Pulmatrix Inc (NASDAQ:PULM) is biotech player in the inhalant therapies space. PULM stock has been on an absolute tear of late, with the prime catalyst stemming from the from the company’s announcement 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.
According to the release, under the QIDP program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix 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.”
Pulmatrix Inc (NASDAQ:PULM) trumpets itself as a clinical stage biopharmaceutical company that engages in developing inhaled therapies to address serious pulmonary diseases using its inhaled Small Particles Easily Respirable and Emitted (iSPERSE) technology.
The company’s proprietary product pipeline focuses on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis, as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. It is also developing PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease.
The company has collaboration with Capsugel to develop inhaled therapeutics to treat serious pulmonary diseases. Pulmatrix, Inc. was founded in 2003 and is headquartered in Lexington, Massachusetts.
According to company materials, “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.”
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As noted above, this stock has been powering higher since it received QIDP designation from the FDA for its PUR1900 drug candidate.
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibros