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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The fire­hose of bio­phar­ma news is gush­ing these days.

That’s why broad­er and deep­er is the theme for 2021 at End­points. You can ex­pect new cov­er­age out­side our core R&D fo­cus, with deep­er re­port­ing in some key ar­eas. When John Car­roll and I launched End­points near­ly five years ago, we were wad­ing in waist-high wa­ters. Now we’re a team of 25 full-time staffers (and grow­ing) with plans to cov­er the flood of bio­phar­ma news, End­points-style.

If you re­ly on us for news, we’re go­ing to need your help.

The sin­gle best way to sup­port us is en­rolling in End­points Pre­mi­um, our an­nu­al sub­scrip­tion pro­gram that un­locks the full End­points ex­pe­ri­ence.

We of­fer two pre­mi­um plans: In­sid­er for in­di­vid­u­als and En­ter­prise for com­pa­nies.

  • En­ter­prise — $1,000/year for your en­tire or­ga­ni­za­tion, re­gard­less of size. We of­fer a rare un­lim­it­ed-seat li­cense, which makes every em­ploy­ee el­i­gi­ble for End­points Pre­mi­um. In ad­di­tion to un­lock­ing the pay­wall for all, em­ploy­ees will re­ceive a cus­tom ver­sion of the dai­ly email re­ports, sig­ni­fy­ing your com­pa­ny’s sup­port of in­de­pen­dent jour­nal­ism. You can see an ex­am­ple of that in the graph­ic above. Oth­er ben­e­fits in­clude two free pre­mi­um job list­ings at End­points Ca­reers and a reprints li­cense for shar­ing our con­tent in­ter­nal­ly any way you see fit. The ap­pli­ca­tion form is here; ac­cess is grant­ed in­stan­ta­neous­ly af­ter pay­ment. We al­so have a fan­tas­tic cus­tomer sup­port team to help you get the most from sub­scrib­ing. You can con­tact them here.
  • In­sid­er — $225/year for in­di­vid­u­als. With an In­sid­er plan, in­di­vid­ual sub­scribers have the op­tion to dis­able ad­ver­tis­ing, in ad­di­tion to un­lock­ing the con­tent li­brary. If you want just the news con­tent and noth­ing else, this is the plan for you.

Most im­por­tant­ly, with both plans, you’re di­rect­ly sup­port­ing the fu­ture de­vel­op­ment of End­points News. As an in­de­pen­dent pub­li­ca­tion, we’ve avoid­ed rais­ing cash from in­vestors. We re­port to our paid sub­scribers and no one else.

To be sure, join­ing End­points Pre­mi­um is op­tion­al. We be­lieve that high-qual­i­ty re­port­ing ought to be free and eas­i­ly ac­ces­si­ble. So we’re com­mit­ted to keep­ing the most es­sen­tial bits avail­able with our no-cost Ba­sic email sub­scrip­tion.

But as we get broad­er and deep­er in 2021, End­points Pre­mi­um is where you’ll find more of that work. So any com­pa­ny or read­er look­ing for the com­plete pic­ture should sign up for a paid plan to­day.

One ex­am­ple of the deep­er work you’ll have ac­cess to is a print­able PDF of all new drug ap­provals in 2020.

Broad­er and deep­er

We’ve got big plans to cov­er new ground and it will be­gin with a new prod­uct launch: End­points Man­u­fac­tur­ing.

Start­ing in Feb­ru­ary, every Thurs­day we’ll de­liv­er the most im­por­tant sto­ries in man­u­fac­tur­ing in one con­ve­nient email re­port. End­points re­porter Con­ner Mitchell will be lead­ing our bio­man­u­fac­tur­ing cov­er­age. It’s a crit­i­cal beat in the bio­phar­ma world and we’re dou­bling down.

Un­der the main End­points News ban­ner, our grow­ing team has af­ford­ed us op­por­tu­ni­ties to go deep­er, too.

We’re do­ing more pre­clin­i­cal sto­ries and phar­ma news too, break­ing ex­clu­sives, and pick­ing more spots to re­port sci­ence news.

Some­times, it’s in the form of In Fo­cus pieces, like Ja­son Mast’s ex­plo­ration in­to a med­ical mys­tery be­hind a gene ther­a­py tri­al. It’s al­so in the End­points 11, where John Car­roll pro­filed eleven of bio­phar­ma’s most promis­ing star­tups in Sep­tem­ber. We went be­yond write-ups and de­liv­ered lengthy video in­ter­views with the win­ners at our vir­tu­al event, and there’s a trea­sure trove of knowl­edge to un­cov­er in these con­ver­sa­tions. It’s a must-watch if you’re in­to biotech en­tre­pre­neur­ship.

That same de­tail went in­to Women in Bio­phar­ma, our De­cem­ber vir­tu­al event. Here you saw con­tri­bu­tions from our en­tire team, led by ed­i­tors Am­ber Tong and Nicole De­Feud­is. I con­sid­er it some of our best work. If you haven’t yet, please take a few min­utes to watch the videos of our hon­orees. It’s a rare treat to hear and learn from these lu­mi­nar­ies di­rect­ly.

We’re go­ing to be do­ing much more of that in 2021.

For cur­rent End­points Pre­mi­um sub­scribers, thank you — there’s no chance we’d be here to­day with­out you. For those of you get­ting one to­day, be sure that we have nev­er been more ap­pre­cia­tive of your sup­port for the in­de­pen­dent mis­sion we have carved out for our­selves as we boot­strapped this start­up.

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.

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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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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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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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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