Unum Therapeutics (UMRX +271.0%) has completed its acquisition of privately held Kiq, a developer of precision kinase inhibitors, in an all-stock deal.
Concurrently, Unum has inked agreements with institutional investors for the sale of Series A Preferred Stock at $880 per share yielding gross proceeds of $104.4M. Each Series A share may be converted into 1,000 common shares at the holder’s option.
Proceeds of the private placement will be used to fund the advancement of PLX9486, a highly potent and selective KIT D816V inhibitor in-licensed by Kiq from Plexxikon, in multiple indications.
The capital should extend the Unum’s cash runway beyond 2022.
The offering should close on July 9.
The FDA has granted emergency use authorization for Becton, Dickinson and Company’s (BDX +1.6%) rapid point-of-care test for the detection of the SARS-CoV-2 virus. The assay, performed on the BD Veritor Plus System, generates results in 15 minutes, enabling healthcare professionals to take action (if positive) while the patient is still onsite.
In clinical studies, the test showed 84% sensitivity (correctly identifying true positives) and 100% specificity (correctly identifying true negatives).
Market launch is underway. It expects to file for 510(k) clearance at a later date. It plans to ramp up production to 2M tests per week by the end of September.
Selected COVID-19 rapid test competitors: Abbott (ABT +1.5%), Roche (OTCQX:RHHBY +0.7%), Thermo Fisher Scientific (TMO +3.0%)
Regeneron Pharmaceuticals (NASDAQ:REGN) initiates a large-scale Phase 3 clinical trial evaluating its double antibody cocktail, REGN-COV2, for the prevention of COVID-19 in uninfected people who have experienced close exposure to a patient with active COVID-19 infection.
The company is jointly conducting the 2,000-subject study with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).
It has also advanced into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials assessing the cocktail in hospitalized and non-hospitalized COVID-19 patients.
REGN-COV2, produced by the company’s proprietary VelocImmune mice, consists of two neutralizing antibodies that bind non-competitively to the critical receptor binding domain of the coronavirus’ spike protein, diminishing the ability of mutant viruses to avoid treatment and protecting against spike variants that have arisen in the human population.
Gilead Sciences (NASDAQ:GILD) licensee Mylan N.V. (NASDAQ:MYL) announces that the Drug Controller General of India has approved its remdesivir 100 mg/vial for restricted emergency use for severely ill hospitalized pediatric and adult COVID-19 patients.
Mylan will launch its version in India under the brand name Desrem at a price of INR 4,800 ($62.40) per vial.
GILD is up 3% premarket and MYL is up 9%, both on light volume.
CytoDyn (OTCQB:CYDY) has signed an exclusive Distribution and Supply Agreement with American Regent, a Daiichi Sankyo Group company for the distribution of leronlimab for the treatment of COVID-19 in the U.S.
Under the terms of agreement, CytoDyn will supply leronlimab and receive quarterly payments based on a profit-sharing arrangement.
CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients.
