Amplia Therapeutics

FDA Fast Track Designation for Narmafotinib in Advanced Pancreatic Cancer

Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia’s Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.


HIGHLIGHTS

  • The US FDA has granted Fast Track Designation to Amplia’s lead drug narmafotinib in advanced pancreatic cancer
  • Fast Track Designation facilitates the development of investigational drugs and allows for expedited review

Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions. It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer.

The Company’s CEO and Managing Director, Dr Chris Burns, commented, “Fast Track Designation for narmafotinib is a significant milestone for the Company. With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease.”

Amplia’s clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea. Earlier this year, the Company announced that the US FDA had cleared its IND1 application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.


Click here for the full ASX Release

This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

The Conversation (0)

Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate

Ratio to receive upfront, and potential milestones and tiered royalty payments

Ratio Therapeutics Inc. ( Ratio ), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration leverages Ratio's radioligand therapy discovery and development expertise as well as its technology platforms for the development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Blank pill bottle spilling a variety of pharmaceutical pills and capsules.

5 Biggest Pharmaceutical ETFs in 2024

The global pharmaceutical market reached a total value of US$1.6 trillion in 2023, according to Statista, up significantly from the US$888 billion seen just over a decade earlier in 2010.

Experienced and novice investors alike may want to consider pharmaceutical exchange-traded funds (ETFs) as a way to gain exposure to the top pharma companies. Like all ETFs, pharmaceutical ETFs are a good option for those who want to trade a set of assets in the pharmaceutical industry instead of focusing solely on individual pharmaceutical stocks.

The main advantage of a pharmaceutical ETF is the fact that it can provide exposure to an overarching sector, but still trades like a stock. Pharma ETFs also offer less market volatility and lower fees and expenses.

Keep reading...Show less
Pill spelling "big pharma."

Big Pharma Stocks Eli Lilly, AbbVie and Pfizer Share Q3 Results

Major pharmaceutical players Eli Lilly (NYSE:LLY), AbbVie (NYSE:ABBV) and Pfizer (NYSE:PFE) reported mixed Q3 results, with each company facing distinct market forces, ranging from supply issues to financial constraints.

In its latest quarterly report, released on Wednesday (October 30), Eli Lilly missed on sales expectations for Zepbound, its popular weight-loss drug, and Mounjaro, its diabetes medication. Despite growing US demand for these products, supply chain management issues impacted the company’s ability to meet Wall Street's expectations.

According to Reuters, Eli Lilly dropped 8 percent on the news, reducing its market valuation by nearly US$70 billion.

Keep reading...Show less
Canada maple leaves on left and pharmaceutical pills in red and blue on right.

4 Best-performing Canadian Pharma Stocks of 2024

From established players to up-and-coming firms, Canada's pharmaceutical company is diverse and dynamic.

Canadian pharma companies are working to discover and develop major innovations amidst an increasingly competitive global landscape. Rising technologies such as artificial intelligence are playing a role in the landscape as well.

Here the Investing News Network lists the top Canadian pharma stocks on the TSX, TSXV and CSE by year-to-date gains. All data was compiled on October 28, 2024, using TradingView’s stock screener, and the companies considered had market caps above C$10 million at that time. Read on to learn about what's been driving their share prices.

Keep reading...Show less
US flag with orange pill bottle on top and white pills spilling out.

Harris vs. Trump: The 2024 US Election, Drug Prices and Healthcare

The exorbitant cost of pharmaceutical drugs in the US has been a contentious issue for years, with the Republican and Democrat parties overtly at odds on the best way to lower drug prices.

Despite the best efforts of lawmakers on both sides of the aisle, prescription drug prices are still on the rise. Figures from the US Department of Health and Human Services show a 15.2 percent increase in the cost of prescription drugs from 2022 to 2023, with an average of US$590 per drug.

In the lead up to the 2024 US general election, the pharmaceutical industry is buttering its bread on both sides with nearly equal contributions to both parties. Citing data from OpenSecrets, KFF Health News reported in late August that drug companies had donated US$4.89 million to Democrats’ coffers and US$4.35 million to Republicans.

Keep reading...Show less
Pills and Australian dollars.

InhaleRx Pens AU$38.5 Million Funding Agreement with Clendon Biotech Capital

Australian healthcare company InhaleRx (ASX:IRX) has entered into a AU$38.5 million funding facility with Melbourne-based Clendon Biotech Capital to cover clinical trial costs for its key projects.

InhaleRx currently has two main projects: its pain asset IRX-211 and its mental health asset IRX-616a.

According to the company, IRX-211 is designed to target breakthrough cancer pain, while IRX-616a focuses on offering fast and effective relief for individuals suffering from panic disorder.

Keep reading...Show less

Latest Press Releases

Related News

×