Tread­ing on Nas­daq turf, NYSE cuts list­ing fees to woo biotech

By cut­ting its fees for com­pa­nies with lit­tle to no rev­enue, the New York Stock Ex­change (NYSE) is lay­ing the ground­work to break Nas­daq’s strong hold on the biotech in­dus­try.

Cheap­er list­ing fees, rel­a­tive­ly lax list­ing stan­dards and the chance to be fea­tured on the Nas­daq Biotech­nol­o­gy In­dex has tra­di­tion­al­ly made Nas­daq the biotech list­ing venue of choice. The ra­tio­nale is sound: Drug de­vel­op­ment is not cheap, and ne­ces­si­tates pa­tience. Biotech firms are typ­i­cal­ly in the red for years be­fore they are ready to take their first drug across the fin­ish line.

NYSE’s new rules — which will re­duce the fees for com­pa­nies with an­nu­al rev­enue of less than $5 mil­lion and have a mar­ket cap­i­tal­iza­tion of at least $200 mil­lion — are set to go in­to force next month. The bourse is of­fer­ing such firms a 75% dis­count off its an­nu­al list­ing fee, as well as cap­ping an­nu­al list­ing fees at $100,000, for three years, NYSE dis­closed in an SEC fil­ing.

“We are pro­vid­ing an im­proved on-ramp for biotech com­pa­nies look­ing to ac­cess the pub­lic mar­kets,” said John Tut­tle, NYSE chief op­er­at­ing of­fi­cer, in an emailed state­ment to End­points News.

The largest com­pa­nies pay as much as $500,000 a year to list on the NYSE, while the Nas­daq — which in­vent­ed elec­tron­ic trad­ing in 1971 — caps its list­ing fees at $155,000. NYSE has long lost out to its main ri­val due to its stricter list­ing stan­dards, but it has been tak­ing steps to re­lax those re­quire­ments to take a bite out of Nas­daq’s stran­gle­hold on cer­tain in­dus­tries.

Over­all, health-and-care fo­cused firms — in­clud­ing biotechs, phar­ma­ceu­ti­cals, med­ical de­vice mak­ers, health­care ser­vices and health in­sur­ers — have over­whelm­ing­ly pre­ferred list­ing on Nas­daq, whose web­site shows 757 such com­pa­nies have cho­sen the stock ex­change. Mean­while, a mere 105 have adopt­ed NYSE.

In fact, since the Hong Kong stock ex­change opened up the list­ing regime to pre-rev­enue biotechs, nine com­pa­nies — in­clud­ing one CRO gi­ant — have joined the bourse in the past year, the South Chi­na Morn­ing Post re­port­ed last month. These com­pa­nies col­lec­tive­ly have raised $3.8 bil­lion in IPO pro­ceeds — mak­ing Hong Kong the sec­ond largest pub­lic biotech hub world­wide af­ter Nas­daq, the re­port not­ed, cit­ing Re­fini­tiv da­ta.

Bi­cy­cle Ther­a­peu­tics made its Nas­daq de­but on Thurs­day, mark­ing the 16th biotech IPO of 2019 — con­tribut­ing to a to­tal of $1.6 bil­lion raised so far. Each of these 16 pre-rev­enue drug de­vel­op­ers has cho­sen to align it­self with Nas­daq.

Im­age: SHUT­TER­STOCK

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Yanay Ofran (L) and Anat Binur (Ukko)

Leaps by Bay­er backs a pro­tein en­gi­neer­ing start­up tak­ing on Aim­mune — and Nestlé — in peanut al­ler­gy

Little capsules of peanut powder drove Nestlé’s $2.6 billion buyout of Aimmune. Now, with $40 million in new funding, a fledgling biotech is promising to bring a more sophisticated version of that protein therapy that can go much, much further.

Ukko’s goal is two-pronged — with the initial products spanning therapeutic and food — but it’s grounded in the same protein engineering platform, co-founder and CEO Anat Binur told Endpoints News.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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As tar­get­ed ther­a­pies get ever more pre­cise, Deer­field un­veils $50M bet on an Har­vard pro­fes­sor's chem­istry in­sights

Behind the seemingly simple concept of targeted cancer therapies is the drug developer’s headache that the target is always changing. Each generation of kinase inhibitors may be ostensibly hitting the same oncogene, but in addition to blocking the wildtype oncogene, they must now also address the mutations that have developed along the way, spurring resistance to current drugs.

The more those target kinases evolve, too, the more they could resemble off-target kinases you don’t want to bind. So each iteration requires more selectivity — sometimes down to differences of a few atoms.