Connect with us

Business

Gamida Cell jumps on FDA lymphoma treatment clearance

Published

on

GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas.


Israeli cell therapy company Gamida Cell Ltd. (Nasdaq: GMDA) today announced that the US Food and Drug Administration (FDA) has clearance its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.

GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.




The company develops NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases. Gamida Cell’s NAM-enabling technology, supported by positive Phase III data, is designed to enhance the number and functionality of targeted cells, enabling the company to pursue a curative approach.

Gamida Cell CEO Julian Adams Ph.D. said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies. Previously announced data from an investigator-sponsored study evaluating the fresh formulation of GDA-201 demonstrated durable complete responses in heavily pretreated patients with relapsed or refractory lymphoma. We are pleased to advance our plans to begin the company sponsored Phase 1/2 study and progress our novel cryopreserved formulation of GDA-201 with objective to address the unmet need that exists for patients with follicular and diffuse large B cell lymphomas.”

Gamida Cell opened 11.7% higher on Nasdaq today at $3.15 per share, giving a market cap of $190 million. On the TASE, the share price of Clal Biotechnology Industries Ltd. (TASE: CBI), which has a 5% stake in Gamida Cell was down 0.36% today.

Published by Globes, Israel business news – en.globes.co.il – on April 26, 2022.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2022.



Dr. Julian Adams Creditr: PR

Dr. Julian Adams Creditr: PR

 

 

This Article was first live here.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published.

Business

G7 finance leaders reaffirm FX commitment in communique By Reuters

Published

on

© Reuters. FILE PHOTO: Attendees pose for a family photo during the G7 Summit in Koenigswinter, near Bonn, Germany May 19, 2022. REUTERS/Benjamin Westhoff

By Leika Kihara and Francesco Canepa

KOENIGSWINTER, Germany (Reuters) – Group of Seven (G7) finance leaders on Friday pledged to closely monitor markets given recent volatility and reaffirmed their commitment on exchange rates, nodding to Japan’s concern over recent sharp declines in the yen.

The G7 advanced economies have an agreement that markets ought to determine currency rates, that the group will closely coordinate on currency moves, and that excessive and disorderly exchange-rate moves would hurt growth.

Japanese policymakers have said the agreement gives Tokyo leeway to jawbone, or even intervene directly in the currency market to counter sharp moves in the yen.

“We will also continue to closely monitor markets given recent volatility. We reaffirm our exchange rate commitments as elaborated in May 2017,” the G7 finance leaders said in a communique issued after a two-day meeting that ended on Friday.

Once welcomed as giving exports a boost, a weak yen has emerged as a source of concern for Japanese policymakers, as it inflates already rising costs of imported fuels and raw materials.

Japanese Finance Minister Shunichi Suzuki told reporters on Thursday Tokyo wanted the G7 to reaffirm its commitment on exchange-rate policy, as the country struggles with the yen’s slide to two-decade lows.

The dollar’s broad ascent has also pushed down the euro, adding inflationary pressure to the region that is feeling the strain from the Ukraine crisis-driven surge in energy costs.

While the yen has bounced back somewhat against the dollar this week as part of the U.S. currency’s broad retreat, many analysts expect prospects of steady interest rate hikes by the Federal Reserve to sustain the dollar’s uptrend.

This Article was first live here.

Continue Reading

Business

Here are Friday’s biggest analyst calls of the day: Amazon, Apple, Salesforce, Costco, Block & more

Published

on

This Article was first live here.

Continue Reading

Business

There’s a fairly inexpensive way companies can save millions in employee turnover costs

Published

on


Saying ‘thank you’ can go a long way to cutting company turnover costs. Read More

This Article was first live here.

Continue Reading

Trending