AwesomeCapital

Samsung Bioepis and Biogen (NASDAQ:BIIB) has announced that the FDA has accepted for review the marketing application for SB11, a proposed biosimilar referencing Genentech's Lucentis (ranibizumab), an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders.
In October, SB11 was accepted by the European Medicines Agency. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three anti-TNF biosimilars in Europe; BENEPALI, IMRALDI and FLIXABI.
In November last year, Samsung Bioepis collaborated with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (Regeneron/Bayer' Eylea aflibercept).
https://seekingalpha.com/news/3637415-fda-accepts-biogens-u-s-application-for-lucentis-biosimilar

GoodRx -4.7% pre-market after J.P. Morgan's Doug Anmuth becomes the first analyst to tag the stock with a bearish call, downgrading shares to Underweight with a $29 price target, citing pressure from Amazon's new plan to allow U.S. customers to order prescription medications for home delivery, including free delivery for Amazon Prime members.
The news sent the stock reeling yesterday, -22.5% to mark a fresh low since the September IPO.
JPM's Ammuth sees Amazon's Prime Rx plan and discount card program taking a 7% bite out of GoodRx's revenues to $698M in 2021 and 11% of EBITDA to $212M; by 2024, the hit grows to 30% in revenues to $1.31B and 39% EBITDA of $466M.
Deutsche Bank cuts its price target on GoodRx to $31 from $50 while maintaining its Hold rating, noting the most challenging problem for the stock is the current valuation at 15x on 2021 revenue and 42x on 2021 EBITDA.
https://seekingalpha.com/news/3637426-goodrx-cut-j-p-morgan-on-new-amazon-plan

Goldman Sachs adds McKesson (NYSE:MCK) to it Conviction Buy List.
The big pullout from the Goldman note is that it doesn't view Amazon’s pharmacy business as an existential threat.
"Further, we do not think AMZN's presence as an online pharmacy represents a signiﬁcant risk to the wholesalers (we provide sensitivity analyses of the potential impact for the Distributors and Retailers within), and as a result see the pullback yesterday as a buying opportunity, particularly with MCK still trading close to 10-year relative lows versus the S&P and S&P HC index."
https://seekingalpha.com/news/3637460-mckesson-lands-on-goldmans-conviction-buy-list

VBI shares rose after interim results from ongoing Phase 1b/2a study of VBI-2601 (BRII-179), a novel recombinant, protein-based immunotherapeutic candidate for the treatment of chronic hepatitis B virus (HBV) infection, in development in collaboration with Brii Biosciences.
Interim data from low-dose cohorts achieved human proof-of-concept, demonstrating restoration of both antibody and T cell responses in chronic HBV patients.
Potent re-stimulation of T cell responses to HBV surface antigens seen in 67% (n=6/9) and 78% (n=7/9) of evaluable patients in the low-dose VBI-2601 unadjuvanted and adjuvanted study arms, respectively.
Antibody responses against HBV surface antigens were observed in 60% of evaluable patients (n=6/10) in unadjuvanted cohort and in 67% (n=6/9) in adjuvanted cohort
Low dose immunotherapeutic was well-tolerated with no safety signals observed.
The two-part dose-escalation study assessing a low dose and a high dose of VBI-2601 has enrolled 46 patients.
Data from the high-dose cohorts expected in Q1 2021.

https://seekingalpha.com/news/3637462-vbi-vaccines-shares-up-4-on-positive-vbiminus-2601-data-in-chronic-hepatitis-b-virus

Therapeutics SPAC, Population Health Investment (PHICU) has priced its initial public offering of 15M units at $10/unit.
Trading commences today on Nasdaq.
Each unit consists of one Class A ordinary share and one-third of one redeemable warrant, to purchase one Class A ordinary share at $11.50.
Underwriters' over-allotment is an additional 2.25M units.
Offering is expected to close on November 20.
Population Health Investment to focus on companies or divisions of companies in the healthcare industry, and in particular the therapeutics sector, in the United States and other developed countries.
https://seekingalpha.com/news/3637466-population-health-prices-150m-ipo-trades-today

FDA designated both Orphan Drug Designation and Fast Track status to PTC Therapeutics' (NASDAQ:PTCT) PTC596 for the treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue.
Furthermore, the FDA has also granted PTC596 a Rare Pediatric Disease and Orphan Drug designations for the treatment of Diffuse Intrinsic Pontine Glioma, an ultra-rare childhood glioma.
PTC596 is an orally bioavailable small molecule tubulin binding agent that arrests tumor cells in G2/M phase, including cancer stem cells, through the action of inhibiting tubulin polymerization.
https://seekingalpha.com/news/3637468-ptc-therapeutics-cancer-drug-nabs-fast-track-and-orphan-drug-tags-for-rare-indications

Lilly and Boehringer Ingelheim report results from EMPA-REG OUTCOME trial assessing Jardiance and placebo, both added to standard of care in adults with type 2 diabetes and established cardiovascular disease.
Total cardiovascular events included 3P-MACE (a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death), hospitalization for heart failure and all-cause hospitalization.
Previously, Jardiance reduced the relative risk of 3P-MACE by 14%, driven by a 38% reduction in the relative risk of cardiovascular death.
https://seekingalpha.com/news/3637472-lillys-jardiance-reduced-risk-of-cardiovascular-events-in-adults-type-2-diabetes

Search This Blog