About half a year af­ter re­ab­sorb­ing its lipid-fo­cused spin­out Akcea, Io­n­is is now putting a ma­jor re­or­ga­ni­za­tion plan in play — one that in­volves shav­ing near­ly 70% of the sub­sidiary’s work­force and ex­pand­ing its dis­tri­b­u­tion deal with So­bi.

Akcea be­gan as a whol­ly-owned sub­sidiary back in 2014, be­fore Io­n­is put about a quar­ter of its shares on the pub­lic mar­kets. In its 2017 pub­lic de­but, Akcea raised $125 mil­lion, plus an­oth­er $50 mil­lion in a pri­vate place­ment with No­var­tis. Then in Au­gust, Io­n­is paid about $500 mil­lion — $18.15 per share — to buy that quar­ter back.

Io­n­is has long been laser-fo­cused on R&D, ink­ing part­ner­ships to com­mer­cial­ize any drugs that might clear reg­u­la­tors — which was part of the com­pa­ny’s think­ing in spin­ning out Akcea. But in the last cou­ple years, par­tic­u­lar­ly since CEO Brett Mo­nia was ap­point­ed in 2019 and amid block­buster rev­enues from Spin­raza, the phar­ma has be­gun to put more fo­cus on the com­mer­cial side.

“For years we have been rec­og­nized for our ex­cel­lence in re­search, ear­ly drug de­vel­op­ment and sci­en­tif­ic in­no­va­tion,” Mo­nia wrote back in De­cem­ber ahead of the com­pa­ny’s In­vestor Day. “We will now add to this by build­ing a strong and ef­fi­cient com­mer­cial or­ga­ni­za­tion of equal ex­cel­lence. All of which will pro­vide sub­stan­tial ben­e­fit to pa­tients and share­hold­ers for years to come.”

The CEO shared in the fil­ing that So­bi would dis­trib­ute two of its drugs in Eu­rope: Tegse­di, for polyneu­ropa­thy (a con­di­tion where mul­ti­ple pe­riph­er­al nerves be­come dam­aged) in adults with hered­i­tary transthyretin amy­loi­do­sis; and Waylivra, for fa­mil­ial chy­lomi­crone­mia syn­drome, a rare ge­net­ic dis­or­der.

The FDA re­ject­ed Waylivra back in 2018, flag­ging sev­er­al con­cerns in­clud­ing the risk of se­ri­ous bleed­ing and low blood platelet count. Tegse­di and Waylivra have been com­mer­cial dis­ap­point­ments so far, earn­ing Io­n­is just $70 mil­lion in 2020, up from about $42 mil­lion in 2019.

On Tues­day, Io­n­is said it ex­pand­ed its deal with So­bi to in­clude Tegse­di dis­tri­b­u­tion in North Amer­i­ca. And as a re­sult, it’s cut­ting 70% of Akcea’s staffers in the US and Cana­da, pri­mar­i­ly those work­ing on Tegse­di, to “bet­ter align with the im­me­di­ate needs of its busi­ness … and to fo­cus on high pri­or­i­ty pro­grams.” That in­cludes IO­N­IS-TTR-LRx, which in­hibits the pro­duc­tion of transthyretin, the same pro­tein tar­get­ed by Tegse­di.

The re­struc­tur­ing will cost Io­n­is be­tween $11 to $14 mil­lion, ac­cord­ing to an SEC fil­ing. The com­pa­ny ex­pects to save up to $50 mil­lion a year be­gin­ning in 2022 due to the ex­pand­ed So­bi agree­ment, it said in a state­ment.

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Back in April 2019, Amgen quietly shut down a Phase I trial for a drug named AMG 986. There was no safety concern; the molecule just didn’t hit the mark on helping the small band of heart failure patients who received it.

A small biotech, though, believes it would stand a chance in the burgeoning anti-aging field.

BioAge Labs has licensed AMG 986 — now renamed BGE-105 — with plans to parlay the existing IND into a quick Phase I trial teasing out the pharmacodynamic effects and set the stage for mid-stage tests focused on acute muscle indications.

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.