Today’s Daily Dose brings you news about ARCA biopharma joining the battle against COVID-19; Genmab’s positive results from amyloidosis trial; MacroGenics’ regulatory update related to breast cancer drug candidate Margetuximab and Simulations Plus receiving the FDA grant award.
1. ARCA Jumps Into COVID-19 Drug Fray; Stock Explodes Over 300%
ARCA biopharma Inc. (ABIO) has decided to evaluate AB201, a potent, selective inhibitor of tissue factor, as a potential treatment for COVID-19 associated coagulopathy and the related inflammatory response.
COVID-19 associated coagulopathy or CAC is one of the most serious adverse effects seen in COVID-19 patients.
The Company anticipates filing an Investigational New Drug (IND) application for AB201 with the FDA in the third quarter and initiating late-stage clinical testing in the second half of this year.
As of March 31, 2020, the Company had cash and cash equivalents of only $6.7 million.
ABIO closed Thursday’s trading at $19.21, up 386.33%.
2. Genmab ANDROMEDA Trial Hits Key Goal
Shares of Genmab A/S (GMAB) closed at an all-time high of $30.97 on Thursday, thanks to positive topline results from its ANDROMEDA trial.
ANDROMEDA is a phase III study of subcutaneous Daratumumab in combination with Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD ) for patients with newly diagnosed light-chain (AL) amyloidosis.
Janssen Biotech Inc. obtained an exclusive worldwide license to develop, manufacture and commercialize Daratumumab from Genmab in 2012.
The ANDROMEDA study, conducted by Janssen, met the primary endpoint of the percentage of patients with hematologic complete response. Patients in the study treated with Daratumumab in combination with CyBorD had a 53.3% hematologic complete response compared to 18.1% of patients who were treated with CyBorD alone.
GMAB closed Thursday’s trading at $30.97, up 4.31%.
3. Imara Gearing Up For The Big Event
Shares of Imara Inc. (IMRA) continues to gain momentum as the Company gears up to present interim data from the ongoing phase IIa study of IMR-687 in patients with sickle cell disease at the 25th Annual European Hematology Association (EHA) Congress to be held virtually June 11-21, 2020.
Enrollment in the IMR-687 phase IIa clinical trial in sickle cell patients was completed in January of this year, with top-line data expected in the fourth quarter of 2020.
IMRA closed Thursday’s trading at $32.38, up 11.27%.
4. MacroGenics To Face FDA In December; No Panel Review
MacroGenics Inc. (MGNX) has been notified that the FDA has no plans to hold an AdComm meeting to review the Company’s Biologics License Application for Margetuximab, proposed for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.
The regulatory agency’s final decision date set for Margetuximab review remains unchanged, which is December 18, 2020.
MGNX closed Thursday’s trading at $23.00, down 0.61%.
5. Simulations Plus Secures Grant Award
Shares of Simulations Plus Inc. (SLP), a developer of drug discovery/development software, touched an all-time high on Thursday, following the receipt of a new Grant Award from the FDA.
The Company has been awarded a new funded cooperative agreement for up to $400,000 over three years to develop physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) approaches to support interspecies translation for ocular drug delivery in GastroPlus.
GastroPlus is a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, and dermal/subcutaneous absorption, pharmacokinetics, and pharmacodynamics in humans and animals, according to the Company.
For its second quarter of fiscal year 2020, the period ended February 29, 2020, net revenues increased 22.2% to $10.3 million from $8.5 million in the year-ago period. Net income for the recent second quarter increased to $2.2 million from $2.1 million in the year-ago quarter while earnings per share remained unchanged at $0.12 per share. The second-quarter results were reported last month.
SLP closed Thursday’s trading at $48.43, up 22.61%.
6. Stocks That Moved On No News
Organogenesis Holdings Inc. (ORGO) closed Thursday’s trading at $4.61, up 33.24%.
IDEAYA Biosciences Inc. (IDYA) closed Thursday’s trading at $9.40, up 22.64%.
Flexion Therapeutics Inc. (FLXN) closed Thursday’s trading at $11.65, up 12.83%.
NantKwest Inc. (NK) closed Thursday’s trading at $6.61, down 12.80%.
Verrica Pharmaceuticals Inc. (VRCA) closed Thursday’s trading at $12.20, down 11.98%.
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