Biotech Stocks With Huge Catalysts in June

 Biotech investors better buckle up for a wild ride this month. Some of the industry's biggest players are waiting for clinical trial results and decisions from the FDA that could send their stock prices rocketing higher overnight or stomp them into the dirt.

Here's why shares of Biogen (NASDAQ:BIIB), Vertex Pharmaceuticals (NASDAQ:VRTX), and Sage Therapeutics (NASDAQ:SAGE) will be extra jumpy this month. 

1. Biogen

This biotech is awaiting an extremely controversial decision the FDA has to make regarding its potential new Alzheimer's drug. Factions within the agency are eager to approve aducanumab for the treatment of early stage Alzheimer's disease despite a troubling lack of evidence it can keep patients from losing their minds.

It's been more than two years since the FDA's last commissioner, Scott Gottleib stepped down and the agency is still flying without an official pilot. The acting commissioner, Janet Woodcock is credited with pushing forward the FDA's most controversial new drug approval decision to date.

It's hard to tell which direction the FDA will take, but it's clear that Biogen needs a new growth driver. In the first quarter, product sales slid 24% year over year as the bottom fell out from under the company's aging multiple sclerosis franchise. Sales of spinal muscular atrophy (SMA) treatment, Spinraza also slid in response to recently approved alternatives like Zolgensma and Evrysdi.

Generic competition for Tecfidera that began last fall isn't going to subside and new treatment options for SMA aren't going away either. If the agency doesn't approve aducanumab, investors can expect Biogen's performance and stock price to deteriorate much further.

2. Vertex Pharmaceuticals

Before Vertex Pharmaceuticals launched its first cystic fibrosis (CF) drug in 2012, inheriting the disorder was considered a death sentence. Now it's a treatable condition for around 90% of people who inherit one of more than 1,700 known mutations to the CFTR gene that can slowly make it impossible to breathe.   

This company's oral treatments for cystic fibrosis (CF) have driven its topline and its stock price to astonishing heights, but there's a problem. Now that there aren't many CF patients left untreated, investors are worried that Vertex's bottom line won't continue growing at its usual pace. That's why all eyes are on expected trial data from VX-864, one of the company's most promising clinical-stage programs at the moment.

In the first quarter, Vertex Pharmaceuticals finished enrolling patients who are alpha-1 antitrypsin (AAT) deficient into a proof-of-concept study with VX-864. Investigators should have wrapped up the trial by now, so we can expect the results soon. 

Last October, Vertex's first attempt at correcting misfolded AAT proteins, VX-814 didn't work out as hoped. The company's hoping VX-864's slightly different structure will be able to get the job done. 

3. Sage Therapeutics

This company develops drugs for depression, but its first treatment to earn FDA approval, Zulresson hasn't made the splash investors had hoped for. Despite launching in 2019, sales of the difficult to administer infusion for women suffering from post-partum depression came in at just $1.6 million in the first quarter.

The pressure's on to launch a new drug, which is why there will be a lot of attention this month for trial results from zuranolone, the most promising clinical-stage program in the company's pipeline. In May, Sage Therapeutics told investors to expect results of a phase 3 trial with zuranolone and MDD patients before the end of June.

Before getting too excited about Sage Therapeutics, you should know that this stock lost half its value when zuranolone failed to meet its primary endpoint as a treatment for major depressive disorder (MDD) in 2019. 

Instead of throwing in the towel, Sage Therapeutics started testing a higher dosage and so far it seems to do the trick. In March, the company showed that 80% of MDD patients who received a higher zuranolone dose responded to the treatment.

Reading the tea leaves

Investors should know that Sage Therapeutics corporate operating officer left the day before the company announced the revival of its zuranolone program. That doesn't necessarily mean it's destined to disappoint, but you'll feel awfully silly about ignoring this warning if the same candidate fails again.

I'll be pleasantly surprised if Vertex Pharmaceuticals AAT program delivers positive data this month. In April the company told investors it was evaluating new AAT treatment candidates beyond VX-864 giving the impression the company expects to move on.

I think the evidence supporting Biogen's Alzheimer's disease drug warrants another phase 3 trial, not approval. That said, I wouldn't be surprised if the agency gives in to pressure from lobbying groups that have been clamoring for aducanumab's approval.

https://www.fool.com/investing/2021/06/02/3-biotech-stocks-with-huge-catalysts-in-june/

Citi picks Goldman partner for healthcare and consumer M&A 'super group'

 Citigroup has poached a Goldman Sachs partner to launch a new M&A advisory franchise in New York focusing on global healthcare, consumer and wellness as it seeks to increase its presence in key industries, according to a memo seen by Reuters.

Chuck Adams, a 16-year Goldman veteran, will take on a new role in December as vice chairman and global head of the new Citi unit, described in the memo as a "super group" which will absorb its existing operations in healthcare as well as consumer and retail.

The move was prompted by a growing convergence among sectors that are becoming "more integrated, consumer-centric, tech enabled and focused on sustainable wellbeing", the memo said.

Adams, who was responsible for Goldman's healthcare investment banking practice on the West Coast and also headed its West Region advisory business, will report to Tyler Dickson and Manolo Falco, global co-heads of Citi's banking, capital markets and advisory (BCMA) business.

"Healthcare, Consumer & Wellness will be one of our largest groups in BCMA and represents one of the greatest opportunities for growth," the pair said in the memo.

The healthcare sector, unlike other industries, has been largely immune to the disruptions caused by the pandemic and is likely to see a wave of consolidation led by cash-rich companies in coming years.

Before joining Goldman, Adams spent 10 years at Morgan Stanley, where he focused on healthcare investment banking. 

https://finance.yahoo.com/news/1-citi-picks-goldman-partner-174807248.html

CanSinoBIO's inhalation COVID-19 shot in mid-stage trial, says CEO

 An inhalation version of CanSino Biologics' COVID-19 vaccine is being tested in a Phase II clinical trial, Chief Executive Yu Xuefeng said late on Wednesday.

Yu made the comment at a panel of the Global Health Forum of the Boao Forum for Asia.

https://news.trust.org/item/20210602114934-bxfdh/

Israel finds a ‘probable link’ between Pfizer vaccine and myocarditis cases

 A small number of cases of myocarditis – a type of heart inflammation – may be linked to the second dose of Pfizer’s BioNTech-partnered COVID-19 vaccine, Israel’s Health Ministry announced this week.

The cases, observed mostly in young men who had received the Pfizer/BioNTech jab, have a ‘probable link’ to the second dose of the vaccine, according to Israel.

Israel’s Health Ministry reported that it was aware of 275 cases of myocarditis occurring between December 2020 to May 2021, with 148 of these cases happening within a short time frame after receiving the Pfizer/BioNTech vaccine.

The ministry added that the majority were seen among men under the age of 30 years and particularly in those aged between 16 and 19 years old.

Of the 5,401,150 who had been given the vaccine within this time period, 27 myocarditis cases were reported, including in 11 people with pre-existing conditions, shortly after their first Pfizer/BioNTech vaccine dose.

This increased after the second dose, however, with 121 cases, including 60 people with pre-existing conditions, developing myocarditis within 30 days out of a total 5,049,424 fully vaccinated individuals in Israel.

The ministry added that most of the cases were mild, with one death linked to myocarditis but not conclusively proven.

Pfizer said that it is ‘aware’ of the reports and findings in Israel of myocarditis in vaccinated people, although it added that no causal link has yet been established.

Last month, a US Centers for Disease Control and Prevention (CDC) advisory group said that further study of myocarditis in young adults who have received mRNA-based COVID-19 vaccines. Pfizer/BioNTech and Moderna’s are the only two mRNA-based vaccines approved for use in the US.

In a statement, the CDC’s Advisory Committee on Immunization Practices said that it had evaluated cases among a very small number of adolescents and young adults who developed myocarditis following COVID-19 vaccination.

The CDC added that it had not seen more cases than would typically be expected in the population, although advisory committee members said that healthcare providers should be wary of the reports of the “potential adverse event”.

https://www.pmlive.com/pharma_news/israel_finds_a_probable_link_between_pfizer_vaccine_and_myocarditis_cases_1371097

India orders unapproved COVID-19 shots as it reels from devastating second wave

India signed its first order for an unapproved COVID-19 vaccine on Thursday, a day after criticism from the Supreme Court over its bungled vaccine rollout that has left millions of people vulnerable after almost 338,000 deaths.

So far, only 4.7% of the 950 million adult population have been given two vaccine doses. The world's second most populous country is reeling from a widespread second wave of infections that killed around 170,000 people in April and May alone.

The government will buy 300 million vaccine doses from local firm Biological-E and has put down an advance of $205.6 million, the health ministry said, even though the vaccine is still going through Phase III clinical trials.

"The arrangement with Biological-E is part of the wider endeavour of the government of India to encourage indigenous vaccine manufacturers by providing them support in research & development and also financial support," the ministry said in a statement.

India has been inoculating its people with AstraZeneca shots produced at the Serum Institute of India, as well as Covaxin made by local firm Bharat Biotech, and is set to commercially launch Russia's Sputnik V in mid-June.

But supplies are running short after the government opened vaccinations to all adults last month. Some vaccination centres have had to close down, prompting criticism from the Supreme Court about a lack of planning.

While the federal government gave free vaccines to the elderly and frontline workers, it left state governments and private hospitals to administer doses to people in the 18-45 age group at a price.

"The policy of the central government of conducting free vaccination themselves for groups under the first two phases, and replacing it with paid vaccination...is, prima facie, arbitrary and irrational," the Supreme Court said.

The government said this week it could have as many as 10 million doses each day in July and August, up from just under three million now.

Pressure is set to mount further on the government to speed up vaccinations, as several states prepare to ease economically damaging lockdowns even amid high numbers of daily infections and deaths.

The western state of Maharashtra, home to financial hub Mumbai, is planning to lift most restrictions across 18 districts this month, based on availability of oxygen beds and infection rates, officials said.

India on Thursday announced 134,154 new infections over the past 24 hours, down more than 65% from a peak of 414,188 reported on May 7. The official recorded caseload since the start of the pandemic now stands at 28.4 million, the second-highest in the world after the United States.

India added 2,887 deaths overnight, pushing the overall toll to 337,989, the world's third-highest toll after the United States and Brazil.

On Thursday, a spokesman for India's foreign ministry said New Delhi was in dialogue with Washington to ensure a supply of raw materials for vaccine production.

India also raised the issue during the recent U.S. visit of its foreign minister, the spokesman said, adding: "It is in our mutual interest to combat the global pandemic by expediting vaccination efforts."

New Delhi's high court has said that some federal officials should be charged with manslaughter over the halting vaccine rollout.

"Who are they referring to, you think? This effectively concludes the debate on that subject," Sanjay Jha, a former Congress official and political commentator, said on Twitter. "This government has failed. And failed its people miserably."

https://news.trust.org/item/20210603111245-5w356/

U.S. appeals court leaves CDC residential eviction ban in place

 A federal appeals court on Wednesday refused to overturn the U.S. Centers for Disease Control and Prevention's (CDC) national ban on residential evictions.

In a blow to landlords, a three-judge panel of the U.S. Court of Appeals for the District of Columbia said it would not lift a stay of a lower court ruling that had declared the eviction ban unlawful.

In language suggesting that the government’s eviction ban was lawful, the panel said the government "has made a strong showing that it is likely to succeed on the merits" of its appeal. The moratorium, which is set to expire on June 30, covers renters whose incomes were hit by COVID-19.

Ever since the CDC implemented the eviction ban in September, landlord groups, arguing that they are on the brink of financial collapse after going months without being paid, have filed challenges in courts across the country, with mixed results.

Legal experts said that Wednesday's ruling means that for now, the eviction ban will remain in effect until its planned expiration date on June 30, though other court challenges are pending.

For low-income housing advocates, "This is a sigh of relief," said Eric Dunn, director of litigation for the National Housing Law Project.

As the coronavirus pandemic moves into its second year, an estimated 7 million renters across the country owe $40 billion in back rent, utilities and fees, Moody’s Analytics estimates. This is more than twice the number of homeowners who lost their homes to foreclosure in the 2008 financial crisis.

Many eviction cases are pending, and some tenants may receive a lifeline from the $50 billion in rent relief approved by Congress, even though so far that aid has been slow to trickle out.

"If the CDC eviction moratorium expires or is overturned before those funds are expended, millions of renters would be at immediate risk of losing their homes. The result would be a historic wave of evictions, with tremendous, harmful consequences to individuals, communities, and our nation’s public health," said Diane Yentel, president of the Low Income Housing Coalition.

Landlords and real estate groups that challenged the moratorium in court said the CDC lacked the power to impose it, and unlawfully took away their right to deal with delinquent tenants.

https://news.yahoo.com/u-appeals-court-leaves-cdc-203018946.html

Amazon starts testing UK staff for variants

 Amazon is testing its front-line staff in Britain for coronavirus variants.

It will then feed the data to public health officials - including in hotspots where a strain first found in India is spreading fast.

The retail giant opened testing labs in the UK and the U.S. last year to provide voluntary testing for staff.

And is now expanding its capabilities to test for variants in Britain.

Aided by a rapid vaccine rollout, the UK is on the verge of reopening its economy after months of lockdowns.

But the variant first found in India, now known as Delta, has spread, including in areas where Amazon has its lab and some fulfilment centres.

The company told Reuters it was open to offering the same service in the U.S.

And did not rule out making its testing programme available to the UK public in future.

Amazon's testing is available to around 30,000 front-line staff in Britain, working in warehouses and logistics departments.

https://news.yahoo.com/amazon-starts-testing-uk-staff-094128771.html