Endpoints News

5/2/2026

Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-break moment for Bristol ...

5/1/2026

Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the products last year. ...

5/1/2026

The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it. The drug will be ...

5/1/2026

Amgen is launching three new late-stage trials for its long-acting obesity shot MariTide, including one designed to test the drug in patients switching away from Eli Lilly and Novo Nordisk's blockbuster GLP-1s. Patients in the ...

5/1/2026

Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeutics veterans, Seaport is ...

5/1/2026

After holding a rally in April, Samsung Biologics union workers on Friday started a five-day strike over wage negotiations. Around 95% of the company's union members voted on the strike, with the ...

5/1/2026

Cue Biopharma announced a reboot Thursday afternoon, bringing in notable biotech executive Shao-Lee Lin as well as a new allergy asset developed in Taiwan and mainland China. The Boston-based biotech has focused on developing T ...

5/1/2026

Q1 earnings recap with Endpoints News After a deal-heavy first quarter, earnings season is in full swing. We're breaking down the news and trends from Big Pharma's first-quarter calls on a special premium subscriber-exclusive episode ...

5/1/2026

🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness and verbal or physical ...

5/1/2026

Summit Therapeutics’ stock price {$SMMT} tumbled nearly 20% after the closing bell Thursday afternoon, following an apparent statistical miss in part of a Phase 3 trial for its cancer drug ivonescimab. In patients with a ...

5/1/2026

Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...

5/1/2026

A trio of biotechs priced their IPOs on Thursday into Friday morning, setting the stage for their public trading debuts with more than $850 million combined. Seaport Therapeutics, Hemab Therapeutics and Avalyn Pharma are the ...

5/1/2026

Johnson & Johnson is scrapping two CAR-T cell programs for B cell lymphoma amid a wave of approvals in recent years for cell therapies and antibody-based drugs addressing the disease. The drugmaker

5/1/2026

→ Boehringer Ingelheim has brought in Christie Bloomquist as SVP, corporate affairs, US human pharma, and she’ll be president of the Boehringer Cares Foundation. Peer Review informed you about her move to ...

4/30/2026

In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn't show a “clinically meaningful” benefit. AstraZeneca touted ...

4/30/2026

Bristol Myers Squibb’s cancer drug Krazati has failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. Krazati had received accelerated approval in 2024 in this setting. But a Phase ...

4/30/2026

A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new drugs. The language was

4/30/2026

A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide. But the court said some of Lilly’s claims involving whether Empower ...

4/30/2026

WASHINGTON — Supreme Court justices gave a few hints about how they intend to rule in a divisive case for the pharmaceutical industry. In its final argument scheduled for this term, the high court on Wednesday ...

4/30/2026

🔔 Avalyn Pharma’s $300M IPO: The Boston, MA-based biotech is selling over 16.5 million shares at $18 apiece. The company is set to start trading as {$AVLN} on the Nasdaq Thursday ...

4/30/2026

Wall Street’s expectations for Bristol Myers Squibb’s upcoming slate of data readouts are reaching a fever pitch. Analysts lobbed questions regarding at least half a dozen trial results expected by the end of 2026, in ...

4/30/2026

Plus, news about PCI Pharma: 🏭 XTL Bio steps into psychedelics: XTL Biopharmaceuticals is acquiring 100% of the outstanding shares of psychedelic-focused biotech Psyga Bio. XTL will gain Psyga’s manufacturing facility ...

4/30/2026

I just came back from the Digital Healthcare Innovation Summit in Boston earlier this week, where I got a good look into what investors are thinking about. A few impressions: Investors see a ...

4/30/2026

CVS Health has been testing AI tools that deliver healthcare, though it sees too many barriers to using them more widely for now. CVS' President of Health Care Delivery Sree Chaguturu told Endpoints News at ...

4/30/2026

About 20,000 people are taking Eli Lilly’s obesity pill Foundayo after its first 20 days on the market, according to the company’s CEO David Ricks. This points to a markedly slower launch of the drug ...

4/30/2026

Talking over pharma pipelines with a major drugmaker's development chief, he noted that if you looked at the biggest 50 drugs by revenue, the final one on the list brought in about $4 billion last ...

4/30/2026

Novartis on Thursday revealed its plans to build another factory in the US, with the Swiss drugmaker noting that it has now allocated every dollar of its $23 billion promise to expand ...

4/29/2026

Threats to AbbVie's immunology dominance took center stage on the company's first-quarter earnings call Wednesday morning, as analysts pressed executives on their defense strategy. The heart of the discussion focused on whether megablockbuster Skyrizi is ...

4/29/2026

The FDA is set to convene its first advisory meeting of oncology experts in about nine months, with a couple of AstraZeneca drugs as the focus of the discussion. Details about the meeting of the ...

4/29/2026

Bristol Myers Squibb is facing a bit of an identity crisis. CEO Chris Boerner is nearly two and a half years into his tenure, with most of his time defined by

4/29/2026

Pfizer’s positive Phase 3 data in multiple myeloma: The company’s Elrexfio produced a “statistically significant and clinically meaningful improvement” in progression-free survival in patients with relapsed or refractory disease who had ...

4/29/2026

Biogen is still looking at deals even after earmarking $5.6 billion to buy Apellis Pharmaceuticals earlier this month. “Most of what we're going to be focusing on is early-stage development and research, because that part ...

4/29/2026

AstraZeneca and the UK government are back in each other's good graces. AstraZeneca on Wednesday said it is lifting its UK investment pause, with a £300 million budget to finish construction of a new office ...

4/29/2026

Chiesi is buying commercial biotech KalVista Pharmaceuticals for about $1.9 billion in an extension of the industry's vigorous spring shopping spree. The Italian pharma will pay $27 per share {$KALV} in cash to buy the ...

4/29/2026

RIO DE JANEIRO — Kyunghyun Cho says he's a free man once again. He makes that observation, semi-jokingly, while looking over countless rows of poster presentations on the sidelines of the International Conference on Learning Representations ...

4/29/2026

GSK is expecting several key late-stage readouts this year and, if they do not succeed, the company could change its team structure, CEO Luke Miels said during its first-quarter earnings call with the media Wednesday. ...

4/29/2026

MPM BioImpact, a leading biotech investor, is going all in on its strategy to take China-born drugs to the global stage. Over the past year, its portfolio company K2 Therapeutics has amassed three drug programs ...

4/29/2026

AstraZeneca said it had stopped several mid- and late-stage trials of some of its pipeline programs in the past few months, potentially limiting some of the life-cycle extensions it was hoping for. Its first-quarter

4/28/2026

The FDA is launching a pilot program to collect and review clinical trial data in real time, giving scientific reviewers access to the data as it flows in, the agency announced Tuesday. AstraZeneca and Amgen ...

4/28/2026

A few years in, admin tech is still reigning as the king of health tech funding. Startups using AI to tackle mundane administrative work in healthcare, such as follow-ups,

4/28/2026

Pfizer is staving off Vyndamax competition for another two years. The drug, also known as tafamidis, is among Pfizer’s top three best-selling medicines and vaccines. Vyndamax is approved for a heart ...

4/28/2026

When the Supreme Court hears arguments this week over a prescription-strength pill derived from fish oil, the entire generic drug industry will be watching. The case could have broad implications on how new generics get ...

4/28/2026

Rocket sells PRV for $180M: The New Jersey gene therapy maker sold the rare pediatric disease priority review voucher to an undisclosed buyer. Rocket Pharmaceuticals got the PRV after securing FDA ...

4/28/2026

The pharma company formerly known as BeiGene has plucked an experimental cancer drug from a Chinese biotech, aiming to go broader than its competitors. BeOne Medicines said it signed a license and option deal with ...

4/28/2026

Incyte intends to seek approval of its JAK1 inhibitor pill in the skin disease nonsegmental vitiligo after the drug, povorcitinib, hit in twin Phase 3 trials. The company revealed the successes ...

4/28/2026

The pan-RAS space continues to gain momentum, as AbbVie signs up for a shot at entering a field with the potential to drastically alter the treatment of certain cancers. The Chicago-area pharma giant has signed ...

4/28/2026

The FDA accused ChemoCentryx of manipulating the results of a pivotal clinical trial used to approve the drug Tavneos, escalating the agency's effort to pull the treatment from the market. "New information shows that the ...

4/28/2026

Devoted Health’s revenue and membership declined in 2025 for the first time since it launched health plans for seniors seven years ago. It’s a sign the high-profile startup, helmed by former Athenahealth executives and an ...

4/28/2026

RIO DE JANEIRO, Brazil — For the past two years, Adaptyv Bio has challenged the AI community to see how good today’s models are at designing proteins. Its latest competition, presented Monday at a top machine-learning ...

4/28/2026

Decades before CRISPR gene editing was invented, scientists tried to manipulate genes with enzymes called recombinases. The proteins were precise but proved tricky to use because they were hardwired to target specific stretches of bacterial ...

4/28/2026

Coultreon Biopharma has patched together $125 million from some of the largest biotech investors in the US and Europe in a bid to join the burgeoning pipeline-in-a-pill approach to autoimmune diseases. The Tuesday morning Series ...

4/28/2026

Novartis CEO Vas Narasimhan said the Swiss company is “very disappointed” by Germany’s plan to shave off more than €60 billion in healthcare costs that would affect pharma sales. Germany wants to slash its healthcare ...

4/28/2026

Obesity patients taking the weight loss injection being developed by Boehringer Ingelheim lost nearly 17% of their weight after about a year and a half, the company said Tuesday. The results are more or less ...

4/27/2026

After a new drug from Revolution Medicines reignited hopes for treating pancreatic cancer, a rival compound from Erasca — which released early-stage data on Monday — could prompt a legal showdown between the biotechs. And it did ...

4/27/2026

Earlier this month, a new cancer drug captivated patients and investors. Now the lawyers get their turn. On Monday, Erasca said it had received a legal threat from Revolution Medicines' lawyers over its cancer drug ...

4/27/2026

Members of Utah’s medical licensing board have called for the suspension of a temporary program allowing a startup to use AI to refill prescription medications. The startup, Doctronic, struck an agreement with Utah’s Office of ...

4/27/2026

Intellia Therapeutics reported this morning on the Phase 3 success of a gene editing treatment for hereditary angioedema, a disease that causes unpredictable, disfiguring and potentially dangerous swelling attacks. The biotech aims to have its ...

4/27/2026

Thermo Fisher Scientific sells microbiology business: Astorg, a European private equity firm, will acquire the unit for $1.075 billion. Thermo Fisher’s microbiology business is part of its specialty diagnostics segment, and ...

4/27/2026

Oruka Therapeutics' Phase 2 psoriasis data could mean there's a future challenger to megablockbuster Skyrizi. The company said on Monday that 40 of 63 patients (63.5%) who took an experimental drug saw their skin plaques ...

4/27/2026

Eli Lilly keeps putting its GLP-1 windfall to use. On Monday, the anti-obesity drugmaker announced its latest deal to expand its pipeline of future drugs, saying it would spend as much as

4/27/2026

A year after it reported a Phase 2/3 success, Compass Therapeutics on Monday revealed further results for its closely watched bispecific antibody in second-line biliary tract cancer. While the investigational drug succeeded ...

4/27/2026

An experimental treatment that uses CRISPR to edit genes directly inside the body has just succeeded in a Phase 3 trial — a first for the technology — putting it on track for a potential FDA approval ...

4/27/2026

Veradermics has succeeded in its first major test as a newly-minted public company. The biotech's form of oral Rogaine cleared the bar in a Phase 2/3 trial in men with mild-to-moderate pattern hair loss, producing ...

4/27/2026

In the early 2000s, way before AI became a ubiquitous buzzword in biotech, billionaire scientist David Shaw was building supercomputers to study molecules at his eponymous research company. Huafeng Xu, a longtime scientific leader at ...

4/27/2026

Indian drug giant Sun Pharma has lined up an $11.75 billion acquisition of Organon, a women’s health and biosimilar maker spun out of Merck in 2021. The all-cash deal came in at $14 per share ...

4/26/2026

After a lull in mid-2025, investment in UK biotechs appears to be picking up, according to data from the UK trade group the BioIndustry Association. In the first quarter of 2026, total equity funding in ...

4/25/2026

Welcome back to another edition of Endpoints Weekly! We’re doing a little bit of celebrating here at Endpoints, as we took home three Neal Awards, which recognize excellence in B2B journalism. The ...

4/24/2026

The FDA said Friday it has issued new fast-track vouchers to three psychedelic companies, and its selections have come as a “surprise” to Wall Street. In an unusual move, the agency didn’t name the sponsors ...

4/24/2026

Avalyn Pharma plots $182M IPO: The biotech, which is making inhaled versions of approved pulmonary fibrosis medicines, anticipates about $182 million in net proceeds if it prices its initial public offering ...

4/24/2026

Novartis has withdrawn its EU application for Pluvicto's expansion into earlier prostate cancer treatment, despite US and UK approval for the same indication. The Swiss drugmaker failed to gain favor with the European regulators for ...

4/24/2026

The new generation of weight loss medicines does an unprecedented job of keeping off the pounds — if people stay on the drugs. Yet numerous studies suggest most of those who start taking GLP-1 drugs quit ...

4/24/2026

Sanofi’s tolebrutinib is on track to get an approval in Europe for a type of multiple sclerosis even after receiving a complete response letter from the FDA in December. On Friday, the European Medicines Agency’s ...

4/24/2026

→ Ex-Citi analyst Andrew Baum has left his role as chief strategy and innovation officer at Pfizer, but he will be a senior strategic advisor to CEO Albert Bourla. BMO Capital Markets broke the news ...

4/24/2026

Daiichi Sankyo has pushed back the reporting of its annual results, saying it needs more time to finalize the numbers. The Japanese company had intended to unveil its financials for its fiscal year that ended ...

4/23/2026

Regeneron has won the first-ever FDA approval for a gene therapy to treat a rare type of inherited hearing loss, and the company plans to offer the treatment for free in the US, though that ...

4/23/2026

Tempero Bio, a drug developer that had big ambitions to shake up the treatment of substance use disorders, is winding down operations, Endpoints News has learned. The shutdown comes after a "serious adverse event" in ...

4/23/2026

MAHA’s sway over HHS could face a fresh test now that President Trump has a new pick for CDC director: Erica Schwartz, a former deputy surgeon general. The position has been empty ...

4/23/2026

The radioligand field is on the cusp of a major competitive moment, as a rival looks to bring the first generic to a market that’s been dominated by Novartis. Radioligand therapy aims to bring the ...

4/23/2026

Longtime Amgen leader David Reese is retiring at the end of June, Amgen announced Wednesday evening. Reese, 63, currently serves as chief technology officer, a role he created at Amgen in 2023 ...

4/23/2026

Esther Wojcicki wants to help healthcare startup co-founders get along. That might seem simple, but co-founder disagreements are a big contributor to startups falling apart, she said. She’s got the track record for it: Her ...

4/23/2026

Novo Nordisk’s GLP-1 pill works in kids with diabetes: Type 2 diabetes patients aged 10 to 17 who took Rybelsus for about six months had a statistically significant 0.83% cut in their blood sugar levels ...

4/23/2026

Plus, news about Avonik, a supply chain transparency bill and Nucleus RadioPharma: 💰 Amneal Pharmaceuticals to acquire biosimilar maker for $375M upfront: The generics and specialty drugmaker is set to buy ...

4/23/2026

Endpoints News was recognized with three 2026 Neal Awards for its coverage of the drug industry's relationship with the Trump administration, a three-part series on the future of CRISPR gene editing, and for its event ...

4/23/2026

A startup that helps healthcare providers handle calls, texts and follow-ups with patients using AI has raised seed funding, Endpoints News learned exclusively. Gravity Rail handles the process of communicating with patients, from enrollment and ...

4/23/2026

Roche still has high sales hopes for its breast cancer pill giredestrant despite the drug’s failure in a first-line trial earlier this year. CEO Thomas Schinecker said Thursday that the drug could ...

4/23/2026

Sanofi’s first-quarter earnings call with the media on Thursday was an exercise in redirecting the narrative before its new CEO steps in next week. CFO François-Xavier Roger defended the company’s appointment of Merck KGaA’s Belén ...

4/22/2026

OpenAI is launching ChatGPT for Clinicians, a free tool for doctors, nurse practitioners, physician assistants and pharmacists. It’s the latest product the AI giant has launched within healthcare, after the company announced ...

4/22/2026

AbbVie has provided new details about its $100 billion pledge to the US, budgeting $1.4 billion for its first manufacturing campus in North Carolina. Construction of the 185-acre campus in Durham, NC, will start this ...

4/22/2026

BridgeBio Oncology Therapeutics is replacing CEO Eli Wallace, putting its CSO Pedro Beltran in the role, and making board member Neil Kumar executive chairman. The changes come as there’s been growing competition in cancer over ...

4/22/2026

The FDA for the first time is facing pharma-backed criticism of its new practice of publicly releasing partially redacted drug rejection letters. The law firm Covington & Burling, on behalf of an unnamed pharmaceutical company ...

4/22/2026

Nektar Therapeutics prices $325 million public offering: The Bay Area biotech is selling about 3.5 million shares of stock at $92 per share. The proceeds will fund “general corporate purposes,” including ...

4/22/2026

Sanofi CEO Paul Hudson bet big on immunology. When Belén Garijo takes over as CEO next week, she will have to decide whether to continue that wager. The direction Garijo elects to pursue will likely ...

4/22/2026

RIPK1 is becoming a relative desert for large drugmakers. Eli Lilly has joined the exodus, ripping apart the remainder of its up to $960 million partnership with Rigel Pharmaceuticals. The move comes ...

4/21/2026

Roche’s multiple sclerosis pill more than doubled patients’ relapse-free interval compared with Sanofi’s marketed MS pill Aubagio, according to data presented late on Tuesday. The drug, a BTK inhibitor called fenebrutinib, demonstrated “the lowest relapse ...

4/21/2026

The Centers for Medicare and Medicaid Services has delayed a key pilot program focused on Medicare coverage for obesity medications, after insurance plans indicated they wouldn’t participate at this time. Abe Sutton, head of the ...

4/21/2026

China is "eating our lunch" on new drug approvals and clinical trial starts, HHS Secretary Robert F. Kennedy Jr. told Congress Tuesday, while praising the FDA's actions so far. "We are losing scientists, we're losing ...

4/21/2026

It’s been a couple of months since Utah raised eyebrows by allowing the startup Doctronic to use AI to refill prescriptions. Turns out, the state has a lot more in store. I recently caught up ...

4/21/2026

Adding Merck’s Welireg to an existing Keytruda regimen didn’t lead to a significant improvement in newly diagnosed patients with advanced kidney cancer, Merck announced on Tuesday. The results mark a setback ...

4/21/2026

UnitedHealth Group said Tuesday it’s on track to invest $1.5 billion in artificial intelligence this year, both to improve its own operations and provide products to other insurers and healthcare providers. The healthcare giant is ...

4/21/2026

A new HIV treatment will soon come to market, and it will spearhead Merck’s attempt to be one of the leading drugmakers in a field many biotechs have deserted. The FDA greenlit ...