Myrtle Potter, Sumitovant CEO (Sumitovant)

An ex-Vant fur­ther im­mers­es it­self in a new um­brel­la, cash­ing out in a $584M M&A deal with Sum­it­o­mo Dainip­pon sub­sidiary

A for­mer Vivek Ra­maswamy biotech is be­ing brought clos­er in­to its new own­er’s fam­i­ly of com­pa­nies.

Sum­i­to­vant, the um­brel­la sub­sidiary of Sum­it­o­mo Dainip­pon that bought five of Ra­maswamy’s “Vants” in Sep­tem­ber 2019, is plan­ning on ful­ly ac­quir­ing Urovant Sci­ences $UROV for $584 mil­lion in an all-cash deal, the com­pa­nies an­nounced Thurs­day af­ter­noon. The merg­er val­ues Urovant at $16.25 per share, a 96% pre­mi­um on the biotech’s clos­ing price of $8.28 on Thurs­day.

In­vestors jumped at the news, with the stock soar­ing 93% in af­ter-hours trad­ing to near­ly meet that pre­mi­um. The deal is ex­pect­ed to close some­time in the first quar­ter of 2021, and pri­or to the ac­qui­si­tion, Sum­i­to­vant owned a rough­ly 72% stake in Urovant.

Urovant — fo­cus­ing on uri­nary dis­eases — was among the five biotechs that Ra­maswamy sold off to Sum­it­o­mo Dainip­pon a lit­tle over 14 months ago, a group that in­clud­ed My­ovant (women’s health and prostate can­cer), En­zy­vant (pe­di­atric rare dis­eases), Al­ta­vant (res­pi­ra­to­ry rare dis­eases) and Spirovant (pul­monary dis­eases). The 2019 deal brought in $3 bil­lion for Ra­maswamy, and in­clud­ed the op­tion of buy­ing an­oth­er 6 of his star­tups.

Af­ter that trans­ac­tion closed, Sum­it­o­mo Dainip­pon es­tab­lished Sum­i­to­vant in De­cem­ber 2019 as the new par­ent com­pa­ny to man­age the Vants. Un­der Thurs­day’s ac­qui­si­tion, Urovant will merge with a sub­sidiary of Sum­i­to­vant and be­come whol­ly owned by the com­pa­ny.

James Robin­son

Urovant’s pri­ma­ry drug can­di­date is vibegron, whose date at the FDA is right around the cor­ner on Dec. 26. That could set up a launch in ear­ly 2021, CEO James Robin­son said in a state­ment.

Vibegron is a once-a-day pill that aims to treat over­ac­tive blad­der. A be­ta-3 ag­o­nist, vibegron claimed a Phase III win back in March 2019 when it hit both co-pri­ma­ry end­points and 7 sec­ondary end­points com­pared to place­bo. But ques­tions re­mained over its po­ten­tial ef­fi­ca­cy over a cheap gener­ic called toltero­dine used as an ac­tive com­para­tor, send­ing Urovant’s stock down at the time.

De­spite vibegron achiev­ing “nu­mer­i­cal­ly bet­ter ef­fi­ca­cy than toltero­dine,” re­searchers did not run a p-val­ue for the Urovant drug against the gener­ic. Ra­maswamy orig­i­nal­ly bagged the drug in a small $25 mil­lion deal from Mer­ck, and Urovant is al­so eval­u­at­ing it in OAB in men with be­nign pro­sta­t­ic hy­per­pla­sia and for ab­dom­i­nal pain as­so­ci­at­ed with ir­ri­ta­ble bow­el syn­drome.

Should the FDA wave through vibegron next month, it would be­come one of the mul­ti­ple drugs with­in the Sum­i­to­vant um­brel­la that Ra­maswamy pre­dict­ed would reach ap­proval by 2022. Ra­maswamy re­mains on the board of Sum­i­to­vant.

Urovant has a gene ther­a­py pro­gram al­so in the pipeline called hMaxi-K, which is be­ing re­searched for pa­tients with OAB symp­toms who have failed oral phar­ma­co­log­ic ther­a­py.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.