Roche ex­ec Pearl Huang re­joins biotech as CEO of Cyg­nal — Flag­ship's bet on 'ex­oneur­al bi­ol­o­gy'

Mark Pearl Huang down as the lat­est il­lus­tri­ous phar­ma ex­ec to take charge of a biotech.

Jump­ing from Roche — where she was the SVP and glob­al head of ther­a­peu­tic modal­i­ties, over­see­ing every­thing from small mol­e­cule to nu­cle­ic acid-based ther­a­pies — Huang has been tapped as the CEO of Cyg­nal Ther­a­peu­tics.

A prod­uct of Flag­ship Pi­o­neer­ing’s in­no­va­tion foundry, Cyg­nal is tar­get­ing mech­a­nisms and path­ways as­so­ci­at­ed with the pe­riph­er­al ner­vous sys­tem, a struc­ture of nerves work­ing out­side the cen­tral ner­vous sys­tem, plough­ing a field they call “ex­oneur­al bi­ol­o­gy.”

“Cyg­nal has un­cov­ered one of the most ex­cit­ing new ap­proach­es to can­cer ther­a­peu­tics that I have seen in al­most 30 years in the in­dus­try,” Huang said, re­fer­ring to a ca­reer that’s spanned se­nior drug dis­cov­ery roles at Glax­o­SmithK­line, Mer­ck and Roche.

While this marks Huang’s first CEO ap­point­ment, her first en­try in­to biotech came ear­li­er in 2010, when she co-found­ed BeiGene — a pi­o­neer among a now-abun­dant class of Chi­na-based biotechs — and steered its first pro­grams in­to the clin­ic as act­ing CSO.

Huang, who’s al­so join­ing Flag­ship as a ven­ture part­ner, is now tasked with build­ing out a pipeline for Cyg­nal, start­ing with can­cer — the area she’s had most ex­pe­ri­ence with — to in­flam­ma­tion and au­toim­mune dis­ease down the line.


Im­age: Pearl Huang. Ken Richard­son, CYG­NAL

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”