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Endpoints News
@endpts.com
· Dec 17
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Cartesian Therapeutics will pause lupus work despite early success, shifting focus to myositis and myasthenia gravis as it advances its cell therapy.
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Despite positive data, Cartesian to pause work in form of lupus in favor of other indications
Cartesian Therapeutics said it will focus development of its lead cell therapy candidate on patients with myasthenia gravis and myositis, and will pause work in systemic lupus erythematosus.
endpoints.news
November 14, 2025 at 9:06 PM
Cartesian Therapeutics will pause lupus work despite early success, shifting focus to myositis and myasthenia gravis as it advances its cell therapy.
endpoints.news/cartesian-to...
endpoints.news/cartesian-to...
Bristol Myers and J&J’s next-gen blood thinner milvexian failed a major Phase 3 trial, marking another blow for pharma’s hopes for factor XI inhibitors.
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Bristol Myers, J&J’s next-gen blood thinner fails key trial in another setback for factor XI
Bristol Myers Squibb and Johnson & Johnson announced that a Phase 3 trial of their experimental drug milvexian was unlikely to succeed in preventing major heart events such as heart attack or stroke.
endpoints.news
November 14, 2025 at 8:07 PM
Bristol Myers and J&J’s next-gen blood thinner milvexian failed a major Phase 3 trial, marking another blow for pharma’s hopes for factor XI inhibitors.
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endpoints.news/bristol-myer...
Lundbeck made a $2.6B bid for Avadel, topping Alkermes’ $2.1B offer and kicking off a new biotech bidding war over the sleep drugmaker’s narcolepsy assets.
Lundbeck fires the first shot in a bidding war with Alkermes over sleep biotech
Avadel Pharmaceuticals said it had received an unsolicited proposal from Lundbeck to acquire it for a total deal value of up to about $2.6 billion.
endpoints.news
November 14, 2025 at 5:56 PM
Lundbeck made a $2.6B bid for Avadel, topping Alkermes’ $2.1B offer and kicking off a new biotech bidding war over the sleep drugmaker’s narcolepsy assets.
Merck will buy Cidara Therapeutics for $9.2B, betting on its late-stage biologic to prevent seasonal flu as the pharma giant looks beyond Keytruda’s patent cliff.
Merck to buy Cidara and its preventive influenza biologic for $9.2B
Merck to acquire Cidara Therapeutics for $9.2B, gaining late-stage antiviral CD388 for seasonal flu. Deal at $221.50/share, represents 3x Cidara's market cap.
endpoints.news
November 14, 2025 at 5:13 PM
Merck will buy Cidara Therapeutics for $9.2B, betting on its late-stage biologic to prevent seasonal flu as the pharma giant looks beyond Keytruda’s patent cliff.
Exclusive: Inside Metsera as Pfizer and Novo battled for obesity’s next big prize — a high-stakes story of rivalries billion-dollar bids, and a half-finished haircut. By Drew Armstrong @drewsnews.bsky.social, Elizabeth Cairns and Kyle LaHucik @kylelahucik.bsky.social.
Caught between giants: Inside Metsera as Pfizer and Novo battled over obesity's next big prize
Paul Berns, Clive Meanwell and Whit Bernard Metsera co-founders, navigate bidding war between Pfizer and Novo Nordisk as they fight for $10B deal for the obesity biotech.
endpoints.news
November 14, 2025 at 3:29 PM
Exclusive: Inside Metsera as Pfizer and Novo battled for obesity’s next big prize — a high-stakes story of rivalries billion-dollar bids, and a half-finished haircut. By Drew Armstrong @drewsnews.bsky.social, Elizabeth Cairns and Kyle LaHucik @kylelahucik.bsky.social.
Bausch + Lomb CEO Brent Saunders sat down with Endpoints’ @andrewedunn.bsky.social to discuss his turnaround plan, AI’s impact on jobs, and why TrumpRx matters.
Q&A: Brent Saunders on pushing Bausch out of neutral, scrutinizing new hires and why TrumpRx matters
Brent Saunders, Bausch + Lomb CEO, discusses company transformation, AI strategy requiring employee training by 2026, and gradual workforce reduction through attrition.
endpoints.news
November 13, 2025 at 9:29 PM
Bausch + Lomb CEO Brent Saunders sat down with Endpoints’ @andrewedunn.bsky.social to discuss his turnaround plan, AI’s impact on jobs, and why TrumpRx matters.
Day One Biopharmaceuticals will acquire Mersana for $129M upfront in a deal that could reach $285M, centered on the struggling biotech’s B7-H4-targeted-ADC.
Day One to buy struggling ADC maker Mersana for $129M
Day One Biopharmaceuticals is bailing out Mersana Therapeutics two years after the antibody-drug conjugate maker’s lead ovarian cancer drug failed a pivotal trial.
endpoints.news
November 13, 2025 at 7:43 PM
Day One Biopharmaceuticals will acquire Mersana for $129M upfront in a deal that could reach $285M, centered on the struggling biotech’s B7-H4-targeted-ADC.
Zealand Pharma paused development of its GLP-1/GLP-2 obesity drug dapiglutide to focus on higher-priority programs.
Zealand pauses development of GLP-1/GLP-2 obesity candidate
Zealand Pharma pauses development of obesity drug dapiglutide to focus on other assets including survodutide (partnered with Boehringer Ingelheim) and petrelintide (Roche).
endpoints.news
November 13, 2025 at 6:07 PM
Zealand Pharma paused development of its GLP-1/GLP-2 obesity drug dapiglutide to focus on higher-priority programs.
BioNTech co-founders Uğur Şahin and Özlem Türeci sat down with Endpoints Senior Editor Max Gelman to discuss their bispecific push, Bristol Myers deal and competing with Pfizer.
Q&A: BioNTech co-founders discuss bispecific efforts, Bristol Myers deal, and the irony of competing with Pfizer
Following its R&D Day event, Endpoints News sat down with CEO Uğur Şahin and CMO Özlem Türeci to discuss a range of topics.
endpoints.news
November 13, 2025 at 4:23 PM
BioNTech co-founders Uğur Şahin and Özlem Türeci sat down with Endpoints Senior Editor Max Gelman to discuss their bispecific push, Bristol Myers deal and competing with Pfizer.
Korro Bio scrapped its lead AATD drug after weak early data and will pivot to a new program for high blood ammonia, cutting a third of staff to extend its cash runway into the second half of 2027.
Korro Bio abandons lead genetic disease drug candidate after disappointing data
Korro Bio ends AATD program KRRO-110 after trial shortfall, shifts to hyperammonemia drug KRRO-121. Stock drops 80%. Company cuts staff by 1/3 to extend runway to 2027.
endpoints.news
November 13, 2025 at 3:22 PM
Korro Bio scrapped its lead AATD drug after weak early data and will pivot to a new program for high blood ammonia, cutting a third of staff to extend its cash runway into the second half of 2027.
⚡ Breaking: FDA unveils new pathway for personalized therapies
FDA unveils new path to speed personalized therapies, inspired by Baby KJ
FDA Commissioner Marty Makary and CBER Director Vinay Prasad laid out how drugmakers can reuse technology and earlier data from past efforts to streamline future regulatory reviews.
endpoints.news
November 12, 2025 at 10:18 PM
⚡ Breaking: FDA unveils new pathway for personalized therapies
Alkermes’ narcolepsy drug hit Phase 2 goals by a slim margin, with results just clearing statistical significance.
Alkermes' stock drops as second Phase 2 narcolepsy trial hits statistical significance — but just barely
Alkermes’ quest to develop a new narcolepsy drug became murkier on Wednesday following another Phase 2 readout.
endpoints.news
November 12, 2025 at 9:31 PM
Alkermes’ narcolepsy drug hit Phase 2 goals by a slim margin, with results just clearing statistical significance.
After a year of major deals, the PD-(L)1xVEGF bispecific race is heating up, with Summit, Pfizer-3SBio, and BMS-BioNTech vying to shape cancer’s next frontier.
After a frenzied year of dealmaking, here’s how the PD-(L)1xVEGF bispecific race is looking so far
For the last couple years, much of the PD(L)1xVEGF attention has focused on Summit Therapeutics and its lead drug ivonescimab. Now, two other challengers have emerged.
endpoints.news
November 12, 2025 at 7:27 PM
After a year of major deals, the PD-(L)1xVEGF bispecific race is heating up, with Summit, Pfizer-3SBio, and BMS-BioNTech vying to shape cancer’s next frontier.
Bayer’s pharma unit gained some wins in Q3 with an FDA nod for Lynkuet and rising core drug sales as CEO Bill Anderson’s restructuring takes hold.
Bayer’s pharma division makes some strides as restructuring continues
Bayer’s pharma unit is riding the wave of a strong year, buoyed by a new drug approval and market launch as well as growing sales for certain core medicines in the third quarter.
endpoints.news
November 12, 2025 at 6:01 PM
Bayer’s pharma unit gained some wins in Q3 with an FDA nod for Lynkuet and rising core drug sales as CEO Bill Anderson’s restructuring takes hold.
Exclusive: Ovid CEO Jeremy Levin will hand the reins to COO Meg Alexander in 2026, marking a planned transition as the biotech rebuilds its neurology pipeline.
Exclusive: Ovid co-founder and CEO Levin plans leadership handoff in 2026
Ten years after founding Ovid Therapeutics, CEO Jeremy Levin plans to step down and hand over the top spot to COO Meg Alexander.
endpoints.news
November 12, 2025 at 5:29 PM
Exclusive: Ovid CEO Jeremy Levin will hand the reins to COO Meg Alexander in 2026, marking a planned transition as the biotech rebuilds its neurology pipeline.
FDA taps Richard Pazdur as new CDER director after Tidmarsh's resignation
FDA taps Richard Pazdur as new CDER director after Tidmarsh's resignation
The FDA on Tuesday named 26-year agency veteran Richard Pazdur as director of the Center for Drug Evaluation and Research.
endpoints.news
November 11, 2025 at 10:22 PM
FDA taps Richard Pazdur as new CDER director after Tidmarsh's resignation
Regeneron’s George Yancopoulos, CRISPR Therapeutics' Sam Kulkarni, and investor Alexis Borisy will represent biotech at Wednesday’s MAHA Summit with top US health officials.
Regeneron, CRISPR Therapeutics execs will represent biotech at Wednesday MAHA event
On a panel entitled 'Making American Biotechnology Accelerate,' Regeneron's George Yancopoulos will be joined by CRISPR Therapeutics CEO Sam Kulkarni and serial biotech investor Alexis Borisy.
endpoints.news
November 11, 2025 at 10:19 PM
Regeneron’s George Yancopoulos, CRISPR Therapeutics' Sam Kulkarni, and investor Alexis Borisy will represent biotech at Wednesday’s MAHA Summit with top US health officials.
Hinge Health CEO Daniel Perez spent two years prepping for an IPO — then went live on the S&P’s worst day of the year. Here’s how he pulled it off.
How Hinge Health pulled off its IPO
Hinge Health CEO Daniel Perez discusses IPO journey, emphasizing 2-year preparation, financial discipline, and market challenges at Endpoints News' Health Tech Day.
endpoints.news
November 11, 2025 at 8:44 PM
Hinge Health CEO Daniel Perez spent two years prepping for an IPO — then went live on the S&P’s worst day of the year. Here’s how he pulled it off.
KalVista’s hereditary angioedema drug brought in $13.7M in Q3, tripling forecasts and doubling patient starts from the previous quarter.
KalVista defies sales expectations again for hereditary angioedema drug
KalVista Pharmaceuticals continued its sales momentum for Ekterly in the third quarter, beating analyst expectations and doubling the number of patient starts for the rare disease drug compared with t...
endpoints.news
November 11, 2025 at 7:32 PM
KalVista’s hereditary angioedema drug brought in $13.7M in Q3, tripling forecasts and doubling patient starts from the previous quarter.
EnGene's stock $ENGN went up by as much as 65% on Tuesday morning after it reported more data for its bladder cancer gene therapy
EnGene posts more pivotal data for bladder cancer gene therapy, plans 2026 filing
EnGene has posted another tranche of encouraging bladder cancer treatment data from a pivotal trial, teeing up a BLA filing in the back half of next year.
endpoints.news
November 11, 2025 at 6:12 PM
EnGene's stock $ENGN went up by as much as 65% on Tuesday morning after it reported more data for its bladder cancer gene therapy
Neurocrine said one of the drugs it licensed from Takeda failed a Phase 2 trial in major depressive disorder.
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Neurocrine reports Phase 2 fail for depression drug it licensed from Takeda
Neurocrine Biosciences said that a candidate for major depressive disorder that it got from Takeda did not succeed in a mid-stage trial.
endpoints.news
November 11, 2025 at 3:55 PM
Neurocrine said one of the drugs it licensed from Takeda failed a Phase 2 trial in major depressive disorder.
endpoints.news/neurocrine-r...
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The FDA plans to pull boxed warnings from the labels of menopause hormone therapies. It's working with companies to remove “references to risks of breast cancer, cardiovascular disease, and probable dementia.”
FDA seeks to remove warnings from labels of hormone therapies for menopause
The FDA is making a concerted effort to increase access to hormone replacement therapies (HRTs) for women by calling on their makers to apply to remove the boxed warnings that the agency added to thei...
endpoints.news
November 10, 2025 at 9:42 PM
The FDA plans to pull boxed warnings from the labels of menopause hormone therapies. It's working with companies to remove “references to risks of breast cancer, cardiovascular disease, and probable dementia.”
Former Lilly Diabetes executives Enrique Conterno and Meg Powell are searching for the newest approaches to obesity treatment with their venture capital firm, 501 Ventures.
Ex-Lilly Diabetes leaders hunt for new obesity drugs at VC firm aimed at 'advancing the science'
Two former executives of Eli Lilly's diabetes unit are searching for the newest and best approaches to obesity treatment.
endpoints.news
November 10, 2025 at 7:00 PM
Former Lilly Diabetes executives Enrique Conterno and Meg Powell are searching for the newest approaches to obesity treatment with their venture capital firm, 501 Ventures.
Exclusive: AI drug discovery startup Iambic raised $100M from investors to expand its HER2 program and advance two more drugs into trials in 2026.
Exclusive: AI biotech Iambic raises $100M, expects three drugs in clinic in 2026
Iambic has raised more than $100 million in a new funding round, CEO Tom Miller exclusively told Endpoints News, and the San Diego biotech plans on using the cash to advance multiple drugs in the clin...
endpoints.news
November 10, 2025 at 5:05 PM
Exclusive: AI drug discovery startup Iambic raised $100M from investors to expand its HER2 program and advance two more drugs into trials in 2026.
Roche’s BTK inhibitor hit Phase 3 goals in two MS studies — a rare double win for a class long beset by safety issues and trial failures.
Roche reports two Phase 3 wins for its BTK inhibitor in multiple sclerosis
Roche’s BTK inhibitor has cleared two registrational studies in different types of multiple sclerosis, a surprise turn for a drug class that’s seen several trial failures and safety setbacks.
endpoints.news
November 10, 2025 at 4:07 PM
Roche’s BTK inhibitor hit Phase 3 goals in two MS studies — a rare double win for a class long beset by safety issues and trial failures.