Arvinas continues uptrend after dual upgrades

 

• Notwithstanding the $250M worth equity offering, Arvinas (NASDAQ:ARVN) extends the near two-fold gain posted yesterday, rising another +25.9% in value as Roth and Guggenheim upgraded their price targets.
• In an announcement yesterday, the company highlighted the promising clinical updates to ARV-471 and ARV-11, two protein degraders targeting metastatic breast cancer and castration-resistant prostate cancer, respectively.
• Noting ‘an impressive clinical benefit rate’ from ARV-471 ‘in heavily treated breast cancer patients’, Roth analyst Zegbeh Jallah writes ‘planned drug filings to start studying medicines in humans for 2021 and 2022 “take on new meaning” as the updates for ARV-110 and ARV-471 showed “supportive proof of concept” results.’ The price target at $120 is more than double that of yesterday’s close.
• Maintaining the ‘Buy’ rating, Guggenheim analyst Michael Schmidt argues that the clinical results ‘further validate its platform and the targeted protein degrader approach in general’ raising the price target to $100 from $48.
• https://seekingalpha.com/news/3644600-arvinas-continues-upward-trend-after-dual-upgrades

Radius Health on-track for record quarterly revenue for TYMLOS-SC

 

• Radius Health (RDUS +4.3%) says that its focus on postmenopausal osteoporotic fracture patients continues to gain traction. In November, a truncated sales month due to the Thanksgiving holiday, Radius added 1,326 net new patients, representing 8% increase from the previous four-month trailing average.
• The current Q4 forecast for TYMLOS-SC net revenue projects a record quarter for the product since its launch. The previous quarterly net revenue high of $56.7M was reported in last year Q4.
• In October, the company entered into a discovery research collaboration with Massachusetts General Hospital to evaluate efficacy, safety, and specificity of small molecules as potential oral anabolic treatment for a broad array of musculoskeletal diseases. The area of focus includes salt inducible kinases and SIK inhibitors.
• https://seekingalpha.com/news/3644604-radius-health-on-track-for-record-quarterly-revenue-for-tymlos-sc

Ionis surges after Cowen upgrade

 

• Ionis Pharmaceuticals (NASDAQ:IONS) jumps +7.1% as Cowen raises the recommendation to outperform from 'market perform' and names the stock 'a best idea' for 2021.
• Citing the programs on hereditary angioedema, acromegaly and treatment-resistant hypertension of the RNA-focused drug developer, the analyst Yaron Werber writes, “the company’s internal pipeline is overlooked and has multiple key catalysts expected in 2021,”
• At the recently-concluded investor day, the company said it was on track for as many as six new product launches through 2026, expecting double-digit revenue growth and substantial earnings growth.
• Yet, the company has lost nearly a quarter of value over the past 12-months, compared to more than a quarter of gain in the iShares Nasdaq Biotechnology ETF.
• https://seekingalpha.com/news/3644612-ionis-surges-after-cowen-upgrade

Celyad in early-stage colorectal cancer study with CAR T candidate

 

• Celyad Oncology (NASDAQ:CYAD) has dosed the first patient in the expansion cohort of the Phase 1 alloSHRINK trial evaluating CYAD-101, its allogeneic T cell receptor inhibitory molecule-based, non-gene edited CAR T candidate for the treatment of refractory metastatic colorectal cancer.
• The study is assessing the safety and clinical activity of three consecutive administrations of CYAD-101 every two weeks administered concurrently with preconditioning chemotherapy.
• In the expansion cohort of the trial, CYAD-101 will be administered at the recommended dose of one billion cells per infusion concurrently with FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) chemotherapy.
• https://seekingalpha.com/news/3644626-dosing-underway-in-celyads-early-stage-colorectal-cancer-study-car-t-candidate

Gilead, Galapagos in new commercialization pact for filgotinib

 

• Following a Type A meeting with FDA discussing complete response letter related to Jyseleca's (filgotinib) marketing application for Rheumatoid Arthritis (RA), Gilead Sciences (NASDAQ:GILD) and Galapagos (NASDAQ:GLPG) have agreed to amend their existing arrangement for the commercialization and development of the drug candidate, with Gilead dropping pursuit of FDA approval of the treatment for rheumatoid arthritis (RA).
• Move follows that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without substantial additional clinical studies.
• Galapagos will assume sole responsibility in Europe for Jyseleca in RA and ulcerative colitis (UC), plus future indications, with Gilead to receive tiered royalties of 8%-15% on net European sales starting in 2024.
• Recently filgotinib trials in psoriatic arthritis, ankylosing spondylitis, and non-infectious uveitis following receipt of the CRL were paused and, the companies no longer believe it is feasible to continue development for filgotinib in these indications. As a result, these trials will be stopped over the coming months.
• Both parties will continue filgotinib study in Inflammatory Bowel Disease (IBD). Filgotinib is currently under review by the European Medicines Agency for UC and is expected to be submitted to the Japanese regulatory authority in 1H of 2021. Further clarity on the potential U.S. filing in IBD, after consultation with FDA.
• Gilead will pay Galapagos €160M to support on-going development, and Galapagos will no longer be eligible to receive any future milestone payments relating to filgotinib in Europe.
• https://seekingalpha.com/news/3644680-gilead-galapagos-inks-new-commercialization-pact-for-filgotinib

CytoDyn completes enrollment in Phase 3 trial for severe-to-critical COVID-19

 

• CytoDyn Inc. (OTCQB:CYDY) announces the full enrollment of its Phase 3 registrational trial for Vyrologix™ (leronlimab-PRO 140) in severe-to-critical COVID-19.
• The company is also finalizing a EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients.
• Generating statistically significant results for NEWS2, CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S.
• 390 patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo in the two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study which has three phases: Screening Period, Treatment Period, and Follow-Up Period.
• The patient data will be analyzed in approximately 28 days, with results to be announced soon after in mid-January 2021.
• The primary outcome measured in this study is: all-cause mortality at Day 28 with secondary outcomes being (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
• CytoDyn is targeting multiple therapeutic applications for leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor, suspected to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
• https://seekingalpha.com/news/3644685-cytodyn-completes-enrollment-in-phase-3-trial-for-severe-to-critical-covidminus-19

Moderna says its COVID-19 vaccine may prevent asymptomatic infection

 Moderna Inc said data from the late stage trial of its COVID-19 vaccine suggests that it could prevent some asymptomatic infections as soon as the first dose of the shot is given.

The vaccine maker said in briefing documents it submitted to the U.S. Food and Drug Administration released on Tuesday that it had not yet completed its full analysis on the efficacy against asymptomatic infection.

Still, it said that 38 trial participants in the placebo arm of its trial tested positive for COVID-19 without exhibiting symptoms at the time of their second dose. That was nearly triple the number in the vaccine arm of the trial, where there were 14 positive tests from asymptomatic people.

https://www.reuters.com/article/health-coronavirus-moderna-asymptomatic/moderna-says-its-covid-19-vaccine-may-prevent-asymptomatic-infection-idUSKBN28P1RY