Pulmatrix Inc. (NASDAQ:PULM)
Shares of Pulmatrix Inc. (NASDAQ:PULM) fell 4.86% in Tuesday’s trading session to end the day at $1.76 a share. The sell-off comes just days after the U.S. Food and Drug Administration (FDA) designated the clinical stage biopharmaceutical company’s candidate drug, Pulmazole (PUR1900), as a Qualified Infectious Disease Product (QIDP).
The designation is designed to speed up the development of novel drugs that have the potential to address important pathogens. Pulmatrix stands to enjoy up to 5 years of market exclusivity should the drug succeed in clinical trials and gain regulatory approval.
The candidate drug has already achieved orphan drug designation for the treatment of fungal infections in the airways of patients with cystic fibrosis. The QIDP designation further expands PUR 1900 status to include Asthma patients
“This second QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to severe asthma patients suffering from fungal lung infections,” said Pulmatrix CEO Robert Clarke, PhD. “It will give us the benefit of an expedited regulatory review and significantly expands the potential population we can treat with our Pulmazole product.
Patent Protection Milestone
In addition to FDA designation milestones, Pulmatrix Inc. (NASDAQ:PULM) has received two important patents from the United States Patent and Trademark Office (USPTO). One of the patents expands the potential of the company’s technology for delivering drugs directly to the lungs.
The company has developed a dry powder that it claims can fly easily through the airways and deliver a wide range of types of drugs. The technology is designed to increase the efficiency of drug delivery while also reducing the side effects associated with existing approaches.
The second patent expands the patent protection of Pulmatrix Inc. (NASDAQ:PULM) candidate drug PURO200 for the treatment of chronic obstructive pulmonary disease. The new patent broadens the intellectual property protection so that it is no longer limited to specific characteristics and performance criteria.
“The new PUR0200 patent will make it more difficult for potential competitors to develop similar products or to work around our product candidate,” explained Robert W. Clarke, Ph.D., Chief Executive Officer for Pulmatrix. “The new claims also will make it possible for us to add in a second therapeutic to create a combination product.”
Pulmatrix Inc. (NASDAQ:PULM) is currently developing PUR0200 in Europe and the United States, following regulatory pathways that offer quickest approvals.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.