Inovio says expects FDA decision on COVID-19 vaccine trial this month

Inovio Pharmaceuticals Inc on Monday said it expects the U.S. Food and Drug Administration to decide this month whether to allow an advanced trial of the company’s experimental COVID-19 vaccine to move forward.

The regulatory agency in September placed a hold on the mid- to late-stage trial, citing the need for more information on the device used to inject the vaccine. Inovio said it provided responses to the FDA’s questions in October.

Shares of Inovio, which closed down 19% at $8.50, were up 5% after hours.

Inovio’s vaccine, known as INO-4800, was designed using the company’s novel DNA medicine platform. It is administered through a device called Cellectra, which sends out an electrical pulse to open pores in a cell so DNA molecules can enter.

Inovio in June announced positive results from an initial trial of its vaccine in volunteers, but the company has lagged behind others in the race to develop vaccines against the new coronavirus.

Pfizer Inc and German partner BioNTech SE on Monday announced the first successful interim data from a large-scale COVID-19 vaccine trial and said they expected to seek U.S. emergency use authorization this month.

For the third quarter, Inovio reported net income of $19.2 million, or 11 cents per share, compared with a year-earlier net loss of $23.1 million, or 25 cents a share, due mainly to a change in value of the company’s convertible bonds and an investment gain.

https://www.reuters.com/article/us-health-coronavirus-inovio-pharma/inovio-says-expects-fda-decision-on-covid-19-vaccine-trial-this-month-idUSKBN27P2UW

Bayer makes 'substantial progress' in Roundup lawsuits: mediator

• Bayer (OTCPK:BAYRY) has made substantial progress in resolving tens of thousands of remaining claims that its Roundup weedkiller causes cancer, court appointed mediator Kenneth Feinberg says.
• Feinberg spoke via Zoom at a hearing in San Francisco federal court, where a judge still oversees nearly 2,000 unresolved cases over glyphosate-based Roundup; other cases are in state courts.
• U.S. District Judge Chhabria previously paused the federal litigation and gave Bayer until Nov. 2 to settle.
• https://seekingalpha.com/news/3634085-bayer-makes-substantial-progress-in-roundup-lawsuits-mediator-says
  

Organogenesis Holdings EPS beats by $0.26, beats on revenue

• Organogenesis Holdings (NASDAQ:ORGO): Q3 GAAP EPS of $0.19 beats by $0.26.
• Revenue of $100.8M (+56.8% Y/Y) beats by $28.85M.
• Shares -3.61%.
• Press Release
• https://seekingalpha.com/news/3634017-organogenesis-holdings-eps-beats-0_26-beats-on-revenue
  

Bristol Myers Yervoy shows no incremental benefit on Merck Keytruda alone in lung cancer

Based on the recommendation from the independent Data Monitoring Committee that the study is unlikely to succeed, Merck (NYSE:MRK) is terminating the Phase 3 KEYNOTE-598 study evaluating the combination of Keytruda (pembrolizumab) and Bristol Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) compared to Keytruda alone for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) with no EGFR or ALK genomic tumor aberrations.

• The addition of Yervoy showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the primary endpoints, compared to Keytruda alone.
• On the safety front, the combo therapy was associated with higher rates of serious, life-threatening and fatal adverse events compared to Keytruda monotherapy.
• Results will be submitted for presentation at a future medical conference.

https://seekingalpha.com/news/3634036-bristol-myers-yervoy-shows-no-incremental-benefit-over-mercks-keytruda-alone-in-lung-cancer

Arena Pharma's etrasimod flunks mid-stage dermatitis study

• Arena Pharmaceuticals (NASDAQ:ARNA) slumps 20% after hours in reaction to results from a Phase 2b clinical trial, ADVISE, evaluating etrasimod (APD334) in patients with moderate-to-severe atopic dermatitis (AD).
• The study failed to achieve the primary endpoint of percent change in Eczema Area and Severity Index (EASI) at week 12 versus placebo.
• Between weeks 4-8, the trial was impacted by "unwarranted" dose interruption (not related to drug safety) in 19% (n=9) of the participants in the 2 mg arm. Adjusting for this interruption, via a post-hoc completer analysis with participants receiving full therapeutic exposure, etrasimod 2 mg showed statistically significant effect on the EASI score compared to placebo (weeks 4 and 12), EASI-75 at week 4, vIGA at week 12 and pruritis through week 8.
• About a third of the patients in the 2 mg group achieved clear or almost clear skin.
• No new safety signals were observed.
• Phase 3 studies are next up.
• Management hosted a conference call at 4:30 pm ET to discuss the results.
• https://seekingalpha.com/news/3633965-arena-pharmas-etrasimod-flunks-mid-stage-dermatitis-study-shares-down-20
  

Voyager Therapeutics reports Q3 results

• Voyager Therapeutics (NASDAQ:VYGR): Q3 GAAP EPS of $2.27.
• Collaboration revenue of $117.84M (+476.8% Y/Y).
• Cash, cash equivalents and marketable debt of of $200M.
• Press Release
• https://seekingalpha.com/news/3633989-voyager-therapeutics-reports-q3-results
  
  

BioNTech hopes COVID-19 vaccine will immunize for at least a year

BioNTech's BNTX.O co-founder and chief executive said he was optimistic that the protective effect of its experimental COVID-19 vaccine, co-developed with Pfizer PFE.N, would last for at least a year.

The two companies earlier on Monday became the first drugmakers to release successful trial data, saying their vaccine was shown to be more than 90% effective, a major victory in the fight against the pandemic.

“We should be more optimistic that the immunisation effect can last for at least a year,” CEO Ugur Sahin told Reuters.

While it was not yet known how long the protection would last, he said research on recovered patients had shown that those with high antibodies levels to begin with have not experienced a sharp drop in those levels, and the same would likely go for vaccinated people.

https://www.reuters.com/article/us-health-coronavirus-vaccines-pfizer-du/biontech-hopes-covid-19-vaccine-will-immunize-for-at-least-a-year-idUSKBN27P1J2