Takeda launches development of coronavirus drug

Takeda Pharmaceutical Company (NYSE:TAK) has initiated development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin, called TAK-888, to potentially treat COVID-19 patients.

Hyperimmune globulins are plasma-derived therapies that have shown effectiveness in treating severe acute respiratory infections.

The company is currently in talks with a range of national health and regulatory agencies and healthcare partners in the U.S., Asia and Europe to accelerate research into TAK-888, including access to source plasma from people who successfully recovered from COVID-19.

https://seekingalpha.com/news/3548907-takeda-launches-development-of-coronavirus-drug

Co-Diagnostics up on strong demand for coronavirus test

Co-Diagnostics (NASDAQ:CODX) announces a surge in domestic and international demand for its CE-IVD Logix Smart COVID-19 Test Kit subsequent to the change in FDA policy allowing laboratories to assay samples after validating the test in-house before formal FDA Emergency Use Authorization.

Selected coronavirus-related tickers: iBio (NYSEMKT:IBIO) (+31%), Alpha Pro Tech (NYSEMKT:APT) (+13%), Novavax (NASDAQ:NVAX) (+9%), Vaxart (NASDAQ:VXRT) (+7%), Lakeland Industries (NASDAQ:LAKE) (+5%), Inovio Pharmaceuticals (NASDAQ:INO) (+5%)

https://seekingalpha.com/news/3548928-co-diagnostics-up-23-premarket-on-strong-demand-for-coronavirus-test

BioCryst Pharma up on Q4 beat

BioCryst Pharmaceuticals (BCRX) Q4 results:

Revenues: $39.7M; Product sales: $15.5M ; Royalty revenue: $2.8M (+55.6%); Collaborative and other R&D: $21.4M.

Net loss: ($2.6M) (+90.5%); loss/share: ($0.02) (+92.0%); Operating cash use (3 months): ($33.5M).

The increase in revenue was primarily due to the recognition of a $20.1M upfront payment from Torii for commercialization rights in Japan for berotralstat, and $13.9M of RAPIVAB (peramivir injection) product sales.

Galidesivir, a broad-spectrum antiviral is currently being developed in a Phase 2 trial (Yellow Fever).

It has been shown to be active against more than 20 RNA viruses in nine different families, including coronaviruses. In Phase 1 trials in healthy volunteers, galidesivir was generally safe and well tolerated.

2020 guidance: Net operating cash use: $125M – 150M.

Key upcoming milestones: Berotralstat NDA accepted by FDA; PDUFA date December 3.

Berotralstat NDA for the prophylactic treatment of HAE accepted in Japan under Sakigake timeline; approval expected H2.

PNH proof of concept data with oral Factor D inhibitor, BCX9930, expected in Q2.

Report data from Phase 1 clinical trial of BCX9250 for treatment of fibrodysplasia ossificans progressiva in H2.

Previously: BioCryst Pharmaceuticals EPS beats by $0.26, beats on revenue (March 5)

https://seekingalpha.com/news/3548961-biocryst-pharmaplus-8-on-q4-beat

Can-Fite joins coronavirus wave

Nano cap Can-Fite BioPharma (NYSEMKT:CANF) is the latest company to take advantage of the market’s enthusiasm for anything coronavirus-related.

This morning, it announced that it is now exploring a collaboration to evaluate Piclidenoson (CF101) for the potential treatment of coronavirus infection, considering reports that rheumatoid arthritis (RA) drugs may show efficacy for this use.

Interim data from a Phase 3 study in RA should be available in Q4.

https://seekingalpha.com/news/3548976-can-fite-joins-coronavirus-wave-up-36-premarket

Quest Diagnostics to launch coronavirus test service next week

Reference lab Quest Diagnostics (NYSE:DGX) says its test service for COVID-19 will be available on Monday, March 9. It is a laboratory-developed test that is pending review by the FDA under its Emergency Use Authorization provision.

The molecular diagnostic assay detects viral RNA in respiratory specimens.

https://seekingalpha.com/news/3549022-quest-diagnostics-to-launch-coronavirus-test-service-next-week

FDA OKs Allergan eye implant for glaucoma

The FDA approves Allergan’s (AGN -1%) Durysta (bimatoprost implant) 10 mcg for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The biodegradable sustained-release implant is administered via intracameral (into the eye cavity) injection.

https://seekingalpha.com/news/3549041-fda-oks-allergan-eye-implant-for-glaucoma

J&J on short end of Remicade patent ruling

A U.S. appeals court has affirmed a lower ruling that Celltrion’s biosimilar to Johnson & Johnson’s (JNJ -1.9%) Remicade (infliximab) does not infringe on the latter’s patent covering the cell culture used in manufacturing.

Related ticker: Pfizer (PFE -2.3%)

https://seekingalpha.com/news/3549051-j-and-j-on-short-end-of-remicade-patent-ruling