­ing a Phase Ib read­out in lym­phat­ic flow dis­or­ders lat­er this year, and is al­so plan­ning to launch a Phase II study for the drug to treat res­pi­ra­to­ry con­di­tions ex­pe­ri­enced af­ter Covid-19.

In ad­di­tion to its own pipeline, PureTech ben­e­fits from a net­work of af­fil­i­ates, in­clud­ing Karuna Ther­a­peu­tics, which is work­ing on neu­ropsy­chi­atric dis­or­der ther­a­pies, Gele­sis, which was FDA cleared for its weight man­age­ment drug Plen­i­ty, and Vedan­ta Bio­sciences, which is de­vel­op­ing mi­cro­bio­me drugs.

PureTech said it in­tends to con­tin­ue trad­ing on the Lon­don Stock Ex­change in ad­di­tion to its po­ten­tial US list­ing. — Nicole De­Feud­is 

Price watch­dog GoodRx rais­es $725 mil­lion, prices IPO

GoodRx, the con­sumer pre­scrip­tion drug plat­form and drug price watch­dog, an­nounced the pric­ing of its IPO Wednes­day morn­ing.

The com­pa­ny, which filed for the pub­lic of­fer­ing at the end of Au­gust, will be­gin trad­ing on the Nas­daq at $33 per share. Ini­tial­ly ex­pect­ing a $750 mil­lion raise, GoodRx came up just shy of that high tar­get and ul­ti­mate­ly pulled in $725 mil­lion.

GoodRx’s ini­tial price is the high­est among biotech IPOs this year — if you can call it a biotech.

So far in 2020, there have al­ready been more than 50 IPOs in the in­dus­try, eclips­ing the to­tal from all of 2019. As of mid-Au­gust, the com­pa­nies have raised a com­bined $11 bil­lion, but GoodRx’s hefty sum will sure­ly add to that to­tal.

GoodRx has be­come quite prof­itable in the last few years, de­spite be­ing main­ly known for com­pil­ing an­nu­al lists of the most ex­pen­sive drug prices and help­ing con­sumers com­pare pre­scrip­tion costs. In 2019 the com­pa­ny net­ted a prof­it of $66 mil­lion, and through the first of half of this year, they were on track to pock­et $100 mil­lion. — Max Gel­man

Ex­pand­ing a Cel­gene lega­cy pact, Bris­tol My­ers grabs celi­ac treat­ment from Anokion

Bris­tol My­ers Squibb is ap­par­ent­ly in­trigued enough by Anokion’s ap­proach for treat­ing au­toim­mune dis­ease to not just keep, but ex­pand the col­lab­o­ra­tion Cel­gene had inked with the Swiss biotech.

In the lat­est move, Bris­tol My­ers is grab­bing Anokion’s lead drug can­di­date, KAN-101, which is de­signed to treat celi­ac dis­ease by to­ler­iz­ing T cells to gluten anti­gens.

“We are in­trigued by the op­por­tu­ni­ty to lever­age this im­mune to­ler­iza­tion plat­form as a treat­ment for celi­ac dis­ease, as well as mul­ti­ple scle­ro­sis,” Ru­pert Vessey, pres­i­dent of R&D, said in a state­ment.

Anokion is get­ting an undis­closed up­front pay­ment. As with the oth­er pro­grams cov­ered in deal, orig­i­nal­ly signed in 2016, the biotech is re­spon­si­ble for com­plet­ing pre­clin­cal and Phase I be­fore Bris­tol My­ers takes over the fund­ing of tri­als and sub­se­quent com­mer­cial work. — Am­ber Tong

Medi­gene chops staffers, switch­es fo­cus to TCR for sol­id tu­mors 

Ger­many’s Medi­gene is lay­ing off a quar­ter of its staff as it hun­kers down to fo­cus on the lead pro­grams in T cell re­cep­tor T cell ther­a­py.

The biotech, which boasts of al­liances with blue­bird and Vivek Ra­maswamy’s Cy­to­vant, not­ed that the chal­lenges as­so­ci­at­ed with treat­ing very sick can­cer pa­tients amid a pan­dem­ic is forc­ing it to take longer with the Phase I dose es­ca­la­tion tri­al of MDG1011 in acute myeloid leukemia and myelodys­plas­tic syn­drome. But once that’s done, it will be look­ing for a part­ner for the Phase II por­tion.

Look­ing ahead, Medi­gene said it will con­cen­trate all pre­clin­i­cal R&D ac­tiv­i­ties on de­vel­op­ing cell ther­a­pies for sol­id tu­mors. — Am­ber Tong

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Langer, Ciechanover god­fa­ther the lat­est AI up­start; Ipsen forges $446M AML de­vel­op­ment pact

There’s a new AI player jumping into the drug discovery game. And they have some high-powered scientific advisors in their corner.

Tel Aviv-based Quris has built what it calls a “patient-on-a-chip” AI platform that it’s touting as a way to circumvent unreliable animal testing with a more efficient way to judge safety and efficacy. Animal testing, particularly involving mice, has proven a notoriously unreliable way to do preclinical testing — though it is well-established with regulators.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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