What’s moving these stocks in the pre-market hours today?
In the Green
1. AMAG Pharmaceuticals Inc. (AMAG) is up more than 37% at $12.89 in pre-market trading Thursday, following a Bloomberg report that the company is in talks with Covis Pharma about getting acquired.
2. ProPhase Labs Inc. (PRPH) is up over 27% at $4.40 in pre-market hours on news of the company’s intention to explore the acquisition of one or more CLIA (Clinical Laboratory Improvement Amendment) accredited labs suitable for COVID-19 and other testing. The company has sought assistance from industry expert Predictive Laboratories, Inc to help in this process.
3. Genetic Technologies Limited (GENE) is up over 8% at $3.75 in pre-market hours today. The company’s COVID-19 sdr, a genomic test to predict the risk of hospitalization and of developing life-threatening complications, should the patient contract COVID-19, is expected to be launched in the market by early Q4, 2020.
4. Genetron Holdings Ltd (GTH) is up over 7% at $12.84 in pre-market trading Thursday, adding to yesterday’s gain. The company’s blood-based next-generation sequencing (NGS) test, HCCscreen, was granted Breakthrough Device designation by the FDA yesterday and the news had sent the stock up 23.09% to $11.94.
5. BioCryst Pharmaceuticals Inc. (BCRX) is up more than 5% at $3.69 in pre-market hours today, gaining some of what it lost yesterday. The company announced new data from a phase I trial of BCX9930 in treatment-naïve paroxysmal nocturnal hemoglobinuria patients, which demonstrated clinical benefits and safety profile of the compound yesterday. Despite the positive news, the stock had fallen by 10% yesterday. BioCryst’s lead drug candidate is ORLADEYO, an oral treatment for hereditary angioedema, under FDA review, with a decision expected on December 3, 2020. Part 1 of a phase I trial of Galidesivir in patients with COVID-19 is underway, with data expected this quarter (Q4, 2020).
In the Red
1. Zosano Pharma Corp. (ZSAN) is down more than 50% at $0.77 in pre-market trading Thursday, following a disappointing notification from the FDA related to the company’s 505(b)(2) New Drug Application for migraine treatment Qtrypta. With the FDA raising certain questions, it is likely that Qtrypta may not be approved on the assigned decision date of October 20.
2. Selecta Biosciences Inc. (SELB) is down over 39% at $1.49 in pre-market hours today as its phase II trial of SEL-212 in chronic refractory gout, dubbed COMPARE, has failed to meet the primary endpoint of statistical superiority. The COMPARE trial compared the efficacy of Selecta’s SEL-212 against the approved gout drug KRYSTEXXA. The primary endpoint measure was a comparison of the percentage of patients on SEL-212 versus KRYSTEXXA who achieved and maintained a reduction of serum uric acid less than 6 mg/dL for at least 80% of the time during months three and six combined. SEL-212 showed a numerically higher response rate on the primary endpoint although it failed to achieve statistical significance.
3. Iterum Therapeutics plc (ITRM) is down 13% at $0.91 in pre-market trading today, giving back some of what it gained yesterday. The company announced its decision yesterday to proceed with an NDA submission for Sulopenem, a bilayer tablet, for the treatment of uncomplicated urinary tract infections in patients with a quinolone-resistant pathogen, based on a meeting with the FDA held recently. The news had sent the stock up over 62% yesterday. The company announced topline phase III results of Sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection in June this year. While the uncomplicated urinary tract infection trial produced mixed results, the complicated urinary tract infection trial failed to achieve the primary endpoint.
4. CTI BioPharma Corp. (CTIC) is down 12% at $1.89 in pre-market hours Thursday, giving back some of what it gained yesterday. The company announced its intention yesterday to proceed with the rolling New Drug Application submission for the potential accelerated approval of Pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. The news had sent the stock soaring over 100% to $2.15. The completion of NDA submission is anticipated next quarter. Pacritinib is also being tested in a phase III trial in hospitalized patients with severe COVID-19.
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