Industry News

Biotechnology Industry News

Capsida Biotherapeutics has paused…

September 11th, 2025|FierceBiotech|

Capsida Biotherapeutics has paused a gene therapy clinical trial after the first patient died. The biotech, which began the phase 1/2 study in July, took the action to give it time to determine the root

LB Pharmaceuticals’ decision to…

September 11th, 2025|FierceBiotech|

LB Pharmaceuticals’ decision to break cover and go public seems to have paid off, with the company bumping up the number of shares on offer for its Nasdaq listing this morning.

Less than two years after breaking…

September 10th, 2025|FierceBiotech|

Less than two years after breaking ground on a ballyhooed 1 billion pound sterling ($1.31 billion) R&D center and future U.K. headquarters in London, Merck is not only bailing on the project but is discontinuing

One week after warning that the…

September 10th, 2025|FierceBiotech|

One week after warning that the United Kingdom is undervaluing life sciences manufacturing investments, trade organization the Association of the British Pharmaceutical Industry has issued another call to action for policymakers and the local biopharma

From now on, MEI…

September 10th, 2025|FierceBiotech|

From now on, MEI Pharma—previously best known for its clinical-stage leukemia drug—will be called Lite Strategy.

PMV Pharmaceuticals has reported a…

September 10th, 2025|FierceBiotech|

PMV Pharmaceuticals has reported a 43% response rate in a midphase ovarian cancer trial, putting the biotech on a track it believes will lead to a filing for FDA approval in the first quarter of

The Trump administration is…

September 10th, 2025|FierceBiotech|

The Trump administration is considering putting “severe restrictions” on the increasing flow of investigational drugs from China, according to reporting by The New York Times.

Odyssey Therapeutics’ team of…

September 9th, 2025|FierceBiotech|

Odyssey Therapeutics’ team of seasoned drug developers is welcoming another impressive fundraising round, closing a $213 million series D round after abandoning plans to go public this summer.

Protara applies modern science,…

September 9th, 2025|FierceBiotech|

Protara applies modern science, manufacturing, and regulatory expertise to reimagine proven medicines and deliver new treatment options for patients.

Capricor Therapeutics has publicly…

September 9th, 2025|FierceBiotech|

Capricor Therapeutics has publicly released its July response to the FDA's rejection of its Duchenne muscular dystrophy cell therapy deramiocel after the agency included deramiocel in a new batch of complete response letters (CRLs) released

Pfizer veteran Suneet Varma has…

September 9th, 2025|FierceBiotech|

Pfizer veteran Suneet Varma has found his next role. Months after leaving the Big Pharma, Varma has taken the CEO position at the newly created inflammation and immunology startup Intent Biologics.

Novartis is paying $1.4 billion to…

September 9th, 2025|FierceBiotech|

Novartis is paying $1.4 billion to get its hands on Tourmaline Bio and its former Pfizer cardiovascular drug that impressed in a phase 2 study earlier this year.

The CNS-focused company is looking…

September 8th, 2025|FierceBiotech|

The CNS-focused company is looking to pull off the first biotech IPO since February and collect $228.5 million in much-needed funding for further clinical development of its schizophrenia candidate.

After previously delaying its…

September 8th, 2025|FierceBiotech|

After previously delaying its decision date, the FDA has outright rejected Saol Therapeutics’ investigational treatment for an ultra-rare pediatric mitochondrial disease.

Dianthus Therapeutics is advancing…

September 8th, 2025|FierceBiotech|

Dianthus Therapeutics is advancing its challenge for the increasingly competitive generalized myasthenia gravis (gMG) market, outlining plans to move into phase 3 on the back of hits in a midphase study.

Atom Therapeutics is touting data…

September 8th, 2025|FierceBiotech|

Atom Therapeutics is touting data from a phase 2b/3 study as evidence that its gout drug has the efficacy and safety profile to stand out from the competition.

A phase 2a trial of Rapport…

September 8th, 2025|FierceBiotech|

A phase 2a trial of Rapport Therapeutics’ focal onset seizure drug candidate has hit its primary endpoint, sending shares in the biotech​​ up more than 157% in premarket trading.