The FDA is forc­ing a small an­tibi­ot­ic play­er back to the clin­ic for a new tri­al — 10 years af­ter first re­jec­tion

Mo­tif Bio $MTFB got a clear enough an­swer from the FDA on what reg­u­la­tors will need to see be­fore they re­con­sid­er an OK on their an­tibi­ot­ic iclaprim. And it’s not what their dwin­dling band of in­vestors want­ed to hear.

The lit­tle biotech con­fi­dent­ly re­port­ed Thurs­day morn­ing that the FDA is re­quir­ing an­oth­er clin­i­cal tri­al to clear up its stub­born con­cerns about the po­ten­tial for liv­er tox­i­c­i­ty — a worst case sce­nario that will once again sig­nif­i­cant­ly de­lay a pro­gram that has been try­ing to make a come­back at the agency for the past decade. 

Gra­ham Lums­den Linkedin

CEO Gra­ham Lums­den says they’ll now be go­ing back to the FDA to de­fine the size of the tri­al need­ed, so they can go about bud­get­ing for it.

“(W)e ex­pect to con­tin­ue our dis­cus­sions with po­ten­tial com­mer­cial part­ners and will de­ter­mine the best op­tions for fund­ing the tri­al once we have clar­i­ty from the FDA,” he added in a pre­pared state­ment.

That’s a tall or­der for a com­pa­ny that built its stock price up past the $10 mark on con­fi­dent ex­pec­ta­tions of win­ning an OK for acute bac­te­r­i­al skin and skin struc­ture in­fec­tions, or AB­SS­SI, and rolling it out in­to the mar­ket. This morn­ing the al­ready bat­tered and bruised stock suf­fered a fresh 41% plunge as they moved down clos­er to the $1 mark.

The over­all drop has erased about 90% of its share val­ue over the past few months.

The an­tibi­ot­ic has been hob­bled by safe­ty con­cerns for years. The FDA punt­ed back the orig­i­nal ap­pli­ca­tion from Roche spin­out Arp­i­da 10 years ago, cit­ing an im­bal­ance in deaths as well as QT pro­lon­ga­tion. And now lit­tle Mo­tif, which has sig­naled it’s run­ning out of cash, will try to do a deal or raise mon­ey with its back against the wall.

An­tibi­otics, in gen­er­al, have suf­fered a num­ber of re­jec­tions at the hands of the FDA in re­cent years. And those that do get past reg­u­la­tors face a cru­el mar­ket, where cheap gener­ics dom­i­nate. 


Im­age: An­drew Harnik AP

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.