Evelo Bio grabs $85M as the lat­est ear­ly-stage biotech de­buts on Nas­daq

Evelo Bio­sciences be­came the lat­est ear­ly-stage biotech com­pa­ny to make the leap in­to Nas­daq. The Cam­bridge, MA-based com­pa­ny priced 5.3 mil­lion shares at $16 — smack dab in the mid­dle of the range — to add $85 mil­lion to its re­serves.

The stock will start trad­ing to­day un­der the $EV­LO sym­bol, fresh ev­i­dence that the mar­ket for new biotech stocks con­tin­ues to have legs in 2018.

Sim­ba Gill

The com­pa­ny is helmed by CEO Sim­ba Gill, who’s out to make “mon­o­clon­al mi­cro­bials” in­to a new drug class. And that’s the kind of sto­ry that has been float­ing dozens of new biotechs over the past 18 months.

The sci­ence at Flag­ship-based Evelo fo­cus­es on the in­ter­sec­tion of the gut and body; specif­i­cal­ly how the gut op­er­ates in di­rect­ing the im­mune sys­tem. By de­sign­ing the right mi­cro­bial strains that op­er­ate in the gut, Evelo’s sci­en­tists be­lieve that they can up-reg­u­late the im­mune sys­tem to go af­ter, say, can­cer, or down-reg­u­late it to pre­vent in­flam­ma­to­ry dis­eases like pso­ri­a­sis or atopic der­mati­tis, rheuma­toid arthri­tis and Crohn’s dis­ease.

Mor­gan Stan­ley, Cowen and BMO Cap­i­tal Mar­kets are act­ing as book-run­ning man­agers for the of­fer­ing. JMP Se­cu­ri­ties is act­ing as lead man­ag­er.

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.”

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

Hans Schambye

Galec­to reaps $64M to bring lead drug across IPF fin­ish line, while mak­ing moves in NASH and be­yond

Back in 2018, Hans Schambye raised $90 million to kick off a late-stage trial that could put Galecto Biotech’s lead drug on the final stretch toward approval for idiopathic pulmonary fibrosis. Two years later, he’s collected another $64 million to complete it.

The Copenhagen-based company has managed to continue recruitment for the 450-patient trial in spite of the pandemic, the CEO told Endpoints News, with data expected by the middle of 2022.

Image credit: AP

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.