Two new IPOs -- up­sized and over the range -- score $226M and sig­nal a pos­si­ble come­back for biotech

Ron Bentsur, Uro­gen

There are two new biotech IPOs out and trad­ing this morn­ing, and both are of­fer­ing some pre­lim­i­nary signs that the biotech win­dow is open­ing up af­ter a long, lean spell.

The big one is go­ing to Bio­haven $BHVN, a start­up that has been whipped in­to shape with a pipeline led by in­dus­try castoffs for pain. Their IPO was priced at $17 a share, ac­tu­al­ly above the range, which we haven’t seen very of­ten. The com­pa­ny scored a rich haul of $168 mil­lion on the sale of 9.9 mil­lion shares.

The New Haven-based biotech’s lead drug is a CGRP ther­a­py for mi­graine, a crowd­ed field in the bio­phar­ma in­dus­try with big and lit­tle com­peti­tors — Eli Lil­ly, Am­gen/No­var­tis, Te­va and Alder — lin­ing up NDAs. Bio­haven re­cent­ly grabbed its drug from Bris­tol-My­ers Squibb. The S-1 spells out a pact that in­cludes up to about $350 mil­lion in de­vel­op­ment and sales mile­stones, but on­ly $9 mil­lion due in 90 days of the fil­ing — $5 mil­lion of that up front.

The sec­ond IPO out this morn­ing be­longs to Uro­Gen Phar­ma, a biotech which def­i­nite­ly isn’t plan­ning a moon­shot.

The lit­tle biotech is us­ing a gel it de­vel­oped to de­liv­er an old, re­for­mu­lat­ed chemother­a­py to the blad­der, in­ject­ed where need­ed to de­liv­er a steady dose to pa­tients suf­fer­ing from urothe­lial can­cer. Its bud­get was small enough last year that a $17.5 mil­lion up­front from an Al­ler­gan deal cov­ered most of its costs.

And it just priced an up­sized of­fer­ing right at the mid­dle of the range that was pro­ject­ed — of­fer­ing an­oth­er sign to a whole large bevy of biotechs anx­ious­ly wait­ing for the IPO win­dow to open up that the time may be right, for the mo­ment at least.

Uro­Gen, which has an R&D group in Is­rael and a US of­fice, had planned to sell 3.5 mil­lion shares at $12 to $14 a share. But they added a mil­lion shares and wound up sell­ing at $13. The stock ($URGN) starts trad­ing to­day.

Arie Bellde­grun

The biotech was ru­mored to be in a group of com­pa­nies look­ing to make the leap to Nas­daq in 2016, but last year’s mar­ket wasn’t very ac­com­mo­dat­ing to biotech, and like dozens of oth­er com­pa­nies, they ev­i­dent­ly bid­ed their time. Uro­Gen jumps in­to the mar­ket with a grow­ing queue of drug de­vel­op­ers look­ing to do the same. It’s not a huge num­ber, but any sign of awak­en­ing is like­ly to be tracked ea­ger­ly by oth­ers in the same boat.

Ron Bentsur, ex-Keryx CEO, is helm­ing the com­pa­ny and its chair­man is Arie Bellde­grun, the Kite CEO who’s rac­ing No­var­tis to the first po­ten­tial ap­proval of a CAR-T. Their lead pro­gram be­gan a piv­otal study ear­li­er this year and the com­pa­ny be­lieves that be­cause they’re not work­ing with a new chem­i­cal en­ti­ty, they could get an ap­proval with an ex­pe­dit­ed ef­fort.

Al­ler­gan stepped in last year with a deal to get rights to the gel, as they be­lieve Botox can help in treat­ing an over­ac­tive blad­der. There’s al­so more than $200 mil­lion in mile­stones on the ta­ble, which the F-1 breaks down as:

$7.5 mil­lion up­on sub­mis­sion of an IND to the FDA for a Li­censed Prod­uct; $20.0 mil­lion up­on ini­ti­a­tion of a Phase 3 clin­i­cal tri­al for a Li­censed Prod­uct for over­ac­tive blad­der; $15.0 mil­lion up­on ini­ti­a­tion of a Phase 3 clin­i­cal tri­al for a Li­censed Prod­uct for a spec­i­fied sec­ond in­di­ca­tion; $50.0 mil­lion and $25.0 mil­lion up­on the first com­mer­cial sale of a Li­censed Prod­uct for over­ac­tive blad­der in the Unit­ed States and the Eu­ro­pean Union, re­spec­tive­ly; $25.0 mil­lion and $15.0 mil­lion up­on the first com­mer­cial sale of a Li­censed Prod­uct for a spec­i­fied sec­ond in­di­ca­tion in the Unit­ed States and the Eu­ro­pean Union, re­spec­tive­ly; and $50.0 mil­lion up­on net sales of all Li­censed Prod­ucts of $500.0 mil­lion.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.