Shares of BridgeBio Pharma Inc. (BBIO) had gained 60% in December, as the Company gears up for some important events in the months ahead.
Palo Alto, California-based BridgeBio Pharma is a clinical-stage biopharmaceutical company focused on developing breakthrough medicines for genetic diseases.
BridgeBio went public on the Nasdaq Global Select Market on June 27, 2019, offering its shares at a price of $17 each. But the stock opened the first day of trading at an impressive $30.75 and closed at $27.55. The lock-up period expired December 24, 2019.
The Company has a well-stocked pipeline – with 3 phase III compounds, 1 phase II compound and 1 phase I compound and a dozen products in the early stage of research/pre-clinical testing.
The most advanced product in the pipeline is Fosdenopterin (BBP-870) for the treatment of molybdenum cofactor deficiency type A, for which the Company initiated the submission of a rolling NDA seeking regulatory approval in the United States based on existing safety and efficacy data, early this month.
Up next is BBP-265 (also known as AG10) that is in an ongoing phase III clinical trial for the treatment of Transthyretin Amyloidosis Cardiomyopathy, dubbed ATTRibute-CM. A phase III study of AG10 in Transthyretin amyloidosis with polyneuropathy, dubbed ATTRibute-PN, is on track to begin in the first quarter of 2020.
A phase III trial of Patidegib Topical Gel 2% (BBP-009) in patients with Gorlin Syndrome, a rare condition in which people develop a type of skin cancer called basal cell cancers of the skin, is also underway. Topline data from this study is expected in 2021.
The other clinical programs include:
A pivotal study of BBP-831 (Infigratinib) in second-line cholangiocarcinoma (bile duct cancer) is ongoing, with data expected in 2020. It is also in preclinical development for the treatment of achondroplasia.
A phase I/II study of BBP-589 for recessive dystrophic epidermolysis bullosa is underway, with topline data anticipated during 2020.
The other anticipated milestones in 2020 are:
— IND filing for BBP-681 for venous and lymphatic malformations. — Begin dosing children in a phase II study of Infigratinib for achondroplasia, a form of short-limbed dwarfism. — IND submission of BBP-812, a gene therapy for Canavan disease, a rare genetic neurological disorder.
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