An­oth­er 4 phar­mas make the fa­bled Nas­daq leap, with com­bined raise rapid­ly ap­proach­ing $4.5B

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The IPO train is once again full-steam ahead with four new pric­ings an­nounced af­ter mar­ket close Thurs­day.

De­sign Ther­a­peu­tics, Edge­wise Ther­a­peu­tics, Ike­na On­col­o­gy and Uni­verse Phar­ma­ceu­ti­cals are all hit­ting Nas­daq on Fri­day. The for­mer three each hauled in more than $100 mil­lion, with De­sign rais­ing $240 mil­lion, Edge­wise net­ting $176 mil­lion and Ike­na pulling off a $125 mil­lion raise. Uni­verse clocked in at $25 mil­lion.

With Fri­day’s pric­ings, the com­bined in­dus­try IPO raise now sits at al­most $4.5 bil­lion and is rough­ly on pace to eclipse 2020’s record sum of $16.5 bil­lion, ac­cord­ing to fig­ures kept by Nas­daq.

The rais­es al­so come short­ly af­ter La­va went pub­lic ear­li­er this week, and the last two weeks have now seen a com­bined nine IPO pric­ings. It sug­gests that biotech de­buts are back in full swing af­ter a brief cool down pe­ri­od at the end of Feb­ru­ary, which it­self fol­lowed a week where 10 com­pa­nies priced their IPOs.

From launch to IPO in a lit­tle over a year

De­sign se­cured its launch round just over a year ago, and is now tak­ing its Gene­TAC plat­form pub­lic with a $20 per share pric­ing.

The San Diego-based biotech fo­cus­es on de­gen­er­a­tive dis­eases linked to nu­cleotide re­peat ex­pan­sions, and is co-found­ed and chaired by Pratik Shah, who pre­vi­ous­ly helped en­gi­neer two mul­ti-bil­lion M&A deals. Shah was CEO of Aus­pex for 2 years be­fore Te­va scooped it up for $3.5 bil­lion in 2015, and he was al­so chair­man at Syn­thorx, which Sanofi bought out for $2.5 bil­lion at the end of 2019.

Gene­TAC, short for gene tar­get­ed chimeras, helps De­sign go af­ter what it says are more than 40 de­gen­er­a­tive dis­eases caused by nu­cleotide re­peat ex­pan­sions. The biotech has two pipeline pro­grams thus far, one in Friedre­ich’s atax­ia and one in my­oton­ic dy­s­tro­phy type-1.

IPO funds are slat­ed to go to­ward both of these pro­grams, De­sign wrote in its S-1. It es­ti­mates $30 mil­lion is need­ed to take the Friedre­ich’s atax­ia can­di­date through a Phase I tri­al and $35 mil­lion to take the DM1 pro­gram through Phase I.

An­oth­er $35 mil­lion will fund a cur­rent­ly undis­closed pro­gram, with the re­main­der of the cash go­ing to­ward gen­er­al R&D and cor­po­rate pur­pos­es.

De­sign will list un­der the tick­er $DS­GN.

Edge­wise takes its mus­cle ther­a­pies pub­lic

Edge­wise hits Nas­daq on Fri­day with $176 mil­lion in new cash and a $16 per share pric­ing.

The biotech is fo­cus­ing on rare mus­cle dis­or­ders, with am­bi­tions in Duchenne mus­cu­lar dy­s­tro­phy, Beck­er mus­cu­lar dy­s­tro­phy, and limb-gir­dle mus­cu­lar dy­s­tro­phy. Its lead pro­gram is al­ready in the clin­ic. Edge­wise says that EDG-5506 is a small mol­e­cule in­hibitor for fast my­ofiber (type II) myosin de­signed to ad­dress the root cause of dy­s­trophinopathies.

It’s cur­rent­ly in a Phase I tri­al for DMD, Beck­er and LGMD and Edge­wise hopes it can lim­it the hy­per­con­trac­tion stress caused by the lack of dy­s­trophin in these dis­eases. About $80 mil­lion of the IPO funds will be fun­neled to­ward this pro­gram to get it through the Phase I study and through the in­ter­im read­out of a Phase II/III study.

An ad­di­tion­al $55 mil­lion is ear­marked for the re­search and de­vel­op­ment of three pre­clin­i­cal pro­grams, EDG-6289, EDG-002 and EDG-003. EDG-6289 is list­ed as a mus­cle sta­bi­liz­er, while the oth­er two are billed as mus­cle de­sen­si­tiz­ers.

Edge­wise will list un­der the tick­er $EWTX.

BMS-part­nered Ike­na plow­ing for­ward 

For­mer­ly known as Kyn Ther­a­peu­tics, Ike­na is al­so pric­ing at $16 per share.

The Bris­tol My­ers Squibb part­ner aims to lever­age meta­bol­ic path­ways and the bro­ken-down mol­e­cules that re­sult from the body’s me­tab­o­lism in­to sup­press­ing the body’s im­mune sys­tem. BMS’ stake orig­i­nal­ly came from Cel­gene pri­or to its buy­out, and the S-1 in­di­cat­ed a few weeks ago that the com­pa­ny’s stake in Ike­na is about 8%, good for 14,545,450 to­tal shares.

Cel­gene bought those shares at $1 a piece back in Jan­u­ary 2019, ac­cord­ing to the S-1. With Ike­na pric­ing at $16, that eq­ui­ty is now worth more than $232.7 mil­lion for BMS.

Ike­na’s lead in-house pro­gram is IK-930, an oral small mol­e­cule in­hibitor of a tran­scrip­tion fac­tor known as TEAD. It hasn’t yet reached the clin­ic, but Ike­na is work­ing with BMS and Mer­ck on a few tu­mor mi­croen­vi­ron­ment pro­grams that have al­ready hit Phase I.

About $35 mil­lion to $40 mil­lion of the IPO funds are slat­ed to go to­ward IK-930 to en­able com­ple­tion of IND stud­ies and a Phase I launch. And $25 mil­lion to $30 mil­lion is pen­ciled in for Ike­na’s ERK5 pro­gram to nom­i­nate a can­di­date and get a Phase I start­ed.

The biotech has $55 mil­lion to $60 mil­lion set for the two BMS-part­nered pro­grams, an­oth­er $10 mil­lion to $15 mil­lion for the Mer­ck-part­nered pro­gram, and $25 mil­lion to $30 mil­lion slat­ed for pre­clin­i­cal pro­grams.

Ike­na will list un­der the tick­er $IK­NA.

East­ern med­i­cine com­pa­ny Uni­verse en­ters IPO par­ty

Uni­verse pulls up the rear this week, pric­ing at $5 per share and rais­ing a mod­est $25 mil­lion sum.

The Ji’an, Jiangxi, Chi­na-based com­pa­ny mar­kets its pro­grams to­ward the el­der­ly in Chi­na with its tra­di­tion­al Chi­nese med­i­cine de­riv­a­tives, with the goal of ad­dress­ing phys­i­cal con­di­tions re­lat­ed to ag­ing as well as their gen­er­al well-be­ing. Uni­verse boasts 26 reg­is­tra­tions and ap­provals with Chi­nese reg­u­la­tors and sells 13 prod­ucts as of ear­ly March.

With­in its F-1, Uni­verse says it’s split­ting the IPO raise in­to four rough­ly equal parts. There is 28% list­ed for up­grad­ing and ex­pand­ing man­u­fac­tur­ing fa­cil­i­ties, 27% for R&D, 24% for mar­ket­ing and 21% for cor­po­rate up­keep.

Uni­verse list­ed un­der the tick­er $UPC.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.