Alexion Pharmaceuticals (ALXN +6.5%) is up on double normal in apparent response to rumors that Biogen (BIIB +0.0%) may be eyeing the company.
ALXN is currently valued at $25.4B. Q2 revenues were ~$1.44B led by Soliris: $975.5M (-0.5%); Ultomiris: $251.1M (+363.3%); Strensiq: $184.3M (+30.4%) and Kanuma: $33.6M (+28.2%). Cash flow ops was up 38% to ~$1.34B.
In an interview yesterday during the Morgan Stanley Healthcare Conference, Moderna (MRNA +4.6%) CEO Stéphane Bancel said its large-scale 30K-subject Phase 3 study had enrolled 23,497 participants as of Friday, September 11. A “significant” number have received the second shot so the base plan for data readouts is November with an upside of next month.
The enrollment rate has been slowed down to ensure robust diversity which was only 27% of target as of September 11.
Will transition into a pediatric setting after the FDA signs off on the safety profile in adults.
Neutralizing antibody responses similar in young adults, those aged 56-70 and 71+.
Production plan remains a firm 500M doses in 2021 with an upside to 1B. GMP space is not a problem. Additional capital equipment should be delivered soon. Unclear, at this time point, whether it can procure enough raw materials to make 1B doses next year. 800M doses may be more realistic.
Vaccine is stored at minus 20 degrees Celsius (many vaccines are minus 17). No on-site dilution required.
SA Authors are Neutral.
At its Investor Day event, Pfizer (PFE -0.1%) reviewed its pipeline of 89 projects spread across six therapeutic areas. Four programs are in registration and 23 are in Phase 3 development.
27 key programs highlighted.
Revenue CAGR of at least 6% over the next five years.
Highlights pertaining to COVID-19:
Vaccine:
Stability data on BNT162b2 supports five-storage at refrigerated (2-8 °C) temperature.
Phase 1 data two weeks after the second shot showed neutralizing geometric mean titers higher than convalescent sera.
Limited blinded tolerability data from ongoing Phase 3 study showed mild-to-moderate tolerability profile.
Application filed with FDA to expand Phase 3 enrollment to ~44K subjects, allowing for recruitment of new populations. Current enrollment is north of 29K.
Data readout on efficacy likely by end of October.
Protease inhibitor:
Initiated a Phase 1b study of PF-07304814, an intravenously administered phosphate prodrug that metabolizes into the active compound PF-00835321 which has demonstrated to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.
Metacrine (MTCR) has priced its IPO of 6.54M at $13.00/share, for expected gross proceeds of ~$85M.
Underwriters’ over-allotment is an additional 981K shares.
Trading kicks off September 16. Closing date is September 18.
OPKO Health (NASDAQ:OPK) initiates a Phase 2 clinical trial, REsCue, evaluating Rayaldee in ~160 symptomatic COVID-19 patients, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk of severe complications.
The study will be conducted at COVID-19 outpatients clinics in the U.S. Enrollment should commence in the coming weeks.
RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. It was approved in the U.S. in June 2016 for secondary hyperparathyroidism in CKD patients.
Shares up 4% premarket on light volume.
Quant rating is Very Bullish.
