As­cen­t­age soars dur­ing its first day on the Hong Kong ex­change, fol­low­ing $53M de­but

As­cen­t­age Phar­ma’s IPO boun­ty might have been mod­est com­pared to pre­vi­ous pub­lic de­buts on the Hong Kong stock ex­change, but it’s prov­ing pop­u­lar among in­vestors on its first trad­ing day.

The Suzhou-based biotech soared as much as 57% ear­ly Mon­day af­ter com­plet­ing a $53 mil­lion raise on Fri­day, Bloomberg not­ed. The launch price of HK$34.2 (around $4.36) fell in the mid­dle of the range, trans­lat­ing to a mar­ket cap of al­most $890 mil­lion. As­cen­t­age’s stock end­ed the day at HK$37.6.

Its list­ing kicks up some ac­tion in the rel­a­tive­ly qui­et biotech cor­ner of HKEX, which last saw Shang­hai Hen­lius reap $410 mil­lion in Sep­tem­ber — the city’s largest float since the sum­mer.

At 9 years old, As­cen­t­age is a well-known name in the Chi­nese biotech cir­cle that brought in $150 mil­lion in a Se­ries C last year be­fore it first filed for an IPO. Sino Bio­pharm — a con­glom­er­ate al­so list­ed on HKEX — was a cor­ner­stone in­vestor, join­ing Yuan­Ming, Oriza Seed Ven­ture Cap­i­tal, Teng Yue Part­ners, Ar­row­Mark Part­ners, HDY In­ter­na­tion­al In­vest­ment, CTS Cap­i­tal and CCB In­ter­na­tion­al in back­ing the com­pa­ny.

Much of the pro­ceeds are ex­pect­ed to go to­ward HQP1351, its lead drug tar­get­ing BCR-ABL-mu­ta­tions in chron­ic myeloid leukemia pa­tients who’ve de­vel­oped re­sis­tance to ty­ro­sine ki­nase in­hibitors. It’s in Phase II tri­als in Chi­na and As­cen­t­age has se­cured an IND from the FDA to run a glob­al de­vel­op­ment pro­gram in par­al­lel.

In its fil­ing, the com­pa­ny sin­gled it out as the on­ly as­set with mon­ey al­lo­cat­ed for com­mer­cial­iza­tion, though it’s al­so ear­mark­ing some cash to its oth­er pro­grams, which cov­er a va­ri­ety of can­cers as well as he­pati­tis B and dry AMD.

While CEO Da­jun Yang orig­i­nal­ly found­ed As­cen­t­age’s R&D op­er­a­tions around his apop­to­sis ex­per­tise — at­tract­ing Uni­ty Biotech­nol­o­gy to a part­ner­ship cen­tered around ag­ing — he’s al­so made next-gen ki­nase in­hibitors a fo­cal point. One of the core drugs in this group, of the c-Met re­cep­tor va­ri­ety, was picked up from Mer­ck for just $500,000 up­front.

Spread out be­tween Chi­na, the US and Aus­tralia, As­cen­t­age planned to build the team up to 400 by the end of this year. An R&D cen­ter and man­u­fac­tur­ing fa­cil­i­ty are in the works on its home turf, which are ex­pect­ed to be com­plet­ed by 2019 and 2020, re­spec­tive­ly.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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