Search This Blog

Tuesday, April 7, 2020

FDA accepts Merck application for expanded use of Keytruda

Under Priority Review status, the FDA accepts Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use Keytruda (pembrolizumab) to treat adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options.
The agency’s action date is June 16.
https://seekingalpha.com/news/3558870-fda-accepts-merck-application-for-expanded-use-of-keytruda

Syneos Health pulls back guidance amid COVID-19

Citing COVID-19 disruptions, Syneos Health (NASDAQ:SYNH) is withdrawing its financial guidance for the year ending December 31, 2020.
The Company expects its Q1 financial results to be in line with previously issued guidance.
Syneos will release Q1 results on April 30, prior to its earnings call at 8:00 a.m. ET.
https://seekingalpha.com/news/3558874-syneos-health-pulls-back-guidance-amid-covidminus-19

India allows limited anti-malaria drug exports after Trump warns of retaliation

India, the world’s main supplier of generic drugs, said on Tuesday it will allow limited exports of the anti-malaria drug hydroxychloroquine that U.S. President Donald Trump has touted as a potential weapon in the fight against the coronavirus.
The Indian government had put a hold on exports of hydroxychloroquine as well as on the pain reliever, paracetamol, saying stocks were depleting because of the hit to global supply chains after the coronavirus emerged in China late last year.
But Trump spoke to Prime Minister Narendra Modi over the weekend seeking supplies and on Monday said India may face retaliation if it didn’t withdraw the ban on exports.
India’s neighbours, including Nepal, have also sought the anti-malaria drug.
“It has been decided that India would licence paracetamol and HCQ in appropriate quantities to all our neighbouring countries who are dependent on our capabilities,” said Indian foreign ministry spokesman Anurag Srivastava.
“We will also be supplying these essential drugs to some nations who have been particularly badly affected by the pandemic,” he said.
Use of hydroxychloroquine has soared as the United States has quickly become the epicentre of the pandemic, though doctors prescribing it have no idea whether it works.
U.S. fatalities from COVID-19, the respiratory disease caused by the virus, hit 10,902 on Monday, rapidly closing in on Italy and Spain, the countries with the greatest loss of life to date, according to a Reuters tally of official data.
In addition, the Indian government said it was lifting curbs on the export of 24 pharmaceutical ingredients and medicines made from them that includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12.
“After having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted, “ foreign ministry spokesman Srivastava said.
https://www.reuters.com/article/us-health-coronavirus-india-drugs/india-allows-limited-exports-of-anti-malaria-drug-after-trump-warns-of-retaliation-idUSKBN21O34B

IRadimed pulls back 2020 guidance amid COVID-19

Citing COVID-19 disruptions, iRadimed (NASDAQ:IRMD) is withdrawing its Q1 and FY 2020 financial guidance.
The company expects to report Q1 revenue of $8.6M to $8.7M.
Additionally, IRMD has no third-party debt or other restrictive covenants.
https://seekingalpha.com/news/3558886-iradimed-pulls-back-2020-guidance-amid-covidminus-19

Livongo +8% premarket on preliminary Q1 revenue

Livongo Health (NASDAQ:LVGO) expects preliminary Q1 revenue in the range of $65.5M to $66.5M, versus prior guidance of $60M to $62M.
The company will hold a conference call on May 6, at 4:30 p.m. ET to discuss results for Q1 ended March 31 and forward guidance.
Shares are up 8% premarket.
https://seekingalpha.com/news/3558936-livongoplus-8-premarket-on-preliminary-q1-revenue

Pluristem jumps 55% premarket on positive effect of PLX cells in COVID-19

Thinly traded nano cap Pluristem Therapeutics (NASDAQ:PSTI) spikes 55% premarket on increased volume in reaction to preliminary data on the use of its PLX cells in severely ill COVID-19 patients in Israel.
Seven ICU-housed patients with acute respiratory distress syndrome were treated under a compassionate use program. Six completed the seven-day follow-up period (the seventh is still within the period).
All survived. Three are in advanced stages of weaning from ventilators and four have experienced improvements in respiratory parameters. One remains on a ventilator but is stable and one deteriorated. Two patients (some are the same as above) with multi-organ failure prior to treatment showed clinical recovery in addition to respiratory improvement.
The company plans to pursue a multinational clinical trial for these patients.
PLX cell therapy utilizes placental cells to secrete therapeutic proteins that trigger the body’s own repair mechanisms which allows it to grow blood vessels and deliver oxygenated blood to damaged tissue, thereby accelerating the healing process.
https://seekingalpha.com/news/3558915-pluristem-jumps-55-premarket-on-positive-effect-of-plx-cells-in-covidminus-19

Bristol-Myers Squibb to provide medicines to unemployed and uninsured

New COVID-19 initiatives/developments from healthcare companies include Bristol-Myers Squibb’s (NYSE:BMY) expansion of its existing patient support program aimed at helping unemployed U.S. patients who have lost their health insurance coverage due to the pandemic. The company is offering its branded medicines at no charge, including those prescribed via telehealth services. Shares up 2% premarket.
Karyopharm Therapeutics (NASDAQ:KPTI) plans to launch a global clinical trial evaluating low-dose Xpovio (selinexor) in severely ill hospitalized COVID-19 patients.
Teva Pharmaceutical Industries (NYSE:TEVA) Canadian unit and Huddol are offering free virtual personal assistance services to families for 30 days via Huddol.com during the pandemic supported by funding from Teva. Afterward, services will be available at a discount. Shares up 3% premarket.
Infinity Pharmaceuticals (NASDAQ:INFI) expects enrollment to be delayed in its clinical trials as well as new site activations. Supply chain unaffected thus far.
https://seekingalpha.com/news/3558885-bristol-myers-squibb-to-provide-medicines-to-unemployed-and-uninsured