FDA OKs emergency use of Bio-Rad’s COVID-19 blood test

The FDA has granted Emergency Use Authorization (EUA) for Bio-Rad Laboratories’ (NYSE:BIO) SARS-CoV-2 Total Ab test, an immunoassay that detects IgG, IgM and IgA antibodies to the COVID-19 coronavirus in the blood with 98% sensitivity (detecting true positives) and 99% specificity (detecting true negatives).

The test can be performed manually or on an automated platform like its EVOLIS system.

The test has also met the CE mark requirements for Europe.

https://seekingalpha.com/news/3567588-fda-oks-emergency-use-of-bio-rad-s-covidminus-19-blood-test

TG Therapeutics up on ublituximab data in MS

TG Therapeutics (NASDAQ:TGTX) perks up 2% premarket on light volume on the heels of results from a Phase 2 clinical trial evaluating ublituximab in patients with relapsing forms of multiple sclerosis (MS). The data were published in the Multiple Sclerosis Journal.

The responder rate was 100% in 48 patients and the annualized relapse rate at week 48 was 0.07 (average follow-up of ~47 weeks).

At weeks 24 and 48, no patient had new or persisting gadolinium-enhancing lesion on any brain MRI scan (100% reduction from baseline; P=0.003).

Two Phase 3 studies are ongoing.

https://seekingalpha.com/news/3567609-tg-therapeutics-up-2-on-ublituximab-data-in-ms

BioLife Solutions sees Q1 revenue of $12M

BioLife Solutions (NASDAQ:BLFS) announces preliminary Q1 2020 total revenue of $12.1M (+110% Y/Y).

Revenue growth was driven by significantly higher demand for biopreservation media, which accounted for ~72% of total revenue.

Citing COVID-19 uncertainties, BioLife is withdrawing financial guidance for 2020.

The Company will announce Q1 results after market close on May 14, and will host a conference call at 4:30 p.m. ET.

https://seekingalpha.com/news/3567624-biolife-solutions-sees-q1-revenue-of-12m-shares-up-5-premarket

XBiotech advancing antibody therapy for COVID-19

XBiotech (XBIT +3.4%) announces that it has identified human immune donors that can support the development of a True Human antibody therapy for COVID-19.

The donors, screened at South Texas Blood & Tissue Center, have high titers of COVID-19 antibodies and do not have a history of serious illness from the coronavirus.

The company is now receiving the blood samples and has begun the discovery process to isolate the genetic information responsible for producing the strong antibody responses.

https://seekingalpha.com/news/3567666-xbiotech-advancing-antibody-therapy-for-covidminus-19

Gilead: After the data come the commercial realities

Gilead’s (NASDAQ:GILD) Q1 results were unsurprisingly overshadowed by discussions on remdesivir, Barclays analyst Carter Gould writes in a note to clients.

Disclosures of up to $1B in remdesivir spend this year and the lack of any meaningful color on its economics will likely weigh on shares near term.

Importantly, donating 1.5M doses also delays any clarity on pricing strategy for at least the next month.

GILD is appropriately reading the room. But the market “has priced in such an optimistic view of remdesivir’s commercial potential that we suspect the near-term uncertainty will weigh on shares notably.”

Upcoming data from the NIAID and SIMPLE studies over the next few weeks should provide further characterization of remdesivir’s profile.

Retains Sell rating. Price target of $67 from $62 implies 24% downside.

Shares are -3.5% on light premarket volume.

Read Gilead’s Q1 earnings call transcript.

https://seekingalpha.com/news/3567471-gilead-after-data-come-commercial-realities

AbbVie Q1 Humira sales up 6%; non-GAAP EPS guidance maintained

AbbVie (ABBV) Q1 results:

Revenues: $8,619M (+10.1%); Immunology: $5,089M (+14.5%); Hematologic Oncology: $1,549M (+32.1%); HCV: $564M (-30.8%).

Key product sales: Humira: $4,703M (+5.8%); Imbruvica: $1,232M (+20.6%); Skyrizi: $300M; Mavyret: $559M (-29.2%); Venclexta: $317M (>100%); Creon: $276M (+21.9%); Lupron: $233M (+1.7%); Synthroid: $205M (+12.3%); Synagis: $270M (-5.6%).

Net Income: $3,010M (+22.6%); EPS: $2.02 (+22.4%); non-GAAP Net Income: $3,613M (+13.2%); non-GAAP EPS: $2.42 (+13.1%).

2020 Guidance: EPS: $7.60 – 7.70 from $7.66 – 7.76; non-GAAP EPS: $9.61 – 9.71 (unch).

Q2 Guidance: non-GAAP EPS: $2.10 – 2.16.

Shares are up 1% premarket.

Previously: AbbVie EPS beats by $0.17, beats on revenue (May 1)

https://seekingalpha.com/news/3567605-abbvie-q1-humira-sales-up-6-non-gaap-eps-guidance-maintained

Downgrades roll in on Gilead; shares off 5%

What’s special about COVID-19,” asked Leerink’s Geoff Porges in the conversation from last earnings call that everyone is talking about (transcript here).

GILD -5.15% premarket.

Porges: “Should we assume the capital returns and the profitability for providing a global treatment for Covid long-term, after the first 200K-300K courses are provided on a donation basis? Should we assume the returns are going to be similar to the returns that you’ve generated in other parts of the business?”

CEO Daniel O’Day: “There’s been no other time like this in the history of the planet… There is no rulebook out there, other than that we need to be very thoughtful about how we can make sure we provide access of our medicines to patients around the globe… So points well taken.” O’Day continued that it’s too early to discuss potential revenue. “We understand our responsibility.”

Raymond James rings the register, downgrading to Market Perform. “We aren’t going to wild guess remdesivir NPV,” goes the title of their note.

SunTrust downgrades to Sell from Hold: “Lack of visibility to growth.” Their $70 price target suggests nearly 20% downside from last night’s close.

JPMorgan downgrades to Neutral from Overweight.

https://seekingalpha.com/news/3567591-downgrades-roll-in-on-gilead-shares-off-5