April show­ers bring more biotechs to Nas­daq, as Rain and Im­pel bump 2021's to­tal raise above $6B

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What’s that in the sky — is it a bird? Is it a plane? No, it’s an­oth­er hand­ful of biotech IPOs.

Two more biotechs priced their pub­lic of­fer­ings late Thurs­day, com­ing just one day af­ter Zymer­gen blew folks away with its $500 mil­lion pric­ing. This week’s win­ners are Rain Ther­a­peu­tics and Im­pel Neu­rophar­ma, who raised $125 mil­lion and $80 mil­lion, re­spec­tive­ly. Rain priced at $17 and Im­pel’s shares de­buted at $15 apiece.

Com­bined, the sec­tor has now raised more than $6 bil­lion among near­ly three dozen de­buts, ac­cord­ing to the End­points News tal­ly. That’s on pace to top last year’s record raise of $16.5 bil­lion and 91 IPOs, per Nas­daq.

Al­so on Thurs­day came the F-1 fil­ing of Swiss biotech Mol­e­c­u­lar Part­ners, which is pen­cil­ing in $100 mil­lion for its leap to Nas­daq. The com­pa­ny is al­ready pub­licly trad­ed in its home coun­try.

Rain stock price could bring com­pa­ny’s val­u­a­tion to $427 mil­lion

Af­ter a 2020 that led to a sig­nif­i­cant ex­pan­sion of its pipeline, Rain Ther­a­peu­tics has priced its IPO.

The biotech that spe­cial­izes in on­col­o­gy has priced its 7,352,941 shares of its stock at $17 a share, and is ex­pect­ed to raise $125 mil­lion. In a re­lease Mon­day, the com­pa­ny stat­ed that price would com­mand a mar­ket cap of $457 mil­lion.

Rain’s pipeline tripled in a sin­gle week around La­bor Day last year, when it li­censed a re­search pro­gram from Drex­el Uni­ver­si­ty and grabbed a Phase II-ready drug from Dai­ichi Sankyo. That pro­gram has be­come RAIN-32. That is the com­pa­ny’s lead pro­gram now, and should see the ma­jor­i­ty of IPO funds fun­neled to­ward it. RAIN-32 is a small mol­e­cule in­hibitor of MDM2 tak­en oral­ly to re­duce tu­mors ac­tiv­i­ty in li­posar­co­ma and oth­er sol­id tu­mors.

In 2018, the com­pa­ny launched the ex­per­i­men­tal drug tar­lox­o­tinib with its $18 mil­lion in Se­ries A fundrais­ing. Last year, it raised $63 mil­lion. Rain will trade un­der the tick­er $RAIN. — Josh Sul­li­van

Im­pel an­nounces IPO to launch mi­graine treat­ment

Im­pel Neu­roPhar­ma is go­ing pub­lic a lit­tle more than two years af­ter its crossover raise, and Thurs­day, the com­pa­ny an­nounced that it would be priced at $15 a share.

Im­pel is ex­pect­ed to take home $80 mil­lion in pro­ceeds with the pub­lic of­fer­ing of 5,333,334 shares of its stock. The biotech from Seat­tle will use that mon­ey to com­mer­cial­ly launch its mi­graine treat­ment Trud­he­sa, de­liv­ered through an up­per nasal for­mu­la­tion of di­hy­droer­go­t­a­mine.

The pro­ceeds will al­so help its INP105 pro­gram, which is de­signed for treat­ment of ag­i­ta­tion and ag­gres­sion as­so­ci­at­ed with autism spec­trum dis­or­der. This can­di­date, like many of the com­pa­ny’s drugs, is de­liv­ered to the brain through the nose, as it’s a nasal re­for­mu­la­tion of olan­za­p­ine.

Shares of Im­pel’s stock — which will be list­ed as $IM­PL — will be­gin trad­ing to­day. — Josh Sul­li­van

Swiss biotech look­ing to hop across the pond with its pro­tein ther­a­pies

Mol­e­c­u­lar Part­ners is os­ten­si­bly seek­ing to cap­i­tal­ize on last month’s news that one of their an­tivi­ral pro­grams will par­tic­i­pate in an NIH-run Covid-19 tri­al. Mol­e­c­u­lar Part­ners teamed up with No­var­tis for the can­di­date, which is what they’re call­ing a “trispe­cif­ic” DARPin an­tivi­ral known as enso­vibep.

Re­searchers will eval­u­ate the an­tivi­ral as part of the NIH’s AC­TIV-3, the hos­pi­tal­ized mild-to-mod­er­ate pa­tient arm of their AC­TIV pro­to­col against Covid-19. If the med­i­cine hits all its mile­stones, No­var­tis will be on the hook for up to $231 mil­lion.

But Mol­e­c­u­lar Part­ners is al­so fo­cus­ing on eye dis­eases, on­col­o­gy and AML. The com­pa­ny has a Phase III pro­gram for wet AMD where they’ve part­nered with Al­ler­gan/Ab­b­Vie and a lead can­cer pro­gram for FAP-pos­i­tive can­cers in col­lab­o­ra­tion with Am­gen.

The biotech has three pro­grams it ex­pects to fund with its IPO: a Phase I tri­al for its sec­ond on­col­o­gy pro­gram seek­ing to bind FAP and CD40, to com­plete a Phase I study for the sec­ond No­var­tis-part­nered Covid-19 pro­gram known as MP0423, and to ad­vance their liq­uid tu­mor port­fo­lio in AML through Phase I as well.

Once the IPO is closed, Mol­e­c­u­lar Part­ners will trade on the tick­er $MOLN, which is al­so their Swiss tick­er. — Max Gel­man

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.