Af­ter a sharp plunge, Epizyme bounces back on some bon­ny fore­casts as shares go on a roller coast­er ride

Robert Baze­more, CEO Epizyme

Yes­ter­day I re­port­ed that Epizyme shares $EPZM took a dive af­ter the com­pa­ny re­port­ed some dis­ap­point­ing da­ta on its DL­B­CL group in an on­go­ing Phase II study of tazeme­to­stat.

But that was just the scary start to a roller coast­er ride that saw the stock shoot back up as an­a­lysts of­fered a thumbs up for oth­er out­comes that have a more up­beat tone.

Leerink’s Ge­of­frey Porges called tazeme­to­stat “one of the most in­trigu­ing small mol­e­cules in the ma­lig­nan­cy field.” He added:

We con­tin­ue to be­lieve that there is a high prob­a­bil­i­ty of ac­cel­er­at­ed ap­proval of tazeme­to­stat for EZH2 mu­tat­ed fol­lic­u­lar lym­phoma, and af­ter spe­cial­ists, in­ves­ti­ga­tors and ex­ec­u­tives come back from the meet­ing, we ex­pect the drug’s pro­file and per­ceived val­ue to rise.

RBC’s Matthew Eck­ler al­so made it clear that he was im­pressed by the FL da­ta.  “As of the 6/1/2017 dat­a­cut, the ORR in the EZH2 mu­tant FL co­hort (n=13) was 92% in­clud­ing 1 CR and 11 PR. DOR da­ta from these pa­tients was still ear­ly, how­ev­er 2 pts showed a re­sponse >10 months and an ad­di­tion­al 9 re­main on study,” he wrote. Eck­ler chimed in:

Bar­ring sig­nif­i­cant dis­ease pro­gres­sion be­tween now and the next up­date (guid­ance is 2018), we think the case for ac­cel­er­at­ed ap­proval in FL re­mains in­tact. Ad­di­tion­al­ly, while ac­knowl­edg­ing the low­ered ORR in mu­tant DL­B­CL, we think tazeme­to­stat still has a shot at ac­cel­er­at­ed ap­proval giv­en DOR re­sults to date in this high­ly re­frac­to­ry pop­u­la­tion.

At one point the stock was up 19%, then start­ed to de­scend and end­ed up 11%.

Stock prices are al­ways a mov­ing tar­get, par­tic­u­lar­ly in this frac­tious mar­ket as Twit­ter of­fers new ways to bloody or beau­ti­fy da­ta. Just be­cause a biotech’s day starts bad­ly doesn’t mean it has to end up that way. Epizyme CEO Robert Baze­more like­ly knows that all too well.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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