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.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.