News brief­ing: Gy­ro­scope and Ta­laris set IPO terms; FDA grants ex­pand­ed nod to Chiesi's sick­le cell drug

In a week where two biotech IPOs were al­ready ex­pect­ed, an­oth­er two prospec­tive en­trants have set their de­but terms ahead of their launch lat­er this week.

Gy­ro­scope Ther­a­peu­tics and Ta­laris Ther­a­peu­tics each set IPO terms Mon­day morn­ing. Gy­ro­scope, based out of the UK, is plan­ning to of­fer 6.8 mil­lion ADSs at a price range of $20 to $22, while Ta­laris ex­pects to of­fer 8.8 mil­lion shares be­tween $16 and $18 each.

Should every­thing go ac­cord­ing to plan, Gy­ro­scope will pull in about $142 mil­lion while Ta­laris will raise rough­ly $150 mil­lion.

Both of those fig­ures are high­er than their ini­tial S-1 es­ti­mates of $100 mil­lion each, though that fig­ure has be­come a place­hold­er with the flood of biotechs en­ter­ing the mar­ket over the last 16 months or so.

Last year’s pan­dem­ic IPO boom hasn’t lost any steam in 2021, with 50 com­pa­nies hav­ing filed or priced their IPOs so far this year. Gy­ro­scope and Ta­laris are ex­pect­ed to join Val­ne­va and Aneb­u­lo in their de­buts lat­er this week, bring­ing the to­tal com­bined IPO raise close to $7 bil­lion, per the End­points News tal­ly. That fig­ure is well on pace to eclipse the amount raised in 2020 of $16 bil­lion-plus, which set a record for the biotech in­dus­try. — Max Gel­man

FDA grants sick­le cell ap­proval to Chiesi, ex­pand­ing use

Chiesi Glob­al Rare Dis­eases re­ceived FDA ap­proval for its sick­le cell dis­ease drug Fer­riprox, the com­pa­ny an­nounced Sat­ur­day.

The ap­proval ex­pands the use of the drug for pa­tients with sick­le cell or oth­er ane­mias, as well as pa­tients with tha­lassemia re­gard­less of pri­or iron chela­tion ex­po­sure. Fer­riprox is an oral­ly ac­tive agent that has proved ef­fec­tive in re­duc­ing iron con­cen­tra­tion by re­mov­ing tox­ic iron from or­gan tis­sues and ex­tra­cel­lu­lar flu­ids. The drug is tak­en as a 1,000 mg, twice-dai­ly tablet.

“We be­lieve that de­liv­er­ing an iron chela­tion ther­a­py that has no dosage ad­just­ment re­quired for pa­tients with mild to se­vere re­nal im­pair­ment may ad­dress a sig­nif­i­cant un­met need in SCD,” CEO Gi­a­co­mo Chiesi said in a state­ment.

The good news comes just days af­ter Chiesi and part­ner Pro­tali Bio­ther­a­peu­tics re­ceived a com­plete re­sponse let­ter Wednes­day for their Fab­ry dis­ease hope­ful. — Josh Sul­li­van

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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