Nek­tar takes a hit as the FDA swerves away from opi­oid re­views — leav­ing NK­TR-181 in lim­bo

Nek­tar Ther­a­peu­tics took an­oth­er hit on Thurs­day af­ter the biotech re­port­ed that its opi­oid pain drug NK­TR-181 was be­ing put on hold at the FDA.

In an SEC fil­ing the com­pa­ny re­port­ed that the agency “con­tin­ues to con­sid­er a num­ber of sci­en­tif­ic and pol­i­cy is­sues re­lat­ing to this class of drugs” and would be post­pon­ing their planned Ad­Comm next month. Their Au­gust 29 PDU­FA date? Well, the FDA might not meet that.

The stock $NK­TR was hurt, end­ing the day down 7%, as in­vestors re­act­ed to the buzz.

For Nek­tar, which had spun this drug off in­to sub­sidiary op­er­a­tion — af­ter ini­tial­ly look­ing hard for a part­ner to come in and pick it up — it was an­oth­er blow for a drug that they have billed as a block­buster-in-the-mak­ing.

An­a­lysts, though, have come up with a wide range of peak sales fig­ures for this drug — rang­ing from pal­try to huge. But just about all of them agree it’s a bit of a sideshow com­pared to NK­TR-214, which has had its own prob­lems.

Jef­feries’ David Stein­berg says he now ex­pects a 1-year de­lay for the en­try of the drug and lop off 30% of its peak rev­enue — trim­ming that to $350 mil­lion.

Im­por­tant­ly, there is no in­di­ca­tion that the FDA will no longer ap­prove opi­oids for pain man­age­ment at this point – al­though that al­ways re­mains a pos­si­bil­i­ty giv­en the sever­i­ty of the cur­rent cri­sis. And we con­tin­ue to view NK­TR-181 as a mean­ing­ful, safer treat­ment op­tion for pa­tients suf­fer­ing from chron­ic pain…

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

Vas Narasimhan, Getty Images

No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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Jeff Jonas, Sage

UP­DAT­ED: Sage's star ex­per­i­men­tal de­pres­sion drug fails the cru­cial MOUN­TAIN study — shares crash

Sage Therapeutics’ crucial MOUNTAIN study for Sage-217 has failed, setting the stage for a quick and ugly investor backlash.

Widely viewed by analysts as the critical clinical study $SAGE needed to win on major depression, researchers say the drug failed to beat out a placebo at day 15, falling well short of the mark for statistical significance on the primary endpoint. And investors reacted with alacrity, fleeing the stock and gutting the price with a 60% instantaneous drop — erasing about $4.6 billion in market cap in an instant.

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Lon Schneider, USC

Bio­gen comes un­der re­newed fire as a lead­ing Alzheimer's ex­pert rais­es se­ri­ous ques­tions about the ad­u­canum­ab da­ta

Biogen execs have lots of explaining to do later this week if they expect to hold on to the massive upswing in market cap $BIIB the big biotech experienced with their upbeat assessment of their chances of winning an FDA approval of aducanumab as the first disease-modifying therapy for Alzheimer’s — widely considered the golden ticket in R&D today for a megablockbuster market.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

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Sue Desmond-Hell­mann says it's time for her to leave the Gates Foun­da­tion. Strat­e­gy chief Mark Suz­man will now take the helm

Sue Desmond-Hellmann, the longtime researcher and executive who helped lead Genentech to develop the first gene-targeted cancer therapies, is stepping down after 5 years as CEO of the Bill & Melinda Gates Foundation.

“Stepping down as CEO of@GatesFoundation is, without a doubt, the toughest decision of my career,” she wrote in the first of a series of tweets announcing and reflecting on her departure. “But one of my mantras is ‘take your own pulse first.’ Over the last few months, I’ve done just that and concluded that I need to slow down.”

Vivek Ra­maswamy’s En­zy­vant is hit with a CRL for man­u­fac­tur­ing — de­lay­ing a new ther­a­py for an ul­tra-rare killer

It was supposed to be Vivek Ramaswamy’s first drug approval, but the regenerative med company he set up to advance a new tissue-based approach to treating an ultra-rare condition in newborns has been hit with a complete response letter from the FDA.

The FDA rejected Enzyvant’s RVT-802, which set out to become the only therapy sanctioned to treat cases of pediatric congenital athymia — a condition marked by extreme immune deficiency.

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Serafim Batzoglou, insitro

Daphne Koller's AI start­up ends wide search for a da­ta chief, tap­ping Stan­ford's Ser­afim Bat­zoglou for the job

A few months back, Illumina VP Serafim Batzoglou got an invite from the woman who had first hired him at Stanford two decades prior: Daphne Koller.

Koller had been searching for months for a chief data officer for her new artificial intelligence biotech insitro. On stage, she spoke about how hard it was to find someone who understood AI and biology and how developing the right people in her field posed as big a challenge as developing the right data.