BioMarin's gene therapy nabs accelerated review in U.S. for a rare metabolic disorder

• The FDA has designated Fast Track status to BioMarin Pharmaceutical's (NASDAQ:BMRN) BMN-307, an investigational gene therapy for the treatment of phenylketonuria.
• Both the FDA and European Medicines Agency have granted BMN 307 Orphan Drug tags.
• Last week, BioMarin dosed the first participant in Phearless Phase 1/2 study with BMN 307
• https://seekingalpha.com/news/3619391-biomarins-gene-therapy-nabs-accelerated-review-in-u-s-for-rare-metabolic-disorder
  

Pelosi sounding optimistic on stimulus after president's COVID-19 diagnosis

• Another fiscal stimulus package was broadly assumed to be left for dead until at least after the election, but comments from House Speaker Nancy Pelosi in a MSNBC interview suggest otherwise.
• She says the president's COVID-19 diagnosis has changed the equation, and that the two sides will find a path on a bill. A "middle ground" will be found.
• Stocks are bouncing a bit off opening lows, the S&P 500 (SP500) now off 0.9% and Nasdaq (COMP) down 1.15%.
• Long-dated Treasury yields are up modestly, the 10-year ahead one basis point to 0.69%. TLT -0.4%.
• As for the Speaker herself, she's awaiting results from her own COVID-19 test.
• https://seekingalpha.com/news/3619406-nancy-pelosi-sounding-optimistic-on-stimulus-following-presidents-covidminus-19-diagnosis
  

Teva launches first generic versions of HIV-1 treatments in U.S.

• Teva Pharmaceuticals (NYSE:TEVA) announces the availability of the first FDA-approved generic versions of Gilead Sciences' (NASDAQ:GILD) TRUVADA (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets.
• These newly available generic medicines are indicated for the treatment of HIV-1 infection or HIV-1 pre-exposure prophylaxis when used alone or in combination with other anti-HIV-1 medicines.
• Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are expected to be available at $48.51 per tablet.
• Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets will be available at a price of $78.86/tablet.
• https://seekingalpha.com/news/3619365-teva-launches-first-generic-versions-of-hivminus-1-treatments-in-u-s
  

Trump says he's tested positive for COVID-19; Pence tests negative

• 
  
• 
  
• Updated at 8:10 AM ET: According to reports, the president is not necessarily asymptomatic, with aides saying they sensed Trump feeling poorly/exhausted on Wednesday, but at that point believing it to be fatigue from an intense schedule. Reuters, meanwhile, reports the president as "not incapacitated," and that he will be working from the White House residence.
• Updated at 8 AM ET: Vice-Presidential press secretary Devin O'Malley says Mike Pence this morning tested negative for COVID-19.
• "Tonight, @FLOTUS and I tested positive for COVID-19," President Trump says on his Twitter feed. "We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!"
• The confirmation from President Trump comes after reports this evening that Hope Hicks, considered his most trusted adviser, tested positive for the virus Wednesday. She has been in close proximity with a number of White House staffers, and first lady Melania Trump, and traveled to the debate on Tuesday.
• A memo from the president's physician says, "The President and First Lady are both well at this time, and they plan to remain at home within the White House during their convalescence."
• S&P 500 futures are down more than 1%.
• Updated 1:30 a.m.: Dow futures and S&P futures are off 1.5%, and Nasdaq futures have slid 1.8%. Treasurys are rallying after the president's positive COVID-19 test. Base metals have extended their declines, while gold has erased its loss and spot silver has moved to a gain.
• Trump's schedule has been scrubbed of events tomorrow aside from a phone call on COVID-19 support with vulnerable seniors.
• The Washington Post reports that after White House officials learned of Hicks' symptoms, Trump and his entourage flew to New Jersey for a fundraiser and speech, where Trump was in contact with dozens of others. An hour ago, MSNBC put up a graphic of people who have been traveling with Hicks recently:
• https://seekingalpha.com/news/3619270-trump-says-tested-positive-for-covidminus-19-pence-tests-negative
  

COVID-19 vaccine developers little changed on news of Trump/First Lady infection

• Investors in COVID-19 vaccine and therapy developers appear unmoved with the news that President Trump and First Lady Melania have both tested positive for the respiratory infection and will begin quarantine immediately.
• Selected tickers: Sanofi (NASDAQ:SNY) (-1%), GlaxoSmithKline (NYSE:GSK) (up a fraction), AstraZeneca (NASDAQ:AZN) (up a fraction), Merck (NYSE:MRK) (down a fraction), Johnson & Johnson (NYSE:JNJ) (-1%), Moderna (NASDAQ:MRNA) (-1%), Pfizer (NYSE:PFE) (-1%), BioNTech SE (NASDAQ:BNTX) (+1%), Dynavax (NASDAQ:DVAX) (-2%), Novavax (NASDAQ:NVAX) (-1%), Gilead Sciences (NASDAQ:GILD) (up a fraction), Eli Lilly (NYSE:LLY) (-1%); Regeneron Pharmaceuticals (NASDAQ:REGN) (-1%)
• https://seekingalpha.com/news/3619371-covidminus-19-vaccine-developers-little-changed-on-news-of-trump-first-lady-infection
  

Humanigen's lenzilumab shows rapid improvement in oxygenation, discharge

• Humanigen (NASDAQ:HGEN) announces patient case report on the use of lenzilumab in critical COVID-19.
• The published case describes a 77-year-old patient with a past medical history of type II diabetes and heart disorder. The patient tested positive for COVID-19 and was admitted to the ICU in March 2020.
• The patient was treated with steroids, broad spectrum antibiotics for community acquired pneumonia and bronchodilators for possible COPD exacerbation and hydroxychloroquine with zinc.
• The patient continued to deteriorate for the next 12 weeks with an increase in oxygen demand and eventually intermittent bilevel positive airway pressure and developed acute respiratory distress syndrome during that time.
• At week 13, seven days following the administration of lenzilumab, the patient's oxygen decreased from high-flow to low-flow nasal cannula and the patient was discharged from the hospital on home oxygen.
• https://seekingalpha.com/news/3619382-humanigens-lenzilumab-shows-rapid-improvement-in-oxygenation-and-discharge
  

Algernon Pharma progress on human study for Covid drug

• Algernon Pharmaceuticals (OTCQB:AGNPF) announces that it has now enrolled 75% of its enrollment target, which is 113 patients, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.
• The trial will be conducted in the U.S., Australia, the Philippines and Romania.
• Company projects completion of study in November 2020 with a planned data readout before Q4 end.
• Press Release
• https://seekingalpha.com/news/3619387-algernon-pharmaceuticals-progress-on-human-study-for-covid-drug