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.
Pfizer’s setback can hurt others with JAK inhibitors
Earlier in the day, Pfizer (NYSE:PFE) announced that its JAK inhibitor XELJANZ® (tofacitinib), approved in the U.S. for active rheumatoid arthritis, failed to meet the co-primary endpoints in a post-marketing required safety study.
The FDA has a black box warning on the drug’s label, which was further expanded in 2019. XELJANZ made up ~4.8% of Pfizer’s revenue in the first nine months of 2020, with a twofold rise from the previous year.
The co-primary endpoints in the study were to see if tofacitinib is as safe as a TNF inhibitor (“TNFi”) when it comes to major adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer).
Brian Abrahams, an analyst at RBC Capital Markets, said that the outcome could make the FDA “even more risk-averse” on the labeling decisions on JAK drugs.
In addition to Pfizer, two other big pharma with JAK inhibitors in their portfolio are also trading lower today.
Olumiant Eli Lilly (NYSE:LLY) and Rinvoq from AbbVie (NYSE:ABBV) have each made up less than ~5% of their top-line in the first three quarters of 2020, with sales of Rinvoq rising ~32.1x from the past year.
EyePoint surges after Cantor Fitzgerald nod; potential of EYP-1901 cited
EyePoint Pharmaceuticals (NASDAQ:EYPT) is up ~11.9% in post-market after Cantor Fitzgerald initiated the coverage on the stock with an overweight rating. The street-high matching target of $22 implies ~2.2x of today’s close.
“The potential peak sales opportunity for EYP-1901 is underappreciated,” the analyst Jennifer Kim argues, expecting the upward revisions for earnings estimates to send EyePoint shares higher.
Announcing the preliminary results for Q4 2020 and the full year of 2020, EyePoint CEO Nancy Lurker commented, “We anticipate the Phase 1 trial for EYP-1901 to begin in 1Q21 and we expect to report topline results in 2H21,” noting the IND filing for the experimental therapy in December.
‘Our analysis concludes EYPT’s liquidity will be “on-fumes” at year-end,’ wrote Seeking Alpha contributor, Boston Biotech Investor in a neutral thesis on the stock.
PhaseBio presents Phase 1/2 data for Pemziviptadil in pulmonary arterial hypertension
PhaseBio Pharmaceuticals (NASDAQ:PHAS) announced data from three patients undergoing a Phase 1b/2a pilot study that evaluates the safety, pharmacokinetics, and pharmacodynamics of the company’s first-in-class, sustained-release vasoactive intestinal peptide analogue, pemziviptadil (PB1046)
Presented at the 15th Pulmonary Vascular Research Institute World Congress today, the study results of pemziviptadil in the treatment of pulmonary arterial hypertension (“PAH”) have highlighted the favorable safety and tolerability profile of experimental therapy.
In addition to stability in functional status with no clinically meaningful deterioration for two patients at two and six months after treatment, a long-term improvement of six-minute walk test (6MWT) distance was seen with one patient after eighteen months of treatment.
Noting that the results were from a small number of patients, John Lee, Chief Medical Officer of PhaseBio Pharmaceuticals said, ‘we are encouraged to see that this novel therapeutic agent has provided symptomatic relief and meaningful clinical benefits.’
The initial results from the Phase 2b trial for PAH are on track for a readout in 2H 2021.
