Six biotechs crowd in­to Nas­daq, rais­ing $568M as the IPO par­ty con­tin­ues to lure com­pa­nies to Wall Street

Usu­al­ly biotech IPOs come one or maybe two at a time. To­day, we have 5 si­mul­ta­ne­ous­ly test­ing in­vestors’ ap­petite for risky com­pa­nies that will ei­ther re­ward them hand­some­ly over the long haul or … well, not. And I’m adding a 6th, from Ei­dos Ther­a­peu­tics, that got a jump on the gang of 5 and an­nounced their pric­ing late Tues­day.

Add it all up and the 6 are ben­e­fit­ing from a to­tal raise of $568 mil­lion, gen­er­al­ly pric­ing shares in the mid­dle of the range — just the lat­est wind­fall to help fu­el the R&D work of a steady stream of play­ers who have been mak­ing the switch to the pub­lic mar­kets.

The num­bers are all ahead of fees as well as the buy-in from un­der­writ­ers that could be ahead.

Here’s the break­out:

Ja­son Gard­ner

$MG­TA, Ma­gen­ta Ther­a­peu­tics, Cam­bridge, MA: The biotech raised a cool $100 mil­lion from the sale of ex­act­ly 6,666,667 at $15 a share. Un­der GSK vet Ja­son Gard­ner, Ma­gen­ta has been mov­ing fast, stock­pil­ing ven­ture cash and hus­tling ahead with a com­pound in-li­censed from No­var­tis. The mon­ey should pay for a piv­otal tri­al.

Ge­off MacK­ay

$AVRO, Avro­bio, Cam­bridge, MA: Avro­bio came in just a hair be­low Ma­gen­ta, with a haul of $99.7 mil­lion to boast about, set­ting the ini­tial price at $19. Op­er­at­ing un­der CEO Ge­off MacK­ay, the biotech has tout­ed an ear­ly suc­cess for Fab­ry dis­ease, where their gene ther­a­py AVR-RD-01 helped spur a pa­tient’s plas­ma a-Gal A ac­tiv­i­ty in­to the nor­mal range. That helped with a $60 mil­lion crossover round for the At­las-launched biotech ear­li­er this year. There’s not a tremen­dous amount of da­ta to go with yet, but gene ther­a­py is hot right now. 

$AP­TX, Aptinyx, Evanston, IL: The com­pa­ny hit the ground run­ning at $16 a share, rais­ing $102.4 mil­lion. Run by CEO Nor­bert Riedel, Aptinyx was spun out of the $1.7 bil­lion buy­out of Nau­rex — with $560 mil­lion in cash — which Al­ler­gan CEO Brent Saun­ders want­ed for its lead NM­DA drug aimed at ma­jor de­pres­sion. That drug is now dubbed ra­pastinel, which won a break­through drug des­ig­na­tion at the FDA.

$KZR, Kezar Life Sci­ences, South San Fran­cis­co: Kezar up­sized their of­fer­ing a bit, go­ing with 5 mil­lion shares at $16 for $75 mil­lion. As our Brit­tany Meil­ing re­port­ed ear­li­er, Kezar is work­ing on a pipeline of au­toim­mune drugs. Spun out of Am­gen with small mol­e­cules from the plate of the for­mer Onyx Phar­ma­ceu­ti­cals, she writes, Kezar’s lead prod­uct is KZR-616. The drug is a se­lec­tive im­muno­pro­tea­some in­hibitor that’s about to be test­ed in a Phase Ib/II tri­al in lu­pus and lu­pus nephri­tis.

$XERS, Xeris Phar­ma­ceu­ti­cals, Chica­go: The biotech raised $85.5 mil­lion at $15 per share. Kezar and Xeris filed their IPOs to­geth­er, and made the leap to­geth­er. Xeris has plans to launch its glucagon pen for di­a­bet­ics. Their glucagon pipeline in­cludes post-bariatric hy­po­glycemia and con­gen­i­tal hy­per­in­sulin­ism.

$EI­DX, Ei­dos Ther­a­peu­tics, San Fran­cis­co: Their raise came to $106.3 mil­lion. The biotech prices at $17 and then watched the share price soar on Wednes­day, ris­ing past the $23 mark. Bridge­Bio chief Neil Ku­mar has been bull­ish about this par­tic­u­lar sub­sidiary in the group, even though it’s up against some heavy­weight play­ers in drug de­vel­op­ment, in­clud­ing Al­ny­lam, Io­n­is and even Pfiz­er. Their drug was ini­tial­ly ad­vanced by Is­abel­la Graef at Stan­ford and Mamoun Al­hamad­sheh, the com­pa­ny sci­en­tif­ic co-founders, who nailed down pre­clin­i­cal ev­i­dence that the drug can sta­bi­lize TTR and pre­vent the cas­cade of events that caus­es the dis­ease — a dis­ease mod­i­fy­ing ap­proach that will now head to the clin­ic.

Im­age: Nas­daq lo­ca­tion in Times Square, 2018 Shut­ter­stock

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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