Biotech Archives - Page 780 of 795

1 minute read

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

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

1 minute read

SVB Likes This ‘Novel Antipsychotic’-Focused Stock

By Vandana Singh

July 14, 2:49 PM

SVB Leerink initiated coverage on Karuna Therapeutics Inc (NASDAQ:KRTX) with an Outperform rating and a price target of $170. SVB notes that…

KRTX

1 minute read

Moderna’s COVID-19 Vaccine Scores Canadian Approval For Kids Below 5 Years

By Vandana Singh

July 14, 1:27 PM

Health Canada has approved the use of Moderna Inc’s (NASDAQ:MRNA) mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 µg…

MRNA

1 minute read

Why Novavax Shares Are Plunging Today Despite Much Awaited FDA Emergency Nod?

By Vandana Singh

July 14, 1:24 PM

The European Medicines Agency identified severe allergic reactions as potential side effects of Novavax Inc’s (NASDAQ:NVAX) COVID-19 vaccine. A few cases of…

NVAX

1 minute read

Summit Therapeutics Mulls Additional Trial For Its Once Failed Infection Candidate

By Vandana Singh

July 14, 11:35 AM

Summit Therapeutics Inc (NASDAQ:SMMT) provided an update on the clinical development of ridinilazole, its lead Phase 3 product candidate for Clostridioides…

SMMT

1 minute read

U.S. FDA Defers Decision On BeiGene’s Filing For Esophageal Carcinoma Due To Pending Inspection

By Ragothaman Srinivasan

July 14, 10:33 AM

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).

BGNE

1 minute read

Clene’s CNM-Au8 Shows Decreased Mortality Amyotrophic Lateral Sclerosis Patients

By Vandana Singh

July 14, 9:34 AM

Clene Inc (NASDAQ:CLNN) reported significantly improved survival in Amyotrophic lateral sclerosis (ALS) patients initially treated with CNM-Au8 compared to initially randomized…

CLNN