Biotech companies have been making some major moves in the markets for the past couple of weeks as news developments both positive and negative come into play.
Today was no different as one of the biggest movers for Wednesday’s trading session was a small biotech company called Savara (NASDAQ: SVRA). The company ended up losing almost three-quarters of its market cap in a single day when their main drug study failed to hit its target.
The company went on to say that a phase 3 study of its core pipeline drug which treats Autoimmune Alveolar Pulmonary Proteinosis (APAP) failed to meet its primary diagnostic criteria, meaning that the drug is, for the most part, a failure.
Specifically, the study didn’t see the primary endpoint of a statistically significant change in a measure of low blood oxygen over 24 weeks.
“We are preparing to meet with the FDA and EMA to discuss the results from this study and to determine our options to seek approval based on the current data, and potentially conduct an additional study incorporating the learnings,” said Rob Neville, Savara’s CEO in a statement. However, the study did succeed in meeting it’s secondary criteria, with the company specifically mentioning the potential positives that could come from these secondary successes. “Most importantly, the impressive improvement in quality of life, as measured by the SGRQ, suggest that Molgradex not only improved objective measures of oxygenation, but also had a clinically meaningful therapeutic effect. I believe these data demonstrate that Molgradex can become an important pharmacological treatment option for patients with aPAP,” said Bruce Trapnell, M.D., Lead Investigator of the IMPALA study in the U.S. and Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine.
APAP is a rare autoimmune disorder where a surfactant accumulates in the tiny air sacs in the lungs known as alveoli, making it difficult for patients to breath. At the moment, there are few potential treatment options for patients suffering from the condition.
While a significant portion of patients recover without treatment (around one-third), those that don’t resort to a lung lavage, a procedure where one lung is cleansed in a salt solution. In severe cases, lung transplantation might be an option.
While there’s a strong demand for a drug that could treat this condition, it seems likely that Savara will have to go back to the drawing board as it meets with regulatory officials on what potential next steps could be. Shares of Savara plunged by 71 percent in response to the news.
Savara Company Profile
Savara Inc is a pharmaceutical company. The company develops novel therapies for the treatment of serious or life-threatening rare respiratory diseases.
It offers products such as AeroVanc, for the treatment of persistent methicillin-resistant staphylococcus aureus and lung infection in cystic fibrosis patients; Molgradex, for the treatment of autoimmune pulmonary alveolar proteinosis and Aironite, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction.
All the business activity of the firm is functioned through the region of United States. – Warrior Trading News
