Black Di­a­mond dou­bles in val­ue hours in­to Nas­daq de­but, mark­ing hot start to the 2020 IPO run

There are few al­losteric ther­a­pies ap­proved, but in­vestors seem to like the idea — and the lat­est duo to pur­sue it.

Black Di­a­mond Ther­a­peu­tics, the young on­col­o­gy com­pa­ny from Tarce­va vets David Ep­stein and Eliz­a­beth Buck, opened its IPO yes­ter­day at $19 per share. By 11:15 am, it was up to $35 per share. And, with a slight rise in the last min­utes, it closed at $39.48. That’s a 108% in­crease on its open­ing ten­der. They col­lect­ed over $200 mil­lion.  The mar­ket cap dou­bled from around $670 mil­lion to $1.3 bil­lion.

On Fri­day, right on the heels of that quick coup, Ar­cutis Bio­ther­a­peu­tics priced its IPO at $17 — the top of the range. That of­fer­ing raised $159 mil­lion through the sale of 9.4 mil­lion shares. It’s start­ing out with a mar­ket val­ue of $657 mil­lion.

The end-of-week surge sug­gests that de­spite some head­winds in­vestors still want to get in ear­ly on what they deem the most promis­ing com­pa­nies, par­tic­u­lar­ly in on­col­o­gy. That bodes well for the start of the 2020 IPO sea­son and will like­ly in­spire oth­ers to jump in­to the game ear­ly — though there’s no way to pre­dict what will hap­pen down the road. The biotech IPO win­dow has been wide open for 5 years now, mark­ing a very long stretch.

Black Di­a­mond’s first-day gain dwarfed the mean for biotech IPOs. Since the start of 2019, they’ve risen on av­er­age 16% on day one and 60% over­all, ac­cord­ing to Re­nais­sance Cap­i­tal.

Black Di­a­mond had raised mon­ey rapid­ly in the pri­vate mar­kets as well. They were the first com­pa­ny to come out of Ver­sant’s Basel-based in­cu­ba­tor and launched with an ini­tial $20 mil­lion from the ven­ture firm. With­in a month of emerg­ing from stealth mode in De­cem­ber 2018, they an­nounced an $85 mil­lion Se­ries B fund­ing. Less than a year lat­er, they net­ted an­oth­er $85 mil­lion. They then im­me­di­ate­ly filed for an IPO.

Buck and Ep­stein are far from alone in pur­su­ing al­losteric ther­a­pies for can­cer and oth­er dis­eases. No­var­tis has a Phase I pro­gram for an al­losteric SHP2 in­hibitor, Rev­o­lu­tion Med­i­cines — now pur­su­ing its own $100 mil­lion IPO –  has an al­losteric SHP2 it li­censed from Sanofi for $50 mil­lion, and back in 2016, Gilead paid Nim­bus $40o mil­lion for fir­so­co­stat, an al­losteric in­hibitor for NASH. (Which did not per­form well last year).

Black Di­a­mond is be­hind those oth­er pro­grams. They have yet to en­ter the clin­ic.

In­vestors are large­ly bet­ting on their MAP plat­form, which works to map out al­losteric mu­ta­tions across the body. Al­losteric sites are grooves away from a pro­tein’s ac­tive bind­ing site but which can nev­er­the­less af­fect the bind­ing site and the pro­tein’s over­all func­tion. A mu­ta­tion there could af­fect the pro­tein’s func­tion, po­ten­tial­ly dri­ving cer­tain can­cers. Sci­en­tists have long known about these sites, but have strug­gled un­til re­cent­ly to find them.

A com­pa­ny with promis­ing map­ping soft­ware could have a sig­nif­i­cant leg up. An­oth­er biotech try­ing to do that, Hotspot Ther­a­peu­tics, launched in 2018 with a $45 mil­lion Se­ries A.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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