Industry News

Biotechnology Industry News

Ono Pharmaceutical subsidiary…

March 3rd, 2026|FierceBiotech|

Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals has dropped an early-stage candidate for advanced cancers from its pipeline, citing strategic reasons unrelated to the asset’s safety or efficacy.

The FDA has released the rejection…

March 3rd, 2026|FierceBiotech|

The FDA has released the rejection letter explaining its recent refusal of Regenxbio’s gene therapy for the rare disease Hunter syndrome, providing further details into the agency’s issues with the biotech’s trial design.

As antibody discovery pipelines…

March 3rd, 2026|FierceBiotech|

As antibody discovery pipelines scale, early developability assessment is increasingly used to support smarter candidate prioritization and downstream decision-making.

Biohaven is powering ahead with…

March 3rd, 2026|FierceBiotech|

Biohaven is powering ahead with its bold ambition to sharply reduce R&D spending—even as analysts warn that the company will need to be even stricter with its expenditures.

After cutting down its pipeline…

March 2nd, 2026|FierceBiotech|

After cutting down its pipeline just a few months ago, OSE Immunotherapeutics is at it again, this time reorganizing as Boehringer Ingelheim walks away from the biotech’s metabolic dysfunction-associated steatohepatitis (MASH) candidate.

T-cell engager (TCE) specialist…

March 2nd, 2026|FierceBiotech|

T-cell engager (TCE) specialist Candid Therapeutics has entered into a reverse merger agreement with Rallybio that will allow Candid to trade on the Nasdaq while dumping RallyBio’s own rare disease maternal-fetal medicine assets.

More than a year after first…

March 2nd, 2026|FierceBiotech|

More than a year after first agreeing to a reverse merger with Pulmatrix, protein degradation biotech Cullgen has instead opted to be bought by Gyre Therapeutics in a $300 million all-stock acquisition.

Shares of uniQure plummeted more…

March 2nd, 2026|FierceBiotech|

Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for Huntington’s disease.

United Therapeutics has linked a…

March 2nd, 2026|FierceBiotech|

United Therapeutics has linked a once-daily drug candidate to a 55% drop in the risk of clinical worsening in a phase 3 trial, setting the company up to seek FDA approval in pulmonary arterial hypertension

Lynk Pharmaceuticals has reported…

March 2nd, 2026|FierceBiotech|

Lynk Pharmaceuticals has reported another phase 3 win in China for its next-gen JAK inhibitor, this time hitting skin clearance goals among patients with eczema.

A second phase 3 study of…

March 2nd, 2026|FierceBiotech|

A second phase 3 study of Roche’s fenebrutinib in relapsing multiple sclerosis has hit its primary endpoint, positioning the company to submit the BTK inhibitor for approval. But the discovery that more patients died on