U.S. COVID-19 cases fall 15% in past week, deaths down for four weeks

The number of new cases of the novel coronavirus reported in the United States fell 15% last week from the previous seven days, and deaths fell for a fourth week in a row, according to a Reuters analysis.

The United States reported on average about 35,000 new cases each day in the week ended Sept. 13, marking the eighth straight week of declines from a peak in July of about 70,000 new cases a day. On average, more than 735 people a day died from COVID-19 last week, with fatalities declining in California and Texas and holding steady in Florida.

Nevertheless, nine states have seen cases rise for at least two weeks, down from 17 states the previous week, according to the Reuters tally of state and county reports. They include North Dakota and Wisconsin in the Midwest and Delaware, New Hampshire and New Jersey in the Northeast. Arkansas, Oklahoma, South Carolina and Utah are also seeing a resurgence in cases.

The United States tested on average 650,000 people a day last week, down 5% from the prior week and down from a peak in late July of over 800,000 people a day.

Nationally, the share of all tests that came back positive for COVID-19 fell for a sixth week to 5.4%, well below a recent peak of nearly 9% in mid-July, according to data from The COVID Tracking Project, a volunteer-run effort to track the outbreak.

However, 27 of the 50 states still have positive test rates above the 5% level that the World Health Organization considers concerning. In South Dakota, where a large motorcycle rally took place in August, 17% of tests came back positive last week. Idaho, Iowa, Kansas and Wisconsin had positive test rates around 15%.

https://www.reuters.com/article/us-health-coronavirus-usa-trends-graphic/u-s-covid-19-cases-fall-15-in-past-week-deaths-down-for-four-weeks-idUSKBN265385

Chinese firms bet on plant-based meat as coronavirus fuels healthy eating trend

A small but growing coterie of Chinese companies are betting on a bright future for plant-based meat products as consumers take their health more seriously in the wake of the COVID-19 pandemic.

Though still a niche business compared to China’s giant meat supply chain, vegetarian alternatives to meat are gaining ground following health scares like the novel coronavirius and African swine fever, analysts and industry insiders said.

U.S.-based Beyond Meat Inc BYND.O said last week it had signed a deal to open a production facility near Shanghai and earlier this year launched a partnership with Starbucks Corp SBUX.O for its plant-based meat products to be sold by the cafe giant in China.

Beijing-based startup Zhenmeat, whose products include plant-based meatballs, beef patty, steak, pork loin, crayfish and dumplings, is one of many small Chinese companies entering the market. Its “meatballs” are now available on a trial basis at a Beijing store of Chinese hot-pot chain Hope Tree.

“Now after COVID-19 consumers are more concerned about health and restaurant brands are responding to this,” Zhenmeat founder and CEO Vince Lu told Reuters in an interview, adding that sales were “up considerably” since June.

Many curious customers at the Beijing Hope Tree restaurant said the meatballs – made from a base of pea and soy protein – tasted like tofu.

“Actually you can tell that it isn’t meat but the feel of it in your mouth is very similar to beef. And I guess that plant-based meat is a little healthier than beef,” said Audrey Jiang, 30.

China Market Research Group Director Ben Cavender said the key to the future of the plant-based meat market was the taste.

“When we interview consumers the vast majority say they’re open to trying these products once,” he said.

“But the big question is how do they like it? Do they see how they can fit it into their diet on daily basis, whether that’s cooking at home or at restaurants? But if they do like it they’ll keep buying.”

Zhenmeat’s Lu said there was a lot of competition in the market but the real competitor was the meat industry itself.

“The most important thing is that our true competitors are not those global giants who have already achieved great success such as Beyond Meat or Impossible Foods,” he said.

“Our true competitor is the whole livestock sector. It’s the animal protein industry.”

https://www.reuters.com/article/us-health-coronavirus-china-plant-based/chinese-firms-bet-on-plant-based-meat-as-coronavirus-fuels-healthy-eating-trend-idUSKBN2660EA

China coronavirus vaccine may be ready for public in November: official

Coronavirus vaccines being developed in China may be ready for use by the general public as early as November, an official with the Chinese Center for Disease Control and Prevention (CDC) said.

China has four COVID-19 vaccines in the final stage of clinical trials. At least three of those have already been offered to essential workers under an emergency use programme launched in July.

Phase 3 clinical trials were proceeding smoothly and the vaccines could be ready for the general public in November or December, CDC chief biosafety expert Guizhen Wu said in an interview with state TV late on Monday.

Wu, who said she has experienced no abnormal symptoms in recent months after taking an experimental vaccine herself in April, did not specify which vaccines she was referring to.

A unit of state pharmaceutical giant China National Pharmaceutical Group (Sinopharm) and U.S.-listed Sinovac Biotech SVA.O are developing the three vaccines under the state’s emergency use programme. A fourth COVID-19 vaccine being developed by CanSino Biologics 6185.HK was approved for use by the Chinese military in June.

Sinopharm said in July that its vaccine could be ready for public use by the end of this year after the conclusion of Phase 3 trials.

Global vaccine makers are racing to develop an effective vaccine against the virus which has killed more than 925,000 people. Leading Western vaccine makers pledged earlier this month to uphold scientific study standards and reject any political pressure to rush the process.

https://www.reuters.com/article/us-health-coronavirus-china-vaccines/china-coronavirus-vaccine-may-be-ready-for-public-in-november-official-idUSKBN2660DW

Outset Medical prices upsized IPO above range at $27

Outset Medical (OM) has priced its upsized IPO of 8,951,111 common shares at $27.00/share, for total gross proceeds of ~$241.7M.

The Company previously planned to offer 7.6M shares in the range of $22-24.

Underwriters’ over-allotment is an additional 1,342,666 shares.

Trading kicks off on September 15. Closing date is Sept. 17.

BofA Securities, Morgan Stanley, Goldman Sachs, SVB Leerink and Stifel are acting as joint book-runners.

The company has developed a novel portable dialysis system called Tablo that requires only an electrical outlet and tap water to operate. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels and allows providers to standardize to a single technology platform from the hospital to the home.

https://seekingalpha.com/news/3613933-outset-medical-prices-upsized-ipo-above-range-27

Humanigen teams up with Lonza for COVID-19 candidate lenzilumab

umanigen (OTCQB:HGEN) and Lonza announce a strategic collaboration to expand the manufacturing capacity for lenzilumab for COVID-19, in advance of potential Emergency Use Authorization in 2020 and subsequent commercialization.

The collaboration enables Humanigen to leverage Lonza’s monoclonal antibody manufacturing and regulatory expertise.

This partnership will provide additional capacity for cGMP production of lenzilumab with operations intended to start in 2021 at Lonza’s manufacturing facilities at Hayward, USA.

Technology transfer is expected to begin in Q3.

https://seekingalpha.com/news/3613939-humanigen-teams-up-lonza-for-covidminus-19-candidate-lenzilumab

Gilead, Pfizer, Eli Lilly CEOs On COVID-19 Treatments, Vaccine Development

Major coronavirus treatments and vaccine maker executives were interviewed on CNBC Monday to discuss their company’s progress in the battle against the disease.

Gilead CEO On Remdesivir: Gilead Sciences, Inc.’s GILD 1.16% remdesivir received an emergency use authorization designation in early May for the treatment of COVID-19, but the company started mass-producing the therapy in January, Gilead CEO and Chairman Daniel O’Day said on CNBC’s “Squawk Box.” Today, the company has enough inventory of the therapy to treat every hospitalized American, the CEO said. 

Gilead is mass-producing the drug and will have enough inventory to “support the rest of the world by October,” he said. 

Parallel studies on how the therapy can be used in conjunction with other agents to better help the patients are underway.

Recently, Gilead found that remdesivir, in conjunction with Eli Lilly And Co’s LLY 0.62% rheumatoid arthritis drug baricitinib, lowered the median recovery time among patients, O’Day said. 

Other ongoing studies include how remdesivir can be used outside a hospital setting and as an inhaled version.

“We are not finished with remdesivir,” he said.

Eli Lilly CEO On Baricitinib: The benefits of combining Gilead’s therapy with Eli Lilly’s baricitinib is “important news” in the battle against the disease, Eli Lilly CEO David Ricks said on CNBC’s “Squawk Box.”

The successful results from a controlled study not only show that patients can recover one day sooner in the hospital, but also see other health improvements, the CEO said. 

30,000 people are hospitalized in the U.S., and many of them could benefit from the combination, provided it is approved by the FDA, he said. 

Pfizer CEO On Vaccine Timeline: An FDA advisory committee will gather on Oct. 22 to discuss vaccines.

It’s “unlikely, but certainly not impossible” for Pfizer Inc. PFE 2.61% to have its vaccine results ready to be presented then, Pfizer CEO Albert Bourla said on CNBC’s “Squawk on the Street.”

The company has a “very good sense” it will be able to offer a conclusive efficacy readout of its Phase 3 vaccine trials before the end of October, the CEO said.

Pfizer isn’t committing to any firm deadline, as it is “just a date,” he said. 

The FDA is looking for companies to demonstrate their vaccines that are at least 50% effective, and this is a reasonable target, Bourla said.

The 50% target is a “good rate,” but Pfizer is hoping for a better outcome, the CEO said. 

Pfizer’s initial objective of studying vaccine results in 30,000 people as part of the Phase 3 trial is mostly complete, he said.

The company is now expanding its trial to around 44,000 people, as it has gained a better understanding of the safety profile.

The expanded study will include more vulnerable individuals, including kids and those with chronic conditions, Bourla said. 

https://www.benzinga.com/general/biotech/20/09/17494195/gilead-pfizer-eli-lilly-ceos-on-covid-19-treatments-vaccine-development

Gilead Analysts Dissect Immunomedics Deal: Pricier, Bold Move Into Oncology September 14, 2020

Gilead Sciences, Inc. GILD 1.16% announced over the weekend a deal to buy Immunomedics, Inc. IMMU 97.99%, which recently transitioned to a commercial-stage biopharma following FDA approval of its antibody-drug conjugate Trodelvy as a third-line treatment for metastatic triple-negative breast cancer.

The Gilead Analysts: SVB Leerink analyst Geoffrey Porges maintained an Outperform rating on Gilead and lowered the price target from $88 to $94. 

Raymond James analyst Steven Seedhouse maintained a Market Perform rating. 

Jefferies analyst Michael Yee maintained a Buy rating and $78 price target.

Cantor Fitzgerald analyst Alethia Young reiterated an Overweight rating and $84 price target. 

The Immunomedics Analyst: H.C. Wainwright analyst Robert Burns downgraded Immunomedics from Buy to Neutral and raised the price target from $56 to $88.

SVB Says Deal Price Assumes Historic Revenues: Gilead’s proposed acquisition of Immunomedics for $21 billion is the largest deal in Gilead’s history, Porges said in a note. Immunomedics brings to Gilead’s stable the first derisked solid tumor oncology program, the analyst said. 

Following Trodelvy’s launch in the second quarter, the drug fetched sales of $20 million, he said. 

The upcoming ESMO presentation of Trodelvy’s activity in triple-negative breast cancer and bladder cancer could alter investor perceptions of the drug and create significant upward pressure on the company’s value, Porges said, citing Gilead.

Gilead’s purchase price represented a 100% premium to Immunomedics’ recent stock price, and the price requires “heroic revenue assumptions” to create value, with break-even being revenue at current consensus peak sales of about $4 billion, the analyst said.

Immunomedics Deal A Good Move, Raymond James Says:  The proposed M&A looks like a good move, bringing something to Gilead that it was lacking, Seedhouse said.

The status quo position at Gilead wasn’t inspiring, with NASH fading away, filgotinib facing rejection/delay, HIV PrEP competitive headwinds, slow CAR-T churn and remdesivir moonshot that probably won’t materialize, the analyst said.

It remains to be seen whether Trodelvy is the Opdivo or Keytruda of ADCs, including in triple-negative breast cancer, where it faces threat from AstraZeneca plc AZN 0.54%/Daiichi Sankyo’s DS-1062, he said. 

“Our positive view of the deal is not enough for us to upgrade the stock though, since the implied >$3B remdesivir sales baked into 2020 guidance looks improbable.”  

Morgan Stanley Says Deal Could Expand Gilead’s Oncology Footprint: The Immunomedics deal builds Gilead’s oncology pipeline, Harrison said.

Immunomedics’ ADC platform features a novel proprietary hydrolyzable linker and validated payload SN-38, and its lead drug Trodelvy is undergoing pivotal trials for additional indications, including HR+/HER2- metastatic breast cancer and metastatic urothelial cancer, the analyst said. 

“This appears to be both an asset and a platform deal, as Trodelvy would immediately provide Gilead with a potential $1B+ approved indication, label expansion opportunities and the validated ADC platform with additional clinical/pre-clinical stage assets could expand Gilead’s footprint in oncology.”

Morgan Stanley sees the acquisition to be 5% accretive to earnings per share for 2024.

Jefferies On Catalysts, Headwinds From Deal: The acquisition will help Gilead move quickly into a commercial footprint for solid tumors and to prepare for other pipeline, Yee said.

“We think GILD is in a better place for 2021 than a year ago and the stock is still at 10x and out of favor,” the analyst said.

A strongly Trodelvy launch; great bladder data; and positive data from the Phase 3 HR+ breast cancer study that’s due in the first half of 2021 could serve as catalysts for increasing the Street’s confidence in the deal, he said. 

The primary pushback is the pricier deal, given the uncertainty over HR+ Phase 3 breast cancer data and the recent complete response letter issued for filgotinib, according to Jefferies. 

Cantor Sees Bold Step Into Oncology: The deal is a big step toward establishing a growth business in hematology/oncology, Young said. 

“We see this deal as a bold step into oncology which brings a revenue generating asset into GILD’s portfolio immediately,” the analyst said.

https://www.benzinga.com/analyst-ratings/analyst-color/20/09/17490141/gilead-analysts-dissect-immunomedics-deal-pricier-but-bold-move-into-oncology