The biotech IPOs keep com­ing at chart-top­ping lev­els — with no slow­down in sight

An­oth­er week, an­oth­er string of new biotech IPOs — and biotech IPOs pric­ing at record lev­els.

In the US, two more ear­ly-stage com­pa­nies broke through the $200 mil­lion mark. The syn­thet­ic lethal­i­ty-fo­cused Re­pare Ther­a­peu­tics up­sized its IPO once from $16 to $18, to $18 to $20, and then priced at the high end to fetch $220 mil­lion. For­ma Ther­a­peu­tics, part­nered with Bris­tol My­ers Squibb and fo­cused on sick­le cell dis­ease, al­so set at $16 to $18, sold at $20 and ul­ti­mate­ly fetched $278 mil­lion.

Mean­while, in South Ko­rea, SK Bio­phar­ma­ceu­ti­cals, a sub­sidiary of the SK hold­ings con­glom­er­ate and mak­er of the epilep­sy drug Xcor­pi, priced at the top of its range to col­lect $794 mil­lion. It was the largest pub­lic of­fer­ing in the coun­try since Cell­tri­on Health earned $900 mil­lion in the sum­mer of 2017, per Reuters, al­though it fell a few dol­lars short of what ear­li­er re­ports had pre­dict­ed.

The lat­est pair of rais­es on the US ex­change add to last week’s gold­mine, when Avid­i­ty, Vax­cyte, and Gen­er­a­tion Bio each cleared $230 mil­lion de­spite not one of them hav­ing put a drug in­to hu­man test­ing. The boom ap­pears to be at least in part a prod­uct of the pan­dem­ic, as in­vestors weary of the oth­er cor­ners of a stunt­ed econ­o­my have poured mon­ey in­to com­pa­nies de­vel­op­ing Covid-19 drugs and al­lowed pri­vate biotechs to go pub­lic at soar­ing rates.

The last two weeks alone have seen more large rais­es for pre­clin­i­cal biotechs than the last three years com­bined. Over that time, on­ly two com­pa­nies raised over $150 mil­lion that ear­ly in their de­vel­op­ment, ac­cord­ing to Re­nais­sance Cap­i­tal.

The trend to­ward larg­er rounds for the ear­ly stage com­pa­nies, though, pre­dates the pan­dem­ic, as pub­lic in­vestors join ven­ture cap­i­tal­ists in their in­creased will­ing­ness to make large bets on promis­ing, al­beit pro­tean, sci­ence. Beam Ther­a­peu­tics, Black Di­a­mond Ther­a­peu­tics, Rev­o­lu­tion Med­i­cines, and Pas­sage Bio all raised over $180 mil­lion in Jan­u­ary and ear­ly Feb­ru­ary.

In­vestors al­so sig­naled their be­lief in bio­phar­ma by back­ing Roy­al­ty Phar­ma’s record $2.2 bil­lion IPO. Roy­al­ty Phar­ma doesn’t make drugs. In­stead, it buys up long term roy­al­ties for in­ves­ti­ga­tion­al and ap­proved ther­a­pies, mean­ing for in­vestors it acts as some­thing akin to an in­dex or port­fo­lio. It’s been a lu­cra­tive busi­ness so far, and in back­ing it, in­vestors es­sen­tial­ly made a bet that mak­ing new drugs in gen­er­al would con­tin­ue be­ing a lu­cra­tive busi­ness.

Ex­clud­ing Roy­al­ty Phar­ma, there’s now been at least 8 $200 mil­lion biotech IPOs in the first half of 2020. That com­pares to 5 through all of 2019, ac­cord­ing to da­ta com­piled by Re­nais­sance Cap­i­tal.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.