Shares in Pulmatrix Inc (NASDAQ:PULM) were as low as .55 on January 10th, 2017 and at the time of publishing this article shares of PULM hit a high of $2.59. Tallying a gain of 371% in just over a two week stretch. In today’s session alone trading volume has exceeded 13.2 million shares, which is over 14 times the 30-day average volume of 861,345 shares.
Jan. 17, 2017 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration.
Under the QIDP program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix, Inc. (NASDAQ: PULM) will receive five years of additional market exclusivity for PUR1900.
In its letter to Pulmatrix, the FDA wrote: “We have reviewed your request and conclude that it meets the criteria for QIDP. Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for….treatment of pulmonary Aspergillus infections in patients with cystic fibrosis.”
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis (CF) patients suffering from fungal lung infections,” said Pulmatrix CEO Robert Clarke, PhD. “It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”
Currently, many CF patients experience allergic reactions when their lungs become infected with a fungus called Aspergillus. Doctors now try to treat those infections with oral drugs such as itraconazole. Oral antifungals require very high doses to get enough of the drug to the lungs through the bloodstream to fight the fungus, causing severe side effects, and oral antifungals are not always effective.
Pulmatrix’s goal is to solve this problem by combining itraconazole with its innovative dry powder iSPERSE™ technology. The combination of iSPERSE™ and itraconazole makes it possible for patients to inhale the drug into their lungs, to the site of infection, where it’s needed.
“By delivering the drug directly to the lungs, we should be able to fight the infection far more effectively than the oral drug can, with far fewer side effects,” explained Pulmatrix’s Chief Scientific Officer, David L. Hava, PhD. “That should bring great benefits to patients.”
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for lung diseases, including opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients with rare disease like cystic fibrosis. Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
If biopharmaceutical stocks like Pulmatrix, Inc. (NASDAQ: PULM) continue to catch our attention, 2017 is going to be a very interesting year for the entire sector. We’re eager to follow PULM, along with a slew of other biopharmaceutical stocks on a continual basis here on Street Register. Stay locked to StreetRegister.com for updates, and we’ll deliver important developments as they unfold. In the meantime, if you’ve yet to sign up for our 100% free newsletter, do so now! Just enter your active email address into the box below and get subscribed!