Co-Diagnostics up on expanded manufacturing capacity for COVID-19 test

Co-Diagnostics (NASDAQ:CODX) inks an agreement with Madison, WI-based Promega for additional manufacturing capacity for its Logix Smart COVID-19 test.

Promega has the capability to produce product in high volumes and can start immediately.

The company says its test is currently available to all CLIA-certified labs.

https://seekingalpha.com/news/3560385-co-diagnostics-up-7-premarket-on-expanded-manufacturing-capacity-for-covidminus-19-test

Molina nixes NextLevel Health Partners tie-up

Apparently at an impasse over the details of the acquisition agreement, Molina Healthcare (NYSE:MOH) has terminated its planned $50M takeover of NextLevel Health Partners announced in January.
https://seekingalpha.com/news/3560390-molina-nixes-nextlevel-health-partners-tie-up

Sanofi and GSK team up to develop COVID-19 vaccine

Sanofi (NASDAQ:SNY) and GlaxoSmithKline (NYSE:GSK) ink a letter of intent to co-develop an adjuvanted vaccine for COVID-19.

Sanofi will contribute its recombinant RNA-based S-protein COVID-19 antigen, while GSK will contribute its adjuvant technology.

A Phase 1 study should launch in H2. If development goes well, the vaccine could be available in H2 2021.

https://seekingalpha.com/news/3560400-sanofi-and-gsk-team-up-to-develop-covidminus-19-vaccine

J&J delivers strong Q1 but lowers guidance amid COVID-19 headwinds

Johnson & Johnson (JNJ) Q1 results:

Revenues: $20,691M (+3.3%); R&D Expense: $3,625M (+9.3%); SG&A: $11,134M (+8.7%); Operating Income: $5,932M (-8.2%).

Net Income: $5,796M (+54.6%); EPS: $2.17 (+56.1%); non-GAAP Net Income: $6,154M (+8.7%); non-GAAP EPS: $2.30 (+9.5%).

Key Product Sales: Remicade: $990M (-10.2%); Simponi/Simponi Aria: $529M (+1.1%); Stelara: $1,819M (+29.5%); Tremfya: $296M (+36.4%); Edurant/rilpivirine: $224M (+6.1%); Prezista/Prezcobix/Rezolsta/Symtuza: $579M (+10.8%); Darzalex: $937M (+49.0%); Invega Sustennn/Xeplion/Trinza/Trevicta: $883M (+11.7%); Imbruvica: $1,031M (+31.6%); Velcade: $108M (-59.0%); Zytiga: $690M (+1.6%); Xarelto: $527M (-2.7%); Opsumit: $389M (+27.4%); Uptravi: $250M (+26.2%); Invokana/Invokamet: $175M (-13.5%); Procrit/Eprex: $155M (-31.6%).

2020 Guidance: Revenues: $77.5B – 80.5B from $85.4B – 86.2B; Non-GAAP EPS: $7.95 – 7.90 from $8.95 – 9.10.

https://seekingalpha.com/news/3560398-j-and-j-delivers-strong-q1-lowers-guidance-amid-covidminus-19-headwinds

Dr. Reddy’s launches two products in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of Amphetamine Sulfate Tablets USP, a therapeutic generic version of Arbor Pharmaceuticals’ Evekeo (amphetamine sulfate) Tablets.

The company also launched authorized generic version of USpharma’s NitroDur (nitroglycerin) Transdermal Infusion System.

According to IQVIA Health, U.S. brand and generic sales for Evekeo and Nitrogylcerin Transdermal Patch products were ~$38M and ~$14.7M, respectively for the year ended January 2020.

https://seekingalpha.com/news/3560406-dr-reddys-launches-two-products-in-u-s

Alnylam’s vutrisiran Fast Track’d for rare inherited nerve disorder

The FDA grants Fast Track status for Alnylam Pharmaceuticals’ (NASDAQ:ALNY) RNAi therapeutic vutrisiran for the treatment of adults with polyneuropathy (damage to multiple peripheral nerves) of hereditary transthyretin-mediated (hATTR) amyloidosis, a rare inherited disorder in which a protein called amyloid builds up in organs and tissues causing the loss of sensation in the limbs, feet and hands.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Topline data from a Phase 3 study, HELIOS-A, should be available in Q1 2021.

https://seekingalpha.com/news/3560415-alnylams-vutrisiran-fast-trackd-for-rare-inherited-nerve-disorder

Moleculin Biotech to hold investor call on April 16

Moleculin Biotech (NASDAQ:MBRX) will host a conference call on April 16, at 4:30 pm ET to explain the significance of recent discovery that the active compound in WP1122 has been shown to reduce replication of SARS-CoV-2 by 100%.
https://seekingalpha.com/news/3560422-moleculin-biotech-to-hold-investor-call-on-april-16-shares-up-12-premarket