A uni­corn joins this week’s stam­pede of biotechs in­to the red-hot Nas­daq casi­no

Now that the Ju­ly 4 hol­i­day week is well be­hind us, Nas­daq is get­ting crack­ing again with new of­fer­ings, and biotech com­pa­nies — in­clud­ing a Flag­ship-built uni­corn — are once again dom­i­nat­ing the lat­est round of IPOs lin­ing up for their Nas­daq close­up this week.

The 5 lined up for their IPO runs this week are hunt­ing more than $500 mil­lion and proof that they share a mar­ket val­ue of about $4 bil­lion. Rough­ly half of that is laid out in Ru­bius’ S-1 as that biotech hunts up $200 mil­lion.

The roundup will add an­oth­er batch of IPOs that are all falling on top of a record-set­ting pace in June. The ques­tion now is how long the win­dow will re­main wide open — and ul­ti­mate­ly who wins and who im­plodes. For now, the in­dus­try is on pace to ri­val the go-go times of 2014 — but the smart mon­ey ex­pects a slow­down.

Of course, the smart mon­ey was al­so sur­prised by the burst of biotech IPOs we’ve been see­ing. And Fri­day’s Urovant fil­ing for $150 mil­lion in­di­cates that Vivek Ra­maswamy thinks the IPO run still has legs to go much fur­ther.

Here’s a snap­shot of this week’s ac­tion at the casi­no, er, mar­ket.

Al­lakos

$AL­LK
Based: San Car­los, CA
Seek­ing: $96 mil­lion
Mar­ket cap: $738 mil­lion

Robert Alexan­der

The scoop: The lead drug tar­gets the in­hibito­ry re­cep­tor Siglec-8, found on the sur­face of mast cells and eosinophils. And Al­lakos be­lieves it has re­al po­ten­tial in a broad range of in­di­ca­tions, in­clud­ing eosinophilic gas­tri­tis, in­do­lent sys­temic mas­to­cy­to­sis, ur­ticaria and se­vere al­ler­gic con­junc­tivi­tis. Last sum­mer the biotech re­cruit­ed a pair of ZS Phar­ma vets — Robert Alexan­der and Adam Tomasi — to take over as CEO and COO/CFO. As­traZeneca ac­quired ZS for $2.7 bil­lion.


Con­stel­la­tion Phar­ma

$CNST
Based: Cam­bridge, MA
Seek­ing: $80 mil­lion
Mar­ket cap: $430 mil­lion

Ji­gar Raythatha

The scoop: In this case we have one of the old­est biotechs of the year go­ing pub­lic af­ter wind­ing in and out of an op­tion deal with Genen­tech — which the S-1 tells us walked from their $40 mil­lion up­front. Kei­th Dionne, then CEO, fa­mous­ly cel­e­brat­ed the end of the Genen­tech op­tion, but was gone soon af­ter and re­placed by Ji­gar Raythatha. The com­pa­ny re­or­ga­nized, and went back at the epi­ge­net­ics draw­ing board. The biotech start­ed a Phase Ib/II study of CPI-1205, an EZH2 in­hibitor com­bined with Yer­voy, that they hope will high­light their po­ten­tial in di­al­ing down gene ex­pres­sion in can­cer path­ways to en­hance im­muno-on­col­o­gy drugs.


Cri­net­ics Phar­ma­ceu­ti­cals

$CRNX
Based: San Diego
Seek­ing: $80 mil­lion
Mar­ket cap: $380 mil­lion

The scoop: The team at Cri­net­ics have been work­ing on new drugs af­ter de­vel­op­ing some nov­el thoughts about the way GPCRs work. The lead pro­gram is fo­cused on acromegaly, a rare dis­ease trig­gered when the pi­tu­itary gland pro­duces ex­cess growth hor­mone, caus­ing en­larged bones that can lead to gi­gan­tism, which caused An­dre the Gi­ant to swell in size. It al­so ul­ti­mate­ly killed him. So­mato­statin can rein that in, but syn­thet­ic so­mato­statin analogs don’t al­ways work. That leaves the biotech in the hunt for a small mol­e­cule that can.


Replimune

$RE­PL
Based: Woburn, MA
Seek­ing: $101 mil­lion
Mar­ket cap: $500 mil­lion

The scoop: The team that orig­i­nal­ly in­vent­ed T-Vec , the pi­o­neer­ing on­colyt­ic virus treat­ment that Am­gen bought and pushed to an ap­proval af­ter ac­quir­ing BioVex, are still play­ing in the same field. On­ly now they feel that they’re lead­ing the next-gen crowd of de­vel­op­ers — which is huge. The com­pa­ny is work­ing close­ly with Re­gen­eron on a com­bo us­ing their PD-1 — slat­ed to soon be­come the sixth check­point to hit the mar­ket with big, big plans of its own.


Ru­bius Ther­a­peu­tics

$RU­BY
Based: Cam­bridge, MA
Seek­ing: $200 mil­lion
Mar­ket cap: $1.8 bil­lion

The scoop: They have a ton of mon­ey, in­clud­ing a re­cent megaround, to re­as­sure in­vestors. And the plan is to con­quer the world with a brand new ap­proach: tak­ing red blood cells — de­signed by na­ture to trans­port oxy­gen — hi­jack them through ge­net­ic en­gi­neer­ing tech and get them to car­ry pro­teins need­ed to fight var­i­ous dis­eases. It’s an off-the-shelf ap­proach, rather than one per­son­al­ized for each pa­tient.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.