There was a time af­ter the 2008 crash that biotech IPOs were about as pop­u­lar as snow in March. But from 2013 through 2015 gen­er­al­ist in­vestors got over their fears and jumped in­to one of the hottest stock games on the plan­et. Funds chased each oth­er for huge re­turns. CEOs be­came overnight mil­lion­aires.

Now the mar­ket pen­du­lum has swung back as the bears pushed aside the bulls. But that doesn’t mean that the new ice age has be­gun, ei­ther.

With H1 com­ing to an end to­mor­row, Nas­daq has count­ed 14 biotech IPOs that col­lec­tive­ly raked in $878 mil­lion, a much re­duced fig­ure from the $4 bil­lion raised in 2015 from 42 biotech IPOs they tracked. And it was lit­tle com­pared to the 61 IPOs that raised $4.3 bil­lion dur­ing the go-go days of 2014.

That’s not too sur­pris­ing, giv­en the gale force winds that have been howl­ing in the biotech sec­tor over the last 6 months. A lot of good com­pa­nies have seen their stock prices fall by half. A hint of bad news now can evis­cer­ate stocks in sec­onds, and there are a host of com­pa­nies that are close to or in pen­ny stock ter­ri­to­ry.

What still draws a crowd on Wall Street? Cer­tain­ly gene edit­ing. If you look over the list of H1 IPOs Nas­daq of­fer­ered me, you’ll see that Ed­i­tas and In­tel­lia scored in the top ranks of new IPOs. That’s why CRISPR Ther­a­peu­tics has been set­ting the stage for an S-1 that’s al­most cer­tain­ly go­ing to shoot for the stars.

Chi­na’s BeiGene got the ball rolling with the biggest of­fer­ing of the year. But with more and more biotechs hang­ing back to wait for a sun­nier in­vest­ment cli­mate, it’s not un­usu­al to see plen­ty of dis­counts on share prices.

There are a cou­ple of biotech IPOs in the queue this week, Sy­ros Phar­ma­ceu­ti­cals and Gem­phire Ther­a­peu­tics, which are to­geth­er hunt­ing about $100 mil­lion more.

The mu­sic hasn’t died in biotech, but it’s not near­ly as loud and ur­gent as the hit tunes from 2013-2015. — John Car­roll, fol­low me @John­Cendpts

H1 2016 IPOs

2015 IPOs

2014 IPOs

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Biogen executive John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.