Leaders of U.S. drug companies should use their influence to stop a ruinous proposal, argues @steveusdin.bsky.social in a BioCentury commentary.

I spoke with co-founder Krishna Polu about the launch of R1 Therapeutics. The start-up has obtained most global rights to a therapy from China-based Alebund that inhibits phosphate transporters in the intestine to treat a common complication of kidney disease: www.biocentury.com/article/6587...

FDA's CBER will review Moderna's mRNA-1010 flu vaccine after all.... www.accessnewswire.com/newsroom/en/...

My BioCentury colleague Lauren Martz looks ahead to a big year of catalysts, with innovations in RNA-targeting therapies leading the way. www.biocentury.com/article/6581...

Rapt Therapeutics has steered into a $2.2b acquisition by GSK, which appears most interested in developing the biotech's IgE-targeting Xolair competitor for a prophylactic food allergy indication. www.gsk.com/en-gb/media/...

Eight public biotechs raised a total of >$3.2 billion overnight. Most had strong data readouts in the past few days. All but one upsized their offerings from their proposed targets. They say a healthy follow-on market augurs a healthy IPO market. $GPCR $WVE $DYN $VERA $FULC $KYMR $TERN $DNLI

Great news for Halda Therapeutics and for prostate cancer patients! HLD-0915 has great potential to help those with metastatic castration resistant prostate cancer, who have failed prior therapies. #Halda #prostatecancer www.jnj.com/media-center...

Biogen is in-licensing Vanqua's C5aR1 program for $70m up front, plus $990m in potential milestones. It's an oral small molecule that complements a mAb in BIIB's pipeline, obtained via its HI-Bio acquisition. Two shots at a pipeline-in-a-product to treat inflammatory diseases.

Ventyx Biosciences' shares are set to double (+100% premarket) following a readout for its CNS-penetrant NLRP3 inhibitor in patients with obesity and CV risk factors: www.globenewswire.com/news-release... My colleague @stephenhansen.bsky.social wrote about the mechanism last year. Story below.

A deal with Takeda could prove transformative for China-based Innovent Biologics as the partners seek to co-commercialize a bispecific oncology therapy in the U.S. Two other therapies are part of the deal as well; a $1.2 billion upfront component could turn into $11.4 billion in total payments.

FGF21 agonist M&A: May 2025: GSK pays $1.2b upfront for Boston Pharma's efimosferin; deal includes $800m in milestones Sept. 2025: Roche buys 89bio for $2.4b upfront, gaining pegozafermin; $1b CVR Today: Novo buys Akero for $4.7b upfront, adding efruxifermin; ~$500m CVR

Months after RFK Jr and Marty Makary pushed Peter Marks out of FDA, the former CBER director has taken an SVP role at Lilly. @steveusdin.bsky.social has the scoop in @biocentury.bsky.social.

TCG X's Chen Yu has reasons to be optimistic during a difficult cycle for biotech investors. I spoke with him about the firm's newly disclosed $1.3 billion third fund, its largest yet. Story: www.biocentury.com/article/6571...

Lazard's annual biopharma survey is out this morning. I spoke with the firm's David Gluckman about the risks and challenges the industry faces -- and some reasons to be optimistic. Story (no paywall): www.biocentury.com/article/6570...

Our story in @biocentury.bsky.social, by @steveusdin.bsky.social.

I spoke with @jmaraganore.bsky.social and Clive Meanwell about their new company, Corsera Health. They're seeking to apply the disease interception model to CV health -- identifying risk at an early age and stopping disease from developing in at-risk people. My story:

What to make of FDA's about-face on Stealth BioTherapeutics' therapy for Barth syndrome? Denied CRL appeal, then signaled it would conduct an unusually quick review -- with a decision due just five weeks after resubmission. Pressure from patient advocates seems to be a factor. Story:

FDA granted full approval to a treatment for a rare disease based on a single-arm study of 35 evaluable patients, even though its sponsor was seeking accelerated approval. No confirmatory trial needed. And this, from CBER director Vinay Prasad, seems like a signal: www.fda.gov/news-events/...

VC-backed Expedition Therapeutics, set up to in-license assets from China and develop them in the West, has struck a deal with Fosun for a clinical DPP-1 inhibitor to treat inflammatory and respiratory indications. $17m up front, $628m in milestones. Read about it in BioCentury's Deals Report 👇

ICYMI (overnight in many geographies) -- Sanofi is paying $1.15b up front to acquire venture-backed vaccine company Vicebio. Early clinical data were the deal's trigger, chairman Giovanni Mariggi of founding investor Medicxi tells me. Story: www.biocentury.com/article/6565...

Good morning #biosky! Merck/MSD is paying $10b to acquire Verona Pharma, obtaining an approved PDE3/PDE4 dual inhibitor for COPD. $107/share price is a 23% premium over Tuesday's close. www.merck.com/news/merck-t...

READ THE COMPLAINT: storage.courtlistener.com/recap/gov.us...

SpliceBio's new round is the largest ever -- by a lot -- for a Spain-based biotech, according to BioCentury's BCIQ database. We've been watching the life sciences ecosystem grow in Spain for some time, and early SpliceBio investor Ysios has been a major driver: www.biocentury.com/article/6410...

Intellia NTLA is -28% just after the morning bell. The biotech disclosed a case of liver toxicity in its Phase 3 amyloidosis study, here in an 8-K and apparently on a private call with analysts last evening: www.sec.gov/ix?doc=/Arch...

Here's a $60m series A for Vima, a newly launched company "with a singular focus: to change the lives of patients with dystonia." That's from co-founder/chairman David Grayzel of Atlas Venture, which led the round. Release here, management team in screenshot: www.globenewswire.com/news-release...

We had noted the slowdown in follow-on activity amid high volatility this year, with no substantial NASDAQ offerings at all by biotechs during April. The overnight offering from Taysha ($200m last evening), looks like the biggest by a biotech since March. Story: www.biocentury.com/article/6558...

RBL, the venture studio formed last year with ties to Rice University and KdT Ventures, has just introduced its first biotech spinout. Sentinel BioTherapeutics will present Phase I data at ASCO for its IL-2 program for immuno-oncology. Our October story on RBL: www.biocentury.com/article/6539...

A patient has passed away in Rocket Pharma’s Phase II study of its gene therapy for Danon disease. The study is under clinical hold and Rocket is evaluating next steps. ir.rocketpharma.com/news-release...

Good morning #biosky! Today Biogen is paying City Therapeutics $46m up front, including a $30m equity investment, to develop RNAi medicines, starting with a CNS target. $1b biobucks + royalties. Release: www.globenewswire.com/news-release...

That giant sucking sound you hear is 80 years of US investment in soft power going down the drain China to donate $500 million to WHO, stepping into gap left by U.S. www.washingtonpost.com/world/2025/0...

BioMarin is buying Inozyme for $4/share, or $270m; it's a 182% premium over Thursday's close of $1.42. Data are due in early 2026 from a Phase III study of $INZY's enzyme replacement therapy for ENPP1 deficiency. Release:

GSK is buying Boston Pharma’s lead asset, an FGF21 agonist for liver disease, for $1.2B up front + $800m milestones. The former Novartis molecule drives a strong return for Boston backer Gurnet Point. Release: www.gsk.com/en-gb/media/... A little background: www.biocentury.com/article/6462...

My op-ed on the large shift of drug discovery moving to China and policy steps the U.S. can take to keep the innovation economy in America. "Five years ago, U.S. drug makers didn’t license any new drugs from China. By 2024, one-third came from Chinese biotech"

The latest biotech to accept a buyout from Tang Capital-backed Concentra: It's Kronos Bio, the company that was until recently led by Norbert Bischofberger. CDK9 discontinued in November; laid off most staff. $112m cash at Dec. 31; complex CVR.

Novartis promised more "value-creating bolt-ons" during yesterday's conference call. Today, the pharma is buying Regulus Therapeutics for $7/share ("$0.8 billion"), with a CVR that could double the price to $1.7b. Regulus' anti-miR oligo for ADPKD is in Phase 1b.

FDA misses PDUFA goal for Stealth’s Barth syndrome treatment It isn’t clear whether staffing cuts or loss of FDA champions have caused FDA to miss the PDUFA goal for an ultrarare disease therapy. www.biocentury.com/article/655776

A few words on this morning's Merck KGaA/SpringWorks deal: Two rare tumor treatments, a takeout consummated after months of rumors, and relief from an M&A drought: www.biocentury.com/article/6557...

Steve Usdin writing in BioCentury: “It’s official: FDA says its cuts are delaying drug regulation — Layoffs, lack of access to journals slow response FDA says”

Two key management moves at Galapagos: - CEO Paul Stoffels (ex-JNJ CSO) is retiring this year, but will remain chairman - Ex-Neumora CEO Henry Gosebruch will be CEO of the planned GLPG spinout Release: www.globenewswire.com/news-release... Background ($): www.biocentury.com/article/6546...

If LLY's +11% premarket stock move holds, it'd gain about $75 billion in market cap. New oral GLP-1 data in diabetic patients is the driver: www.prnewswire.com/news-release...

I hadn't heard of Earendil Labs -- this may be its first announcement, datelined Middletown, Delaware -- but it's receiving $125m up front from Sanofi for rights to two bispecifics (α4β7xTL1A, TL1AxIL23) for IBD/autoimmune disease. $1.72b biobucks, plus royalties. www.prnewswire.com/news-release...

RFK Jr cited pseudo-science to justify holding up of Novavax COVID vaccine. He said single-antigen vaccines don’t protect against respiratory diseases. There are 2 FDA-approved sgl antigen vaccines for RSV. And data on Novavax solid, FDA reviewers said. www.biocentury.com/article/655591

More competition in the IgA nephropathy arena as Novartis wins accelerated approval of Vanrafia atrasentan. No REMS, apparently satisfying a $2/share CVR tied to Novartis' 2023 acquisition of Chinook. www.prnewswire.com/news-release...

I'm hearing from @steveusdin.bsky.social that another key official has been forced out from FDA. Peter Stein, longtime director of CDER’s Office of New Drugs, faced demotion and resigned. BioCentury story coming today.

Novo is paying Lexicon $75m up front for rights to an oral therapy targeting ACSL5 to treat obesity; the non-incretin treatment is still preclinical. www.globenewswire.com/news-release...

Good morning #biosky! Merck is paying $200m for ex-Greater China rights to an Lp(a) program from Jiangsu Hengrui, now in Phase 2 testing in China. Deal includes $1.77m in biobucks. Recall: AZ paid CSPC $100m in October for rights to an Lp(a) disruptor. www.businesswire.com/news/home/20....

A few words on Amvuttra's label expansion this evening to include the larger ATTR indication with cardiomyopathy -- helping Alnylam fulfill its ambition to reach profitability this year: www.biocentury.com/article/6554...

I had a word with Sofinnova's Graziano Seghezzi about how the firm will deploy €165m to back companies in what is now the largest biotech accelerator in Europe: www.biocentury.com/article/6553...

Curevo will put a new $110m round toward development of its Shringrix competitor, which it believes has tolerability advantages over the incumbent shingles vaccine. I spoke with the company, new board member Moncef Slaoui (ex-GSK) and lead investor Medicxi. Story: www.biocentury.com/article/6553...