Brent Saunders (Richard Drew, AP Images)

Brent Saun­ders rides $400M wave to the top of the SPAC boom

Brent Saun­ders’ de­ci­sion to join the SPAC gold rush ap­pears to have paid off nice­ly, al­beit not quite as nice­ly as he and his for­mer Al­ler­gan col­leagues had hoped.

Saun­ders’ spe­cial pur­pose ac­qui­si­tion com­pa­ny Ves­per Health­care Ac­qui­si­tion raised $400 mil­lion, sell­ing 40 mil­lion shares at 10 bucks a pop. That’s a bit short of the $460 mil­lion he and for­mer Al­ler­gan ex­ec Man­isha Narasimhan had ini­tial­ly sten­ciled in as the max­i­mum po­ten­tial of­fer­ing, but it still leaves one of phar­ma’s most fa­mous — and oc­ca­sion­al­ly no­to­ri­ous — wheel­ers and deal­ers with one of the largest hauls for a life sci­ence shell com­pa­ny yet, eclips­ing the $385 mil­lion Cas­din Cap­i­tal and Corvex Man­age­ment raised ear­ly this month.

Saun­ders will now have two years to find a new home for all that cash, look­ing in a hand­ful of fa­mil­iar ar­eas: med­ical aes­thet­ics, eye care, longevi­ty and well­ness.

Al­though the small hand­ful of life sci­ence SPACs to suc­cess­ful­ly merge with pri­vate com­pa­nies have large­ly been small­er, sev­er­al al­so came with ad­di­tion­al ex­ter­nal fund­ing to boost the over­all val­ue of the deal. Cerev­el, for in­stance, an­nounced they would go pub­lic ear­li­er this year on a deal that saw them merge with Per­cep­tive Ad­vi­sors’ $150 mil­lion SPAC and raise $445 mil­lion in a con­cur­rent pri­vate round.

Still, when Saun­ders first filed for the SPAC, one life sci­ences in­vestor told End­points News that it could trans­late in­to a com­pa­ny worth $1.5 bil­lion to $2 bil­lion — or in the range of what Re­lay Ther­a­peu­tics, the biggest biotech IPO in a year full of big biotech IPOs, was worth on its de­but.

And Saun­ders plans to own a de­cent chunk of the even­tu­al com­pa­ny; the S-1 not­ed he would re­tain 20% of the SPAC post-of­fer­ing.

So far, this marks just Saun­ders’ sec­ond pub­lic move since he avoid­ed a spot on Ab­b­Vie’s board post-buy­out. He al­so joined Bridge­Bio’s board, help­ing Neil Ku­mar steer an um­brel­la of com­pa­nies try­ing to rein­vent biotech.

For a man who very re­cent­ly had the work­ing hours of a Big Phar­ma CEO, that pre­sum­ably leaves room on his plate for more.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Michel Vounatsos, Biogen CEO (via YouTube)

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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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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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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