Endpoints News

5/23/2026

Welcome back to another edition of Endpoints Weekly! My usual co-author Nicole DeFeudis was out this week on a much-deserved vacation, so I’m instead joined by Kyle LaHucik in rounding up the headlines. We had ...

5/22/2026

Gilead has at long last won US approval of its hepatitis D treatment Hepcludex, which the FDA previously rejected over issues with its manufacturing and distribution. The drug, known generically as bulevirtide, treats chronic hepatitis ...

5/22/2026

A key Republican congressman asked the Trump administration to restrict the stream of money into China’s biotech sector, threatening to squelch the dealmaking that’s become big business for some US investment companies and large pharma. ...

5/22/2026

An AstraZeneca breast cancer drug received a positive opinion from European regulators, despite an FDA advisory committee voting against the drug last month. Novo Nordisk’s Wegovy pill also got the EU go-ahead. The European Medicines ...

5/22/2026

Utah has released early data from a closely watched program that tests using AI to renew prescriptions for patients with chronic conditions. Since mid-December, Doctronic has been automating prescription renewals for nearly ...

5/22/2026

The FDA has approved the TROP2-directed antibody-drug conjugate Datroway as a first-line option for triple-negative breast cancer, giving Daiichi Sankyo and AstraZeneca a leg up over their competitor Gilead. The approval marks Datroway’s third, after ...

5/22/2026

Plus, news about Immunovant and Retro Biosciences. 💸 CVC and GBL launch tender offer for Recordati: CVC Capital Partners and Groupe Bruxelles Lambert (GBL), a Belgian investment holding company, launched their cash voluntary tender

5/22/2026

As health tech gets more competitive, a strategy companies use to stand out is providing their products for free. They’re betting this will help build up a large and loyal ...

5/22/2026

Novartis said it's working to get the most out of its $12 billion acquisition of Avidity Biosciences by finding ways to apply its underlying science to diseases beyond muscular dystrophy. The drugmaker’s 2025

5/22/2026

Biogen and Denali Therapeutics’ LRRK2 inhibitor has flunked a Phase 2b trial in early Parkinson’s disease, leading the companies to drop the program in certain patients. The small-molecule drug, known as BIIB122, missed the study’s ...

5/22/2026

All of the regular ASCO abstracts dropped Thursday afternoon, with the biggest news coming from the VEGF bispecific race, Merck and Kelun-Biotech’s TROP2 ADC known as sac-TMT, and multiple ...

5/22/2026

→ Peter Griffith will be the second high-profile exec to leave Amgen this year when he retires on Sept. 1. Thomas Dittrich will replace him as CFO and return to Amgen ...

5/21/2026

Merck partner Kelun-Biotech fleshed out a Phase 3 win in lung cancer from a study in China for the experimental antibody-drug conjugate sac-TMT, raising hopes that the benefit could translate to Western patients. Patients who ...

5/21/2026

Head and neck cancer has always been a tough nut to crack. These tumors can suppress immune responses through multiple pathways, meaning blocking one of those usually isn’t enough. Merck’s Keytruda is approved for head ...

5/21/2026

Much of the attention heading into the annual ASCO meeting next week has focused on Summit Therapeutics and Akeso’s plenary presentation for their bispecific drug ivonescimab. But two of ivonescimab’s biggest competitors are also releasing ...

5/21/2026

Biohaven CEO Vlad Coric finally had the attention of the FDA, and most importantly, Commissioner Marty Makary. In late April, after the company’s spinocerebellar ataxia drug had been rejected last year, Coric had won a ...

5/21/2026

It’s no secret that Akeso’s presentation will be one of the most closely watched readouts from the American Society of Clinical Oncology annual meeting this year. Slated for May 31, HARMONi-6 marks the first plenary ...

5/21/2026

BioMarin Pharmaceutical will seek expanded approval for its bone growth-stimulating drug Voxzogo after the shot improved growth speed in children with a form of short stature, the company said Wednesday. The ...

5/21/2026

Over a 35-year history, Incyte has grown into a $19 billion biopharma company. The Delaware-based drugmaker is now turning to AI to power through the coming decades.

5/21/2026

Plus, news about Gilead and West Pharma: 🏭Bristol Myers Squibb looks to Texas: The drugmaker is considering building a new pharma campus in Generation Park Management District in Houston, TX, which ...

5/21/2026

Many developers of obesity drugs are fond of saying that it’s not a competition to produce the strongest and fastest level of weight loss. They had better hope they’re right, because if it is a ...

5/20/2026

The money continues to flow for drug development startups that are working on inflammatory and immunology medicines licensed from other companies. A new San Diego biotech called cAMPfield Therapeutics is the latest to secure backing ...

5/20/2026

Last week at our biopharma and healthcare summit with the Financial Times, I was asked during one of our breaks when we’ll see the first truly multinational Chinese pharma company. “Five years, and it’ll be ...

5/20/2026

Pharmaceutical companies’ ability to interact with the patients taking their medications has changed over the last few years. The rise of direct-to-consumer channels, driven largely by consumer willingness to pay for GLP-1s for weight loss ...

5/20/2026

💉 Pfizer’s experimental 25-valent pneumococcal shot beats Prevnar 20: The vaccine candidate, codenamed PF-07872412, produced higher geometric mean titers for serotype 3 than Pfizer’s approved 20-valent vaccine in a head-to-head Phase 2 trial in healthy ...

5/20/2026

BOSTON — Over the past year, I’ve begun hearing rumblings from scientists who secretly think it’s time to stop being stodgy about editing the genes of human embryos. For the most part, they are still too ...

5/20/2026

Parabilis Medicines, the decade-old and well-funded "undruggable" biotech out of Greg Verdine's Harvard lab, seeks to become the 12th drug developer to conduct an initial public offering this year. The biotech

5/20/2026

European healthcare investor GHO Capital and asset management firm CBC Group are set to join forces, with the new entity to manage over $21 billion. In a Wednesday release, they said ...

5/19/2026

The Trump administration is significantly building the portfolio of drugs available through its direct-to-consumer platform TrumpRx, adding more than 600 generic medicines. President Donald Trump on Monday touted the increase as ...

5/19/2026

They say stick to what you know. And Paragon Therapeutics knows how to do reverse mergers. In a deal announced Tuesday, the hub-and-spoke biologics company is moving its migraine drug offshoot ...

5/19/2026

After success with the drug Winrevair, a band of entrepreneurs has found their next challenge in a difficult-to-treat lung disease. On Tuesday, Oorja Bio launched with a $30 million Series A round, all from Westlake ...

5/19/2026

On Thursday, the Health Tech team led a series of conversations at the Financial Times’ US Pharma and Biotech Summit, held in collaboration with Endpoints News. The sessions focused on ...

5/19/2026

Just as Maziar Mike Doustdar took the helm at Novo Nordisk in the summer of 2025, the company said it would reorganize its R&D activities, merging the teams that focused on early ...

5/19/2026

Wave Life Sciences reported an updated cut of data from its early-stage study of an RNA editing treatment for alpha-1 antitrypsin deficiency, suggesting it can dose its genetic therapy monthly. People ...

5/19/2026

Plus, news about Accro Bioscience, Hansa Biopharma, Shanghai Best-Link Bioscience and UCB. Full-Life Technologies gets $150M: The radiotherapy company has raised $110 million in a Series D round and another $40 ...

5/19/2026

Nourish, a telehealth platform that arranges virtual appointments with nutritionists, just raised a new round that bumped its valuation to $1.75 billion, according to a person familiar with the matter. The New York-based startup is ...

5/19/2026

Relay Therapeutics’ first data readout for zovegalisib in a rare genetic disease beat Wall Street expectations, expanding the PI3Kα inhibitor’s R&D prospects beyond breast cancer. The biotech on Tuesday shared Phase 2

5/19/2026

BioMarin’s enzyme replacement therapy for a rare genetic disorder called ENPP1 deficiency delivered mixed results in a late-stage study. Patients with the condition don't produce enough of the ENPP1 enzyme, which generates plasma inorganic pyrophosphate ...

5/18/2026

The FDA wants it off the market. European regulators are investigating data-integrity concerns. And now, a pharma company selling the drug in Japan is warning doctors against writing new prescriptions. Still, Amgen remains resolute in ...

5/18/2026

An analysis launched by former FDA leaders to look into claims of pediatric deaths related to Covid-19 vaccines was published by a Republican lawmaker, months after the agency's self-imposed deadline to produce the report. Last ...

5/18/2026

As Regeneron’s cancer portfolio continues to suffer setbacks, the company is placing a bet in a different direction through a deal with Parabilis Medicines valued at as much as $2.2 billion. Parabilis is focused on ...

5/18/2026

Plus, news about Enhertu and Tecentriq. 💪 Design Therapeutics shares Phase 1/2 data in Friedreich's ataxia: The California biotech’s DT-216P2 given at 1 mg/kg led to an average 6.4-point improvement on ...

5/18/2026

An experimental antibody-drug conjugate from Merck and China-based Kelun-Biotech succeeded in a global Phase 3 study for the first time, giving Merck a key pipeline victory as it approaches the patent cliff for its best-selling ...

5/18/2026

The Supreme Court says it won’t wade into the pharma industry’s yearslong legal battle over Medicare drug price negotiations. The justices declined to review multiple cases brought by AstraZeneca, Johnson &amp ...

5/18/2026

Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clinical setbacks for candidates targeting the LAG-3 ...

5/14/2026

Here we go again? Biogen reported heavily anticipated Alzheimer’s data on Thursday morning, saying its tau-targeting drug BIIB080 did not meet its primary endpoint in a Phase 2 study. But the company said it slowed ...

5/14/2026

Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027. The biotech hopes to be the second company to commercialize ...

5/14/2026

BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in a rare but aggressive form of blood cancer, where AbbVie and Genentech’s Venclexta is used off-label. The FDA greenlit ...

5/13/2026

BOSTON — Early last year, startup iECURE’s experimental gene therapy seemingly cured a baby of a life-threatening genetic disease. But new results testing the same therapy in a larger number of babies show ...

5/13/2026

Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in ...

5/13/2026

French vaccine maker Valneva is laying off 10% to 15% of its workforce and reducing revenue projections due to "an emerging adverse trend in travel vaccine uptake across key markets." The drugmaker

5/13/2026

Plus, news about Amicus Therapeutics, Fosun Pharma, Duality Biotherapeutics, BioNTech and C4 Therapeutics. 👁️ Abeona drops eye gene therapies, pivots to solid tumor T cell therapy: The biotech, which is known for marketing the rare ...

5/13/2026

Marty Makary never stood a chance. Over the last few days, the now-former FDA commissioner had been left to twist in the wind, after headlines emerged late last week that President Donald Trump had signed ...

5/13/2026

CHICAGO — From a 22nd-floor office overlooking the Chicago Riverwalk, in the heart of the Midwest hub’s white-collar downtown district, Lakefront Biotherapeutics’ executives hope to stage the company’s turnaround. It’s here where the work-in-progress rebranding — and ...

5/13/2026

BOSTON — Tessera Therapeutics has created an experimental gene editing drug for sickle cell disease that could compete with commercial cell therapies but is delivered as an infusion — no complex cell engineering or chemotherapy preconditioning ...

5/13/2026

Merck KGaA appears to have a big-picture view of how the Iran war is affecting the pharma industry so far. The German company is seeing an uptick in demand for its lab equipment products as ...

5/12/2026

Reducing the dose of Eli Lilly’s obesity shot Zepbound could provide a safe, effective and potentially cheaper option for the maintenance of weight loss, according to new data. The findings come from a trial called ...

5/12/2026

The Critical Medicines Act reached its next milestone on Tuesday, after the European Parliament and the Council provisionally voted it through. The proposed regulation aims to improve the European Union’s supply chains for critical medicines ...

5/12/2026

FDA Commissioner Marty Makary has resigned after his job status hung in the balance for days. President Donald Trump confirmed the news Tuesday in a social media post. Makary’s decision centered ...

5/12/2026

As the Iran war enters its third month, its knock-on effects on raw materials, energy costs and shipping are beginning to be felt in the pharma industry. While the Middle East is barely a player ...

5/12/2026

Last week, I was reminded that reporting on AI in healthcare requires continuous scrutiny of the incentives that drive it. Thanks to a fellowship hosted by SABEW, in partnership with ...

5/12/2026

Isomorphic Labs said Tuesday it had closed a $2.1 billion Series B round, cementing its bellwether role in using AI for drug discovery. For privately held companies, Isomorphic’s raise is the second-largest in biotech history ...

5/12/2026

Pfizer has turned $1 billion into $35 million. The New York-based pharma company and its partner Arvinas are selling rights to their recently approved breast cancer drug to Rigel Pharmaceuticals. They decided last year that ...

5/12/2026

Bayer is back on the market for drug acquisitions after a half-decade on the sidelines, according to CEO Bill Anderson. “We’re going to be careful, but also aggressive,” Anderson said on a first-quarter earnings call ...

5/12/2026

Plus, news from Vistagen, Enterprise Therapeutics, Cerevance and Memento Medicines. 😴 Alkermes’ narcolepsy drug succeeds in Phase 3 study: The company’s drug Lumryz, approved in 2023 for narcolepsy, hit its primary ...

5/12/2026

A startup that spun out of UC Berkeley aims to improve healthcare operations by getting AI to think like a doctor would. Knit Health launched with $11.6 million in seed funding co-led by Uncork Capital ...

5/12/2026

BOSTON — Serif Biomedicines, a startup launched last month by Flagship Pioneering, believes it has solved two technical challenges that have long prevented gene therapy from being delivered without troublesome viruses. Viruses are ...

5/12/2026

It's becoming Hengrui Pharma's world, and some Western drugmakers are just living in it. China's largest pharma company, which boasts one of the biggest pipelines in the industry, has lined up Bristol Myers Squibb as ...

5/11/2026

UnitedHealth Group’s Optum Rx on Monday unveiled a new approach to prescription drug benefits that it said offers its customers transparency into the entire drug supply chain. Under the new model, launching in 2027, the ...

5/11/2026

It seems there’s room for two in the MASH market. When Novo Nordisk’s blockbuster weight loss drug Wegovy won approval in August 2025 to treat the fatty liver disease, some investors thought it would put ...

5/11/2026

Daiichi Sankyo is betting on its oncology franchise to push it past 3 trillion Japanese yen ($19 billion) in 2030 revenues. The drugmaker published a new five-year business plan on Monday ...

5/11/2026

Plus, label expansions for two drugs targeting rare diseases, and Genmab scraps a Phase 1 cancer trial: 🧠 Novo's Parkinson's cell therapy finds a biotech home: Novo Nordisk has found a home for an early-stage ...

5/11/2026

San Diego-based biotech Inhibrx is claiming that it outperformed Merck’s Keytruda in a difficult-to-treat cancer. The combination of Keytruda and Inhibrx’s experimental drug INBRX-106 shrank more tumors than Keytruda alone in patients with metastatic head ...

5/11/2026

Braveheart Bio said Monday that the heart muscle therapy it licensed from China’s Jiangsu Hengrui Pharmaceuticals has succeeded in a mid-stage trial for the same condition in which Cytokinetics recently scored a

5/11/2026

Drug developers are racing to make gene therapies that could replace chronic GLP-1 injections and pills with a one-and-done treatment. Now, a company based just outside of Boston is poised to become ...

5/11/2026

CSL's stock hit its lowest price since early 2017 on Monday after it lowered its full-year revenue guidance by about 4% and said it would have to take a new $5 billion impairment charge. The ...

5/9/2026

Welcome back to another edition of Endpoints Weekly! Earnings season is in full swing, but we had plenty of original reporting and exclusives you won’t find anywhere else this week. Chief among them: Andrew Dunn’s ...

5/8/2026

FDA Commissioner Marty Makary is expected to be fired from his role, according to multiple media reports. The plans haven’t been finalized and could still change, said the Wall Street Journal ...

5/8/2026

Daiichi Sankyo is scrapping plans to build antibody-drug conjugate manufacturing capacity and recorded an "extraordinary loss" of 149.4 billion Japanese yen ($950 million) after overpromising demand for its ADCs to third-party manufacturers. The Japanese company ...

5/8/2026

🗓️ FDA delays subcutaneous Leqembi decision: Originally slated for later this month, the decision date now falls on August 24, Biogen and Eisai said. The agency asked for more information from ...

5/8/2026

RIO DE JANEIRO — Mazdak Abulnaga should be the poster child for the type of employee pharma companies want to hire this year. Abulnaga, a 33-year-old postdoctoral fellow at MIT and Harvard Medical School, is building ...

5/8/2026

→ It didn’t take long for Natalie Holles to rebound after the decision to wind down operations at her previous company. She has replaced Elisabet de los Pinos as CEO of ...

5/8/2026

Capricor Therapeutics said Thursday it has filed a lawsuit against Nippon Shinyaku over a distribution and commercialization agreement for deramiocel, a cell therapy candidate for Duchenne muscular dystrophy (DMD) that’s getting a second chance at ...

5/8/2026

Odyssey Therapeutics pulled together $279 million from its initial public offering, the autoimmune disease drug developer said Thursday night. Odyssey began trading on the Nasdaq on Friday. The biotech sold 15.5 million shares {$ODTX} at ...

5/7/2026

Astellas reported promising results with its stem cell-derived therapy in an age-related eye disease, though data in a handful of high-dose patients in the early-stage study raised questions. The experimental stem cell therapy, called ASP7317 ...

5/7/2026

The Ozempic pill is coming to Amazon Pharmacy’s prescription drug kiosks. It’s an expansion for the kiosks, which operate like vending machines and have been stocking oral Wegovy since February. Amazon has touted the kiosks ...

5/7/2026

EnGene’s latest Phase 2 results on an experimental treatment for certain bladder cancer patients alarmed investors and raised concerns around the therapy’s future prospects. The Canadian biotech's shares {$ENGN} fell 80% Thursday morning after reporting ...

5/7/2026

Last year, health insurer after health insurer slashed or withdrew their profit outlooks after being sucker-punched by high medical costs. This year is shaping up ...

5/7/2026

Blackstone Life Sciences, fresh off one of the largest private investment funds in industry history, is putting $250 million to work on a little-known biotech seeking to drastically reduce the number of ...

5/7/2026

Plus, news about BioCryst, GSK and Roche. 🙃 Entrada’s Duchenne drug disappoints: The biotech reported initial data in six patients who received the low dose of its exon 44 skipping drug ...

5/7/2026

Plus, news about FDA's one-day inspections and BioMADE: 🇵🇷 Amgen pours another $300M into Puerto Rico: The funds will be used to bolster its biologics production in Juncos, which was established ...

5/7/2026

There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said ...

5/7/2026

The state of Pennsylvania has sued Character.AI, a startup that lets users chat with different AI-generated personas, for illegally presenting a chatbot as a licensed doctor in the state. This is the first lawsuit brought ...

5/7/2026

Angelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s portfolio: Firdapse for Lambert-Eaton myasthenic syndrome, Agamree ...

5/6/2026

At least two drugmakers say they’re feeling the impact of the Inflation Reduction Act, after the first drug prices negotiated under the law took effect in January. Amgen and AbbVie reported in their first-quarter earnings ...

5/6/2026

Eli Lilly is committing to its roots, allocating $4.5 billion for new manufacturing investments across Indiana as drugmakers pledge more US projects. The world’s largest pharma company, headquartered in Indianapolis,

5/6/2026

BeOne Medicines has greatly expanded its pipeline over the years, bringing 18 new molecular entities to the fore across 2024 and 2025. But that also means the drugmaker will likely cull more experimental medicines as ...

5/6/2026

BASEL, Switzerland — Lonza said it wants to own the commercial market for antibody-drug conjugates, with a new manufacturing site set to come online next year and plans to increase its headcount. The CDMO is planning ...

5/6/2026

🚀 Madrigal Pharmaceuticals' MASH drug beats expectations: The biotech’s Rezdiffra sales came in at $311 million for the first quarter, surpassing analysts’ projections by about $10 million, according to TD Cowen analysts. The Pennsylvania drugmaker ...

5/6/2026

Two scientists think they've solved a technical problem that has kept the mRNA revolution from reaching its full potential. Now, they're launching ParcelBio with $13 million in seed funding to develop drugs based on their ...