Bicycle to lay off 30% of staff, pivot away from Padcev challenger

The company now expects a longer path to approval than anticipated, leading it to deprioritize a therapy billed as a threat to Pfizer’s fast-selling bladder cancer drug. 

By Jonathan Gardner • March 17, 2026

R1 starts up with $78M, aiming for a better kidney drug

The startup believes a pill it licensed from a Chinese biotech company could be more potent, and convenient to take, than existing treatments for a common complication of chronic kidney disease.

By Gwendolyn Wu • March 17, 2026

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases or in reprogramming cells inside the body.

By BioPharma Dive staff

CytomX surges on positive data for ‘masked’ ADC in colorectal cancer

Company shares spiked more than 60% after the therapy surpassed Wall Street benchmarks in Phase 1 testing against late-line colorectal tumors. 

By Delilah Alvarado • March 16, 2026

Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial

Testing revealed weight loss effects some Wall Street analysts believe compare favorably to Lilly’s orforglipron, which regulators could approve within weeks. 

By Jonathan Gardner • March 16, 2026

Sarepta tests new Elevidys safeguards; Sana advances diabetes cell therapy

Sarepta has begun evaluating a regimen meant to lower the risk of liver damage in Elevidys recipients. Elsewhere, Inovio laid off staff and a Bayer kidney drug notched another trial victory.

By Ben Fidler • March 16, 2026

With FDA go ahead, a China biotech notches a first in cell therapy testing

The trial clearance for Shanghai-based Unixell is another step forward for the rapidly advancing Chinese biotech ecosystem, which has invested heavily in cell and gene therapy technology.

By Jacob Bell • March 13, 2026

Evotec, Vistagen lay off staff; Immutep shares collapse on study failure

Evotec will cut 800 employees in its second layoff round since 2024. Elsewhere, Ultragenyx got a needed win and a twice-rejected cell therapy is getting an audience at the FDA.

By BioPharma Dive staff • March 13, 2026

FDA to unify agency’s ‘fragmented’ safety surveillance system

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.

By Kristin Jensen • March 12, 2026

Biogen builds case for Spinraza successor with fresh data

More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis' Zolgensma.

By Gwendolyn Wu • March 11, 2026

With $100M, Vima pursues an oral drug for movement disorders

Incubated by Atlas Venture, the biotech startup is advancing a daily pill it sees potentially helping people with dystonia or Parkinson's disease regain control of movement.

By Gwendolyn Wu • March 11, 2026

BioNTech founders to step down and helm new mRNA startup

Ugur Sahin and Özlem Türeci, who directed the COVID vaccine maker’s rise to prominence, will helm an as-yet-unnamed company dedicated to mRNA discovery work.

By Delilah Alvarado • March 10, 2026

Xenon hits a ‘home run’ in epilepsy; FDA restarts review of Duchenne cell therapy

Xenon shares skyrocketed nearly 50% on results that handily beat Wall Street expectations. Elsewhere, Capricor got a decision date for a spurned cell therapy and AbbVie and Regeneron showcased obesity data.

By BioPharma Dive staff • March 10, 2026

Vertex kidney disease drug hits mark in late-stage study

Company shares surged in after-market trading on results for a drug Vertex acquired in a multibillion-dollar deal and sees as having “best-in-class potential” in a competitive field.

By Ben Fidler • Updated March 10, 2026

UniQure leads genetic medicine biotech rally after news of Prasad’s exit

Vinay Prasad contributed to an uncertain regulatory climate for gene therapy makers focused on rare conditions. Shares of many developers rose on the chance of a more industry-friendly successor.

By Jacob Bell • March 9, 2026

Ipsen to withdraw cancer drug acquired in buyout due to safety concerns

Ipsen found cases of secondary malignancies in a confirmatory study of Tavzerik, a medicine it got in a purchase of Epizyme and that it has struggled to sell. 

By Delilah Alvarado • March 9, 2026

Servier to build cancer drug pipeline with $2.5B purchase of Day One

The proposed acquisition would hand Servier a couple experimental drugs in human testing as well as Ojemda, an approved therapy for certain hard-to-treat brain tumors that affect children.

By Jacob Bell • March 6, 2026

Pfizer nabs first obesity approval; Alnylam, Tenaya search for heart drugs

The clearance in China comes weeks after Pfizer acquired rights to the therapy. Elsewhere, Alnylam is looking for “novel” cardiovascular targets and investors sold off Helus shares. 

By BioPharma Dive staff • March 6, 2026

A startup making drugs for blood disorders banks $160M

Atavistik Bio is using the cash to develop “allosteric” medicines it believes can precisely impact on diseases like myelofibrosis and the blood condition HHT.

By Gwendolyn Wu • March 5, 2026

Moderna to pay up to $2.25B to end mRNA vaccine patent fight

Announced days before a trial, the deal settles a longstanding dispute and avoids what one analyst called a “worst-case scenario” financially for Moderna.

By Delilah Alvarado • March 4, 2026

FDA again targets GLP-1 compounders; Intellia to restart heart disease trial

The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.

By Ben Fidler • March 4, 2026

Kyowa Kirin abandons touted eczema drug following safety review

A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug’s mechanism to the onset of a type of skin cancer.

By Delilah Alvarado • March 3, 2026

UniQure says FDA wants another study of Huntington’s gene therapy

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

By Jacob Bell • March 2, 2026

Candid, in a reverse merger with RallyBio, to go public

Candid, which is making bispecifics for immune diseases, has also raised $505 million in a private financing for the newly formed company.

By Gwendolyn Wu • March 2, 2026

Why it’s critical to close open steps in cell therapy manufacturing

Reduce risk, cut costs and scale smarter by closing open steps in cell therapy manufacturing.

March 2, 2026

Atrium spins out of Avidity, aiming to target rare heart diseases with RNA

Four months after Avidity’s $12 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its predecessor’s work in cardiovascular disease.

By Ben Fidler • Feb. 27, 2026