Pre-market Movers In Healthcare Sector: GNFT, HUGE, ACOR, AQST...

(RTTNews) - What's moving these stocks in the pre-market hours today?

In the Green

1. Genfit SA (GNFT) is up over 46% at $6.12 in pre-market trading Monday, following a five-year exclusive licensing agreement with LabCorp (LH). As part of the agreement, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by Genfit's NIS4 technology throughout the U.S. and Canada to help identify patients with at-risk non-alcoholic steatohepatitis. The test is expected to be available from LabCorp by early 2021. A phase III study evaluating Genfit's Elafibranor in Primary Biliary Cholangitis, dubbed ELATIVE, is underway.

2. FSD Pharma Inc. (HUGE) is up over 19% at $3.20 in pre-market trading today on no specific news. On August 31, the company had filed an Investigational New Drug Application seeking FDA clearance to conduct a phase II trial of FSD201 to treat COVID-19. The phase II trial will be conducted at 25-30 sites in North America to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with the standard of care ("SOC") compared to SOC alone in hospitalized patients with documented COVID-19 disease.

3. Acorda Therapeutics Inc. (ACOR) is up over 18% at $0.73 in pre-market hours on no news. The company markets INBRIJA, which is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. For the quarter ended June 30, 2020, INBRIJA net revenue was $4.7 million compared to $3.0 million for the same quarter in 2019.

In the Red

1. Aquestive Therapeutics Inc. (AQST) is down over 30% at $5.20 in pre-market hours Monday, following FDA's refusal to approve the company's Libervant Buccal Film for management of seizure clusters. In the Complete Response Letter issued for Libervant, the FDA cites exposure levels (Cmax) in certain weight groups were lower than desired. The company believes that there will be no need to conduct any further clinical studies. A Type A meeting with the FDA is expected to be requested by the company in the coming weeks, with resubmission of the New Drug Application anticipated prior to the end of 2020.

2. Sonnet BioTherapeutics Holdings Inc. (SONN) is down over 10% at $2.20 in pre-market hours Monday on no news. The company's lead compound is SON-080, for chemotherapy-induced peripheral neuropathy, ready to enter phase II development. An IND for SON-1010, an oncology compound, is expected to be submitted in 2021.

3. Mallinckrodt plc (MNK) is down 8% at $1.05 in pre-market hours today. On September 14, the FDA refused to approve the company's investigational agent Terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

4. Rockwell Medical Inc. (RMTI), a revenue-generating biopharmaceutical company, is down over 4% at $1.02 in pre-market hours today, on no news. The company's flagship drugs Triferic AVNU and Triferic Dialysate, approved by the FDA, are indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Triferic AVNU is under review by Health Canada, with a decision expected in mid-2021.