Pablo Legorreta, Royalty Pharma CEO (Photographer: Patrick T. Fallon/Bloomberg via Getty Images)

Pablo cap­i­tal­ized: Roy­al­ty Phar­ma scores $2.2B IPO — the biggest of the year

A phar­ma IPO has snatched the crown for the largest US list­ing of the year.

Roy­al­ty Phar­ma raised $2.2 bil­lion — the ex­act amount out­lined in the lat­est fil­ing — by pric­ing at $28 per share, the top of the range. On its first day on the Nas­daq, it’s val­ued at $16.67 bil­lion.

The com­pa­ny jumped from rel­a­tive ob­scu­ri­ty to (biotech) house­hold fame in less than three weeks, as CEO Pablo Legor­re­ta re­vealed to Wall Street, af­ter 24 years of shy­ing away from the lime­light, just how much rev­enue the world’s biggest buy­er of drug roy­al­ties can bring in.

De­spite nev­er de­vel­op­ing a drug of its own, Roy­al­ty Phar­ma played a cru­cial role in see­ing some fa­mil­iar block­busters through, of­fer­ing $3.3 bil­lion to the Cys­tic Fi­bro­sis Foun­da­tion for its roy­al­ties on Ver­tex’s fran­chise and $2.85 bil­lion to Bio­gen to share rev­enue from the mul­ti­ple scle­ro­sis drug Tysabri, among oth­ers.

The cur­rent port­fo­lio, built on $18 bil­lion of hard cash, spans 45 com­mer­cial prod­ucts plus three ex­per­i­men­tal drugs in late-stage de­vel­op­ment.

Roy­al­ty Phar­ma’s float marks the sec­ond largest phar­ma IPOs ever, Reuters re­port­ed, trail­ing on­ly be­hind Zoetis (the an­i­mal health-fo­cused Pfiz­er spin­off). It leads a string of health­care com­pa­nies slat­ed for pub­lic de­buts this week. None are near­ly as big — two are ear­ly-stage biotechs and two are di­ag­nos­tics play­ers — but all ben­e­fit from a pan­dem­ic IPO boom that shows no sign of re­ced­ing just yet.

Legor­re­ta kept a siz­able chunk of stock $RPRX for him­self, now worth well over $1 bil­lion. But he’s still got plen­ty on his plate in what he calls the gold­en age for in­no­v­a­tive fi­nanc­ings in biotech.

“There are so many dif­fer­ent ther­a­peu­tic class­es that still re­quire huge in­vest­ment,” he said at the Milken In­sti­tute con­fer­ence in 2018, as quot­ed by Forbes. “Alzheimer’s for ex­am­ple, and many oth­er dis­eases. It is a shame to see how the in­dus­try has with­drawn from many of those ar­eas … We have to be a lit­tle bit more thought­ful the way we go ahead.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.