- Freeline Therapeutics Holdings plc (NASDAQ: FRLN) stock jumped 38.78% in premarket on Thursday.
- The healthcare company received FDA clearance for its investigational new drug (IND) application for FLT201.
- The stock gained over 6% in a week, but it was down about 88% over the past year.
Shares of Freeline Therapeutics Holdings plc (NASDAQ: FRLN) jumped 38.78% to US$2.72 in the premarket on Thursday after it received clearance from the US Food and Drug Administration (FDA) for its investigational new drug application for FLT201.
The trading volume also rose to 38,184,104 compared to its 90-day average of 126,492.
The stock rallied after the UK-based company on Thursday said that it received approval from the FDA for its investigational new drug application for FLT20.
On Wednesday, the stock closed at US$1.96, down 3.45%.
The FLT201 drug is used for treating type 1 Gaucher disease.
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According to Freeline's chief medical officer Pamela Foulds, the preclinical proof studies suggest that FLT201 can reach bone marrow and lungs that are addressed insufficiently by the standard-of-care enzyme replacement therapy.
The data shows the FLT201 treatment might have a transformative impact on reducing or eliminating the enzyme or need for substrate replacement therapy, she added.
Freeline Therapeutics Financials
Freeline Therapeutics, founded in 2015, develops transformative adeno-associated virus (AAV) vector-mediated gene therapies for treating systemic debilitating diseases in patients.
The FRLN stock has a P/Book ratio of 0.46. Its 90-day beta is 0.49.
Freeline launched its IPO in August 2020. It currently has 35.81 million outstanding shares and 32.86 million shares in free-floats.
The stock gained over 6% in the past week. Yearly, it was down 88.36%.
Its peers, Beam Therapeutic, fell 10.19% in one month, and Avrobio Incorp fell 40.52% in the same period.
In the nine months ended Sept 30, 2021, the company earned no revenue. It reported operating expenses of US$108 million.
Its net loss was US$105.7 million or US$(2.96) per share diluted. In the year-ago period, its net loss was US$58 million or US$(8.39) per share diluted, with an operating expense of US$70.19 million.
The company had US$136.38 million in cash and cash equivalents as of Sept 30, 2021, compared to US$229.97 million as of Dec 31, 2020.
The Nasdaq Biotechnology Index fell 9.36% in a year and 3.73% over the past month. The healthcare sector has performed well, helped by the pandemic-fuelled demand for various services. Drug approvals are critical for these companies as they spur bottom-line growth.