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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.