Biotech week ahead, Aug. 2

Biotech stocks showed a lack of direction in the week ending July 30 amid earnings releases from big pharma companies.

Most pharma majors reported strong quarterly results. Earnings momentum sent shares of Bristol-Myers Squibb Company BMY 0.34% to a record high midweek, although they have pulled back since then. Pfizer, Inc.'s PFE 0.02% COVID-19 vaccine sales buoyed its quarter results and prompted the company to raise its guidance. Merck & Co, Ltd. MRK 0.13%, however, reported a bottom-line miss.

The Alzheimer's Association International Conference presentations moved stocks during the week. Annovis Bio, Inc. ANVS 21.02% shares lost about 71% during the week after data presented at the conference failed to cut ice with investors.

The week also witnessed a slew of IPOs from among biopharma, diagnostics and medical devices companies.

Here are the key events/catalysts scheduled for the upcoming week:

PDUFA Dates

The Food and Drug Administration is scheduled to announce its verdict on Eton Pharmaceuticals, Inc.'s (NASDAQ: ETON) new drug application for topiramate oral solution. The decision is due by Friday, Aug. 6. The drug candidate is being evaluated as a treatment option for three indications – as a monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years age and older, an adjunctive treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older, and as preventative treatment for migraine patients 12 years of age and older.

Pending Regulatory Filings

Coherus BioSciences, Inc. CHRS 0.68%: biologic license application filing for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma as well as completion of rolling submission of BLA for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (middle of 2021)

bluebird bio, Inc. BLUE 0.97%: completion of rolling BLA submission for approval of elivaldogene autotemcel gene therapy in patients with cerebral adrenoleukodystrophy as well betibeglogene autotemcel for transfusion-dependent β-thalassemia (middle of 2021)

Marinus Pharmaceuticals, Inc. MRNS 2.39%: NDA filing for the use of ganaxolone in CDKL5 deficiency disorder (mid-2021)

Clinical Readouts

Pending Mid-2021 Releases

BeyondSpring Inc. BYSI 1.55%: (DUBLIN-3): Topline overall survival data from pivotal Phase 3 non-small cell lung cancer study of plinabulin, dubbed DUBLIN-3

Celyad Oncology SA CYAD 2.92%: additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome

F-star Therapeutics, Inc. FSTX 4.24%: update on the progress of SB 11285 in the phase 1 clinical trial

Dynavax Technologies Corporation DVAX 1.58%: Clover is due to release interim data for vaccine efficacy from the Phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 in combination with Dynavax's CpG 1018 advanced adjuvant and alum.

Crinetics Pharmaceuticals, Inc. CRNX 2.16%: preliminary Phase 1 data for CRN04894 in Cushing's disease and congenital adrenal hyperplasia and CRN04777 in congenital hyperinsulinism

Praxis Precision Medicines, Inc. PRAX 0.51%: Preliminary topline data from the Phase 2a trial of PRAX-944 in essential tremor, and safety, tolerability and PK data from the ongoing Phase 1 trial of PRAX-562

MorphoSys AG MOR 0.57% unit Constellation Pharma: Phase 1 data update for CPI-0209 in solid tumors and Phase 2 MANIFEST translational data update for pelabresib in myelofibrosis

Enanta Pharmaceuticals, Inc. ENTA 1.1%: Phase 1 data for EDP-297 in non-alcoholic steatohepatitis

Dicerna Pharmaceuticals, Inc. DRNA 0.97%: data from the PHYOX2 pivotal Phase 2 trial of nedosiran in patients with primary hyperoxaluria

Kaleido Biosciences, Inc. KLDO 4.57%: Topline Phase 2 data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis

INmune Bio, Inc. INMB 3.79%: Data Safety Monitoring Board review of data from Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications

Earnings

Monday

Minerva Neurosciences, Inc. NERV 1.6% (before the market open)
SI-BONE, Inc. SIBN 1.3% (after the close)

Tuesday

X4 Pharmaceuticals, Inc. XFOR 4.49% (before the market open)
Rhythm Pharmaceuticals, Inc. RYTM 6.44% (before the market open)
Myriad Genetics, Inc. MYGN 1.22% (before the market open)
Seres Therapeutics, Inc. MCRB 1.57% (before the market open)
Neuronetics, Inc. STIM 0.45% (before the market open)
Kiniksa Pharmaceuticals, Ltd. KNSA 2.68% (before the market open)
ADC Therapeutics SA ADCT 0.76% (before the market open)
Aptose Biosciences Inc. APTO 3.07% (after the close)
Theravance Biopharma, Inc. TBPH 1.37% (after the close)
Pulmonx Corporation LUNG 1.81% (after the close)
Invitae Corporation NVTA 0.28% (after the close)
Cytosorbents Corporation CTSO 0.13% (after the close)
Rigel Pharmaceuticals, Inc. RIGL 2.2% (after the close)

Wednesday

TherapeuticsMD, Inc. TXMD 3.85% (before the market open)
Intellia Therapeutics, Inc. NTLA 3.53% (before the market open)
Surmodics, Inc. SRDX 0.54% (before the market open)
Vericel Corporation VCEL 1.54% (before the market open)
UroGen Pharma Ltd. URGN 0.06% (before the market open)
Horizon Therapeutics Public Limited Company HZNP 2.52% (before the market open)
IVERIC bio, Inc. ISEE 0.58% (before the market open) (before the market open)
Flexion Therapeutics, Inc. FLXN 1.02% (after the close)
Aerie Pharmaceuticals, Inc. AERI 0.5% (after the close)
AxoGen, Inc. AXGN 0.84% (after the close)
INmune (after the close)
Bionano Genomics, Inc. BNGO 2.63% (after the close)
DermTech, Inc. DMTK 1.89% (after the close)
Fate Therapeutics, Inc. FATE 3.77% (after the close)
G1 Therapeutics, Inc. GTHX 0.4% (after the close)
Otonomy, Inc. OTIC 2.29% (after the close)
Xencor, Inc. XNCR 3.18% (after the close)
Celyad Oncology (after the close)

Click here to access Benzinga's FDA Calendar

Thursday

Salarius Pharmaceuticals, Inc. SLRX 4.53% (before the market open)
OrthoPediatrics Corp. KIDS 3.7% (before the market open)
Mersana Therapeutics, Inc. MRSN 1.26% (before the market open)
Lumos Pharma, Inc. LUMO 3.26% (before the market open)
Karyopharm Therapeutics Inc. KPTI 0.48% (before the market open)
Galmed Pharmaceuticals Ltd. GLMD 0.8% (before the market open)
Jounce Therapeutics, Inc. JNCE 4.36% (before the market open)
Kala Pharmaceuticals, Inc. KALA 1.43% (before the market open)
Arena Pharmaceuticals, Inc. ARNA 0.77% (before the market open)
Antares Pharma, Inc. ATRS 1.12% (before the market open)
Arbutus Biopharma Corporation ABUS 2.54% (before the market open)
Aldeyra Therapeutics, Inc. ALDX 1.33% (before the market open)
Provention Bio, Inc. PRVB 0.5% (before the market open)
Autolus Therapeutics plc AUTL 0.19% (before the market open)
Wave Life Sciences Ltd. WVE 4.34% (before the market open)
Amarin Corporation plc AMRN 2.36% (before the market open)
Verona Pharma plc VRNA 7.35% (before the market open)
Chimerix, Inc. CMRX 4.47% (before the market open)
Concert Pharmaceuticals, Inc. CNCE 3.76% (before the market open)
Syros Pharmaceuticals, Inc. SYRS 2.53% (before the market open)
Stealth BioTherapeutics Corp MITO (before the market open)
Strongbridge Biopharma plc SBBP 3.63% (before the market open)
Synthetic Biologics, Inc. SYN 5.52% (after the close)
CTI BioPharma Corp. CTIC 0.84% (after the close)
Y-mAbs Therapeutics, Inc. YMAB 1.19% (after the close)
Kura Oncology, Inc. KURA 0.37% (after the close)
Aligos Therapeutics, Inc. ALGS 0.68% (after the close)
Arcus Biosciences, Inc. RCUS 4.76% (after the close)
AVEO Pharmaceuticals, Inc. AVEO 0.39% (after the close)
Assertio Holdings, Inc. ASRT 3.82% (after the close)
Anika Therapeutics, Inc. ANIK 2.43% (after the close)
T2 Biosystems, Inc. TTOO 0.96% (after the close)
Caladrius Biosciences, Inc. CLBS 1.48% (after the close)
CytomX Therapeutics, Inc. CTMX 2.52% (after the close)
Collegium Pharmaceutical, Inc. COLL 0.44% (after the close)
Chembio Diagnostics, Inc. CEMI 1.79% (after the close)
Nabriva Therapeutics plc NBRV 0.9% (after the close)
Enanta Pharma (after the close)
TransMedics Group, Inc. TMDX 2.33% (after the close)
iRhythm Technologies, Inc. IRTC 0.06% (after the close)
Sangamo Therapeutics, Inc. SGMO 1.44% (after the close)
Revance Therapeutics, Inc. RVNC 0.55% (after the close)
Spero Therapeutics, Inc. SPRO 2.77% (after the close)
Outset Medical, Inc. OM 1.94% (after the close)
Oncternal Therapeutics, Inc. ONCT 1.52% (after the close)
Natera, Inc. NTRA 2.1% (after the close)
Opiant Pharmaceuticals, Inc. OPNT 3.33% (after the close)
Novavax, Inc. NVAX 2.54% (after the close)
Mirum Pharmaceuticals, Inc. MIRM 1.98% (after the close)

Friday

PLx Pharma Inc. PLXP 0.21% (before the market open)
ANI Pharmaceuticals, Inc. ANIP 2.69% (before the market open)
Twist Bioscience Corporation TWST 3.33% (before the market open)
Oncolytics Biotech Inc. ONCY 2.52% (before the market open)
Orthofix Medical Inc. OFIX 1.53% (before the market open)

IPOs

IPO Pricing

Philadelphia, Pennsylvania-based Context Therapeutics, Inc. is planning an initial public offering of 1.5 million shares at an estimated price range of $12-$14. The company has applied for listing its shares on the Nasdaq under the ticker symbol CNTX. Context is a clinical-stage biopharmaceutical company developing therapies for women living with cancer.

Providence, Rhode Island-based Ocean Biomedical, Inc. has filed to offer 3.2258 million shares in an IPO. The company expects to price the offering in the range of $14-$17. The biopharma focuses on licensing tech and innovations and developing them into products. It has applied to list its shares on the Nasdaq under the ticker symbol OCEA.

IPO Quiet Period Expiry

TransCode Therapeutics, Inc. RNAZ 0.34%
Unicycive Therapeutics, Inc. UNCY 3.16%

https://www.benzinga.com/general/biotech/21/08/22263165/the-week-ahead-in-biotech-aug-1-7-biopharma-earnings-pick-up-pace-eton-awaits-fda-decision-focus-

Pfizer and Moderna raise prices for COVID-19 vaccines in EU

 Pfizer Inc and Moderna Inc have raised the prices of their COVID-19 vaccines in their latest European Union supply contracts, the Financial Times reported https://on.ft.com/3j8mbTb on Sunday.

The new price for the Pfizer shot was 19.50 euros ($23.15)against 15.50 euros previously, the newspaper said, citing portions of the contracts seen.

The price of a Moderna vaccine was $25.50 a dose, the contracts show, up from about 19 euros in the first procurement deal but lower than the previously agreed $28.50 because the order had grown, the report said, citing one official close to the matter.

The European Commission said on Tuesday that the EU is on course to hit a target of fully vaccinating at least 70% of the adult population by the end of the summer.

In May, the EU said it expects to have received more than a billion doses of vaccines by the end of September from four drugmakers.

https://finance.yahoo.com/news/1-pfizer-moderna-raise-prices-121400124.html

Hackers Shut Down System for Booking COVID-19 Shots in Italy's Lazio Region

 Hackers have attacked and shut down the IT systems of the company that manages COVID-19 vaccination appointments for the Lazio region surrounding Rome, the regional government said on Sunday.

"A powerful hacker attack on the region's CED (database) is under way," the region said in a Facebook posting.

It said all systems had been deactivated, including those of the region's health portal and vaccination network, and warned the inoculation programme could suffer a delay.

"It is a very powerful hacker attack, very serious... everything is out. The whole regional CED is under attack," Lazio region's health manager Alessio D'Amato said.

According to ANSA, Italy's postal police and Rome prosecutors are looking into the matter and could open an investigation to find out who is behind the attack.

Italy recently followed France in announcing that proof of vaccination or immunity from COVID-19 would become mandatory for an array of activities.

The move triggered a series of protests across the country against introduction of the so-called Green Pass which shows people have been vaccinated, tested negative or recovered from COVID-19.

https://www.usnews.com/news/world/articles/2021-08-01/hackers-shut-down-system-for-booking-covid-19-shots-in-italys-lazio-region

Fauci says he expects no new U.S. lockdowns despite surging Delta

 President Joe Biden's chief medical adviser Dr. Anthony Fauci said on Sunday he does not expect the United States will return to lockdowns, despite the growing risks of COVID-19 infections posed by the Delta variant.

"I don't think we're going to see lockdowns," Fauci, who is also director of the National Institute of Allergy and Infectious Diseases, said on ABC's "This Week."

"I think we have enough of the percentage of people in the country - not enough to crush the outbreak - but I believe enough to not allow us to get into the situation we were in last winter."

Although Fauci does not think the United States will need to shut down again as it did last year, he warned on ABC that "things are going to get worse" as the Delta variant continues to spread.

"We have 100 million people in this country who are eligible to be vaccinated who are not getting vaccinated," he said.

The average number of new cases reported each day has nearly doubled in the past 10 days and the number of hospitalized patients in many states is surging, according to a Reuters analysis. https://tmsnrt.rs/2WTOZDR

At the same time, the number of Americans getting vaccinated has increased. (Graphic on global vaccinations) https://tmsnrt.rs/3tUM8ta

"The silver lining of this is that people are waking up to this and this may be a tipping point for those who have been hesitant," National Institutes of Health Director Francis Collins told CNN on Sunday. "That's what desperately needs to happen if we're going to get this Delta variant put back in its place, because right now it's having a pretty big party in the middle of the country."

https://news.trust.org/item/20210801135120-aoqql/

Over 100K vaccine breakthroughs identified in US: report

 There have been more than 100,000 breakthrough cases, or cases where fully vaccinated individuals contracted the coronavirus, identified in the U.S., according to a Bloomberg analysis.

Bloomberg has gathered data from 35 states since the Centers for Disease Control and Prevention (CDC) stopped tracking all breakthrough cases and found that more than 111,000 breakthrough cases have occurred in those states within the past two months. 

There are more than 164 million Americans fully vaccinated against the coronavirus. 

The CDC stopped tracking all breakthrough cases in May as the delta variant started spreading throughout the U.S.

The CDC only began tracking breakthrough cases that have resulted in a person's hospitalization or death, which is a small percentage compared to the number of breakthrough cases that have occurred.

The delta variant began picking up steam in June and has since caused an increase in cases across the country as it is considered to be the most contagious variant to date.

The CDC gave a statement to Bloomberg saying it has still tracked breakthrough coronavirus cases despite officially stopping the count of all cases in May.

“CDC is actively tracking breakthrough cases as part of what are called cohort studies, which often involve tens of thousands of people across the country,” spokesperson Kristen Nordlund told the outlet. “We will continue to publish additional results from these cohort studies as they are available.”

States have continued tracking breakthrough cases, making it possible to have an estimate of all the breakthrough cases that have occurred.

The fear of breakthrough cases and the ability of vaccinated people to spread the virus has caused the CDC to ask fully vaccinated individuals to wear masks in areas with high transmission rates of the virus.

https://thehill.com/policy/healthcare/565702-cdc-stopped-tracking-breakthrough-cases-as-delta-variant-spread

Hundreds of staffers at two San Francisco hospitals test Covid positive

 At least 233 staffers at a pair of San Francisco hospitals have tested positive for COVID-19, the majority of whom were fully vaccinated but became infected with the delta variant.

More than 50 cases were discovered among staff members at Zuckerberg San Francisco General Hospital, the hospital’s chief medical officer Dr. Lukejohn Day told The New York Times on Saturday. Of those who tested positive, roughly 75 to 80 percent were fully vaccinated.

At The University of California, San Francisco Medical Center, 183 staff members had tested positive as of Friday, 153 of whom were fully vaccinated, the Times reported.

Most of the infections were reportedly from the highly infectious delta variant, which has taken hold in the U.S. as the dominant COVID-19 strain.

Two of the infected staff members from U.C.S.F. Medical Center were hospitalized, according to the Times.

None of those who tested positive at San Francisco General required hospitalization, and most of the infections caused mild to moderate symptoms, Day told the newspaper. Asymptomatic cases were also detected through contact tracing.

The Hill reached out to both hospitals for comment.

Day told the Times that the cases would be far worse if staff members were not vaccinated.

“We’re concerned right now that we’re on the rise of a surge here in San Francisco and the Bay Area,” Day said. “But what we’re seeing is very much what the data from the vaccines showed us: You can still get COVID, potentially. But if you do get it, it’s not severe at all.”

The city of San Francisco mandated workers in high-risk workplaces, such as hospitals, to be vaccinated against COVID-19 by Sept. 15. In a statement revealing the infections, U.C.S.F. Medical Center said it was “doubling down on our efforts to protect our staff. This includes requiring all employees and trainees to comply with the new UC-systemwide Covid-19 vaccination mandate, with limited exceptions for medical or religious exemptions,” the newspaper reported.

The cluster of cases at the San Francisco hospitals come as concerns are rising regarding the delta variant, especially with the country’s vaccination rate plateauing.

Breakthrough cases, referred to infections detected in fully vaccinated individuals, are still rare throughout the U.S.

Of the more than 164.2 million people who have been fully inoculated, only 125,682 breakthrough cases have been reported in 38 states, according to data collected by NBC News.

That number translates to less than .08 percent, the network noted.

https://thehill.com/policy/healthcare/565814-hundreds-of-staffers-at-two-san-francisco-hospitals-test-positive

Biden hits resistance from unions on vaccine requirement

 Influential public sector unions are pushing back on a new vaccination requirement for federal workers in a rare split with the Biden administration.

President Biden’s latest vaccine push, announced Thursday, requires federal employees to attest that they have been vaccinated against COVID-19 or be subject to masking, social distancing and weekly testing.

While labor groups representing government employees have urged their members to get vaccinated, most of the leading public sector unions either oppose the vaccine requirement or say it must first be negotiated.

Groups representing educators, postal workers, law enforcement officers, Treasury Department personnel and other government employees expressed unease about the vaccine requirement this week. Only a few public sector unions outright endorsed the measure.

“We expect that the particulars of any changes to working conditions, including those related to COVID-19 vaccines and associated protocols, be properly negotiated with our bargaining units prior to implementation,” Everett Kelley, president of the American Federation of Government Employees, which represents nearly 700,000 workers, said in a statement.

Larry Cosme, president of the Federal Law Enforcement Officers Association, said requiring vaccinations “is not the American way and is a clear civil rights violation no matter how proponents may seek to justify it.”

National Treasury Employees Union President Tony Reardon said in a statement that the group has “a lot of questions about how this policy will be implemented and how employee rights and privacy will be protected.”

Most of the public sector unions that expressed concern over the new vaccine rule endorsed Biden’s election bid in 2020 and cheered his overall efforts to bolster a federal workforce that former President Trump often targeted with criticism and spending cuts.

But their support for Biden is not extending to his vaccine rule, which doesn’t apply to the much larger private sector.

“In order for everyone to feel safe and welcome in their workplaces, vaccinations must be negotiated between employers and workers, not coerced,” American Federation of Teachers President Randi Weingarten said in a statement earlier this week. The group represents educators and health care workers at various levels of government.

The American Postal Workers Union said “it is not the role of the federal government to mandate vaccinations for the employees we represent” and that any new rules for its workers must be discussed with union leaders.

Experts say the responses from unions aren’t entirely surprising.

“As a matter of principle, union leaders just don’t like anything called a ‘mandate’ that comes from management where they’re cut out of the bargain,” said Daniel DiSalvo, professor and chair of political science at the Colin Powell School at the City College of New York–CUNY.

The White House anticipated that unions would want a seat at the table on the new requirement. The administration’s own task force on workplace safety wrote in a memo Thursday that “agencies are reminded to satisfy applicable collective bargaining obligations” when implementing new vaccine rules.

Still, public sector unions’ demands could slow Biden’s federal vaccination campaign, and their resistance indicates that similar efforts by states and municipalities could face roadblocks as well.

New York City Mayor Bill de Blasio (D) announced earlier this week that municipal workers must get vaccinated or be tested weekly. He quickly encountered pushback from unions representing first responders, which said that about half of their members were vaccinated, lower than the city average.

“The internal structure of unions forces this kind of responsiveness to the membership,” DiSalvo said. “If you’re a union leader, you need to represent all employees.”

The American Federation of State, County and Municipal Employees, the nation’s largest public employee union, did not respond to a request for comment about its position on vaccine requirements.

A handful of national unions backed Biden’s order this week. The American Foreign Service Association, a union that represents foreign service officers, welcomed the measure, citing last month’s COVID-19 outbreak in the U.S. Embassy in Kabul, Afghanistan.

The International Federation of Professional and Technical Engineers, a union that represents 25,000 federal workers at NASA, the Justice Department, the Government Accountability Office and other agencies, also backed Biden’s order.

“We don’t think either our members or their mission should be placed at risk by those who have been hesitant to take a shot,” Paul Shearon, the group’s president, said in a statement.

AFL-CIO President Richard Trumka endorsed a mask mandate in an interview with C-SPAN on Tuesday, contradicting some of his member unions.

“If you come back in and you’re not vaccinated, everybody in that workplace is jeopardized,” he said. “If we don’t know whether you have been vaccinated or not, we can’t make the proper accommodations to make sure that you are protected and everyone else is protected.”

Biden’s order would affect millions of workers between federal employees and government contractors. Earlier this week, the Department of Veterans Affairs required its front-line health care workers to be vaccinated, and Biden has asked the Pentagon to examine “how and when” it will require service members to get the vaccine.

“With incentives and mandates, we can make a huge difference and save a lot of lives,” Biden said in a speech Thursday.

The urgency comes as the highly contagious delta variant spreads rapidly in areas of the U.S. with low vaccination rates.

Biden wants the private sector to follow his lead and encourage the remaining 31 percent of U.S. adults who have yet to receive at least one dose of the COVID-19 vaccine.

Several companies have announced vaccine mandates in recent weeks, including Google, Shake Shack, Netflix, Morgan Stanley and Delta Air Lines.

https://thehill.com/business-a-lobbying/565744-biden-hits-resistance-from-unions-on-vaccine-requirement