Cabaletta Bio says small number of autoimmune patients responded to its CAR-T...
A microcap biotech from Philadelphia released early, but positive findings from its CAR-T trial for a rare autoimmune disorder, suggesting it could be administered without one of the most arduous...
View ArticleBiopharma is wagering billions of dollars that CAR-T therapy can be easier....
Large biopharma companies have spent over $4 billion in 2025 to buy startups working on in vivo CAR-T therapies as the first data in humans emerge. While it's still early days for in vivo cell ...
View ArticleWhite House, AstraZeneca expected to announce drug price deal
The White House and AstraZeneca are expected to announce a deal on drug pricing later Friday, according to people familiar with the matter, as President Donald Trump strikes a second agreement under...
View ArticleJ&J is in discussions to buy out Protagonist Therapeutics — report
Johnson & Johnson is reportedly in talks to acquire a partner that’s developing a linchpin of its future immunology plans. J&J and Protagonist Therapeutics are in discussions for a buyout, the...
View ArticleHead of FDA's orphan drug office is removed from role
The head of the FDA office that helps determine orphan drug designations has been reassigned and is no longer in the role, an administration official confirmed to Endpoints News. Sandra Retzky,...
View ArticleNew study suggests patients with anti-AAV antibodies may still receive gene...
SEVILLE, SPAIN — Gene therapies are offering new hope to some patients with rare disease, but not everyone. A third or more of patients are often turned away because they've already been infected with...
View ArticleAstraZeneca strikes pricing deal with Trump
British pharma AstraZeneca has reached a drug pricing deal with the Trump administration, agreeing to similar discounts across its portfolio to what Pfizer signed onto last week. Under the deal...
View ArticleMeet this year’s Women in Biopharma; Peter Marks goes to Eli Lilly; Bob...
Willkommen, bienvenue, welcome back to another edition of Endpoints Weekly. We’re supposed to get a Nor’easter this weekend on the East Coast after a mostly dry summer. The rain is needed, but...
View ArticleRegeneron heads to FDA to seek approval for hearing loss gene therapy
Regeneron reported on Sunday that nine of 12 children who received its gene therapy for a form of deafness at birth reached a level of hearing where they would no longer require cochlear implants, and ...
View ArticleBiopharma dealmaking trends: Q3 shows an uptick
US biotech market activity ticked up along a slate of key indicators in the third quarter, raising the question of whether we’re finally seeing the initial signs of a comeback — or yet another head...
View ArticleNovo Nordisk quits cell therapy as restructure continues
Novo Nordisk has shut down its research efforts into cell therapies in the latest move by CEO Maziar Mike Doustdar to remake the company. The drugmaker told Endpoints News it had opted to discontinue...
View ArticleGilead, Arcus’ TIGIT approach exceeds two years of median survival in Phase 2...
Gilead and Arcus’ anti-TIGIT-based regimen has yielded promising survival data in a mid-stage study that enrolled digestive tract cancer patients, and the companies said the results support their...
View ArticleExcellergy debuts with $70M Series A and plan to take on Xolair
A new startup believes it’s found a way to revolutionize treatment for allergic and immunologic diseases, and it got things started with a hefty Series A and a scientific paper that puts a longtime...
View ArticleTvardi's stock crashes as STAT3 drug fails Phase 2 after dropouts from side...
A fibrosis biotech saw its stock price crater Monday morning after it reported a Phase 2 failure for its lead program. Tvardi Therapeutics said the experimental drug, called TTI-101, did not ...
View ArticleSystImmune’s $250M milestone; Teva’s Uzedy approved to treat bipolar disorder
Plus, news about Avidity, Biophytis, the Novo Nordisk Foundation, ADC Therapeutics and Apogee Therapeutics: 💸 SystImmune to get $250M from Bristol Myers Squibb: The milestone payment is the result of...
View ArticleModerna previews cancer antigen therapy in melanoma ahead of ESMO
Moderna has shared early data in patients with an advanced form of skin cancer who received its cancer antigen therapy designed to elicit targeted T cell responses. The biotech’s mRNA-4359 combined...
View ArticleFDA hands OAI classification to Novo Nordisk’s troubled Indiana site
The FDA issued an “official action indicated” classification to Novo Nordisk’s facility in Bloomington, IN after two biotechs received site-related complete response letters. Scholar Rock, one of the...
View ArticleCalifornia enacts state law building on PBM reforms
California Gov. Gavin Newsom signed into law what his office called a “sweeping reform” of PBM practices last week. The legislation, SB 41, prohibits spread pricing, calls for greater transparency and ...
View ArticleFDA on pace for lowest number of new drug approvals since 2022
The FDA in 2025 is set to approve its lowest number of new drug and biologic applications since 2022, even as more than a dozen companies await the regulator's decisions on their new molecular entities...
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