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.

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.