With Big Phar­ma castoffs in hand, Mereo files for $81M IPO; Lon­don's Verona sees stock surge on PhI­Ib COPD da­ta

→ Mereo Bio­Phar­ma, a Lon­don biotech de­vel­op­ing a pipeline of as­sets it snagged from Big Phar­ma shelves, is head­ing to the Nas­daq with hopes of rais­ing around $81 mil­lion in an IPO. The com­pa­ny is al­ready list­ed on the Lon­don Stock Ex­change and plans to use the ex­tra cash to de­vel­op at least three drug can­di­dates through mid-stage tri­als. In an SEC state­ment sig­nal­ing the stock of­fer­ing, Mereo said the mon­ey would fu­el two pro­grams it picked up from No­var­tis and one it got from As­traZeneca. The pro­ceeds should get BPS-804 (setrusum­ab), an ex-No­var­tis rare dis­ease drug for pa­tients with os­teo­ge­n­e­sis im­per­fec­ta, in­to Phase IIb/III tri­als in 2018. The cash will al­so fund the ex-No­var­tis drug BGS-649 for the treat­ment of hy­pog­o­nadotrop­ic hy­pog­o­nadism in obese men through Phase IIb and in­to late-stage tri­als; and AZD-9668, a res­pi­ra­to­ry dis­ease as­set Mereo out-li­censed from As­traZeneca last fall, through proof-of-con­cept tri­als. Mereo plans to list un­der the stock sym­bol $MPH.

→ Lon­don-based Verona Phar­ma saw its Lon­don-list­ed stock (LON: $VRP) jump 19% Mon­day fol­low­ing news that its Phase IIb study test­ing its chron­ic ob­struc­tive pul­monary dis­ease (COPD) treat­ment RPL554 had promis­ing re­sults. The drug showed “a clin­i­cal­ly and sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment” in pa­tients with COPD com­pared to place­bo. “These re­sults are very en­cour­ag­ing and strong­ly sup­port the pro­gres­sion of RPL554 in­to lat­er stage de­vel­op­ment as an in­haled treat­ment for COPD pa­tients,” said Jan-An­ders Karls­son, CEO of Verona Phar­ma, in a state­ment. “The fu­ture clin­i­cal de­vel­op­ment and the po­si­tion­ing of this nov­el treat­ment will be in­formed by these da­ta as well as by the out­come of the clin­i­cal study as an add-on to es­tab­lished com­bi­na­tion ther­a­pies planned to start this year, and our on­go­ing mar­ket re­search.”

AR­MO Bio­Sciences $AR­MO, fresh off a $120 mil­lion IPO, re­port­ed out an ear­ly look at its PhI­II tri­al test­ing AM0010 (pegilode­cakin) with Fol­fox in pa­tients with pan­cre­at­ic can­cer. The in­ter­im analy­sis showed the com­bo was cleared to pro­ceed through the tri­al. The analy­sis, done by the Da­ta Mon­i­tor­ing Com­mit­tee (DMC), was meant to find out if the com­bo was safe based on over­all sur­vival as well as phar­ma­co­ki­net­ics in the first 60 sub­jects en­rolled in the study that re­ceived at least four months of ther­a­py. AR­MO’s CMO Joseph Lev­eque had this to say: “The DMC’s rec­om­men­da­tion sup­ports the safe­ty pro­file we have seen with pegilode­cakin when com­bined with 5-flu­o­roura­cyl and plat­inum-based chemother­a­py which is the ba­sis for a num­ber of dif­fi­cult to treat can­cers.  As such, we be­lieve that pegilode­cakin in com­bi­na­tion with Fol­fox could pro­vide a safe and ef­fi­ca­cious ther­a­peu­tic op­tion for sec­ond-line pan­cre­at­ic duc­tal ade­no­car­ci­no­ma pa­tients.” Fi­nal da­ta are ex­pect­ed in 2020.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.