Upcoming PDUFA dates may be ensnared by Trump's pause at HHS, analyst says
President Donald Trump's communications pause for HHS, FDA and other health-related agencies could push some drug approval decisions to later dates, a Raymond James analyst told investors on Thursday....
View ArticleMerck and Eisai reveal late-stage fail for Keytruda and Lenvima in...
The combination of Merck’s Keytruda and Eisai’s Lenvima failed to prolong patients’ lives versus the comparator in another cancer study, but the companies say they are committed to the approach. In the...
View ArticleWith Sam Altman’s help, Retro Biosciences eyes $1B to extend lifespan by 10...
Disease-reversal startup Retro Biosciences is aiming for a $1 billion funding round, a spokesperson for the company confirmed in a Friday email to Endpoints News. It would be one of the largest funding...
View ArticleBiogen paring back research efforts; Will Chinese biotechs threaten US...
Welcome to the weekend! We saw a flurry of health-related news from Washington DC this week as the Trump administration officially began its transition. Let’s go over it. On the day he was sworn into ...
View ArticleAgenus continues partnership talks for anti-CTLA-4 combo with new Phase 2 data
Five months after the FDA blocked its plans for accelerated approval, Agenus is moving ahead with discussions with potential pharma partners to chart a more conventional registrational path for its...
View ArticleMaze looks to lead IPO queue with $113M Nasdaq debut
Maze Therapeutics is eyeing a $113 million initial public offering a little under two months after revealing a $115 million Series D. The clinical-stage biotech — which has been through an FTC snafu ...
View ArticleLeerink Partners hires M&A bankers, grows health deals team
In a dramatic turnaround from bankruptcy court less than two years ago, Leerink Partners is now on the offensive and hiring away from rival banks to build out its M&A practice. The healthcare...
View ArticleMetsera outlines $250M IPO plans as obesity biotech competition rises
Metsera, a well-funded biotech trying to angle toward the front of the obesity medicine pack, has proposed a $250 million IPO. That would be the size of net proceeds Metsera would gain from its Nasdaq ...
View ArticleAurion Biotech files for IPO amid legal battle with Alcon
Investors typically celebrate IPOs as milestone moments — and potential exit opportunities — for their startups. In an unusual twist, the eye giant Alcon has taken a different view, suing a startup it...
View ArticleAllakos restructures after Phase 1 failure; AB2 inks deal with Nippon Shinyaku
Plus, news about GSK: Allakos reports Phase 1 failure, lays off 75% of staff: The biotech said AK006 did not produce a clinical benefit in patients with chronic spontaneous urticaria, a ...
View ArticleVeru's drug lessens loss of lean mass in patients taking Wegovy
Veru says its muscle-maintaining drug preserved more lean mass in older patients taking a GLP-1, but skittish investors didn’t celebrate. The Miami biotech on Monday reported new Phase 2b data for ...
View ArticleTrump healthcare transition: Live updates, biotech, pharma news
It’s been one week since President Donald Trump returned to the Oval Office. We've already seen a flood of executive orders, and the pause on health agency communications has created a bit of a frenzy ...
View Article#ASCOGI25: Bristol Myers shares IO combo data in colorectal cancer; Pfizer...
Several drugmakers shared new clinical data at this year’s ASCO GI Symposium in San Francisco, and Endpoints News has rounded up a handful of notable presentations from Bristol Myers Squibb, Pfizer,...
View ArticleSage rejects Biogen’s deal offer, will look at other options
Sage Therapeutics knows it needs to do something. But it doesn't want to sell to its partner Biogen. On Monday, the troubled biotech said its board had unanimously rejected Biogen's ...
View ArticlePfizer inks $60M settlement to close Nurtec anti-kickback suit
Pfizer will pay nearly $60 million to settle claims that its subsidiary Biohaven used illegal kickbacks to drive sales of its migraine medicine Nurtec ODT. A Pfizer spokesperson said the company has...
View ArticleObesity startup Found drives weight loss with low-cost generic drugs over...
Found, a telehealth startup that treats obesity with medication and lifestyle coaching, unveiled new research showing tens of thousands of its patients lost significant amounts of weight through its...
View ArticlePharmacy middlemen lose bid to toss new Hawaii complaint
The state of Hawaii can proceed with a lawsuit against the three largest pharmacy benefit managers after it updated its complaint, a federal judge has ruled. Judge Leslie Kobayashi of the US District...
View ArticleSarepta shares two-year DMD data that may inform Europe decision
Sarepta Therapeutics unveiled new results from the second part of a clinical trial for its Duchenne muscular dystrophy gene therapy Elevidys, showing that patients who received the gene therapy...
View ArticleUpdated: Cell therapy biotech Affini-T Therapeutics reduces staff
Affini-T Therapeutics laid off an undisclosed number of employees last week, CEO Jak Knowles confirmed in a post-publication email to Endpoints News on Tuesday. The startup was coming up on a likely...
View ArticleVersant's fourth obesity biotech starts with $65M and a GIP antagonist
Another obesity biotech emerged on Tuesday morning, this time taking a different approach to the GIP antagonism story than Amgen and another startup called Antag Therapeutics. Helicore Biopharma broke...
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