iHub News
3週前
Belite Bio shares rise after first-quarter earnings outperform expectations (BLTE)May 20, 2026 6:57 AM
IH Market News Belite Bio, Inc. (NASDAQ:BLTE) reported first-quarter results on Wednesday that came in ahead of analyst forecasts, with the clinical-stage biotech group posting an adjusted loss per share of -$0.34 versus consensus expectations of -$0.64.Shares of the company gained 2.49% in premarket trading following the earnings announcement. Losses widen as research and commercialization spending increases Belite Bio reported an adjusted net loss of $13.7 million for the three months ended March 31, 2026, compared with an adjusted net loss of $7.6 million recorded during the same quarter a year earlier.On a GAAP basis, the company posted a net loss of $26.9 million, or -$0.68 per share, compared with a net loss of $14.3 million, or -$0.45 per share, in the first quarter of 2025.“This has been an exciting start to the year for Belite. In April, we announced the initiation of our rolling NDA submission to the FDA for tinlarebant in STGD1, an important step on our path to becoming a commercial company and potentially bringing the first ever treatment for this devastating disease to patients,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. FDA submission advances for Stargardt disease treatment The company said it began a rolling New Drug Application submission to the U.S. Food and Drug Administration in April 2026 for tinlarebant as a treatment for Stargardt disease type 1, with the full submission expected to be completed during the second quarter of 2026.Belite Bio also confirmed that it has filled all key commercial leadership positions as it prepares for a potential product launch.Research and development expenses increased to $15.7 million from $9.4 million year over year, mainly due to costs tied to the DRAGON II clinical trial and manufacturing activities.Selling, general and administrative expenses rose to $17.0 million from $6.1 million in the prior-year period, driven by higher share-based compensation, professional service expenses and increased staffing costs linked to the company’s expansion efforts. Strong cash position supports development plans As of March 31, 2026, Belite Bio held $798.6 million in cash, cash equivalents and U.S. Treasury securities, providing substantial liquidity to support its ongoing clinical and commercial development strategy.Belite Bio stock price Original: Belite Bio shares rise after first-quarter earnings outperform expectations (BLTE)
conix
4年前
'Novel Approach For Retinal Disease Needs' Stock Belite Bio Has 70% Potential Upside According To This Analyst
Vandana Singh
Mon, August 1, 2022
HC Wainwright initiated coverage on Belite Bio Inc (NASDAQ: BLTE) with a Buy rating and price target of $58 per ADS.
Belite Bio is focused on developing a novel once-daily oral drug for the treatment of Stargardt disease (STGD1)—a rare inherited juvenile-onset form of macular degeneration.
The lead drug candidate is LBS-008 (or Tinlarebant).
HC Wainwright says that as LBS-008 is administered orally once a day, it could be adopted rapidly by ophthalmologists and patients once the drug obtains regulatory approval, as the intravitreal injection procedure was found unpleasant.
"We believe LBS-008 has the potential to be developed as the first and best-in-class oral drug for the treatment of STGD1," the analyst writes.
The analyst expects the Phase 2 portion to report 1-year data in 2H22.
Meanwhile, the company has initiated a Phase 3 trial of LBS-008 in adolescent STGD1 in 1H22, slated to enroll approximately 60 patients. Enrollment for Phase 3 trial to complete in mid-2023.
conix
4年前
Belite Bio stock soars 65% in wake of strong IPO performance
May 03, 2022 12:30 PM ETBLTEBy: Val Kennedy, SA News Editor
IPO Initial Public Offering
Mikko Lemola/iStock via Getty Images
Belite Bio (BLTE) stock soared 65% on Tuesday on the heels of a strong performance last Friday following its $36M initial public offering.
Shares of the ophthalmology drug developer opened at $10.60, recently changing hands at $14.70, up 65%, at approximately $12.05 p.m. ET.
BLTE held its IPO on April 29, offering 6 million American Depositary Shares at $6 per ADS. Underwriters were granted an option to buy up to 900k additional shares ADSs at the public price. The company’s principal stockholder, Taiwan’s Lin BioScience, agreed to buy around $15M of the offering.
The stock rocketed following the IPO on Friday, reaching a session high of $17.50 before closing at $10.59, up 77% over its offering price. The stock slid 16% on Monday.
BLTE has been focused on developing treatments for eye and metabolic diseases. The company plans to use proceeds from the IPO in part to fund Phase 3 clinical testing for its drug candidate LBS-008 for Stargardt disease and further development of the product for the treatment of dry age-related macular degeneration.