• Loading stock data…

Week in Review: April 13th and an FDA Second

Last Updated on April 19, 2020 by Chris Stang

This week we saw great excitement as President Trump and the Corona Virus Task Force unveiled plans to open the country back up. Furthermore, we saw appreciation of biotechnology companies as reports have surfaced that Gilead’s (GILD) candidate remdesivir is showing efficacy in the treatment of patients with COVID-19. Overall, the XBI finished the week up 9.73% and the IBB finished the week up 9.36%.

Moving onto our community, premium members shared in the gains with our daily email trade ideas and intra-day text alerts. Impressively, these gains occur in a short time period which allows for the compounding of growth, which is where the real money is made. These wins include the price appreciation of our core positions. Our biggest text-alert mover was THMO, running over 54% in 4 days. Additionally, BCRX (one of our core positions) ran 27% in one day on our text alerts as we swung additional shares around our core holdings. Finally, Sultan provided a quarterly update for one of our core positions LJPC, which can be found here.


Moving along onto our MS Intel Section, we saw four FDA approvals this week. First, the FDA gave the nod for UroGen’s (URGN) Jelmyto, which was featured on last week’s weekly update. Urogen finished the week up 11.6% among all the excitement. On Monday, the FDA approved Koselugo (selumetinib) for the treatment of pediatric patients two years of age and older with neurofibromatosis type 1 (NF1). This drug will be marketed by Merck and AstraZeneca. Then on Friday, we had two approvals. First, was the approval of Seattle Genetics’ (SGEN) Tukysa (tucatinib). This represents just the second NDA approval under the FDA’s Real Time Oncology Review Program (RTOR). The RTOR program seeks to review applications in a more timely manner. As such, this approval came over 4 months early, helping get this drug in the hands oncologists to address an unmet need. Additionally, the FDA approved Incyte’s (INCY) Pemazyre (pemigtinib) for the treatment of metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. This approval came nearly a month and half early, ahead of the scheduled PDUFA date.

Upcoming PDUFA Dates

April 25th is the PDUFA Date for Sanofi’s (SNY) meningococcal vaccine candidate. Unfortunately, a company this large is unlikely to provide much of a price appreciation for our community. The second upcoming PDUFA date is April 26th for Neurocrine’s (NBIX) Parkinson’s disease candidate opicapone. Neurocrine has a current market cap of $9.2 billion, closing Friday at $98.96 per share. The average 12-month price target of Neurocrine is $118.65.

New PDUFA Dates

Fennec Pharma (FENC) – FDA Priority PDUFA date of 8/10/2020 for sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors.

ANI Pharmaceuticals (ANIP) – FDA PDUFA date of 7/23/2020 for corticotropin injection, which will be a branded generic product.

Regeneron (REGN) – FDA Priority PDUFA date of 10/25/2020 for REGN-EB3, which is a cocktail for the treatment for Ebola virus infection.

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

Print Friendly, PDF & Email
Spread the word

Reader Interactions

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: