Pre-market Movers In Healthcare Sector: AIMT, HUGE, AMRN, EVFM, LPCN...

stockmarkets dec21 31aug20

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

In the Green

1. Aimmune Therapeutics Inc. (AIMT) is up over 170% at $34.03 in pre-market trading Monday as the company is all set to be acquired by Sociétés des Produits Nestlé S.A., part of Nestlé Health Science, for $34.50 per share in cash, representing a total equity value of $2.6 billion. Aimmune's Palforzia is the first drug for the treatment of peanut allergy for children in the U.S. The European Medicines Agency's decision on peanut allergy drug Palforzia is expected in the fourth quarter of 2020.

2. FSD Pharma Inc. (HUGE) is up over 17% at $3.80 in pre-market trading today on news of filing of 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. Tyme Technologies, Inc. (TYME) is up over 10% at $1.20 in pre-market hours on no news. In preclinical testing, the company's drug candidate TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. TYME and its collaborating partners at Massachusetts General Hospital and Weill Cornell Medical Center are initiating a proof-of-concept study to evaluate TYME-19 versus placebo in newly diagnosed, symptomatic COVID-19 patients.

4. Intec Pharma Ltd. (NTEC) is up over 10% at $0.33 in pre-market hours today. On August 7, the company entered into a definitive agreement with Aspire Capital Fund for the purchase and sale of 7.13 million of the Company's ordinary shares at a purchase price of $0.3511 per share. The gross proceeds to Intec from this offering were estimated to be $4.9 million.

5. HEXO Corp. (HEXO) is up over 9% at $0.78 in pre-market hours. Earlier this month, the company completed a C$34.5 million at-the-market offering program.

6. Amarin Corporation plc (AMRN) is up more than 8% at $7.97 in pre-market hours today. On Friday, the company announced promising results from a trial evaluating its flagship drug Vascepa in reducing plaque burden among patients with known angiographic coronary artery disease (CAD) on statins, dubbed EVAPORATE Trial.

7. Viveve Medical Inc. (VIVE) is up more than 6% at $0.65 in pre-market hours. On August 25, the company announced positive primary efficacy data from its three-arm, five-month Stress Urinary Incontinence (SUI) feasibility study comparing its Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for mild to moderate SUI in women. The company's Investigational Device Exemption application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT Trial for improvement of SUI in women was cleared by the FDA last month.

8. Evofem Biosciences Inc. (EVFM) is up more than 6% at $3.32 in pre-market hours. The company's Phexxi, which won FDA approval in May, is expected to be launched in September. Phexxi is approved for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

9. Inovio Pharmaceuticals, Inc. (INO) is up over 6% at $12.88 in pre-market hours. The company's COVID-19 DNA vaccine INO-4800 is under a phase I study and positive interim data from the first two cohorts in the U.S. trial were reported in June. A phase II/III clinical study of INO-4800 in the U.S. is expected to start in September.

In the Red

1. Lipocine Inc. (LPCN) is down over 18% at $1.35 in pre-market hours Monday. On August 28, the company was informed by the FDA that it needs additional time to complete the review of Tlando, an investigational testosterone replacement therapy. The FDA was supposed to announce its decision on Tlando on August 28. The FDA has not asked for any additional data and has not provided a timeline on a new action date.

2. CHF Solutions Inc. (CHFS), a medical device company, is down more than 7% at $0.34 in pre-market hours. On August 21, the company closed an underwritten public offering of units for gross proceeds of about $14.37 million, including the full exercise of the over-allotment option. The units were priced at $0.45 each.

3. Edesa Biotech Inc. (EDSA) is down over 5% at $7.68 today, giving back some of what it gained on Friday. The company received Canadian regulatory approval to begin a Phase 2/Phase 3 clinical study of its biologic drug candidate, EB05, as a potential treatment for hospitalized COVID-19 patients in June. Last month, the company submitted its application seeking FDA clearance to initiate a Phase 2/Phase 3 clinical study of EB05 for the treatment of hospitalized COVID-19 patients.

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