Second wave virus fears weigh on Europe

European markets are trading lower as second wave fears could trigger new lockdown measures.

London is trading down 0.4%, Germany is -0.25%, France -0.16% and Italy -0.1%.

Virus fears push gold near one-month high at $1,758.

https://seekingalpha.com/news/3584780-second-wave-virus-fears-weigh-on-europe

Evelo Bio’s EDP1815 to advance into mid-stage TACTIC-E COVID-19 tria

Evelo Biosciences (NASDAQ:EVLO) is up 25% premarket on the heels of the announcement that EDP1815 will be included in the TACTIC-E clinical trial, evaluating the safety and efficacy of certain experimental therapies to prevent and treat complications of COVID-19.

Phase 2/3 TACTIC-E trial will evaluate up to 469 patients per arm at Addenbrooke’s Hospital and other leading UK clinical centres.

EDP1815 has been observed to have favorable tolerability and anti-inflammatory activity in a Phase 1b trial for psoriasis.

The primary outcome measure is a reduction in the number of patients who develop severe complications of organ failure, ventilation, or death.

Secondary outcomes include duration of stay in hospital, duration of oxygen therapy and time to clinical improvement.

Interim data are anticipated in Q4.

Additionally, if the COVID-19 trial is successful, the Company plans to investigate EDP1815 as a potential therapy for other diseases, such as influenza, in which cytokine storm and hyperinflammation play a role.

https://seekingalpha.com/news/3584802-evelo-bios-edp1815-to-advance-mid-stage-tactic-e-covidminus-19-trial

Myomo restarts fitting MyoPro devices

Myomo (NYSEMKT:MYO) has resumed in-person patient visits for casting, fitting and delivering its MyoPro powered braces, post COVID-19 shutdowns in states that are now allowing such interactions.

As a result, the company expects Q2 revenue in the range of $0.6M to $0.7M.

https://seekingalpha.com/news/3584805-myomo-restarts-fitting-myopro-devices

Merck’s Keytruda OK’d in China for 2nd-line esophageal cancer

China’s National Medical Products Administration has approved Merck’s (NYSE:MRK) Keytruda (pembrolizumab) for the treatment of patients with locally advanced/metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy.

In China, more than 90% of esophageal cancers are squamous cell carcinomas.

https://seekingalpha.com/news/3584810-mercks-keytruda-okd-in-china-for-2nd-line-esophageal-cancer

Fusion Pharmaceuticals sets IPO terms

Fusion Pharmaceuticals (FUSN) has filed an updated preliminary prospectus for its IPO of 8.35M common shares at $14-16 per share.

Underwriters’ over-allotment is an additional ~1.25M shares.

Fusion Pharmaceuticals readies IPO

https://seekingalpha.com/news/3584812-fusion-pharmaceuticals-sets-ipo-terms

Merck pneumonia vaccine successful in late-stage studies

Merck (NYSE:MRK) announces positive results from two Phase 3 clinical trials evaluating V114, its 15-valent pneumococcal conjugate vaccine.

Data from PNEU-WAY (V114-018) in adults at least 18 years old with HIV showed an immune response to all 15 serotypes in V114, including serotypes 22F and 33F (serotypes associated with invasive disease worldwide).

Results from PNEU-FLU (V114-021) in healthy adults at least 50 years old showed that V114 can be given simultaneously with the quadrivalent influenza vaccine.

The data, along with results from another Phase 3, V110-029, evaluating Pneumovax-23 (Pneumococcal Vaccine Polyvalent) in healthy adults at least 50 years old, were published online at the International Symposium on Pneumococci and Pneumococcal Diseases.

https://seekingalpha.com/news/3584816-merck-pneumonia-vaccine-successful-in-late-stage-studies

Agenus out-licenses cancer drugs to Betta Pharma in Greater China

Agenus (NASDAQ:AGEN) inks an agreement with Hangzhou-based Betta Pharmaceuticals for the development and commercialization of PD-1 inhibitor balstilimab and CTLA-4 inhibitor zalifrelimab in Greater China, including the mainland, Hong Kong, Macau and Taiwan.

Under the terms of the deal, AGEN will receive $15M in upfront cash plus a $20M equity investment, up to $100M in milestones and royalties on net sales. Betta will have exclusive rights to both drugs either as monotherapies or in combination, exclusive of intravesical (drug administered directly into the bladder) delivery.

https://seekingalpha.com/news/3584840-agenus-out-licenses-cancer-drugs-to-betta-pharma-in-greater-china