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.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.

New trade deal knocks out long-sought bi­o­log­ics pro­tec­tions for drug­mak­ers

House Democrats negotiating with the Trump Administration on a new North American trade deal settled early on four issues: enforcement, labor and environmental standards and drug pricing.

On drug pricing, Politico reports, Trump crumbled within weeks of heightened negotiations.

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