News Sources: Morning Brew

Lead Gapper:

+109%  7m Shares 21M Market Cap

• 12.0 months average overall survival benefit, including 13.4 months in patients with 2+ HLA matches and 12.5 months in patients with Grade I/II tumors(1)

• Top Responder: 21.4 months survival plus 100% resolution of ‘eye-bulging’ orbital tumor

• Compares to 7.2-9.8 months survival in historical comparison treatment trials(2)

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, today provides an update on the overall survival (OS) data on its previously disclosed advanced breast cancer patients. These women were treated with BriaCell’s lead candidate Bria-IMT™ as monotherapy and also in combination with checkpoint inhibitors, including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) and Incyte’s retifanlimab (manufactured and provided under a corporate collaboration with Incyte Corporation).

+40% 55m float 81m mc

Stealth BioTherapeutics Corp (NASDAQ:MITO) said the European Medicines Agency has granted orphan drug designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition.

The designation, the company said, it with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU Member States, and if approved, marketing exclusivity in the EU for 10 years.

The stock jumped 28.97% to $1.87 in after-hours trading.

+55% 62.23M Float 81M MC

• The FDA has granted Orphan Drug Designation to Soleno Therapeutics Inc (NASDAQ:SLNO) DCCR (diazoxide choline) Extended-Release tablets for the treatment of Glycogen Storage Disease Type 1a (GSD 1a), or von Gierke disease.
• Von Gierke disease is a condition in which the body cannot break down glycogen. Glycogen is a form of sugar (glucose) that is stored in the liver and muscles. 
• DCCR previously received Orphan Drug Designation for the treatment of Prader-Willi syndrome.
• Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years upon FDA approval.
• Price Action: SLNO shares are up 29.9% at $1.33 during the market session on the last check Wednesday.

Copyright © 2021 Benzinga (BZ Newswire, http://www.benzinga.com/licensing). Benzinga does not provide investmentadvice. All rights reserved.
Write to editorial@benzinga.com with any questions about this content. Subscribe to Benzinga Pro (http://pro.benzinga.com).