Apel­lis nabs pri­or­i­ty re­view for ge­o­graph­ic at­ro­phy pitch; Bris­tol My­ers ex­tends of­fer time­line on Turn­ing Point buy­out

The FDA will de­cide by Nov. 26 whether to ap­prove the first treat­ment for ge­o­graph­ic at­ro­phy sec­ondary to age-re­lat­ed mac­u­lar de­gen­er­a­tion, an ir­re­versible dis­ease that leads to vi­sion loss. And the agency won’t hold an ad­comm for it.

The mak­er of the po­ten­tial treat­ment is Apel­lis, which put out long-term da­ta on the drug in March and quashed some mar­ket con­cerns af­ter mixed da­ta last year, with one an­a­lyst peg­ging the chance for ap­proval at 80%.

Jef­feries an­a­lysts ap­peared bull­ish on the drug’s prospects.

“We are pleas­ant­ly sur­prised at no Ad­Comm, as pot’l ques­tions on safe­ty/ef­fi­ca­cy re­mained in in­vestor and our minds. With agency seem­ing­ly sat­is­fied and PDU­FA date of No­vem­ber 26, 2022, launch by YE in GA is in the cards,” the an­a­lysts wrote in a note Tues­day morn­ing.

The drug, known as pegc­eta­coplan, re­mained durable at an 18-month fol­low-up for both pa­tients who re­ceived the treat­ment month­ly and once every two months. The two Phase III stud­ies were sta­tis­ti­cal­ly sig­nif­i­cant, de­spite one of them hav­ing pre­vi­ous­ly missed the mar­ket at the 12-month cut­off in Sep­tem­ber 2021.

Apel­lis mar­kets the drug as Em­paveli for parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, which the biotech se­cured ap­proval for in May 2021. The com­pa­ny will ask the EU’s reg­u­la­to­ry sys­tem to ap­prove the drug be­fore year’s end, as well.

“This im­por­tant mile­stone marks our sec­ond NDA ac­cep­tance in less than two years, a tes­ta­ment to the po­ten­tial of tar­get­ing C3 to treat se­ri­ous dis­eases with sig­nif­i­cant un­met need,” Apel­lis CDO Jef­frey Eise­le said in a state­ment.

Turn­ing Point ac­qui­si­tion not com­plete yet as Bris­tol My­ers ex­tends of­fer win­dow 

Bris­tol My­ers Squibb and Turn­ing Point Ther­a­peu­tics made an M&A splash to kick off AS­CO 2022 a few weeks ago, with the move com­ing as a sur­prise to many em­ploy­ees at the biotech, but the of­fer time­line has now been ex­tend­ed.

The com­pa­nies have yet to sub­mit all forms to the FTC’s an­titrust unit, ac­cord­ing to an SEC fil­ing Tues­day morn­ing. The $4.1 bil­lion of­fer, at $76 per share, was an­nounced June 3.

The of­fer was pre­vi­ous­ly set to ex­pire as the clock turned over from Ju­ly 18 to Ju­ly 19, but the Big Phar­ma has ex­tend­ed the of­fer to 5 p.m. East­ern time on Aug. 15, with the deal slat­ed to close in the third quar­ter.

“We be­lieve that this is the ide­al next step and best path for­ward to con­tin­ue to achieve our vi­sion to be a leader in pre­ci­sion on­col­o­gy. Bris­tol My­ers Squibb is a rec­og­nized on­col­o­gy leader and we are con­fi­dent in their abil­i­ty to de­liv­er on our pipeline,” CEO and pres­i­dent Athena Coun­tou­ri­o­tis wrote to em­ploy­ees in an email short­ly af­ter the ear­ly-June deal an­nounce­ment.

Turn­ing Point has a few late-stage pro­grams in ad­vanced non-small cell lunger can­cer and ad­vanced sol­id tu­mors, with a slate of ear­ly-stage work across oth­er sol­id tu­mors and a com­bi­na­tion study with EQRx’s EGFR in­hibitor au­mol­er­tinib, which is ap­proved in Chi­na.

Ed­i­tor’s note: This sto­ry was up­dat­ed to clar­i­fy the EGFR in­hibitor is owned by EQRx and is part of a com­bo study with Turn­ing Point.

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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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.

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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.

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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.