Target to $11 from $16
Wednesday, September 22, 2021
Onconova: Encouraging Data Support Lung Cancer Candidate
Preliminary Phase 1/2a trial data show an early signal of activity in extensively pre-treated population with 2 partial responses out of 7 evaluable patients
Responses were seen in patients with different KRAS mutations
Data supports further development of rigosertib, in combination with immune checkpoint inhibitors in KRAS mutated (KRAS+) non-small cell lung cancer
Management hosting webinar with key opinion leaders to discuss data today at 4:30 p.m. ET
Slides from the presentation titled, “Phase 1/2 Trial of Rigosertib & Nivolumab in KRAS-Mutated NSCLC in 2nd+ Line” will be available on the “Scientific Presentations” section of the Onconova website following the conference.
Webinar Featuring Expert Overview from Key Opinion Leaders
Onconova will host a webinar today, September 22, 2021, at 4:30 p.m. ET to discuss the preliminary Phase 1/2a data. The call will feature expert discussion with Dr. Veluswamy and Scott Antonia, M.D., Ph.D., Professor of Medicine at the Duke Cancer Institute and Director of its Center for Cancer Immunotherapy. A question and answer session with these experts will follow formal presentations by Dr. Veluswamy and members of the Onconova management team.
To attend the webinar, click here. A replay of the webinar will be available by visiting the investors and media page on Onconova’s website at www.onconova.com and clicking on the webcast link.
https://finance.yahoo.com/news/onconova-therapeutics-announces-encouraging-clinical-120000736.html
Inovio to Conduct Phase 3 Efficacy Trial of COVID-19 DNA Vax in Mexico
News follows recent regulatory authorizations to proceed with the trial in Brazil and the Philippines
INOVIO and partner Advaccine are collaborating on the global Phase 3 trial in regions underserved by COVID-19 vaccines; to focus on Latin America, Asia, and Africa
https://finance.yahoo.com/news/inovio-receives-regulatory-authorization-conduct-120000867.html
Cassava: Top-line Interim Results from Open-label Study Evaluating Simufilam in Alzheimer’s
Cognition Scores Improved 3.2 Points on ADAS-Cog, Baseline to Month 12 (p<0.001)
Two Independent Biostatisticians Analyzed Changes in ADAS-Cog Scores, Baseline to Month 12
No Behavior Disorders on NPI in Over 50% Of Study Subjects at Month 12
Initiation of Pivotal Phase 3 Clinical Program Remains On-track for Q4 2021, with Special Protocol Assessments from FDA
Pfizer, BioNTech to Provide 500M More COVID Vaccine Doses for Donation
Expanded agreement brings the total number of COVID-19 vaccine doses to be supplied to the U.S. government for donation to one billion
Effort contributes to companies’ pledge to deliver two billion COVID-19 vaccine doses to low- and middle-income countries by the end of 2022
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies’ COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them. This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion.
https://finance.yahoo.com/news/pfizer-biontech-expand-collaboration-u-100200431.html
Remdesivir Significantly Cut Hospitalization in High-Risk Patients with COVID
– Double-Blind Placebo-Controlled Study Evaluated the Efficacy of Early Use of Veklury IV in Non-Hospitalized Patients –
– Late-breaking Data to be Presented at IDWeek 2021 –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury® (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. This late-breaking data will be presented at the IDWeek 2021 virtual conference.
In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In the study, no deaths were observed in either arm by Day 28.
Enrollment for this trial was stopped prior to fulfilling enrollment targets in April 2021, reflecting the changing epidemiology and adoption of additional treatment options at the time; however, the study continued to collect data on enrolled participants and both investigators and participants remained blinded to their assignment of Veklury or placebo. These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression.
https://finance.yahoo.com/news/veklury-remdesivir-significantly-reduced-risk-130100993.html
Hims & Hers Expands Customizable, Compounded Skincare Offerings
Hims & Hers Health, Inc. ("Hims & Hers") (NYSE: HIMS), the multi-specialty telehealth platform focused on providing modern personalized health and wellness experiences to consumers, recently launched Hims Overnight Anti-Aging Duo and a customized Hers Clear Skin System.
"Skincare is a lifelong journey and certainly not a one-size-fits-all proposition," said Hilary Coles, co-founder and SVP of Brand & Innovation, Hims & Hers. "We have worked hand-in-hand with experienced dermatologists to offer customizable prescription creams that can be used both individually and in combination with other Hims & Hers skincare offerings so our customers have the opportunity to experience their best skin possible."
Hims Overnight Anti-Aging Duo was developed with dermatologists to combat wrinkles and sun damage while moisturizing and nourishing skin. It includes a customizable prescription Anti-Aging Cream mixed with three clinical ingredients and available in three different strengths, as well as the nonprescription Goodnight Wrinkle Cream made with hyaluronic acid. Both the customizable prescription Anti-Aging Cream and Goodnight Wrinkle Cream will also continue to be available for purchase individually on ForHims.com. Those consumers looking to purchase the prescription cream -- as part of the Duo or individually -- will need to first complete a consultation with a healthcare provider through the Hims & Hers platform to see if a prescription treatment is medically recommended and will be able to purchase the prescription cream only if deemed appropriate by the healthcare provider. The Goodnight Wrinkle Cream is available for purchase directly from Hims without a prescription.
Hers’ Clear Skin System provides consumers with the ability to have both clean and hydrated skin with the support of an experienced medical professional. If appropriate, customers can receive a customizable prescription acne cream tailored to their individual needs with a blend of up to five powerhouse ingredients: tretinoin, clindamycin, azelaic acid, zinc pyrithione and niacinamide, as well as the Deep Sea Cleanser, a gentle, hydrating cleanser made with red seaweed extract and rosehip; and the Tidal Wave Moisturizer, made with hyaluronic acid and squalane to hydrate without clogging pores.
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