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

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

News brief­ing: Gilead com­pletes $21B buy­out of Im­munomedics; In­nate re­ceives $50M mile­stone pay­ment from As­traZeneca

Gilead’s $21 billion mega-acquisition of Immunomedics is now officially complete, the companies announced Friday morning.

The full merger process took a little over a month, with Gilead and Immunomedics signing an agreement on Sept. 13. Gilead acquired all outstanding stock of Immunomedics for $88 per share, a 108% premium on the previous day’s closing price.

Gilead’s big prize was Trodelvy, approved in July for the treatment of metastatic triple-negative breast cancer. The drug also impressed at last month’s ESMO conference, reducing the risk of death by 52% in a Phase III study.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.