Stuck on FDA hold, Reg­u­lus CEO hits the ex­it as re­or­ga­ni­za­tion slash­es staff at the be­lea­guered biotech

With their lead drug stuck on a full clin­i­cal hold and no hope of re­lief be­fore the end of this year — a year af­ter it had ini­tial­ly fore­cast the end of its spell in pur­ga­to­ry — Reg­u­lus Ther­a­peu­tics $RGLS is bid­ding good­bye to its CEO (again) and slash­ing staff.

Jay Ha­gan

Af­ter the mar­ket closed on Thurs­day the be­lea­guered com­pa­ny an­nounced plans to cut its head­count by 30%, or ap­prox­i­mate­ly 30 staffers af­ter it list­ed 97 em­ploy­ees at the end of 2016. CEO Paul Grint, who stepped up from the CMO’s job af­ter found­ing CEO Klean­this Xan­thopou­los re­signed in 2015, is leav­ing the com­pa­ny, with COO Jay Ha­gan re­plac­ing him at the helm.

Reg­u­lus was cre­at­ed in 2007 as a joint ven­ture be­tween Al­ny­lam and Io­n­is, then called Isis, with a spe­cial fo­cus on mi­croR­NA ther­a­pies.

The new CEO’s first task was to re­as­sure in­vestors that the com­pa­ny is squared away and fo­cused on hit­ting its marks with a sec­ond ther­a­py, RG-012. But the mes­sage didn’t sit well with its in­tend­ed au­di­ence.

The biotech’s stock cratered again, drop­ping 30% on the news of the lat­est set­back and chang­ing of the guard. It’s now trad­ing at a lit­tle more than a dol­lar a share, just a frac­tion of what it was two years ago.

Lead drug RG-101 went on full clin­i­cal hold last sum­mer af­ter a sec­ond pa­tient came down with jaun­dice. Grint in­sist­ed that the team could get all of the agency’s ques­tions an­swered by the 4th quar­ter of 2016, then in Jan­u­ary said that the FDA want­ed more safe­ty and ef­fi­ca­cy da­ta that wouldn’t be avail­able un­til the 4th quar­ter of this year.

Things looked con­sid­er­ably bet­ter a year ago when RG-101 ap­peared to look good in a small Phase II study for hep C, with high cure rates. Now the en­tire mar­ket is ex­pe­ri­enc­ing a swoon as lead­ers like Gilead cure pa­tients at a faster pace than they can be di­ag­nosed. RG-101 had po­ten­tial to cure pa­tients in just a few weeks, but that added val­ue is shrink­ing steadi­ly in sig­nif­i­cance to pay­ers.

Reg­u­lus had $57.5 mil­lion at the end of the first quar­ter, with plans to cir­cle its wag­ons around a Phase II study for RG-012 for Al­port syn­drome, a ge­net­ic con­di­tion that trig­gers the grad­ual loss of kid­ney func­tion. Net loss for the first quar­ter was $20 mil­lion.

“We are very grate­ful for the lead­er­ship of Dr. Grint and the many con­tri­bu­tions of our oth­er im­pact­ed em­ploy­ees who have ded­i­cat­ed them­selves to Reg­u­lus’ ef­forts in ad­vanc­ing the sci­ence of mi­croR­NAs,” said Ste­lios Pa­padopou­los, the com­pa­ny’s board chair­man.  “We are con­fi­dent that Reg­u­lus is well po­si­tioned for suc­cess un­der Jay’s guid­ance.”

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus pric­ing just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a plan to near­ly dou­ble its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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