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 Wall Street Journal reports that Medicare won’t cover the cost of any coronavirus vaccine approved under an FDA Emergency Use Authorization (EUA), consistent with current policy of not covering EUA drugs considering the lower approval standards.
The situation, if not rectified, could impact vulnerable seniors who represent 44M Americans (~15% of the U.S. population).
The Trump administration is exploring options to quickly address the issue since the Coronavirus Aid, Relief and Economic Security Act, passed in March, ensures free vaccine coverage and no out-of-pocket costs for Medicare beneficiaries.
Selected tickers: Pfizer (PFE -3.0%), BioNTech SE (BNTX -5.0%), AstraZeneca (AZN -2.1%), Moderna (MRNA -3.8%), Johnson & Johnson (JNJ -3.6%)
Teva Pharmaceutical Industries (NYSE:TEVA) announces the U.S. commercial launch of the AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and ArmonAir Digihaler (fluticasone propionate) inhalation powder for the control of asthma symptoms in patients at least 12 years old.
Neither digital inhaler is designed for the relief of sudden breathing problems from asthma and neither replaces the need for a rescue inhaler.
Shares down 2% premarket on light volume.
Bristol Myers Squibb (BMY -3.6%) announces positive results from two late-stage clinical trials evaluating Opdivo (nivolumab) in patients with stomach cancer or cancer of the esophagus.
Phase 3 CheckMate-649 assessed the combination of Opdivo and chemo in patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma in a first-line setting.
Median overall survival (OS) in the Opdivo arm was 14.4 months compared to 11.1 months in the chemo-only arm. Median PFS higher for Opdivo, 7.7 months vs. 6.0 months.
The rate of serious/life-threatening treatment-related adverse events (TRAEs) was 17% in the Opdivo group versus 10% in the chemo alone group. The discontinuation rate due TRAEs of any grade was higher in the Opdivo arm, 36% vs. 24%.
Phase 3 CheckMate-577 evaluated adjuvant treatment with Opdivo in patients with esophageal or GEJ cancer following neoadjuvant chemoradiation therapy (CRT) and tumor resection.
Median disease-free survival (DFS) in patients receiving Opdivo after surgery was 22.4 months compared to 11.0 months in patients receiving placebo after surgery. Median duration of treatment with Opdivo was 10.1 months versus 9.0 months for placebo.
On the safety front, the rate of serious/life-threatening treatment-related adverse events (TRAEs) in the Opdivo group was 13% compared to 6% in the placebo group.
Baylor University Sammons Cancer Center’s Ronan Kelly, M.D., MBA, says, “While about 25% to 30% of patients with esophageal or gastroesophageal junction cancer achieve a complete response following chemoradiation therapy and surgery, the remaining 70% to 75% do not, and there is currently no adjuvant treatment option available for these patients with the potential to improve their outcomes. Adjuvant treatment with nivolumab in the CheckMate-577 trial doubled patients’ time without disease recurrence, representing the first adjuvant treatment advancement for these patients with esophageal or gastroesophageal junction cancer.”
Quant rating is Very Bullish.
Ampio Pharmaceuticals (NYSEMKT:AMPE) soars 28% premarket after receiving an an Investigational New Drug (IND) from the FDA, allowing the Company to proceed with clinical trials for the use of Ampion as an inhalation therapy for respiratory distress due to COVID-19 infection.
Phase I trial of inhaled Ampion will enroll 40 patients, and assess the safety and efficacy of inhaled Ampion added to the standard of care (SOC) for COVID-19 patients hospitalized for respiratory distress.
Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome (ARDS).
Knight Therapeutics (OTC:KHTRF) and TherapeuticsMD (NASDAQ:TXMD) announces approval of BIJUVA capsules by Health Canada.
Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to BIJUVA and IMVEXXY.
Shares +3% AH
