As­traZeneca push­es back OS read­out on MYS­TIC to H2; An­thera shares oblit­er­at­ed in re­peat PhI­II flop

→ The much-an­tic­i­pat­ed over­all sur­vival da­ta of As­traZeneca’s $AZN piv­otal lung can­cer tri­al will be de­liv­ered lat­er than ex­pect­ed, the UK drug­mak­er an­nounced this morn­ing. In­vestors will now have to wait un­til the sec­ond half of 2018 for the fi­nal analy­sis of Imfinzi’s im­pact on OS, in­stead of the first half. The re­sults from the MYS­TIC tri­al re­mains a ma­jor cat­a­lyst af­ter the check­point in­hibitor failed to meet the pri­ma­ry end­point of pro­gres­sion-free sur­vival (PFS), send­ing a shock wave to As­traZeneca’s stock prices last Ju­ly. The tri­al tests Imfinzi both as a monother­a­py and in com­bi­na­tion with treme­li­mum­ab against chemother­a­py in first-line non-small cell lung can­cer, an all-im­por­tant are­na in the bat­tle for check­point drug dom­i­nance.

If at first you don’t suc­ceed in biotech, maybe you should just cut your loss­es and move on. That les­son may be top of mind to­day for An­thera $ANTH af­ter re­searchers re­port­ed that its lead drug Sollpu­ra failed a re­peat Phase III study for cas­es of ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy caused by cys­tic fi­bro­sis. The biotech had al­ready felt the sting of in­vestor dis­sat­is­fac­tion when an ear­li­er Phase III al­so failed. This time sci­en­tists had hoped that more agres­sive dos­ing would fix the prob­lem. It didn’t. An­thera’s shares were evis­cer­at­ed, drop­ping 82% and leav­ing the stock deep in pen­ny stock ter­ri­to­ry.

Malvern, PA-based Realm Ther­a­peu­tics says that their Phase II study of a new ther­a­py for al­ler­gic con­junc­tivi­tis failed, forc­ing the biotech to dump the drug. PR013 was a top­i­cal oph­thalmic so­lu­tion. Realm’s shares (AIM: $RLM) took a dive on the news.

→  Ox­ford Uni­ver­si­ty spin­out OxSy­Bio stepped out to­day with a £10 mil­lion ($13.9 mil­lion) Se­ries A round, join­ing the in­creas­ing­ly crowd­ed space of “tis­sue bio­print­ing” star­tups. This one is de­vel­op­ing a 3D print­er tech­nol­o­gy that can print bi­o­log­i­cal ma­te­ri­als, with the ul­ti­mate goal of mak­ing ther­a­peu­tic tis­sues for pa­tients. This is not un­like the goals of San Diego’s more ma­ture Organo­vo, or the rel­a­tive new­com­er Ste­moniX. OxSy­Bio was found­ed back in 2014 on re­search con­duct­ed in the lab of Pro­fes­sor Ha­gan Bay­ley, the found­ing aca­d­e­m­ic be­hind Ox­ford Nanopore Tech­nolo­gies. The new fi­nanc­ing round was led by Wood­ford In­vest­ment Man­age­ment along­side new and ex­ist­ing back­ers, ac­cord­ing to a com­pa­ny state­ment.


With ad­di­tion­al re­port­ing by Brit­tany Meil­ing and Am­ber Tong.

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.

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 Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

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.