It’s a record! Biotech IPO fren­zy out­paces 2017 in half the time as 4 new ar­rivals on Nas­daq raise $556M

Be­tween one Boston-based biotech run by some vet­er­an stal­warts and two up­starts in the Bay Area, an ex­tend­ed hot streak of biotech IPOs has blast­ed past last year’s an­nu­al to­tal. And even as an­a­lysts cau­tion of a like­ly slow­down, we have one more IPO fil­ing to sug­gest that the in­dus­try may yet chal­lenge the high peak hit in 2014.

Ger­rit Klaern­er

San Fran­cis­co-based Tri­ci­da $TC­DA may not be as well known as many of the bean town biotechs to go pub­lic this year, but it nev­er­the­less brought in a whop­ping $222 mil­lion haul on an up­sized of­fer­ing of shares that came it at $19 each — above the range.

Run by Re­lyp­sa founder Ger­rit Klaern­er, Tri­ci­da timed its IPO per­fect­ly, lin­ing up pos­i­tive Phase III da­ta while drop­ping its S-1 in a mar­ket seem­ing­ly ready to pounce on every pass­ing biotech of­fer­ing to come its way right now. Tri­ci­da stood out from the av­er­age ear­ly-stage drug de­vel­op­er in this queue, with a com­mer­cial­iza­tion plan in hand for its lead drug, de­signed to treat meta­bol­ic aci­do­sis in CKD pa­tients.

Ron Re­naud

Then there was Trans­late Bio $TBIO, which priced 9.35 mil­lion shares to­day at $13, rais­ing $122 mil­lion. That’s right in the mid-range, and CEO Ron Re­naud will take it glad­ly. The French gi­ant Sanofi re­cent­ly hand­ed over a $45 mil­lion up­front to part­ner with Trans­late, which will now set out to de­vel­op mes­sen­ger RNA vac­cines for up to 5 tar­gets. Trans­late will al­so be in line for up to $760 mil­lion in mile­stone cash if the work proves suc­cess­ful.

Late on Wednes­day, Forty Sev­en came bar­rel­ing along with $112 mil­lion to add to the to­tal, sell­ing shares at $16. Forty Sev­en $FTSV came out of the lab of Stan­ford’s Irv Weiss­man, and ranks as one of the lead­ers in the CD47 field in on­col­o­gy R&D.

These three IPOs fol­low Neon Ther­a­peu­tics’ $100 mil­lion raise Tues­day.

What do these com­pa­nies have in com­mon? They are all run by ex­ecs with a lengthy track record, backed by some se­ri­ous in­vestors and have a plau­si­ble shot at de­vel­op­ing new drugs. And they are all high risk of­fer­ings.

The four IPOs al­ready launched this week — for a 6-month to­tal of 33 com­pared to last year’s 31 — ac­count­ed for a fresh wind­fall of $546 mil­lion. As we tal­lied up on Mon­day, a batch of biotech IPOs raised $718 mil­lion last week, so the 10-day to­tal now comes in at $1.27 bil­lion.

Quick­ly adding up the pre­vi­ous biotech IPOs we’ve seen so far this year, and you can add $2 bil­lion to that score, with a to­tal of $3.25 bil­lion to date. And that doesn’t in­clude the buy-in from the bankers af­ter the ini­tial raise.

All these new bil­lions are be­ing added to a record run of ven­ture cash now com­ing in to back a new gen­er­a­tion of star­tups — many of which will soon be look­ing to file IPOs of their own. Un­less, of course, the sud­den fren­zy runs in­to a sud­den chill.

The com­mon wis­dom sug­gests that we should be in for a sum­mer slow­down, but no one sug­gest­ed that to Aque­s­tive Ther­a­peu­tics. The CNS drug de­vel­op­er filed to­day for a rel­a­tive­ly mod­est $69 mil­lion IPO, even though un­like most of these new ar­rivals on Wall Street the com­pa­ny can ac­tu­al­ly boast about rev­enue. The biotech plans to list as $AQST.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.