RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
The Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government has cleared CytoDyn (OTCQB:CYDY) to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistant HIV patients.
The clearance included a treatment regimen of one injection per week of 350 mg of leronlimab, as contrasted to the dosage of two consecutive 175 mg injections per week used in the U.S. Phase 3 trial.
CytoDyn and the MHRA discussed in detail the primary components of BLA filing: non-clinical, clinical and manufacturing.
In connection with the manufacturing section, the cCompany confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.
“We are very pleased with the MHRA’s decision to clear our BLA for filing and our team is finalizing the remaining details to ensure a complete filing very soon. We hope to receive notice of acceptance within two weeks of our filing,” commented Nader Pourhassan, Ph.D., President and CEO.
CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S.
Exelixis’ (NASDAQ:EXEL) partner Takeda Pharmaceutical (NYSE:TAK) and Ono Pharmaceutical have submitted a supplemental application in Japan for manufacturing and marketing approval of CABOMETYX in combination with OPDIVO (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).
Per the terms of Exelixis and Takeda’s collaboration and license agreement, EXEL is eligible to receive a $10M milestone payment as a result of this latest submission for RCC.
Following the regulatory filing milestone, Exelixis will be eligible to receive a first-sale milestone payment of $20M related to the combination and additional milestones for potential future cabozantinib indications and royalties on cabozantinib sales in Japan.
Centene (NYSE:CNC): Q3 Non-GAAP EPS of $1.26 beats by $0.30; GAAP EPS of $0.97 beats by $0.31.
Revenue of $29.09B (+53.3% Y/Y) beats by $790M.
Health benefits ratio of 86.4% vs. consensus of 87.0%
Shares +0.17% PM.
Merck (NYSE:MRK): Q3 Non-GAAP EPS of $1.74 beats by $0.31; GAAP EPS of $1.16 beats by $0.14.
Revenue of $12.55B (+1.2% Y/Y) beats by $340M.
FY20 guidance: Revenue of $47.6B-$48.6B from prior guidance of $47.2B-$48.7B vs. $48.01B consensus.
EPS of $5.91-$6.01 from prior guidance of $5.63-$5.78 vs. $5.72 consensus.
Pfizer (NYSE:PFE): Q3 Non-GAAP EPS of $0.72 beats by $0.01; GAAP EPS of $0.39 misses by $0.18.
Revenue of $12.13B (-4.3% Y/Y) misses by $170M.
2020 Guidance: Revenues: $48.8B-49.5B from $48.6B-50.6B; non-GAAP EPS: $2.88-2.93 from $2.85-2.95.
Shares -0.84% PM.