Healthcare Roundup – CytoDyn not being considered for Warp Speed initiative, Abbott wins FDA approval of $5, 15-minute COVID test

医疗保健精选——CytoDyn未被纳入“Warp Speed initiative”;雅培用时15分钟的COVID试剂获FDA批准
Published on: August 26, 2020
Author: Amy Liu

CytoDyn not being considered for Warp Speed initiative – Trump administration

According to a senior administration official, CytoDyn (OTCQB:CYDY -4.7%) is not being considered for inclusion in Operation Warp Speed, dashing enthusiasm of hopeful longs after IncellDx CEO Bruce Patterson, a former advisor to CytoDyn, told TV host Dr. Drew Pinsky that he thought the company would forward with the program which is aimed at fast-tracking COVID-19 treatments and vaccines.

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The company has been heavily touting leronlimab for the treatment of patients with the coronavirus infection. An ongoing Phase 2 study missed the primary efficacy endpoint but achieved a secondary endpoint measured by an objective scale called NEWS2.

Shares have rallied 31% off the recent low of $2.76 on August 18 but this appears driven by recent news, including the above study, filing an application in the U.S. seeking emergency use authorization, an application in the UK seeking fast track approval and the advancement of a Phase 3 study (results expected in October).

SA Authors like leronlimab’s prospects rating the company Bullish.

Update: In an interview posted on, CEO Nader Pourhassan took issue with the WSJ article saying the company never applied for inclusion in Operation Warp Speed and if it did, it wouldn’t talk about. He questions the identity of the paper’s Trump administration source who allegedly stated that it was not being considered for inclusion. He says investors should only buy CYDY stock if they believe in the company and its fundamentals. The SA article was based on the WSJ report.

Abbott wins FDA approval of $5, 15-minute COVID test

Abbott Laboratories (NYSE:ABT) +6.5% after-hours following news that the FDA granted emergency use authorization for the company’s 15-minute COVID-19 test that will be priced at just $5.

Abbott says BinaxNOW works without relying on lab equipment – at a time when labs can take as long as two weeks to produce results – and uses a nasal swab and a small reactive card that can be administered by a range of healthcare workers, including pharmacists.

The company plans to ship “tens of millions’ of test in September, ramping to 50M tests per month by the end of October.

The new test “can be used at a massive scale to help overcome the current waiting game for test results,” John Hackett, divisional VP of applied research and technology at Abbott Diagnostics, tells Bloomberg.

CVS Health prices tender offers

CVS Health (CVS -2.0%) announced applicable reference yields and total consideration to be paid in connection with the earlier announced cash tender offers.

For up to $3B principal amount of its 4.000% senior notes due 2023 and 3.700% senior notes due 2023 and the 2.800% senior notes due 2023 issued by its wholly-owned subsidiary, Aetna and (ii) up to $3B principal amount of its 4.100% senior notes due 2025 and 3.875% senior notes due 2025.

“The current valuation levels are below the company’s historical averages and provide an attractive risk-adjusted point of entry to purchase shares,” noted Simplivest on Seeking Alpha.

Heat Biologics COVID-19 vaccine shows encouraging action in preclinical study

Heat Biologics (NASDAQ:HTBX) perks up 21% premarket on robust volume in reaction to results from a preclinical study testing its gp96-based COVID-19 vaccine candidate. Key observations:

Significant CD4+ and CD8+ T cell responses in airways and lung interstitium (support tissues within the lung that includes alveolar epithelium).

Protein S-specific CD8+ T cells were induced in human leukocyte antigen (HLA)-A2-02-01 transgenic mice implying that the vaccine will likely work in humans.

The vaccine uses a cellular heat shock chaperone protein called glycoprotein 96 (gp96) to deliver SARS-CoV-2 spike protein to the immune system to induce cell-mediated immune responses.

Shares are poised for another rally since selling off from its late July spike after it first announced preclinical data on the vaccine.

Tyme plans to test TYME-19 as COVID-19 treatment

Tyme Technologies (TYME +2.1%) has announced to initiate a proof-of-concept Respond trial to investigate its TYME-19 metabolic agent as a therapy against Covid-19.

TYME-19 is an oral synthetic bile acid, that has demonstrated broad spectrum antiviral activity as well as efficacy against COVID-19 in preclinical studies.

The company has partnered with Massachusetts General Hospital and Weill Cornell Medical Center to design a trial to evaluate TYME-19 versus placebo, for recently diagnosed, symptomatic patients. Trial is set to begin as soon as customary clinical trial site approvals are complete.

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