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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”