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.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Michel Vounatsos, Getty Images

UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.