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Week in Review: April 6th

Last Updated on April 11, 2020 by Chris Stang

This week we witnessed one of the best weekly gains on record, which is in stark contrast to the loss of jobs that Americans have suffered. It is estimated that over 10% of Americans have lost their jobs since mid-March. All is this is on-going while the Federal Reserve continues to plow forward with stimulus programs, including the most recently announced $2.3 trillion in loans for smaller businesses and municipalities.

Moving onto our community, premium members shared in the gains with our daily email trade ideas and intra-day text alerts. PSTI was a real money maker for our members, while NGM and BCRX added modestly as part of our long-term hold given their strong fundamentals. We will highlight that BCRX announced Thursday after-hours that they will be initiating of its antiviral candidate galidesivir for COVID-19. This trial is being funded by the National Institute of Allergy and Infectious Diseases. BCRX closed afterhours trading up 40% Thursday. For more information on BCRX, read Sultan’s recent update here.


Moving along onto our MS Intel Section, we saw one FDA approval, which was Pfizer’s encorafenib in combination with cetuximab for BRAF mutated metastatic colorectal cancer. This compound was part of the lucrative buyout of Array Bio (ARRY). This approval came 22 days, showing that the FDA is still up and functioning amid the COVID-19 crisis. I will note, this a supplementary NDA, and I still anticipate the FDA will take nearly the full time to approve initial NDAs and BLAs.

Upcoming PDUFA Dates

April 18th is the PDUFA date for Urogen’s (URGN) mitomycin gel for the treatment of low-grade upper tract urothelial cancer. This application is being reviewed under priority review. Urogen has a current market cap of $450.6 million, and closed trading on Thursday at $21.30. The average 12-month price target is $40.29, suggesting significant upside if everything goes according to plan.

New PDUFA Dates

Merck (MRK) – FDA Priority PDUFA date of 6/16/2020 for pembrolizumab for the treatment of patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase.

Bristol-Myers Squib (BMY) – FDA Priority PDUFA date of 8/6/2020 for nivolumab and ipilimumab for the treatment of non-small cell lung cancer.

Genentech (Roche, RHHBY) – announced that the FDA extended the PDUFA date for risdiplam to 8/24/2020. Risdiplam is being developed for the treatment of Spinal Muscle Atrophy (SMA).

Liquidia (LQDA) – FDA PDUFA dates of 11/24/2020 for treprostinil for the treatment of pulmonary hypertension.

See our full FDA PDUFA calendar at https://biotechwinners.com/fda-pdufa-calendar/

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