Uni­corn Mod­er­na joins line­up to list on Hong Kong's ex­change; Proces­sa li­cens­es com­pound from Con­cert

→ Ru­mors are fly­ing that biotech’s biggest uni­corn, Mod­er­na, which was re­cent­ly val­ued at $7 bil­lion, is plan­ning a dual IPO list­ing on both the Nas­daq and the Hong Kong ex­changes. That’s ac­cord­ing to a Wall Street Jour­nal re­port, which cites un­named sources fa­mil­iar with the com­pa­ny’s plans. The list­ing, they say, could be as ear­ly as next year. Mod­er­na would be one of sev­er­al biotechs lin­ing up to list on Hong Kong’s ex­change, which just re­cent­ly an­nounced a rule change that would al­low life sci­ence star­tups to list. An­nounced in De­cem­ber (and tak­ing ef­fect this year), the rule change will al­low com­pa­nies that haven’t earned rev­enue or prof­it to ap­ply for IPOs in Hong Kong — as long as they’re val­ued at HK$1.5 bil­lion (US$192 mil­lion). The com­pa­nies must meet some cri­te­ria first, like be­ing at least 2 years old and hav­ing some patents. An­oth­er biotech uni­corn, Grail, which has raised over $1 bil­lion and whose back­ers in­clude GV (for­mer­ly Google Ven­tures) and Bill Gates, is al­so gear­ing up for a $500 mil­lion Hong Kong list­ing. The rules for the Hong Kong ex­change are ex­pect­ed to be fi­nal­ized in late April. When the gate lifts, we ex­pect to see lots of biotechs trot­ting through.

→ Hanover, Mary­land-based Proces­sa Phar­ma­ceu­ti­cals has picked up a li­cense for a com­pound called CTP-499, which it says has po­ten­tial for mul­ti­ple phar­ma­co­log­i­cal tar­gets. First, the com­pa­ny says its tack­ling a chron­ic, dis­fig­ur­ing con­di­tion called Necro­sis Lipoidi­ca (NL). “The Proces­sa de­vel­op­ment team has al­ready met with the FDA on NL and has a sol­id strat­e­gy for mov­ing for­ward with the de­vel­op­ment of CTP-499 in NL start­ing with a Phase II clin­i­cal tri­al in NL pa­tients in 2018,” said Proces­sa’s CEO David Young in a state­ment. “We al­so hope to meet with the FDA on a sec­ond clin­i­cal stage in­di­ca­tion for CTP-499 in the next few months.” For the li­cense, Proces­sa is pay­ing $8 mil­lion in shares to Con­cert Phar­ma­ceu­ti­cals. Con­cert is el­i­gi­ble to re­ceive roy­al­ties on com­mer­cial sales.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Gos­samer push­es ahead with failed asth­ma drug; Cull­gen gets $50M Se­ries B for pro­tein de­graders

After getting beaten up by investors over the key failure of its lead drug GB001, Gossamer had already indicated that they thought they could move ahead in asthma, though likely through a partnership. And the biotech is pushing forward on that front, according to a Q4 statement today, following talks with regulators.

The company reported:

Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.