FDA postpones foreign inspections due to COVID-19

Citing the risks of the COVID-19 outbreak, the FDA is postponing most foreign inspections through April, effective immediately. In the meantime, the agency will consider ex-U.S. inspections deemed mission-critical on a case-by-case basis.

The FDA based its decision on the State Department’s Level 4 travel advisory (prohibits travel for U.S. government employees), CDC recommendations, access restrictions imposed on foreign visitors imposed by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of FDA staffers.

ETFs: THW, BME, GRX, IXJ, GDNA, KMED, XLV

https://seekingalpha.com/news/3550219-fda-postpones-foreign-inspections-due-to-covidminus-19

Co-Diagnostics down 39% on proliferation of COVID-19 competitors

Co-Diagnostics (CODX -38.9%) represents a shining example of the risks in playing a highly volatile stock amid market turmoil related to COVID-19. Shares are down 72% from the high of $21.67 on March 2. The high represented a 20-fold rally from the close of $1.07 on January 17.

Today’s action represents profit-taking and the (now) widespread availability of testing services for patients. Adding to the selloff was the news this morning that Aytu BioScience has secured exclusive U.S. rights to a rapid point-of-care blood test used to screen for SARS-CoV-2 infection. Aytu rocketed almost 8-fold before retracing, still up 443% from yesterday.

https://seekingalpha.com/news/3550243-co-diagnostics-down-39-on-proliferation-of-covidminus-19-competitors

Wainwright reiterates bullish call on Co-Diagnostics, sees 195% upside

H.C. Wainwright reiterates its Buy recommendation of COVID-19 test maker Co-Diagnostics (CODX -28.8%) with a $20 (195% upside) price target.

Analyst Yi Chen says the company was the first U.S.-based firm to receive CE Mark certification for its test and recent FDA policy changes aimed at accelerating the availability of tests in America should boost sales.

Mr. Chen says the company is currently shipping its Logix Smart COVID-19 screening test to countries in the U.S., Europe, Asia and Australia.

Shares are currently exchanging hands at $6.95, down 68% from its high of $21.67 on March 2.

https://seekingalpha.com/news/3550271-wainwright-reiterates-bullish-call-on-co-diagnostics-sees-195-upside

J&J antibody nabs accelerated review for lung cancer

The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies’ JNJ-6372 a Breakthrough Therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose cancer has progressed on or after platinum-based chemotherapy.

Phase 1-stage JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.

NSCLC with EGFR Exon 20 insertion mutations is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy and represents a poor prognosis for patients. The current standard-of-care is conventional cytotoxic chemo.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3550299-j-and-j-met-antibody-nabs-accelerated-review-status-for-certain-lung-cancer-patients

NuCana’s Acelarin shows positive action in mid-stage ovarian cancer study

Preliminary data from a Phase 2 clinical trial evaluating NuCana’s (NASDAQ:NCNA) Acelarin (NUC-1031) in heavily pretreated patients with platinum-resistant ovarian cancer showed a treatment effect.

45 patients who received at least three prior lines of chemo were evaluable for response. There were three responders, one complete, and 16 with stable cancer implying a disease control rate (DCR) of 42% (n=19/45). The response rate and DCR improved to 13% and 83%, respectively, in 23 patients who received two or more cycles of Acelarin.

Consistent with its December 2019 announcement that it is focusing its resources on Acelarin in biliary tract cancer and NUC-3373 in colorectal cancer, the company will not proceed with the second part of the trial.

The company says Acelarin, based on its ProTide technology, is a “pre-activated” version of gemcitabine, engineered to outperform the chemo agent by virtue of its ability to overcome cancer cells’ resistance mechanisms. A Phase 3 study comparing Acelarin to gemcitabine in pancreatic cancer patients failed, however.

Shares up 4% after hours.

https://seekingalpha.com/news/3550329-nucanas-acelarin-shows-positive-action-in-mid-stage-ovarian-cancer-study

Coronavirus updates, March 10

New York Governor Cuomo has deployed the National Guard to New Rochelle (suburb north of NYC – one town over is Mamaroneck where golf’s U.S. Open is being held in June) to help in the containment effort at what’s become a coronavirus hot spot.

Harvard has joined a number of other colleges telling kids not to return from spring break and instead moving instruction online. A decent list of those doing same is here. Harvard was also to be the site of this weekend’s Ivy League basketball tournament, but that’s reportedly been canceled.

Update at 4:01 PM ET: Morgan Stanley (NYSE:MS) said an employee at its suburban New York office tested positive for coronavirus, following confirmed cases at Barclays, BlackRock, and Wells Fargo.

Update at 3:30 PM ET: Treasury Secretary Steven Mnuchin says the Treasury Department is exploring its options for taking independent actions to help lessen the economic fallout of the coronavirus, Bloomberg reports.

He said he had a good meeting with House Speaker Nancy Pelosi to discuss a potential stimulus package. “We are having discussions on a bipartisan basis and there’s a lot of interest to get something done on a bipartisan basis,” he said.

Update at 1:29 PM ET: New Jersey reports first death in the state from Covid-19; the individual was a male in his 60s.

Yesterday, New Jersey declared a state of emergency, which allows state agencies and departments to use state resources to assist affected communities responding to Covid-19 cases.

https://seekingalpha.com/news/3550231-coronavirus-updates-ny-sends-in-natl-guard-harvard-going-online

Gilead’s vesatolimod shows modest effect early-stage HIV study

Gilead Sciences (GILD -3.9%) announces results from a Phase 1b clinical trial evaluating toll-like receptor 7 (TLR7) agonist vesatolimod in 25 HIV-positive participants. The data are being presented at the Conference on Retroviruses and Opportunistic Infections in Boston.

Enrollees demonstrated partial viral suppression prior to starting antiretroviral therapy (ART). They received either 10 biweekly doses of vesatolimod or placebo while continuing ART, followed by treatment interruption, then monitored for viral rebound and safety.

Patients receiving the TLR7 agonist showed a longer period of viral suppression than control, but the difference was modest. Median time to viral rebound (>50 copies/mL) in the vesatolimod cohort was 4.1 weeks compared to 3.9 weeks for placebo (p=0.036). Median time to rebound based on a higher threshold (>200 copies/mL) also favored vesatolimod, five weeks vs. four weeks (p=0.024). Four participants in the vesatolimod group had no virologic rebound (>50 copies/mL) for at least six weeks.

Vesatolimod (GS-9620) is part of the company’s HIV cure research program.

Principal investigator Prof. Steven Deeks says, “This is the first study done in people that has shown with an immunotherapy that you can enhance immune function resulting in both a smaller viral reservoir and an increased time to viral rebound after treatment is interrupted. The effects are modest, and no one came close to any definition of a cure, but the data suggests real progress might be made when the drug is used in combination with other approaches.”

https://seekingalpha.com/news/3550263-gileads-vesatolimod-shows-modest-effect-early-stage-hiv-study