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Sunday, February 2, 2020

Biotech week ahead, Feb. 3

Biotech stocks see-sawed through the week ended Jan. 31 and ended the month lower overall. Big pharma earnings of the week were mostly disappointing.
Pfizer Inc. PFE 0.49% reported disappointing fourth-quarter earnings and Amgen, Inc. AMGN 4.47% guided 2020 below consensus, while Eli Lilly And Co LLY 2.11% managed to outperform expectations.
The week continued to see coronavirus-related spikes, with Cleveland BioLabs, Inc. CBLI 34.29%, NanoViricides, Inc. NNVC 40.15%, Vir Biotechnology, Inc. VIR 13.17% and Vaccinex, Inc. VCNX 8% among the stocks riding on the momentum.
Acceleron Pharma Inc XLRN 5.19% was one of the standout gainers of the week, thanks to a positive midstage clinical readout.
The much-anticipated FDA verdict on Aimmune Therapeutics Inc’s AIMT 2.91% peanut allergy drug Palforzia came through in the week, with the regulatory agency greenlighting the drug.

Turning ahead to the unfolding week, the following are key catalysts that could create a ripple in the biotech space.

Conferences

  • 2nd International Scientific & Clinical Congress on Spinal Muscular Atrophy: Feb. 5-7 in Paris, France
  • The European Association for Hemophilia and Allied Disorders, or EAHAD, 2020 Congress: Feb. 5-7 in Hague, Netherlands
  • ASCO-SITC Clinical Immuno-Oncology Symposium: Feb. 6-8 in Orlando, Florida
  • Angiogenesis, Exudation, and Degeneration 2020: Feb. 8 in Miami, Florida

Clinical Readouts

Forty Seven Inc FTSV 7.11% is due to present at the ASCO-SITC Symposium Phase 1b data for magrolimab + avelumab in ovarian cancer.
Jounce Therapeutics Inc JNCE 0.47% will present at the ASCO-SITC Symposium Phase 1/2 data for vopratelimab, codenamed JTX-2011, in solid tumors. (Feb. 6)
Catalyst Biosciences Inc CBIO 5.46% is scheduled to present at the EAHAD Congress Phase 2b data for dalcinonacog alfa in hemophilia B. (Feb. 7)
Kodiak Sciences Inc KOD 2.19% is due to present at the Angiogenesis, Exudation, and Degeneration 2020with Phase 1b data for KSI-301 in diabetic macular edema (Feb. 8)
Adverum Biotechnologies Inc ADVM 5% will present at the Angiogenesis, Exudation, and Degeneration 2020 with Phase 1 data for ADVM-022 in wet age-related macula degeneration. (Feb. 8)

Earnings

Monday
  • Catalent Inc CTLT 1.39% (before the market open)
  • Taro Pharmaceutical Industries Ltd. TARO 0.64% (after the close)
Tuesday
  • Zimmer Biomet Holdings Inc ZBH 2.19% (before the market open)
  • Haemonetics Corporation HAE 1.84% (before the market open)
  • BIO-TECHNE Corp TECH 1.42% (before the market open)
  • Neurocrine Biosciences, Inc. NBIX 1.41% (after the close)
  • Gilead Sciences, Inc. GILD 1.3% (after the close)
  • Qiagen NV QGEN 0.66% (after the close)
Wednesday
  • Merck & Co., Inc. MRK 1.21% (before the market open)
  • Boston Scientific Corporation BSX 3.59% (before the market open)
  • Arrowhead Pharmaceuticals Inc ARWR 0.94% (after the close)
  • Cardiovascular Systems Inc CSII 3.86% (after the close)
  • Misonix Inc MSON 5.06% (after the close)
  • SurModics, Inc. SRDX 1.3% (after the close)
Thursday
  • ABIOMED, Inc. ABMD 0.3% (before the market open)
  • Bristol-Myers Squibb Co BMY 1.35% (before the market open)
  • Alnylam Pharmaceuticals, Inc. ALNY 0.57% (before the market open)
  • Regeneron Pharmaceuticals Inc REGN 0.52% (before the market open)
  • Twist Bioscience Corp TWST 3.28% (after the close)
  • Anavex Life Sciences Corp AVXL 1.04% (after the close)
  • Pacific Biosciences of California PACB 0.43% (after the close)
  • Enanta Pharmaceuticals Inc ENTA 1.94% (after the close)
  • Myriad Genetics, Inc. MYGN 2.23% (after the close)
  • Seattle Genetics, Inc. SGEN 1.35% (after the close)
  • Natus Medical Inc NTUS 1.57% (after the close)
  • LeMaitre Vascular Inc LMAT 0.85% (after the close)
  • Ligand Pharmaceuticals Inc. LGND 2.23% (after the close)
Friday
  • AbbVie Inc (NYSE: ABBV (before the market open)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO (before the market open)

IPOs

Beam Therapeutics plans to offer 6.25 million shares in an IPO, with the offering expected to be priced between $15 and $17. The company, which is engaged in developing therapies based on single-base gene editing, has applied for listing its shares on the Nasdaq under the ticker symbol “BEAM.”
Contract research organization PPD is planning a 60-million-share IPO to be priced in the range of $24-$27. The shares are to be listed on the Nasdaq under the ticker symbol “PPD.”
https://www.benzinga.com/general/biotech/20/02/15229115/the-week-ahead-in-biotech-merck-bristol-myers-earnings-conference-presentations-in-focus

Impacts of Apple’s China closure are negligible – Wedbush

How will Apple’s (NASDAQ:AAPL) decision to temporarily shutter its stores in China (through Feb. 9) affect the iPhone maker’s top line?
“We believe with the limited transportation in major cities throughout China and limited foot traffic in Shanghai, Beijing, and other cities that at most ~1M iPhones in the region could be at risk of shifting out of the March quarter into the June quarter if this continues into late February,” according to Wedbush analysts Daniel Ives and Strecker Backe.
That the sum represents less than 3% of annual Chinese iPhone sales and the impact will likely be negligible.
https://seekingalpha.com/news/3537092-impacts-of-apples-china-closure-are-negligible-wedbush

What changed about the coronavirus over the weekend

Chinese officials reported a surge in new coronavirus cases. The death toll in China rose to at least 304. More than 2,000 new cases were also recorded in China in the past 24 hours. (NY Times)
The PBOC said it will inject 1.2T yuan ($174B) into markets via reverse repo operations on Monday to ensure sufficient liquidity supply. This is the largest single-day reverse repo operation it has ever conducted.
The CSRC has issued a verbal directive to brokerages to bar clients from shorting stocks Feb. 3. CSRC is also considering launching hedging tools for the A-share market to help dampen market panic and will suspend evening sessions of futures trading starting Monday. (Reuters)
The coronavirus claimed its first fatality outside of China, a 44-year-old Chinese man in the Philippines. (WSJ)
Gilead (NASDAQ:GILD) says it has provided doses of its experimental antiviral drug remdesivir to doctors for emergency treatment of a small number of patients infected by coronavirus. It also formalized an agreement with Chinese authorities to conduct a trial of remdesivir in patients infected with the coronavirus.
https://seekingalpha.com/news/3537113-changed-coronavirus-over-weekend

Herbal remedies for the coronavirus spark debate in China

A claim by Chinese scientists that a liquid made with honeysuckle and flowering plants could help fight the deadly coronavirus has sparked frenzied buying of the traditional medicine, but doubts quickly emerged.
As the from the SARS-like pathogen sweeping the country continues to rise, shoppers have swamped pharmacies in search of “Shuanghuanglian”.
The rush came after influential state media outlet Xinhua reported Friday that the esteemed Chinese Academy of Sciences had found the concoction “can inhibit” the virus.
Videos shared online showed long lines of people in surgical masks lining up at night outside drug stores, purportedly in hope of snapping up the product, despite official advice that people avoid public gatherings to prevent infection.
It quickly sold out both online and at brick-and-mortar stores, but responses to the remedy’s supposed efficacy have ranged from enthusiasm to scepticism on Weibo, China’s Twitter-like social media platform.
And state media sounded a more cautionary note on Saturday, with broadcaster CCTV publishing an interview with Zhang Boli, one of the researchers leading outbreak containment efforts, who warned of potential side effects from the medicine.
The People’s Daily newspaper, a government mouthpiece, said experts advised against taking traditional remedies without professional guidance.
But the claim comes as Beijing looks to incorporate traditional Chinese medicine (TCM) into its nationwide fight against the virus, which has killed more than 300 people and infected over 14,000 in the country. On Sunday the Philippines reported the first death outside of China.
Researchers at the state-run academy, a top government think tank, are also studying the potential use of a plant commonly known as Japanese knotweed to alleviate symptoms.
The National Health Commission on Tuesday said TCM practitioners were among nearly 6,000 reinforcement medical personnel being sent to Wuhan in Hubei province, ground zero of the outbreak.
‘No difference’
The strategy has reignited fierce and long-running debate about the efficacy of TCM, which has a history going back 2,400 years and remains popular in modern-day China.
Marc Freard, a member of the Chinese Medicine Academic Council of France, told AFP he believed traditional formulations could be used to treat people with symptoms ranging from fever to thick phlegm.
But he warned that many remedies on the market were of questionable quality and admitted that TCM “lacks scientific standards of efficacy” because it relied on “individualised treatment”.
Traditional medicines were widely used in China in conjunction with Western methods during the 2003 epidemic of SARS, or Severe Acute Respiratory Syndrome, which killed 774 people worldwide.
But a 2012 study in the Cochrane Database of Systematic Reviews found combining Chinese and Western medicines “made no difference” in battling the disease.
Nationalism
The Chinese government has increasingly promoted traditional medicine abroad in recent years, often with nationalistic undertones.
Beijing issued its first white paper on TCM in 2016, laying out plans to build medicine centres and dispatch practitioners to developing countries in Africa and Southeast Asia.
President Xi Jinping has called TCM a “treasure of Chinese civilisation” and said at a meeting in October that it should be given as much weight as other treatments.
China is “working hard to spread the message internationally about its traditional culture”, and medicine is a part of this, Freard said.
In 2019 the World Health Organization (WHO) even added Chinese medicine to its “International Classification of Diseases”—a reference document for medical trends and global health statistics—after years of campaigning by Beijing.
But the move was slammed by members of the scientific community, with the European Academies’ Science Advisory Council calling the decision “a major problem” due to the lack of evidence-based practice.
The WHO did not immediately respond to AFP’s request for comment.
Fang Shimin, a prominent writer in China known for his campaigns against academic fraud, told AFP he believes the government’s promotion of traditional “panders to nationalism and has nothing to do with science”.
It is an enormous industry in China worth more than $130 billion in 2016—a third of the country’s entire medical industry—according to state news agency Xinhua.

Explore further
New China virus ‘not as powerful as SARS’: health official

India to Cut Taxes, Increase Spending in Bid to Revive Growth

India is cutting income taxes and increasing spending, hoping to resuscitate growth, which has tumbled to a 10-year low in Asia’s third-largest economy.
Some economists and executives, however, warned that some of the measures unveiled over the weekend could end up hurting the economy more than they help it.
In its national budget released Saturday, the government of Prime Minister Narendra Modi said it was delaying plans to rein in the fiscal deficit so it could spend more as the economy needs government help to create jobs for its 1.3 billion people.
“This is the budget to boost [Indians’] incomes and enhance their purchasing power,” Finance Minister Nirmala Sitharaman said at the start of a more than 2 1/2 -hour budget speech Saturday. “Only through higher growth we can achieve that and have our youth gainfully and meaningfully employed.”
In the past year, Mr. Modi has been implementing a series of controversial social measures long on the wish list of the country’s Hindu nationalist groups. Citizens and companies were looking to the budget for signs he has a clear plan to reverse the county’s economic slowdown.
Growth in India’s gross domestic product is likely to dip to a more than 10-year low of 5% or less for the fiscal year ending March 31, according to economists. As India’s working-age population grows by 10 million people annually, that is a disappointing performance for a popular prime minister who came to power promising to make India an economic superpower.
On Saturday the government unveiled a long list of measures to energize consumption and investment. It lowered income taxes and some corporate taxes and pledged more investment in infrastructure, rural development, education and health care.
To accommodate the spending, India decided to miss its own budget-deficit target. It had intended to drop the deficit to GDP ratio to 3.0% in the year beginning this April but now plans to let that rise to 3.5%.
The government said it would try to increase its revenue by selling stakes in state-owned companies, including one of the country’s largest insurance companies, Life Insurance Corp.
Optimists had predicted that in the face of the sudden slowdown — India has seen its GDP expansion rate fall from the fastest in the world for large countries to slower than many peers in Asia — Mr. Modi’s administration might have been more ambitious. They were hoping for even more spending and progress on long-discussed overhauls such as easing restrictions on hiring and land use.
The benchmark Sensex stock index tumbled close to 2.5% in special Saturday trading on budget day, reflecting their disappointment, said Aurodeep Nandi, a Mumbai-based economist with Nomura.
“The markets plunged because they were expecting the budget to be a game changer,” he said. “They were expecting some growth-reviving announcements like massive increase in expenditure, which didn’t happen.”
The Indian auto sector, which is in the middle of its biggest slump with car and motorcycle sales down more than 20% in recent quarters from a year earlier, was hoping for help.
The Indian automobile industry was looking forward to some direct benefits in the budget, which could have helped in reviving demand,” said Rajan Wadhera, president of industry group the Society of Indian Automobile Manufacturers. “The Budget speech was not what we were expecting.”
Some executives were also discouraged by the budget’s bias toward protecting local companies from international competition. The budget included a slew of higher import tariffs on electronics, electric vehicles, toys and other products and repeatedly mentioned the importance of combating the dumping of goods on the South Asian market.
Joining the growing global trend towards protectionism may shelter some less competitive local companies for a while, economists said. But in the long run it may mean India misses a unique opportunity to step up and become an integral part of the global supply chain as the U.S.-China trade war forces manufacturers to look for new bases. More tariffs could also further aggravate already tense trade relations with the U.S.

https://www.marketscreener.com/SENSEX-7426/news/India-to-Cut-Taxes-Increase-Spending-in-Bid-to-Revive-Growth-29929631/

China to inject $174 billion of liquidity on Monday as markets reopen

China's central bank said it will inject 1.2 trillion yuan ($174 billion) worth of liquidity into the markets via reverse repo operations on Monday as its stock markets prepare to reopen amid an outbreak of a new coronavirus.

Chinese authorities have pledged to use various monetary policy tools to ensure liquidity remains reasonably ample and to support firms affected by the virus epidemic, which has so far claimed 305 lives, all but one in China.
The People's Bank of China made the announcement in a statement on Sunday, adding the total liquidity in the banking system will be 900 billion yuan higher than the same period in 2019 after the injection.
According to Reuters calculations based on official central bank data, 1.05 trillion yuan worth of reverse repos are set to mature on Monday, meaning that 150 billion yuan in net cash will be injected.
Investors are bracing for a volatile session in Chinese markets when onshore trades resume on Monday after a break for the Lunar New Year which was extended by the government.
China's stock, currency and bond markets have all been closed since Jan. 23 and had been due to re-open last Friday.
There will be no further delays to the reopening, the securities market regulator said in an interview in the People's Daily newspaper on Sunday.
The China Securities Regulatory Commission (CSRC) said it had taken the decision after balancing various factors, and believed the outbreak's impact on the market would be short term.
To support firms affected by the epidemic, the CSRC said companies that had expiring stock pledge agreements could apply for extensions with securities firms, and it would urge corporate bond investors to extend the maturity dates of debt.
The CSRC is also considering launching hedging tools for the A-share market to help alleviate market panic and will suspend evening sessions of futures trading starting from Monday, it said.
"We believe that the successive introduction and implementation of policy measures will play a better role in improving market expectations and preventing irrational behavior," it told the People's Daily.
China is facing mounting isolation as other countries introduce travel curbs, airlines suspend flights and governments evacuate their citizens, risking worsening a slowdown in the world's second-largest economy.
State news agency Xinhua said on Sunday that China's economy was resilient enough to counter the shock caused by the virus, and said remarks made by a U.S. federal official - whom it did not name - that the virus could bring jobs back to the United States were "self-centered, unprofessional and unethical".
U.S. Secretary of Commerce Wilbur Ross said last week that the virus could force companies to re-evaluate their supply chains, potentially returning some jobs to the United States.
"The remarks only served to taint the U.S. image as a major global player," Xinhua said in the commentary.
"An outbreak of a disease like this could not be the basis for multinational companies to make serious and long-term investment decisions in China...If the Chinese economy slows drastically, the U.S. economy will also suffer."
https://www.marketscreener.com/BANK-OF-CHINA-LIMITED-1412661/news/China-to-inject-174-billion-of-liquidity-on-Monday-as-markets-reopen-29929087/?countview=0

NanoViricides: ‘May Be Significantly Ahead’ On Potential Virus Treatment

Shares of NanoViricides Inc NNVC 40.15%, which is engaged in the creation of special nanomaterials for antiviral therapy, has been seeing upward momentum since the outbreak of coronavirus contagion in the Wuhan province of China.
The company confirmed in a late Thursday release that it’s working on developing a treatment for the novel coronavirus 2019-nCoV aka Wuhan coronavirus.
“Our platform technology enables possibly the most rapid pathway for new drug development against viral diseases,” said Anil Diwan, President and Executive Chairman of NanoViricides.
NanoViricides sought support from governmental and international agencies such as the U.S. CDC, WHO and Chinese CDC for developing these treatments. The company said it intends to seek relevant collaboration for testing its drug candidates soon.
While noting it already has some lead candidate ligands in its chemical library, NanoViricides said it may be already significantly ahead in developing a potential treatment for the Wuhan virus. It also said it has begun preparing for testing less threatful viruses that can help screen its broad-spectrum antiviral drug candidates.
From under $3.50 a share prior to the reporting of the Wuhan virus outbreak, NanoViricide’s stock rallied to a high of $17.77 this week.
The stock surrendered some of the gains but began picking up momentum Thursday on reports of the company working on a cure for the deadly virus that has thus far claimed 213 lives in China and has left about 10,000 infected.
https://www.benzinga.com/general/biotech/20/01/15224649/nanoviricides-we-may-be-already-significantly-ahead-in-developing-potential-wuhan-coronavirus-tre