Incyte Q1 Jakafi sales up 22%; guidance affirmed

Incyte (INCY) Q1 results:

Revenues: $568.5M (+14.2%); Jakafi: $459.5M (+22.3%); Iclusig: $27.2M (+32.0%); Jakavi product royalty: $56.3M (+23.5%); Olumiant product royalty: $25.4M (+58.8%).

Net loss: ($720.6M); loss/share: ($3.33); non-GAAP Net loss: ($618.9M); non-GAAP loss/share: ($2.86).

2020 Guidance: Jakafi sales: $1.88B – 1.95B (unch); Iclusig sales: $100M – 105M (unch).

Previously: Incyte EPS misses by $2.50, beats on revenue (May 5)

https://seekingalpha.com/news/3569043-incyte-q1-jakafi-sales-up-22-guidance-affirmed

FDA OKs emergency use of PerkinElmer COVID-19 blood test

The FDA has signed off on emergency use of PerkinElmer’s (PKI +1.5%) Anti-SARS-CoV-2 ELISA (IgG) blood test developed at subsidiary EUROIMMUN.

The company says the test has 100% sensitivity (correctly identifying true positives) and 99% specificity (correctly identifying true negatives) after 21 days following the onset of COVID-19 symptoms.

https://seekingalpha.com/news/3569114-fda-oks-emergency-use-of-perkinelmer-covidminus-19-blood-test

Athersys up on MultiStem study in COVID-19 advances

Enrollment is underway in a pivotal Phase 2/3 clinical trial evaluating Athersys’ (NASDAQ:ATHX) MultiStem cell therapy in COVID-19 patients with acute respiratory distress syndrome.

Target enrollment is 400 subjects. The primary endpoint is the number of ventilator-free days through day 28 versus placebo.

https://seekingalpha.com/news/3569108-athersys-up-3-premarket-multistem-study-in-covidminus-19-advances

Diffusion Pharma up 18% premarket on potential use of TSC in COVID-19

Nano cap Diffusion Pharmaceuticals (NASDAQ:DFFN) is up 18% premarket on robust volume in reaction to its announcement that the FDA will accelerate the review of its clinical development plan for using lead drug trans sodium crocetinate (TSC) to treat COVID-19 patients with severe respiratory symptoms and low oxygen levels.

The company believes that small molecule TSC’s oxygen-enhancing mechanism of action could help these patients.

https://seekingalpha.com/news/3569084-diffusion-pharma-up-18-premarket-on-potential-use-of-tsc-in-covidminus-19

Akebia up on positive vadadustat data

Akebia Therapeutics (NASDAQ:AKBA) announces positive results from the two Phase 3 clinical trials in its INNO₂VATE program comparing vadadustat to darbepoetin alfa (similar to erythropoietin) in adult patients on dialysis with chronic kidney disease-related anemia.

Both studies met the primary and secondary endpoints demonstrating vadadustat’s non-inferiority to darbepoetin alfa as measured by the mean change in hemoglobin from baseline to weeks 24 – 36 (secondary evaluation period was weeks 40 – 52).

The company plans to file a U.S. marketing application “as quickly as possible.”

https://seekingalpha.com/news/3569012-akebia-up-25-premarket-on-positive-vadadustat-data

Adverum gene therapy shows positive action in macular degeneration

Adverum Biotechnologies (NASDAQ:ADVM) announces positive preliminary data from the first three cohorts in a Phase 1 dose-ranging clinical trial, OPTIC, evaluating gene therapy candidate ADVM-022, administered via intravitreal injection, in patients with wet age-related macular degeneration (wet AMD).

The company says ADVM-022 continues to show “robust” efficacy with long-durability of beyond a year from a single administration with no rescue injections in cohort 1.

On the safety front, the gene therapy continues to be well-tolerated with a favorable safety profile.

Mean gain in best corrected visual acuity (BCVA) in cohort 3 was +6.8 letters.

It plans to file an IND for ADVM-022 in diabetic retinopathy (DR) this quarter.

Key H2 milestones: Present data from all four cohorts in OPTIC and launch enrollment in Phase 1/2 study of ADVM-022 in DR.

https://seekingalpha.com/news/3569040-adverum-gene-therapy-shows-positive-action-in-wet-amd-shares-up-22-premarket

Chembio up on launch and initial orders of COVID-19 blood test

Chembio Diagnostics (NASDAQ:CEMI) announced Q1 results after the close yesterday that missed views, but investors are reacting to its update on activities related to its DPP COVID-19 IgM/IgG blood test that it recently launched. Key developments:

Selected by Stony Brook Medicine to identify COVID-19 survivors for a convalescent plasma study.

Received a $4M purchase order from Rio de Janeiro-based Bio-Manguinhos.

It also completed a reproducibility study of its DPP HIV-Syphilis test and submitted the data to the FDA.

https://seekingalpha.com/news/3569049-chembio-up-15-on-launch-and-initial-orders-of-covidminus-19-blood-test