Af­ter get­ting start­ed in 2017 with a $25 mil­lion launch round, Fu­sion Phar­ma­ceu­ti­cals has bagged a $105 mil­lion mega round to ad­vance their work on new ra­dio­phar­ma­ceu­ti­cals, a field that has gar­nered new at­ten­tion as No­var­tis builds up its pipeline in the same are­na.

Their lead drug, now sit­ting on the thresh­old of Phase I, us­es an an­ti­body to guide al­pha-par­ti­cle emit­ting med­ical iso­topes to can­cer cells, cre­at­ing a kind of flash grenade of lo­cal­ized ra­di­a­tion to kill ma­lig­nant cells. And they’re tout­ing an in-house plat­form tech for link­ers they say will help pa­tients clear their bod­ies of med­ical iso­topes that aren’t bound to can­cer cells.

Chau Khuong

Var­i­an and Or­biMed are lead­ing the round for the com­pa­ny, with fa­cil­i­ties in Cana­da and Boston. And they’ve been joined by a big syn­di­cate, in­clud­ing new in­vestors Per­cep­tive Ad­vi­sors, Piv­otal bioVen­ture Part­ners and Rock Springs Cap­i­tal. They joined Health­cap, Adams Street Part­ners, J&J In­no­va­tion, TPG Biotech, Ser­o­ba Life Sci­ences, Genesys Cap­i­tal and FAC­IT.

“There is sig­nif­i­cant re-emerg­ing com­mer­cial in­ter­est in ra­dio­phar­ma­ceu­ti­cals giv­en re­cent ad­vances in the field and Fu­sion is at the fore­front,” claimed Or­biMed’s Chau Khuong in a pre­pared state­ment.

No­var­tis has helped spot­light the field with a se­ries of new in­vest­ments. Late last year, weeks af­ter the phar­ma gi­ant snapped up En­do­cyte and its ra­dioiso­tope drug Lu-PS­MA-617 in a $2.1 bil­lion deal — adding it to the Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions group it ac­quired a lit­tle more than a year ago for $3.9 bil­lion — its deal­mak­ing crew added glob­al rights to a new ra­dio­phar­ma­ceu­ti­cal called FF-10158 for on­col­o­gy in­di­ca­tions.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

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.