News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months af­ter Rea­ta Phar­ma­ceu­ti­cals sug­gest­ed its Friedre­ich’s atax­ia pro­gram omavelox­olone could be de­layed, the com­pa­ny re­vealed that is in­deed go­ing to be the case.

Rea­ta $RE­TA shares took a nose­dive Wednes­day af­ter the biotech re­vealed that the FDA said sup­ple­men­tal da­ta for its piv­otal tri­al did not strength­en the case for ap­proval. As a re­sult, the drug is like­ly to need an­oth­er study be­fore the FDA takes up the case.

In ear­ly Wednes­day morn­ing trad­ing, Rea­ta stock was down rough­ly 8% off the news. It’s a small­er dive than when the com­pa­ny first said the pro­gram could be set back, though, as shares lost about a third of their val­ue at the time.

As such, this news was not en­tire­ly un­ex­pect­ed but still proved dis­ap­point­ing to an­a­lysts.

“While the path for­ward for omavelox­olone in the US re­mains to be de­ter­mined, we be­lieve it is large­ly de­risked by the pos­i­tive re­sults seen” in the study, SVB Leer­link’s Joseph Schwartz wrote to in­vestors.

Baird’s Bri­an Sko­r­ney took a more bull­ish view, de­scrib­ing the up­date as mere­ly an “in­cre­men­tal neg­a­tive.” Sko­r­ney said he has been op­er­at­ing with a de­lay be­ing the “base-case as­sump­tion” and that the news doesn’t af­fect Rea­ta’s oth­er pro­gram, bar­dox­olone for rare kid­ney dis­eases, which is ex­pect­ed to be filed in the first quar­ter of 2021.

The FDA did not rule out re­con­sid­er­ing omavelox­olone’s ap­pli­ca­tion once the new study has been com­plet­ed, Rea­ta not­ed.

J&J’s Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Four months af­ter nab­bing an ex­pand­ed la­bel in the US for ac­tive pso­ri­at­ic arthri­tis, J&J’s Trem­fya has got­ten the OK for the in­di­ca­tion in Eu­rope as well.

Trem­fya, al­so known as guselkum­ab, had pre­vi­ous­ly been ap­proved on the con­ti­nent for mod­er­ate to se­vere plaque pso­ri­a­sis. The drug is a mon­o­clon­al an­ti­body tar­get­ing p19 in the IL-23 and in­hibits its in­ter­ac­tion with the IL-23 re­cep­tor.

Wednes­day’s ap­proval comes on the ba­sis of two Phase III stud­ies look­ing at adults who had ac­tive PsA and those who were bi­o­log­ic-naïve. Both stud­ies looked at pa­tients who had pre­vi­ous­ly failed stan­dard ther­a­pies.

Back when it first got US ap­proval in 2017, an­a­lysts pegged peak an­nu­al sales for the drug at $1.6 bil­lion, which would make it a top 20 drug. Through the first three quar­ters of 2020, Trem­fya had net­ted J&J and Janssen $965 mil­lion world­wide.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.