Cheers! End­points News turns 1 to­day — and we're un­wrap­ping in­fo on a new sub­scrip­tion plan

To­day, End­points News is one year old. Like any thriv­ing in­fant, we’ve been grow­ing at a fast pace, out­grow­ing a hasti­ly craft­ed chris­ten­ing gar­ment.

Start­ing from scratch, with just so­cial me­dia and a lot of word of mouth to re­ly on, web traf­fic to End­points was less than 14,000 vis­its per week. To­day we notch 14,000 per day, with a to­tal of 139,000 unique read­ers com­ing to the web­site in May.

Email sub­scrip­tions — the most im­por­tant met­ric we track — grew from zilch to 16,000 dai­ly bio­phar­ma sub­scribers drawn to our in­de­pen­dent style of jour­nal­ism. This was a re­sult of or­gan­ic, word-of-mouth ad­vo­ca­cy from our biggest fans. End­points’ “open rate”, the per­cent­age of read­ers who ac­tu­al­ly open and read the email re­ports, has nev­er fall­en be­low 40% — far above in­dus­try av­er­ages and more than dou­ble the rate you see at sim­i­lar pub­li­ca­tions.

I’ve writ­ten — this is a rough ball­park fig­ure — more than 650,000 words on R&D over the past 12 months. And we con­tin­ue to grow our traf­fic month­ly at a dou­ble-dig­it rate.

I am es­sen­tial­ly at about 60% of the read­er­ship I had be­fore I de­cid­ed to do a boot­strap start­up pub­li­ca­tion for bio­phar­ma R&D. And be­lieve me, it’s the best 60%, as I’ve found dur­ing events we’ve host­ed along the way of our maid­en voy­age in San Fran­cis­co and Boston and Eu­rope. The rest will come along, and we’ll be ready to shoot past old mark­ers and fo­cus on achiev­ing big­ger goals in the year ahead.

So where do we go from here?

Com­mit­ment to open-ac­cess and high ex­pec­ta­tions for free con­tent

My part­ner, Ar­salan Arif, and I grew up in this on­line busi­ness me­dia world. We be­lieve that to get a big au­di­ence you need to con­cen­trate on an open-ac­cess mod­el.

In plain Eng­lish, the news must re­main free.

That hasn’t changed and it’s not go­ing to. But we are look­ing to grow the team here at End­points, adding con­tent as we ex­pand read­er­ship fur­ther. And that’s go­ing to take new rev­enue, on top of the ad­ver­tis­ing we’ve built up and con­tin­ue to grow.

A few weeks ago, we ran a read­er sur­vey ask­ing you whether you would con­sid­er pay­ing $200 a year for a sub­scrip­tion. Most said there wasn’t a chance. You have high ex­pec­ta­tions for free con­tent and you weren’t about to change. Some said they’d pay, but the fig­ure sound­ed high. And you were fine with the email blasts from ad­ver­tis­ers.

To all of you, we say thank you for spend­ing part of your work day with us. We’ll work for you every day of the week.

But about 20% of you felt that you would glad­ly pay that, ei­ther to sup­port the work we’re do­ing here or to pay for di­rect ac­cess to the re­port with­out any email blasts from ad­ver­tis­ers.

It was, in fact, about 50/50 on that score.

An­nounc­ing End­points In­sid­er

On Ju­ly 10, we’ll roll out End­points In­sid­er, our paid sub­scrip­tion mod­el. If you’d like to sup­port our work here — or sim­ply want all the con­tent with­out the ad­ver­tis­ing — please sign up here. The cost is $200/year (no pay­ment de­tails re­quired to­day).

End­points In­sid­er pre-reg­is­tra­tion
No pay­ment de­tails re­quired to­day

In ad­di­tion to sup­port­ing us and en­joy­ing an ad-free ex­pe­ri­ence, I’ll be mov­ing my opin­ion pieces be­hind the pay­wall, of­fer­ing eas­i­er ac­cess to the ed­i­to­r­i­al team for any queries you may have, and In­sid­ers can in­stant­ly down­load print-ready PDF ver­sions of all ar­ti­cles so you can print or share in­ter­nal­ly on your terms. Lat­er we’ll add a few oth­er sub­scriber-on­ly pieces, but all of the dai­ly bio­phar­ma news we pub­lish will re­main free and eas­i­ly ac­cessed to those of you who like things as they are. That is not go­ing to change and you don’t have to do any­thing to keep re­ceiv­ing End­points News and mes­sages from our ad­ver­tis­ers.

I’d like to thank you all for the lit­er­al­ly thou­sands of mes­sages of sup­port we’ve re­ceived along the way. When you start up your own in­de­pen­dent busi­ness in an in­dus­try like this, you find lots of sup­port for the en­tre­pre­neur­ial at­ti­tude we’ve adopt­ed. And if you would like to add your sub­scrip­tion to help sup­port that, we’d ap­pre­ci­ate that as well.

One way or the oth­er, we’ll keep work­ing 24/7 on your be­half. It’s been quite a ride, and we’re just get­ting start­ed putting can­dles on that cake. But with­out you, this all means noth­ing. — John Car­roll

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 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.