In post-IPO par­ty, Nas­daq’s new­com­ers Ar­mo, Men­lo and Sol­id soar with­in hours of list­ing

Three new­ly-mint­ed biotech stocks are leap­ing in val­ue just days af­ter list­ing on the Nas­daq, send­ing a clear sig­nal to in­dus­try that in­vestors’ in­sa­tiable ap­petite will car­ry in­to 2018. Al­though there’s no sign of this ac­tiv­i­ty slow­ing down, the col­lec­tive gid­di­ness of the in­dus­try is start­ing to alarm the more con­ser­v­a­tive among us. Go-go days come to an end at some point, right?

One com­pa­ny reap­ing the ben­e­fits of the mar­ket is Ar­mo Bio­sciences $AR­MO, which went pub­lic just this morn­ing rais­ing $128 mil­lion. The late-stage im­munother­a­py com­pa­ny priced its of­fer­ing at $17 per share on a $526 mil­lion val­u­a­tion. Ar­mo quick­ly saw its share price soar, clos­ing the day at $29.74 — 75% high­er than where it start­ed. Mar­ket cap? $845 mil­lion by mar­ket close.

In­de­pen­dent biotech in­vestor Brad Lon­car said he knew Ar­mo would do well be­cause its lead prod­uct can­di­date plays in a pop­u­lar are­na.

“‘Cy­tokines’ is a buzz­word we will be hear­ing a lot in 2018,” Lon­car wrote in an email. “(Nek­tar) is the biggest sto­ry of the year so far, and it’s easy for bankers to call this the next Nek­tar.”

Jet­ting north, Ar­mo is joined by Men­lo Ther­a­peu­tics $MN­LO, which we saw go pub­lic yes­ter­day rais­ing $119 mil­lion. The com­pa­ny priced at $17 per share on a $403 mil­lion val­u­a­tion. By to­day at mar­ket close, its stock was up 68% clos­ing at $28.51.

And last, there’s Sol­id Bio­sciences $SLDB, which list­ed on the Nas­daq this morn­ing. It raised $125 mil­lion at $16 per share. De­spite new rev­e­la­tions that its most ad­vanced drug can­di­date has been un­der FDA scruti­ny since mid-No­vem­ber, Sol­id still man­aged to close the day up at $22.62 per share — a 41% in­crease.

Lon­car said the per­for­mance of the first batch of IPOs this year — helped along by two ma­jor M&A deals from Cel­gene and Sanofi — cer­tain­ly bodes well for the im­me­di­ate fu­ture.

“Biotech is on fire since those two deals on Mon­day and I do think it is in­dica­tive of a strong IPO sea­son ahead,” Lon­car said.

Still, things are start­ing to look a lit­tle too hot for some. “You keep your hand on the eject but­ton,” an un­named hedge fund man­ag­er told STAT’s Dami­an Garde. And Lon­car — un­prompt­ed — tacked this on the end of his email.

“To be hon­est, I think it is all too frothy,” Lon­car wrote. “But it usu­al­ly takes months of froth for a reck­on­ing to hap­pen. I wouldn’t be sur­prised if we are still in the ear­ly stages of this.”


Im­age: shut­ter­stock

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.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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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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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

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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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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