FibroGen plans new round of cost cuts after latest study setback

The biotech is planning a “significant cost reduction” effort in the U.S. following a Phase 3 failure in idiopathic pulmonary fibrosis, the third trial miss it’s reported since May.

By Ben Fidler • June 26, 2023

Biogen shareholders vote in favor of new board member

Susan Langer, whose nomination stirred controversy due to her ties to an outgoing director, will now join seven other board members who successfully ran for re-election.

By Jacob Bell • June 26, 2023

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

Intercept to abandon NASH research, lay off staff after FDA drug rejection

The FDA for the second time turned back Intercept’s application for approval of its drug obeticholic acid in the liver disease, spurring the restructuring.

By Ben Fidler • June 23, 2023

Spyre, a new biotech spinout, launches via merger with Aeglea

The company, which emerged from Paragon Therapeutics, is developing bowel disease drugs similar to Takeda's Entyvio and an experimental Prometheus drug just bought by Merck & Co. 

By Ned Pagliarulo • June 22, 2023

Startup Tagworks raises $65M to make ‘click-to-release’ cancer drugs

The biotech is borrowing from Nobel Prize-winning “click chemistry” to develop medicines that can precisely target a variety of solid tumors.

By Gwendolyn Wu • June 22, 2023

Argenx wins FDA approval for under-the-skin injection of rare disease drug

Clearance of a subcutaneous form of Argenx’s medicine, known as Vyvgart, could help pad a launch that’s already exceeded Wall Street expectations.

By Ned Pagliarulo • June 21, 2023

Flagship’s latest startup aims to take the guesswork out of small molecule drugs

Empress Therapeutics claims its technology can identify chemical drug candidates faster and more reliably. The biotech now has $50 million from Flagship to prove it.

By Gwendolyn Wu • June 21, 2023

Patient death spurs FDA to pause test of Arcellx’s Gilead-partnered cell therapy

The company said limitations on “bridging treatment” used to hold cancer in check could be to blame, and is working to change the study’s protocol.

By Jonathan Gardner • June 20, 2023

Attovia, a new California biotech, launches with plans to rethink how drugs bind their targets

A spinout of Alamar Biosciences, Attovia aims to create nanobody-based drugs that are more effective in treating autoimmune diseases and cancer.

By Gwendolyn Wu • June 20, 2023

Cell and gene therapy manufacturing: the next generation of startups

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

By Gwendolyn Wu • June 20, 2023

A right-first-time approach to development

Avoid costly delays, don't let development oversights derail your advanced therapy commercialization. Read the article.

June 20, 2023

Verve partners with Lilly on gene editing therapy for heart disease

Lilly will pay the genetic medicine specialist $60 million upfront to work together on a treatment targeting a risk factor known as Lp(a).

By Ned Pagliarulo • June 15, 2023

Astellas delves deeper into protein degrading drugs with Cullgen deal

The alliance is Astellas’ second recent partnership involving protein degraders, an emerging area of drug research the company has recently made a focus.

By Ben Fidler • June 15, 2023

Acadia gives once-rejected Prader-Willi drug a second chance

The FDA last year turned back an approval request from the drug’s former developer, Levo Therapeutics. That biotech is now owned by Acadia, which will run a new study designed to boost its odds of success.

By Delilah Alvarado • June 14, 2023

Biogen’s latest board shake-up includes potentially controversial pick

Three board members — Alex Denner, William Jones and Richard Mulligan — will not stand for re-election. Susan Langer, who was previously the company’s head of corporate strategy, has been nominated to fill one of their seats.

By Jacob Bell • June 13, 2023

A cell therapy startup looks to an IPO to avert financial peril

In a sign of the impact the downturn has had on young biotechs, Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is “substantial doubt” it can survive.

By Ben Fidler • June 13, 2023

Built from biotech parts, Beacon launches with $120M to develop eye gene therapies

Beacon Therapeutics will be led by former executives of other ocular gene therapy developers, including Nightstar, Gyroscope and AGTC.

By Jacob Bell • June 12, 2023

Illumina CEO Francis deSouza resigns weeks after surviving Icahn board battle

DeSouza is departing unrepentant about his decision to close the Grail deal, telling colleagues his belief in the merger “remains unshakeable.”

By Nick Paul Taylor • June 12, 2023

Upstream Bio raises $200M in fresh funding for asthma drug

The biotech’s experimental drug, currently in Phase 1 testing, has drawn investor attention despite a difficult funding environment for drug startups.

By Kristin Jensen • June 8, 2023

After years of disappointment, cancer vaccines show new promise

Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.

By Jonathan Gardner • June 8, 2023

Armed with new gene therapy tools, a biotech startup promises a better way to target muscle diseases

Two-year-old Kate Therapeutics is launching publicly with $51 million and a licensing deal with Astellas Pharma for a neuromuscular disease gene therapy.

By Ned Pagliarulo • June 8, 2023

Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi

Agency advisers are meeting Friday to discuss whether recent trial data confirm Leqembi’s benefit. A vote is expected in the late afternoon. 

By Jacob Bell • June 7, 2023

With new startup Bitterroot, Forty Seven founder takes aim at heart disease

Co-founded by Stanford University professor Irv Weissman, the company debuted with $145 million and plans to use CD47 antibodies, best known as potential cancer immunotherapies, to reduce the risk of heart attacks. 

By Ben Fidler • June 7, 2023

Using twin viruses, startup AAVantgarde aims to extend gene therapy’s reach

The biotech has raised about $65 million to test two ways to deliver larger genes into the body, which could help gene therapy treat more diseases.

By Ben Fidler • June 6, 2023

FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

By Jacob Bell • June 6, 2023