Presto! Wall Street ma­gi­cian Vivek Ra­maswamy has an­oth­er in­stant biotech IPO to sell you

A pair of biotechs are look­ing to raise more than $250 mil­lion through IPOs, slip­ping in­to the short queue on the last work­ing day of Q3. One is from a Bermu­da-based ad­ven­tur­er with a knack for shak­ing loose cheap, late-stage as­sets from phar­ma’s R&D shelves and the oth­er is a ven­ture-backed play­er with plans to carve out a share of a block­buster fran­chise.

The first is My­ovant Sci­ences, an­oth­er in­stant-mix biotech from the 30-year-old for­mer hedge fund man­ag­er Vivek Ra­maswamy. This time, the young fi­nancier has con­jured a com­pa­ny with a re­spect­ed sci­en­tist at the helm and for­mer HHS Sec­re­tary Kath­leen Se­be­lius on the board.

Ra­maswamy made waves dur­ing the wan­ing days of the biotech boom last year by grab­bing a failed Alzheimer’s drug from Glax­o­SmithK­line for a song, then rais­ing an eye-pop­ping $315 mil­lion in an IPO Ax­o­vant is us­ing to pay for a re­vised Phase III tri­al, look­ing to cap­i­tal­ize on a sliv­er of pos­i­tive re­sults spied in the clin­ic while trans­form­ing a shelved ther­a­py in­to an overnight for­tune. Ra­maswamy told Forbes that he wants to be­come the Berk­shire Hath­away of biotech. But in­stead of in­vest­ing heav­i­ly in uni­ver­sal­ly known con­sumer prod­ucts, he’s grab­bing risky drug de­vel­op­ment pro­grams and look­ing for a quick score in Phase III.

In­vestors have been eat­ing it up, so far. And Ra­maswamy now has a $172.5 mil­lion IPO feast planned for My­ovant, which was whipped up last June.

My­ovant’s as­sets are com­ing from Take­da, which is un­der­go­ing a top-to-bot­tom R&D over­haul that shook out re­l­u­golix. Picked up at the end of Phase II, My­ovant is look­ing for cash to pay for a Phase III ef­fort that in­cludes a trio of late-stage stud­ies for uter­ine fi­broids, en­dometrio­sis-as­so­ci­at­ed pain and prostate can­cer. Its sec­ond drug is RVT-602, an oligopep­tide kisspeptin ana­log for the treat­ment of fe­male in­fer­til­i­ty.

Ra­maswamy had to pay GSK $5 mil­lion for its Alzheimer’s drug, lunch mon­ey in the bio­phar­ma world, but the S-1 re­veals that he didn’t need cash for the Take­da drug. Ac­cord­ing to the S-1, Take­da ac­cept­ed about $7.7 mil­lion worth of stock and a war­rant – val­ued at $5.3 mil­lion – that guar­an­tees the Japan­ese com­pa­ny a 12% eq­ui­ty stake in the com­pa­ny for a lim­it­ed amount of time.

Take­da, mean­while, is run­ning a pair of its own Phase III tri­als for re­l­u­golix, which it plans to use for a mar­ket­ing ap­pli­ca­tion in Japan. And My­ovant has the right to use Take­da’s da­ta in its own NDA in the U.S.

Not a drug de­vel­op­er, Ra­maswamy re­cruit­ed Lynn Seely from Medi­va­tion to run the start-up show, which now in­cludes a to­tal of 9 staffers work­ing un­der Ra­maswamy’s um­brel­la group. Seely, the for­mer CMO at Medi­va­tion, has plen­ty of mar­ket cred­i­bil­i­ty as a de­vel­op­er, as Pfiz­er’s $14 bil­lion takeover of Medi­va­tion in Au­gust helped prove.

Like Take­da, Seely was al­so wooed with stock. Seely picked up 2 mil­lion shares (2.6% of the com­pa­ny) when she start­ed and is in line for an­oth­er mil­lion shares in a year, which all vest over time. Se­be­lius’s board po­si­tion should al­so add some heft to the com­pa­ny’s rep.

Ra­maswamy’s record Ax­o­vant IPO was com­plet­ed at the tail end of the go-go pe­ri­od for biotech stocks, but he’ll have to con­tend with a dif­fer­ent mar­ket now, with gen­er­al­ists on the side­lines and in­sid­ers ex­pect­ed to do much of the pur­chas­ing. Some re­cent IPOs have been do­ing well, though, which per­haps in­di­cates that Ra­maswamy’s tim­ing is still good.

Cam­bridge, MA-based Ra Phar­ma­ceu­ti­cals, which has a big block­buster in its sights, is fac­ing the same sit­u­a­tion. The folks at Ra sim­ply be­lieve that they have a bet­ter pep­tide chem­istry plat­form to make a new and im­proved C5 in­hibitor that will prove safer and more ef­fec­tive than Soliris, the most ex­pen­sive ther­a­py in the U.S., which is mar­ket­ed by Alex­ion. And they’re us­ing that ar­gu­ment in an IPO that pen­cils in an $86 mil­lion haul in the S-1.

Like Soliris, their drug is be­ing de­vel­oped for the rare blood dis­or­der parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, or PNH. And the biotech plans to use that lead pro­gram, now poised at the thresh­old of Phase II, to break a path for a pipeline of drugs that ad­dress ail­ments as­so­ci­at­ed with dys­func­tion of the com­ple­ment sys­tem com­po­nent of the im­mune sys­tem. That’s a rich ar­ray of tar­gets, rang­ing from CNS dis­eases to rare blood, neu­ro­log­ic, oph­thal­mo­log­ic, re­nal and in­flam­ma­to­ry con­di­tions.

RA Cap­i­tal Man­age­ment, No­vo Ven­tures, and Light­stone Ven­tures led a $58.5 mil­lion crossover round last sum­mer, jump­ing in­to a syn­di­cate that in­clud­ed new in­vestors Rock Springs Cap­i­tal and Limu­lus Ven­ture Part­ners. A pro­lif­ic New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, Mor­gen­thaler Ven­tures and Am­gen Ven­tures fund­ed the start­up, which says it has enough mon­ey to get through the first half of 2017 with­out new fund­ing.

Ra Phar­ma and My­ovant are both lin­ing IPOs up along­side CRISPR Ther­a­peu­tics, a gene edit­ing com­pa­ny which hopes to see some of the same mar­ket suc­cess ex­pe­ri­enced by Ed­i­tas and In­tel­lia.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.