Here come the 2019 uni­corns: Alec­tor, Gos­samer set to launch IPOs don­ning $1B-plus mar­ket caps

Are you ready for swelling biotech IPO val­u­a­tions?

Alec­tor and Gos­samer Bio are set to de­but on Nas­daq lat­er this week at mar­ket caps of $1.4 bil­lion and $1 bil­lion re­spec­tive­ly, mark­ing the first biotech uni­corn list­ings in 2019. The col­lec­tive boun­ty they are shoot­ing for? $406 mil­lion.

Sure, IPO trends can be short lived and the in­dus­try’s crys­tal balls are murky at best, but the duo are emerg­ing from a harsh win­ter last De­cem­ber that rav­aged biotech stocks across the board, with one an­a­lyst de­scrib­ing the mood as sink­ing “be­low dis­in­ter­est to­ward anger.” In par­tic­u­lar, the af­ter­math of Mod­er­na’s record-break­ing $604 mil­lion IPO $MR­NA con­tin­ues to shad­ow the field af­ter watch­ing al­most a third of its mar­ket cap van­ish in­to thin air.

Ei­ther way, both Alec­tor and Gos­samer are flush with cap­i­tal to de­vel­op their ear­ly-stage as­sets tack­ling for­mi­da­ble dis­ease ar­eas — and the pair will like­ly set the barom­e­ter for a string of biotechs wait­ing in line, in­clud­ing Kalei­do, Cir­ius, TCR2, Po­sei­da and Stealth Bio (but not Alzheon).

Arnon Rosen­thal

Alec­tor, best known for its Alzheimer’s ef­forts, has based its pipeline on the the­o­ry that neu­rode­gen­er­a­tion and de­men­tia are caused by im­mune sys­tem dys­func­tion. Ac­cel­er­at­ing the im­mune at­tack or re­mov­ing the brakes by fo­cus­ing on ge­net­i­cal­ly in­formed tar­gets, it ar­gues, of­fer a shot at suc­cess that’s so far elud­ed the amy­loid be­ta crowd.

In­sid­ers have re­port­ed­ly agreed to pick up about half of the 9.3 mil­lion shares Alec­tor is sell­ing at $18 to $20 a share, trans­lat­ing to $176 mil­lion at the mid-point of the range. The biotech will trade as $ALEC.

Sheila Gu­jrathi

Gos­samer, mean­while, is led by Fa­heem Has­nain and Sheila Gu­jrathi, the ex-Re­cep­tos ex­ecs who’ve been snap­ping up as­sets in im­munol­o­gy, in­flam­ma­tion and on­col­o­gy. A biotech in a hur­ry, it had trot­ted down the rarely used fixed priced IPO route in an at­tempt to raise $230 mil­lion when the SEC was par­a­lyzed by a gov­ern­ment shut­down, on­ly to re­turn to its orig­i­nal plan about a week lat­er.

The plan is to of­fer 14.4 mil­lion shares priced at $16/share un­der the sym­bol $GOSS. Ex­ist­ing stock­hold­ers have in­di­cat­ed their in­ter­est in pur­chas­ing about $100 mil­lion in shares.

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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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 with any issues.

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As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources.