Anthem stays the course with 2020 outlook

Anthem (NYSE:ANTM) discloses that it will be speaking with investors over the next several weeks and intends to reaffirm its 2020 EPS guidance of more than $21.00, inclusive of ~$1.30 of net unfavorable items. Non-GAAP EPS should be greater than $22.30. About 70% of its non-GAAP earnings pre share will be generated in H1.

Guidance does not include any other adjustments beyond those reported in Q1 results.

https://seekingalpha.com/news/3581410-anthem-stays-course-2020-outlook

Amphastar Pharma receives FDA approval for generic Quelicin

The FDA has approved Amphastar Pharmaceuticals’ (NASDAQ:AMPH) Abbreviated New Drug Application for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial, a therapeutic equivalent of Pfizer’s Quelicin.

It is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

According to IQVIA, the annual U.S sales figure for year March 31, 2020 for Succinylcholine Chloride Injection USP was ~$75M.

https://seekingalpha.com/news/3581420-amphastar-pharma-receives-fda-approval-for-generic-quelicin

CytoDyn to update on pipeline progress on June 11

CytoDyn (OTCQB:CYDY) will host an investment community conference call on June 11 at 4:00 p.m. ET to provide an update on several recent clinical and regulatory developments, potential uplisting and potential licensing and/or distribution agreements.
https://seekingalpha.com/news/3581432-cytodyn-to-update-on-pipeline-progress-on-june-11

Can-Fite rallies on advancement of Piclidenoson for COVID-19

Nano cap Can-Fite BioPharma (NYSEMKT:CANF) is up 14% premarket on robust volume on the heels of its announcement that the FDA has provided guidance regarding the potential use of Piclidenoson to treat COVID-19 patients. The company says the information allows it to proceed with an IND filing for the indication.

If the FDA signs off on the IND, it will launch a Phase 2 trial comparing Piclidenoson to standard-of-care treatment in COVID-19 patients with moderate-to-severe symptoms.

Can-Fite is currently developing the A3AR agonist for rheumatoid arthritis and psoriasis.

https://seekingalpha.com/news/3581458-can-fite-rallies-on-advancement-of-piclidenoson-for-covidminus-19

Immunic launches mid-stage IMU-838 trial in COVID-19

Immunic (NASDAQ:IMUX) is up 8% after receiving FDA allowance to initiate its phase 2, CALVID-1 clinical trial of IMU-838, an oral, selective dihydroorotate dehydrogenase inhibitor, in COVID-19 at centers in U.S.

Top-line data are expected later this year.

https://seekingalpha.com/news/3581460-immunic-launches-mid-stage-imuminus-838-trial-in-covidminus-19

Lilly teams up with Evox Therapeutics in neurological disorders

Eli Lilly (NYSE:LLY) will collaborate with Oxford, England-based Evox Therapeutics on potential treatments of neurological disorders. The partnership will leverage Evox’s proprietary DeliverEX platform to develop RNA interference and antisense oligonucleotide drug payloads for up to five targets.

Evox will be responsible for exosome engineering aimed at brain/CNS targeting, drug loading and analytics and some in vitro assay development. Lilly will take over after the completion of preclinical proof-of-concept studies.

Lilly will pay Evox $20M upfront, research funding for three years, up to $1.2B in milestones and tiered royalties up to low double digits on net sales. Lilly will also invest $10M in Evox in exchange for a convertible bond.

https://seekingalpha.com/news/3581471-lilly-teams-up-evox-therapeutics-in-neurological-disorders

Thermo Fisher teams up with Agios on second companion diagnostic

Thermo Fisher Scientific (NYSE:TMO) has expanded its partnership wit Agios Pharmaceuticals (NASDAQ:AGIO) adding the co-development of a second companion diagnostic in oncology.

The test, run on TMO’s Ion Torrent Genexus System, will be used to identify low-grade glioma patients with IDH1 and IDH2 genetic mutations that may be suitable for Agios’ vorasidenib (AG-881).

Under the terms of the agreement, both companies will collaboratively validate the biomarkers for the test using TMO’s Oncomine Precision Assay. TMO will retain the right to commercialize the test globally and will lead regulatory filings.

The parties inked their first agreement in 2017 aimed at developing a companion diagnostic for Tibsovo (ivosidenib).

https://seekingalpha.com/news/3581442-thermo-fisher-teams-up-agios-on-second-companion-diagnostic