Alzheimer’s play­er AC Im­mune taps IPO for $58M raise, sees shares soar

AC Im­mune CEO An­drea Pfeifer

Swiss biotech AC Im­mune fol­lowed through on its IPO $ACIU to­day, pric­ing at $11 a share . That’s the low end of the range, but the com­pa­ny bumped the net to $58 mil­lion by adding 1.5 mil­lion shares, in­creas­ing the to­tal to 6 mil­lion.

The big pay­off came af­ter the open on Fri­day, though, as the biotech’s shares rock­et­ed up 42% on its de­but.

AC Im­mune has been a promi­nent play­er in Alzheimer’s, one of the tough­est games in biotech. Backed in part by bil­lion­aire Di­et­mar Hopp, the biotech is part­nered with Roche on crenezum­ab, now ad­vanced in­to a piv­otal study af­ter mixed re­sults in an ear­li­er study.

Mixed re­sults, though, are a big plus in Alzheimer’s, which has known lit­tle more than fail­ure over the past 10 years-plus. Ear­li­er to­day, the 5-HT6 ag­o­nist idalopir­dine from Lund­beck and Ot­su­ka failed the first of three Phase III stud­ies, and an­a­lysts im­me­di­ate­ly all but wrote it off for dead.

AC Im­mune CEO An­drea Pfeifer, though, has fol­lowed a more fa­mil­iar path, pur­su­ing amy­loid be­ta, the tox­ic clus­ters of­ten found in the brains of Alzheimer’s pa­tients. But the ex­pe­ri­enced ex­ec al­so be­lieves that it will ul­ti­mate­ly take a com­bi­na­tion of drugs to even­tu­al­ly start to con­trol the dis­ease, and is al­so pur­su­ing tau as a like­ly cul­prit.

The com­pa­ny has been build­ing some siz­able cash re­serves, adding $43.5 mil­lion in ven­ture cash last spring and bring­ing the to­tal ven­ture cash re­port­ed so far for its work on Alzheimer’s treat­ments to $121.5 mil­lion

The com­pa­ny has been pa­tient­ly suss­ing out a dif­fi­cult — but not im­pos­si­ble — IPO mar­ket. Fol­low­ing a three-year IPO boom, the in­dus­try has seen a marked pull back as gen­er­al­ists fled the kind of daunt­ing risk pre­sent­ed by drug de­vel­op­ment. But there has nev­er­the­less been a steady stream of new of­fer­ings, if not the kind of sea­son­al tor­rent that hit in 2014 and the first half of 2015.

This year biotech IPOs have re­quired a heavy dose of in­sid­er sup­port.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.