U.S. stocks closed mixed on Thursday following the release of weekly jobless claims data. Here is the list of some big stocks moving higher in the previous session.
Regulatory decisions have yet to pick up pace this year. July’s calendar was light, but the good news was that most decisions turned out to be positive. That said, none of the drugs approved during the month were new molecular entities, underlining a lack of innovation going on in the sector.
Beigene Limited (NASDAQ: BGNE) provided a regulatory update on the anticipated US approval decision for the Biological License Application for tislelizumab in 2L metastatic esophageal squamous cell carcinoma (ESCC).
The U.S. Food and Drug Administration (FDA) has deferred decision on the Biologics License Application (BLA) for BeiGene’s (NASDAQ: BGNE) tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
FDA Defers Action on BLA Until Required Inspections Can Be Completed
Due to COVID Travel Restrictions, Inspections Could Not Be Completed During Review Period
The biotech sector is poised to end June on a positive note, despite largely disappointing regulatory decisions scheduled during the month, thanks to a reversal in broader market sentiment.
BeiGene and NewBridge Pharmaceuticals To Bring BRUKINSA to Patients in MENA Region, Following Approval for Previously Treated Mantle Cell Lymphoma in Kuwait, Bahrain and Qatar
BRUKINSA has Previously Been Approved by
Key takeaways:
Innovent Biologics terminated a plan to sell its bevacizumab biosimilar in North America with a local partner after trials for the drug fell behind schedule
The company’s loss tripled last year on growing competition for its core product, whose sales fell 22% in this year’s first-quarter
Gainers
Trecora Resources (NYSE: TREC) shares jumped 26.6% to $9.56 as the company agreed to be acquired by an affiliate of Balmoral Funds at $9.81 per share in cash or an enterprise value of $247 million.