One month af­ter $115M megaround, mus­cle dis­ease-fo­cused Dyne goes pub­lic with $233M IPO

Af­ter com­plet­ing a fi­nanc­ing megaround for $115 mil­lion just a lit­tle over a month ago, Dyne Ther­a­peu­tics is ready to hit the Nas­daq on Thurs­day.

The biotech has raised $233 mil­lion for its pub­lic of­fer­ing af­ter pric­ing shares at $19 apiece, above its ex­pect­ed range of $16 to $18. That’s an of­fer­ing that’s well-up­sized — by about 33% — af­ter Dyne ini­tial­ly filed its S-1 in late Au­gust, when it es­ti­mat­ed on­ly a $100 mil­lion raise. Dyne will trade un­der the tick­er $DYN.

More than four dozen biotechs have al­ready gone pub­lic this year, sur­pass­ing the to­tal from all of 2019. Com­bined, the com­pa­nies have raised more than $11 bil­lion in what con­tin­ues to be a ban­ner year for the in­dus­try. Over half of those biotechs, in­clud­ing Dyne, raised at least $200 mil­lion each.

With­in the S-1, the com­pa­ny did not give much of a look be­hind the cur­tain re­gard­ing how it would use the pro­ceeds from the raise. The fil­ing in­di­cat­ed ad­vanc­ing R&D in pre­clin­i­cal pro­grams and IND-en­abling stud­ies, but wouldn’t go any fur­ther than that.

Dyne fo­cus­es its re­search around mus­cle dis­eases, cre­at­ing a plat­form that aims to use oligonu­cleotides to de­grade RNA re­spon­si­ble for the dis­ease. The the­o­ry goes that by link­ing an an­ti­body to an oligonu­cleotide, ther­a­pies can be en­gi­neered to tar­get mus­cle cells and de­grade the RNA, avoid­ing tox­i­c­i­ty-re­lat­ed prob­lems.

The com­pa­ny’s lead pro­gram is de­vel­op­ing ther­a­pies for my­oton­ic dy­s­tro­phy, a dis­ease caused by an ab­nor­mal ex­pan­sion in a re­gion of the DMPK gene. Dyne hasn’t yet reached the clin­ic, but the com­pa­ny says that its pre­clin­i­cal stud­ies showed a re­ver­sal of my­oto­nia af­ter a sin­gle dose in a dis­ease mod­el, dura­bil­i­ty of re­sponse up to 12 weeks and en­hanced mus­cle dis­tri­b­u­tion.

Fur­ther along the pipeline are pro­grams for Duchenne mus­cu­lar dy­s­tro­phy and fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy, as well as dis­cov­ery work in the car­diac and meta­bol­ic are­nas.

Dyne go­ing pub­lic Thurs­day is the lat­est in a se­ries of quick jumps, as the com­pa­ny came out of stealth with a $50 mil­lion launch round backed by At­las in April 2019. Ex­ec­u­tive chair­man Ja­son Rhodes, a part­ner at the in­cu­ba­tor, will own a 31.1% stake in the com­pa­ny, with For­bion’s Dirk Ker­sten get­ting 19.6% and MPM’s Ed­ward Hur­witz own­ing 15.8%. The April round was fol­lowed by an ad­di­tion­al $115 mil­lion in fund­ing in ear­ly Au­gust, a round led by Vi­da Ven­tures and Sur­vey­or Cap­i­tal.

At the time of the Au­gust raise, Dyne re­mained mum on how its gene ther­a­pies, specif­i­cal­ly for Duchenne, would com­pare to ap­proach­es at oth­er com­pa­nies like Sarep­ta, whose con­tro­ver­sial Ex­ondys 51 did not prove to be cost-ef­fec­tive nor par­tic­u­lar­ly ben­e­fi­cial, ac­cord­ing to ICER. The or­ga­ni­za­tion found that the im­pact of Sarep­ta’s ther­a­py on Duchenne pa­tients was un­clear and wouldn’t reach cost-ef­fec­tive­ness be­low a $150,000 bench­mark, a con­clu­sion Sarep­ta called “fa­tal­ly flawed.”

So­cial im­age: Joshua Brumm, Dyne CEO

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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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, 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.