Alex Denner (Getty Images)

A sec­ond Carl Ic­ahn pro­tégé jumps in on SPAC spree, as Alex Den­ner guns for $175M

A sec­ond Carl Ic­ahn pro­tégé is jump­ing in­to the biotech SPAC rush, this time one with a lot more ex­pe­ri­ence — and a lot more of a rep­u­ta­tion — in drug de­vel­op­ment.

Alex Den­ner, the man­ag­ing part­ner at Saris­sa Cap­i­tal and ar­chi­tect of ac­tivist at­tacks at a hand­ful of ma­jor biotechs over the last decade, has filed to raise $175 mil­lion of a spe­cial­ty ac­qui­si­tion com­pa­ny that would fo­cus on “health­care and bio­phar­ma,” with cell and gene ther­a­py gar­ner­ing par­tic­u­lar em­pha­sis in the S-1.  The SPAC will be known as Saris­sa Cap­i­tal Ac­qui­si­tion.

That makes Den­ner the sec­ond for­mer Ic­ahn dis­ci­ple to try and get in on what has proven to a very lu­cra­tive game this sum­mer. Kei­th Meis­ter, the young ex­ec­u­tive wide­ly seen as Ic­ahn’s right-hand man be­fore he left Ic­ahn En­ter­pris­es a decade ago, and his firm Corvex Man­age­ment helped launch a $385 mil­lion life sci­ences SPAC in Au­gust, one of the largest ever. Meis­ter, though, had lit­tle ex­pe­ri­ence in bio­phar­ma be­fore and teamed up with Cas­din Cap­i­tal for the shell they called CM Life Sci­ences.

Den­ner, by con­trast, helped craft Ic­ahn’s bio­phar­ma strat­e­gy as a young in­vestor at his firm, most no­tably help­ing wrest Bio­gen in a new di­rec­tion and bring in George Scan­gos to head the ail­ing gi­ant. Since then, he’s led ac­tivist at­tacks at Iron­wood, Aege­ri­on and Ari­ad. Af­ter sig­nif­i­cant price hikes to their FDA-ap­proved drug and a souped up R&D line, the lat­ter was bought out by Take­da for $5.2 bil­lion, net­ting Saris­sa Cap­i­tal $260 mil­lion.

Den­ner’s ag­gres­sive style has not al­ways en­deared him across to folks in the in­dus­try — Iron­wood man­age­ment suc­cess­ful­ly plead­ed with its di­rec­tors not to give him a board seat — but he’s bet­ting that re­tail in­vestors will see a prof­itable record. The fil­ing high­lights one re­cent move: the 2018 shake­up of the Med­i­cines Com­pa­ny. At the time, the com­pa­ny was worth $2 bil­lion and al­ready work­ing to sell off oth­er prod­ucts and fo­cus all its ef­forts on in­clisir­an, their RNAi cho­les­terol drug. Den­ner takes cred­it, though, for guid­ing in­clisir­an through ap­proval in “record” time and or­ches­trat­ing a $9.7 bil­lion No­var­tis buy­out that the Big Phar­ma ad­mit­ted in SEC doc­u­ments was an over­pay by their cal­cu­la­tions.

Den­ner will now have 2 years to pick a biotech to merge with. Un­like his most fa­mous moves to date, that will mean pick­ing a pri­vate as op­posed to pub­lic com­pa­ny and help­ing steer it from there.

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.

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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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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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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.