Biotech Archives - Page 721 of 733

3 minute read

Novavax (NVAX) Down As EU Adds Side Effects To COVID Jab Label

July 15, 12:14 PM

Shares of Novavax (NASDAQ: NVAX) fell 26.2% on Jul 14, after the European Medicines Agency's (TSE: EMA) Pharmacovigilance Risk Assessment Committee ("PRAC") updated the product label of Nuvaxovid, the company's COVID-19 vaccine, to include some potential side effects like severe aller

BNTX

1 minute read

Alnylam Hits Moderna With Another Patent Infringement Suit-Related To COVID-19 Vaccine

By Vandana Singh

July 15, 10:44 AM

Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) added one more patent infringement lawsuit against Moderna Inc (NASDAQ:MRNA), claiming it violated a newly obtained patent. The…

ALNY

1 minute read

Why Codexis Shares Are Slumping Today

By Vandana Singh

July 15, 6:49 AM

Codexis Inc (NASDAQ:CDXS) expects Q2 sales of approximately $38 million and FY22 sales of 135 million to $141 million, below the…

CDXS

1 minute read

NexImmune Shares Soar Following FDA’s Clearance To Initial-Stage HPV Cancer Study

By Ragothaman Srinivasan

July 14, 5:24 PM

NexImmune, Inc. (NASDAQ: NEXI) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its first cellular therapy product candidate NEXI-003 addressing solid tumors.

NEXI

1 minute read

Omega Therapeutics Gets FDA Nod For Initial-Stage Liver Cancer Study

By Ragothaman Srinivasan

July 14, 4:55 PM

The U.S. Food and Drug Administration (FDA) has announced clearance to Omega Therapeutics’ (NASDAQ: OMGA) Investigational New Drug (IND) to initiate a Phase 1/2 clinical study of its candidate OTX-2002 for the treatment of hepatocellular carcinoma (HCC).

OMGA

2 minute read

NexImmune Announces IND Clearance By US FDA For NEXI-003 For Treatment Of HPV-Related Cancers

By Bill Haddad

July 14, 4:12 PM

First IND for NexImmune's AIM nanoparticle platform in solid tumors IND clearance enables commencement of a clinical trial to evaluate NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), in

NEXI

1 minute read

Oncternal Therapeutics Announces Clinical Trial Collaboration To Advance Zilovertamab Phase 3 Study In Combination With Ibrutinib For Patients With MCL

By Benzinga Newsdesk

July 14, 4:01 PM

Clinical trial collaboration supports global registrational Phase 3 study ZILO-301, to treat patients with relapsed or refractory MCL with zilovertamab plus ibrutinib Agreement is supportive of the planned initiation

ONCT

1 minute read

Beigene’s Inspections Delay Suggest Eventual Approval, Says This Analyst

By Vandana Singh

July 14, 2:53 PM

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).

BGNE