Israel-based SpliSense said that it has initiated a Phase 1/2 trial of its SPL84 inhaled anti sense oligonucleotide for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has been granted Orphan Drug designation from both the EMA and the FDA. The company said that the SAD portion of the trial will evaluate SPL84 in healthy … [Read more...] about SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF
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Vistagen announces agreement to acquire Pherin Pharmaceuticals
Vistagen, which is developing two pherine-based nasal sprays licensed from Pherin Pharmaceuticals (PH10 and PH94B), announced that it has reached an agreement to acquire Pherin and its entire pipeline. According to Vistagen, the deal includes ~12.4 million shares of the company's common stock as well as "a nominal amount of cash." PH10 was recently granted Fast … [Read more...] about Vistagen announces agreement to acquire Pherin Pharmaceuticals
Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe … [Read more...] about Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
Formulated Solutions to expand its aerosol manufacturing capacity with acquisition of Tennessee facility
Florida-based CDMO Formulated Solutions announced that it has acquired a 455,000 sq ft production facility in Cleveland, TN, USA that includes two buildings fitted with pharmaceutical production and packaging lines for a variety of dose forms such as liquids, bag-on-valve aerosols, and nasal sprays. The Tennessee facility was most recently owned by German skincare … [Read more...] about Formulated Solutions to expand its aerosol manufacturing capacity with acquisition of Tennessee facility
Third Pole gets $32 million to support development of eNOcare inhaled nitric oxide device
Inhaled nitric oxide (iNO) delivery device developer Third Pole Therapeutics announced that it has received a $32 million equity investment "from a large medical device innovator." In February 2022, the company announced the closing of a $25 million financing. Chiesi acquired global rights to develop and commercialize Third Pole's tankless iNO technology in April … [Read more...] about Third Pole gets $32 million to support development of eNOcare inhaled nitric oxide device
Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
According to Virpax Pharmaceuticals, the FDA has provided guidance in response to the company's pre-Investigational New Drug NobrXiol (VRP324) CBD nasal powder, which Virpax is developing for the for the treatment of epilepsy. In September 2021, Virpax announced that it had acquired exclusive worldwide rights to Nanomerics’s molecular envelope technology (MET) for use … [Read more...] about Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
CF Foundation invests $4.85 million in Aridis Pharmaceuticals to support development of AR-501 inhaled gallium
According to Aridis Pharmaceuticals, the Cystic Fibrosis Foundation has made a $4.85 million investment in Aridis common stock to support continued development of AR-501 nebulized gallium citrate for the treatment of chronic lung infections in CF patients, bringing the CF Foundation's total funding for the project to $12.5 million. AR-501 has been granted orphan, … [Read more...] about CF Foundation invests $4.85 million in Aridis Pharmaceuticals to support development of AR-501 inhaled gallium
FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Vertex Pharmaceuticals said that it plans to initiate a Phase 1 SAD trial of its VX-522 inhaled mRNA therapy after the FDA cleared the company's IND. VX-522 contains lipid nanoparticle-encapsulated mRNA that is designed to treat cystic fibrosis in patients who do not produce cystic fibrosis transmembrane conductance regulator (CFTR) and are therefore not helped by a … [Read more...] about FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Evoke gets new US patent covering Gimoti metoclopramide nasal spray
According to Evoke Pharma, the United States Patent and Trademark Office (USPTO) has issued a new patent covering Evoke's Gimoti metoclopramide nasal spray. The new patent (No. 11,517,545), which expires in 2038, is titled "Treatment of Moderate and Severe Gastroparesis." The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020 and granted 3 … [Read more...] about Evoke gets new US patent covering Gimoti metoclopramide nasal spray
Pulmocide raises $52 million for further development of inhaled opelconazole
Pulmocide announced that it has closed a $52 million a Series C extension round, with the proceeds to be used for continued development of its PC945 inhaled opelconazole for the treatment of invasive pulmonary Aspergillosis (IPA). Opelconazole has been granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations. In December 2021, … [Read more...] about Pulmocide raises $52 million for further development of inhaled opelconazole