Max Gelman

Are PD-1xVEGF bispecifics being tested in the wrong kinds of cancer? Summit Therapeutics is running late-stage trials for biopharma’s buzziest drug in lung cancer, but some industry experts believe ivonescimab and other PD-1xVEGF bispecifics may better target another t...

Had a lot of great conversations reporting on this the last few months -- Are PD-1xVEGF bispecifics being tested in the wrong kinds of cancer?

endpoints.news/are-pd-1xveg...

A fresh biotech has a radical plan to treat inflammation and allergies, setting its sights on Xolair Startup Excellergy debuts with $70M Series A to develop drugs targeting allergic diseases, aiming to compete with Roche/Novartis' Xolair through new immune response approach.

Had a lot of fun digging into the science about how this new startup wants to treat food allergies

endpoints.news/excellergy-d...

Merck wins approval of subcutaneous Keytruda, in bid to extend life of world's top-selling drug FDA approves Keytruda Qlex, Merck's new subcutaneous formulation of Keytruda, offering more convenient administration and patent protection through 2039.

Subcutaneous Keytruda approved in solid tumors endpoints.news/merck-wins-a...

The Fed cut interest rates by a quarter point. How much will it move the needle for biotech? Biotechs and their investors have long called for lower interest rates since the pandemic’s free-flowing fundraising environment dried up a few years ago. But there are other challenges facing the industry.

The Fed cut interest rates by a quarter point. How much will it move the needle for biotech?

endpoints.news/federal-rese...

Pfizer has a VEGF bispecific strategy. And it’s very different than Summit’s As Wall Street continues to digest this week’s disappointing results for Summit Therapeutics’ PD-1xVEGF bispecific cancer drug, Pfizer is primed to take advantage.

Pfizer has a VEGF bispecific strategy. And it’s very different than Summit’s

endpoints.news/pfizer-has-a...

Summit plays defense for the first time as questions loom over Phase 3 lung cancer readouts Summit Therapeutics is facing fresh scrutiny after mixed Phase 3 trial results for its cancer drug ivonescimab, leading to a 25% stock drop and questions about FDA approval.

Summit plays defense for the first time as questions loom over Phase 3 lung cancer readouts

endpoints.news/summit-plays...

A British mitochondrial startup wants to break ground in ALS and Parkinson's. It has £50M to try NRG Therapeutics announced the close of a £50 million Series B round that should take it through a Phase 2 study in ALS and a Phase 1b trial in Parkinson’s.

A British mitochondrial startup wants to break ground in ALS and Parkinson's. It has £50M to try

endpoints.news/mitochondria...

Summit says long-awaited data in Western patients are a success. But they come with caveats

endpoints.news/wclc25-summi...

FDA approves Eisai and Biogen's subcutaneous Leqembi, gaining new ground in competition against Lilly The FDA approved a new formulation of Eisai and Biogen’s Alzheimer’s drug Leqembi, an incremental step in the companies’ strategy to compete with Eli Lilly’s Kisunla.

SubQ Leqembi approved endpoints.news/fda-approves...

Amvuttra's first full-quarter sales for ATTR-CM are in. And they're a boon for Alnylam A recent label expansion is sending sales of Alnylam’s Amvuttra through the roof. The drug pulled in $492.0 million in revenue in the second quarter, up 114% from the ...

A recent FDA approval was seen as a bellwether for Alnylam. Now its sales are through the roof.

endpoints.news/alnylam-shar...

Vinay Prasad is out at FDA, following Sarepta decision and vaccine controversies FDA's CBER head Vinay Prasad exits agency after Sarepta gene therapy controversy and criticism over Covid vaccine decisions. Conservative media targeted his political views.

Breaking from @drewsnews.bsky.social: Vinay Prasad is out at FDA

endpoints.news/vinay-prasad...

Celcuity posts Phase 3 win in breast cancer, setting up challenge to Novartis and Roche Celcuity reports gedatolisib with fulvestrant reduced disease progression risk by 67% vs fulvestrant alone in Phase 3 breast cancer trial

A small biotech's breast cancer drug more than tripled patient outcomes in a Phase 3 trial, putting it in position to displace medicines from Novartis and Roche.

endpoints.news/celcuity-pos...

The FDA’s new SSRI experts have long questioned antidepressant use FDA panel on antidepressant use in pregnancy features experts known for opposing medical consensus, includes discussion with Commissioner Marty Makary on Monday.

FDA is holding an Expert Panel on the use of SSRIs during pregnancy this morning, but participants have long questioned antidepressant use endpoints.news/the-fdas-new...

Q&A: Retiring Arvinas CEO John Houston talks PROTACs, investor confidence and what’s next with Pfizer John Houston is planning to retire at Arvinas after more than eight years at the helm, the company announced Wednesday, as its lead protein degrader program approaches an inflection point.

Sat down virtually with Arvinas CEO John Houston about his announced retirement this morning, where we talked about PROTACs, the company's sliding stock price and what might happen with their Pfizer partnership

endpoints.news/retiring-arv...

🍨🍨🍨 from Andy

FDA grants accelerated approval to datopotamab deruxtecan-dlnk On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.).

Another cancer drug approval coming weeks ahead of the deadline www.fda.gov/drugs/resour...

Biopharma leaders carving a path for the industry’s LGBTQ+ community Welcome to the fourth edition of Endpoints News’ special report on scientists, executives, investors and other stakeholders in the biopharma’s LGBTQ+ community.

One of my favorite Endpoints traditions is our annual look at the LGBTQ+ leaders in biopharma. We've got 13 awesome profiles this year, be sure to give it a read. And props to @kylelahucik.bsky.social for organizing it once again!

endpoints.news/biopharma-le...

AstraZeneca details its oral SERD 'switching' regimen as feasibility questions remain AstraZeneca is planting its flag in the oral SERD space, touting positive Phase 3 breast cancer data for a program it expects to exceed more than $5 billion in annual peak sales.

More #ASCO25 news this morning!

Feasibility questions about AstraZeneca's breast cancer drug: endpts.com/asco25-astra...

Researchers debate how to best use checkpoint inhibitors: endpts.com/asco25-resea...

Takeda and Protagonist's plenary data: endpts.com/asco25-taked...

Gilead, Merck reveal 'practice-changing' data for Trodelvy-Keytruda combo in aggressive breast cancer CHICAGO — Gilead and Merck made a strong case for combining Trodelvy and Keytruda in the first-line setting for an aggressive form of breast cancer. The combination of Trodelvy and Keytruda ...

Saturday AM #ASCO25 news!

Trodelvy+Keytruda "practice-changing" data: endpts.com/asco25-gilea...

Pfizer PROTAC no better than oral SERDs: endpts.com/asco25-arvin...

Enhertu extends life by 3 months in stomach cancer: endpts.com/asco25-enher...

Early data from Immatics: endpts.com/asco25-immat...

Summit’s disappointing survival readout raises stakes for full data Summit Therapeutics’ mixed results for its potential competitor to Merck’s Keytruda left an important question unanswered: How mature, exactly, were the data?

Summit blew up my morning 🫠🫠🫠 endpts.com/summits-disa...

RFK Jr. Swims in Washington Creek That Flows With Sewage and Bacteria

Robert F. Kennedy Jr., the health secretary, posted photos on Sunday of himself and his grandchildren swimming in a contaminated Washington creek where swimming is not allowed because it is used for sewer runoff.

Pope Leo XIV Is A Sox Fan, Despite The Early Hope From Cubs Fans, His Brother Confirms The Cubs' Marquee Sports Network, citing ABC News, said the new pontiff supports the North Siders. But his brother said that is not true.

Best Chicago controversy of the new Pope is the Cubs trying to lay claim to him and his brother having to speak up to clear up that he's a Sox fan. blockclubchicago.org/2025/05/08/p...

Biotech stocks plunge and industry figures left to wonder after Prasad's FDA appointment How did biopharma stocks react to Vinay Prasad’s appointment as director of one of the FDA's top jobs? Not well. Prasad, a hematologist-oncologist by training who gained prominence for criticizing ...

I spoke to some folks yesterday about Vinay Prasad’s appointment as director of CBER and what it means for biopharma.

endpts.com/vinay-prasad...

Bristol Myers' schizophrenia drug fails Phase 3 trial for adjunctive treatment Bristol Myers Squibb’s attempt to turn Cobenfy into a megablockbuster neuroscience drug ran into a stumbling block Tuesday afternoon.

Bristol Myers Squibb’s schizophrenia drug Cobenfy failed a Phase 3 study in the adjunctive setting, the company announced Tuesday afternoon.

endpts.com/bristol-myer...

Most people haven’t heard of this test, which is available in the US. It accurately predicts Alzheimer’s (not just if there’s a risk, but when). It is modulated by exercise and likely other lifestyle factors.
Here’s (almost) everything we know about it
erictopol.substack.com/p/the-breakt...

J&J's Duato says 'not tariffs, but tax policy' is best way to boost US manufacturing The Johnson & Johnson CEO subtly but assertively criticized the Trump administration’s plans for pharmaceutical tariffs, saying they are not an effective tool to onshore drug manufacturing to the US.

Johnson & Johnson CEO Joaquin Duato subtly but assertively criticized President Donald Trump's plans for pharmaceutical tariffs, saying tax policy is a better way to onshore US drug manufacturing.

endpts.com/jj-ceo-chide...

Trump pharma tariffs inch closer as administration confirms US trade probe Tariffs on pharmaceutical products that President Donald Trump has teased for weeks are one step closer to fruition after the Department of Commerce confirmed it's launched an investigation into the s...

Pharma-specific tariffs inched closer after the Trump administration confirmed that it launched a 232 probe. That investigation actually began two weeks ago, on April 1. endpts.com/trump-drug-t...

Makary wants to replace animal testing with organoids. It may take a while Under the 11-page 'roadmap' outlined Thursday, the goal is for alternative methods to become 'the exception rather than the norm' in the next three to five years.

FDA commissioner Marty Makary wants to phase out animal testing and replace it with organoids, lab-grown cultures of human cells that can mimic and recreate organs.

But the process may take longer than the 3-5 year timeline he proposed. Story w/@scienceboss.bsky.social:

endpts.com/fda-unveils-...

Really enjoyed this conversation with Johan Luthman, be sure to give it a read

Stock market melts down over Trump’s tariffs, and biotech's pain keeps growing The fallout comes amid a yearslong slog for biotech, which has struggled since high interest rates and inflation curbed what was a booming market during the Covid-19 pandemic.

The stock market meltdown is raising more questions for an already beleaguered biotech industry.

endpts.com/as-stock-mar...