A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

Rockville, MD-based CASI Phar­ma­ceu­ti­cals has in-li­censed an an­ti-CD19 T cell ther­a­py from Chi­na’s Ju­ven­tas. CASI is mak­ing an $11.6 mil­lion in­vest­ment in Ju­ven­tas in lieu of an up­front pay­ment. They’ll joint­ly con­tin­ue the de­vel­op­ment work.

Flex Phar­ma is hav­ing a lit­tle bit of trou­ble in ex­e­cut­ing its re­verse merg­er deal with Salarius Phar­ma­ceu­ti­cals. The failed biotech $FLKS says it needs to see more votes cast by share­hold­ers af­ter fail­ing to achieve a quo­rum — in per­son or proxy — at a spe­cial meet­ing. Its be­lea­guered shares dropped 24% to a mere 49 cents in pre-mar­ket trad­ing on Mon­day.

Ar­bu­tus Bio­phar­ma tapped William Col­lier as its next pres­i­dent and CEO. Col­lier suc­ceeds Mark Mur­ray, who is re­tir­ing on June 23. Col­lier has had over 30 years of ex­pe­ri­ence in the phar­ma­ceu­ti­cal in­dus­try. He served as pres­i­dent and gen­er­al man­ag­er, North Amer­i­ca at Vi­iV Health­care, in ad­di­tion to a stint at GSK $GSK as well. 

→ Med­ical ge­net­ics com­pa­ny, In­vi­tae Cor­po­ra­tion, is set to ac­quire Sin­gu­lar Bio to help in­crease ac­cess to ge­net­ic screen­ing in ear­ly preg­nan­cy. Sin­gu­lar Bio is “a pri­vate­ly held com­pa­ny de­vel­op­ing sin­gle mol­e­cule de­tec­tion tech­nol­o­gy that en­ables low­er costs and ex­pand­ed use of high-qual­i­ty, cell-free nu­cle­ic acid analy­sis, ini­tial­ly for ap­pli­ca­tion in non-in­va­sive pre­na­tal screen­ing (NIPS).”

In­cyte $IN­CY on Sat­ur­day pre­sent­ed 24-week re­sults from a mid-stage study of its JAK in­hibitor rux­oli­tinib, which showed the drug met the main goal of in­duc­ing ≥50% im­prove­ment in the fa­cial vi­tili­go. “This 24-week in­ter­val was the first part of a 3-part, 104-week study, and await 52- and 104-week da­ta to con­firm the safe­ty and ef­fi­ca­cy seen this week­end,” Cred­it Su­isse an­a­lysts wrote in a note. 

Calithera $CALA on Mon­day broke out da­ta from a mid-stage study test­ing its glu­t­a­m­i­nase in­hibitor, tela­gle­na­s­tat, in com­bi­na­tion with chemother­a­py everolimus. The tela­gle­na­s­tat com­bi­na­tion achieved a  me­di­an pro­gres­sion-free sur­vival (mPFS) of 3.8 months, while everolimus-treat­ed pa­tients ex­pe­ri­enced mPFS of 1.9 months. “While the top-line da­ta are en­cour­ag­ing, they do ap­pear to have de­te­ri­o­rat­ed vs. ear­li­er Phase I re­sults,” SVB Leerink an­a­lysts wrote in a note. 

→ A 15-month long sweep­ing in­ter­nal in­ves­ti­ga­tion en­com­pass­ing more than a mil­lion doc­u­ments, thou­sands of hours of se­cret video sur­veil­lance — in­stalled un­der the aus­pices of for­mer CEO Park­er “Pe­te” Pe­tit — and over 80 wit­ness­es, paint­ed a sor­did pic­ture of the scan­dalous past of the wound care com­pa­ny MiMedx in May. Ear­li­er this month, MiMedx begged its share­hold­ers not to fall for ma­ligned Pe­tit’s bid to re­turn to the com­pa­ny’s board, along with two of his busi­ness as­so­ciates. A pre­lim­i­nary vote count sug­gests stock­hold­ers have lis­tened, the com­pa­ny said on Mon­day.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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