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Catalent stays hot as it inks deal with French pharma that suffered PhIII flop

Just a couple of deals in a couple of days for Catalent.
The New Jersey-based CDMO’s latest move is a long-term supply agreement with Erytech Pharma,…

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Just a couple of deals in a couple of days for Catalent.

The New Jersey-based CDMO’s latest move is a long-term supply agreement with Erytech Pharma, a French clinical-stage biopharma, and the purchase of its cell therapy manufacturing site in the motherland.

The deal is good for $44.5 million, and 40 of Erytech’s Princeton, NJ employees will be offered employment by the site’s new owner. Catalent will now make Erytech’s lead candidate Graspa for clinical and commercial supply in the US. Graspa is in Phase I trials in patients suffering from pancreatic cancer right now and is in talks with the FDA for a BLA submission in hypersensitive ALL. That’s targeted in Q3 2022.

“Erytech will now further focus capital resources on the development of potentially transformative therapeutics for serious diseases,” CEO Gil Beyen said in a statement. “We are also continuing to evaluate further strategic options for the company, including additional partnerships and addition of complementary assets, through which we can leverage our ERYCAPS® platform and our development and manufacturing capabilities.”

The deal comes just days after Catalent announced that it was doubling down on its faith in Bloomington, IN as the home of drug substance manufacturing with $350 million and the announcement that it would add up to 1,000 new jobs in the upcoming years. That project builds upon a previously pledged 600 jobs and $50 million upgrade that came with dedicating a filling line to Moderna’s Covid-19 jab.

Erytech made waves four years ago when it revealed impressive Phase IIb data for Graspa, but that hype fizzled out a bit when it failed the Phase III pivotal. That led the stock to fall 30% after the hazard ratio came in at 0.92 with a p-value of 0.375.

Catalent will offer up its late-stage and commercial manufacturing expertise to help Erytech with production, regulatory inspections and approvals. Its 30,900 square-foot site has the flexibility to support multiple cell therapy production requirements and capacities, and Catalent plans on building out that site, using the staff it already has to broaden its manufacturing portfolio.

Manja Boerman

Meanwhile, Erytech will keep its Lyon, France site. The company reported 2021 earnings of $38.1 million, and that will jump up to $60 million upon the closing of this deal. The sale of the Princeton site will also cut $7.5 million a year in operating costs. The deal is expected to fund Erytech’s next stage of operations until the middle of 2024.

“The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allows Catalent to expand rapidly to create a U.S. campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world,” Catalent president of cell and gene therapy Manja Boerman said in a statement.

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Looking Ahead In The Macro Market—Stock Market Preview For The Week Of June 27, 2022

A weekly stock market preview and the data that will impact the tape. Early Futures Open (6:24pm, June 26, 2022) – Stock Market Preview Weekend News…

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A weekly stock market preview and the data that will impact the tape.

Early Futures Open (6:24pm, June 26, 2022) – Stock Market Preview

Weekend News And Developments

Canadian Prime Minister drives action on food security, climate change and gender equality at Commonwealth Heads of Government Meeting.

Carvana (NYSE:CVNA) Sought to Disrupt Auto Sales. It Delivered Undriveable Cars—OpEd Barron’s

Honourable Jean-Yves Duclos, Minister of Health, and Member of Parliament for Bourassa, Emmanuel Dubourg, will make an important funding announcement supporting long-term care in Quebec; June 27, 11:15am.

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), announced that GSK presented positive results from an interim analysis of the Phase 2b B-Clear clinical study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B virus (CHB).

Madrigal Pharmaceuticals, Inc. announced data from multiple resmetirom abstracts presented at the European Association for the Study of the Liver’s International Liver Congress (EASL 2022), including a late-breaking presentation of data from the Phase 3 MAESTRO-NAFLD-1 study and three additional oral presentations from the resmetirom clinical development program.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. 

President Joe Biden and Western allies opened a three-day summit in the Bavarian Alps on Sunday intent on keeping economic fallout from the war in Ukraine from fracturing the global coalition working to punish Russia’s aggression.

Saudi Exchange announces its intention to launch Single Stock Futures Contracts on the 4th of July 2022.

United States: The Biden admin alongside the G-7 announced that they will ban Russian gold imports to “further impose financial costs on Moscow for its invasion of Ukraine.”

What We’re Watching

U.S. Economic Calendar

TIME (ET)REPORTPERIODACTUALMEDIAN FORECASTPREVIOUS
Monday, June 27
8:30 AMDurable goods ordersMay0.20%0.50%
8:30 AMCore capital goods ordersMay0.80%
10:00 AMPending home sales indexMay-4.00%-3.90%
Tuesday, June 28
8:30 AMTrade in goods (advance)May-$105.9 billion
9:00 AMS&P Case-Shiller U.S. home price index (year-over-year)April20.60%
10:00 AMConsumer confidence indexJune101.1106.4
Wednesday, June 29
8:30 AMGross domestic product revision (SAAR)Q1-1.50%-1.50%
8:30 AMFinal domestic demand revision (SAAR)Q12.70%
8:30 AMGross domestic income revision (SAAR)Q12.10%
Thursday, June 30
8:30 AMPCE inflation (monthly)May0.20%
8:30 AMCore PCE inflation (monthly)May0.40%0.30%
8:30 AMPCE inflation (year-over-year)May6.30%
8:30 AMCore PCE inflation (year-over-year)May4.70%4.90%
8:30 AMReal disposable incomeMay0.00%
8:30 AMReal consumer spendingMay0.70%
8:30 AMNominal personal incomeMay0.50%0.40%
8:30 AMNominal consumer spendingMay0.40%0.90%
8:30 AMInitial jobless claimsJune 25227,000229,000
8:30 AMContinuing jobless claimsJune 181.32 million
9:45 AMChicago PMIJune60.3
Friday, July 1
9:45 AMS&P Global U.S. manufacturing PMI (final)June52.4
10:00 AMISM manufacturing indexJune54.90%56.10%
10:00 AMConstruction spendingJune0.40%0.20%

Meme Of The Week

Key Upcoming Earnings (US Markets)

DaySymbolCompanyEarnings Call TimeEPS Estimate
KPRXKiora Pharmaceuticals IncAfter Market Close-0.23
BYSIBeyondSpring IncTime Not Supplied-0.23
Monday, June 27KLDOKaleido Biosciences IncBefore Market Open-0.51
BMTXBm Technologies IncAfter Market Close0.08
CNTGCentogene NVBefore Market Open-0.53
CGRNCapstone Green Energy CorpAfter Market Close-0.28
CNXCConcentrix CorpAfter Market Close2.84
GPGreenPower Motor Company IncBefore Market Open-0.08
CTKYYCooTek (Cayman) IncBefore Market Open0.13
DLNGDynagas LNG Partners LPAfter Market Close0.17
TALTAL Education GroupBefore Market Open-0.05
EXPIeXp World Holdings IncTime Not Supplied0.01
JEFJefferies Financial Group IncAfter Market Close0.51
TCOMTrip.com Group LtdAfter Market Close-0.08
LVOLiveOne IncTime Not Supplied-0.13
NKENike IncTAS0.81
Tuesday, June 28AEMDAethlon Medical IncTAS-0.14
XAIRBeyond Air IncAfter Market Close-0.27
AVAVAeroVironment IncAfter Market Close0.39
FIZZNational Beverage CorpTime Not Supplied0.43
SJRShaw Communications IncTime Not Supplied0.3
SNXTD Synnex CorpBefore Market Open2.65
EPACEnerpac Tool Group CorpBefore Market Open0.28
PRGSProgress Software CorpAfter Market Close0.95
Wednesday, June 29CDMOAvid Bioservices IncAfter Market Close0.01
BSETBassett Furniture Industries IncTime Not Supplied0.45
BNEDBarnes & Noble Education IncBefore Market Open-0.17
BBBYBed Bath & Beyond IncBefore Market Open-1.37
CULPCulp IncAfter Market Close-0.35
CJREFCorus Entertainment IncBefore Market Open0.15
PDCOPatterson Companies IncBefore Market Open0.55
MKCMcCormick & Company IncBefore Market Open0.65
UNFUniFirst CorpBefore Market Open1.9
FCFranklin Covey CoAfter Market Close0.18
MSMMSC Industrial Direct Co IncBefore Market Open1.74
FTRPField Trip Health LtdAfter Market Close-0.18
SGHSMART Global Holdings Inc.After Market Close0.75
GISGeneral Mills IncBefore Market Open1.01
SCHNSchnitzer Steel Industries IncBefore Market Open2.3
NGNovaGold Resources IncAfter Market Close-0.03
PAYXPaychex IncBefore Market Open0.79
MLKNMillerKnoll IncAfter Market Close0.47
Thursday, June 30ACCDAccolade IncAfter Market Close-0.66
AYIAcuity Brands IncTAS2.95
WBAWalgreens Boots Alliance IncTAS0.92
WTERAlkaline Water Company IncBefore Market Open-0.1
STZConstellation Brands IncBefore Market Open2.52
LNNLindsay CorpBefore Market Open1.6
SMPLSimply Good Foods CoBefore Market Open0.35
TNPTsakos Energy Navigation LtdBefore Market Open-0.21
MUMicron Technology IncAfter Market Close2.44
Frdiay, July 1None

FDA Calendar

Spero Therapeutics, Inc. (Nasdaq: SPRO): The FDA is planning to hold an Advisory Committee meeting to discuss this application and has also set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022.

Short Interest Gainers

Carvana (CVNA) +33%: Short interest increased from 33.3% to just shy of the 35% mark—the highest level since December of 2020. Days to cover on Carvana rose from 1.3 to 1.6.

Chewy (CHWY) +32.96%: Short interest increased two percentage point increase to 28% to a two-month high. In the four-day period covered through Thursday, shares of Chewy are up 14.7%, though the stock remains down nearly 40% year-to-date.

Lemonade (LMND) +13.95% : Estimated short interest on the stock rose for the third consecutive week from 30.5% to 32.0%. Days to cover on Lemonade was also up nearly two points from 12.2 to 14.1- an all-times high.

Short Interest Decliners

Canoo (GOEV) -7.46%: Estimates short interest was down for the fourth consecutive week this week, slipping from 25.1% to 22.3%. Trading volume in the name has been particularly heavy this week with 5.5M-7.1M shares exchanging hands despite the absence of any meaningful news.

Citi Trends (CTRN) +3.58%: Estimated short interest peaked at an all-time high above 55% in mid-May, but has declined to just 30.1% since then as shorts cover on declining price action.

Tags: stock market preview, stock market preview June 27, 2022.

The post Looking Ahead In The Macro Market—Stock Market Preview For The Week Of June 27, 2022 appeared first on The Dales Report.

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40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

Up to 40,000 Army National Guard troops – around 13% of the force…

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40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

Up to 40,000 Army National Guard troops - around 13% of the force - could be fired for not getting the mandated COVID-19 vaccine (which has limited efficacy against Omicron, doesn't stop transmission, has been linked to elevated heart problems, and has been mandated for a healthy demographic that rarely dies of the disease).

Michigan Army National Guard Sgt. Mark Abbott administers a COVID-19 vaccine

Guard soldiers have until Thursday to get the jab, according to the Associated Press, which notes that between 20% and 30% of Guard soldiers in six states remain unvaccinated.

"We’re going to give every soldier every opportunity to get vaccinated and continue their military career. Every soldier that is pending an exemption, we will continue to support them through their process," Lt. Gen. Jon Jensen, director of the Army National Guard, told AP. "We’re not giving up on anybody until the separation paperwork is signed and completed. There’s still time."

Last year, Defense Secretary Lloyd Austin ordered all service members to get the vaccine, with different branches maintaining different deadlines for the jab. The Army National Guard was given the maximum amount of time, largely because its roughly 330,000 soldiers are scattered throughout the country, including remote locations.

The Army Guard’s vaccine percentage is the lowest among the U.S. military — with all the active-duty Army, Navy, Air Force and Marine Corps at 97% or greater and the Air Guard at about 94%. The Army reported Friday that 90% of Army Reserve forces were partially or completely vaccinated.

The Pentagon has said that after June 30, Guard members won’t be paid by the federal government when they are activated on federal status, which includes their monthly drill weekends and their two-week annual training period. Guard troops mobilized on federal status and assigned to the southern border or on COVID-19 missions in various states also would have to be vaccinated or they would not be allowed to participate or be paid. -AP

Complicating matters is a rule that Guard soldiers deployed on state active duty may not require a vaccination, depending on state-level mandates. 

According to the report, at least seven governors have asked Austin to reconsider, or drop, the vaccine mandate for National Guard members - with some having filed or joined lawsuits to that end.

Austin, apparently following his own special brand of science, told them to pound sand, saying that Covid-19 "takes our service members out of the fight, temporarily or permanently, and jeopardizes our ability to meet mission requirements," adding that troops will either need to get vaccinated or lose their Guard status.

"When you’re looking at, 40,000 soldiers that potentially are in that unvaccinated category, absolutely there’s readiness implications on that and concerns associated with that," said Jenson, adding "That's a significant chunk." 

AP reports that around 85% of Army Guard soldiers are fully vaccinated, while 87% are at least partially vaccinated.

Tyler Durden Sun, 06/26/2022 - 18:00

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CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

Authored by Zachary Stieber via The Epoch Times…

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CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The Centers for Disease Control and Prevention (CDC) confirmed in late 2021 that a person died from blood clotting after receiving a COVID-19 vaccine that had been linked with an increased risk of blood clotting, but did not alert the public for two weeks, newly obtained emails show.

A general view of the Centers for Disease Control headquarters in Atlanta, Ga., on April 23, 2020. (Tami Chappell/AFP via Getty Images)

Dr. Tom Shimabukuro, a CDC official, told colleagues at the CDC and the Food and Drug Administration (FDA) on Dec. 2, 2021, “We have confirmed a 9th TTS death following Janssen vaccination,” according to emails obtained by The Epoch Times through a Freedom of Information Act request.

TTS refers to thrombosis with thrombocytopenia syndrome, a condition that features low platelet levels combined with blood clots.

Officials had recommended a nationwide pause on the administration of the vaccine, produced by Johnson & Johnson (J&J) subsidiary Janssen, in April 2021 after six women experienced TTS after J&J vaccination and three died. But they lifted the pause after determining the vaccine remained safe and effective.

The condition was not discussed much in the ensuing months, despite the CDC later reporting that five additional deaths occurred before Aug. 31, 2021. Shimabukuro gave a single update, in mid-October 2021, saying five total deaths had been reported.

That was until December 2021. Twelve days after Shimabukuro alerted colleagues of the ninth death, the FDA urged healthcare workers not to administer the vaccine to people with certain conditions because of the TTS risk. Two days after that, Dr. Isaac See, another CDC official, informed the public during a meeting that nine deaths had occurred post-vaccination.

It’s unclear when the CDC learned of the sixth, seventh, and eighth deaths.

The CDC takes reports made to the Vaccine Adverse Event Reporting System and attempts to confirm the reports, including post-vaccination deaths. A higher number of post-vaccination TTS deaths have been reported to the system than the number the CDC has verified.

One day after Shimabukuro confirmed the ninth death, his message was forwarded by Dr. Amanda Cohn, another CDC official, to CDC Director Dr. Rochelle Walensky.

“See below, information on a 9th completely tragic death from TTS,” Cohn wrote.

Many thanks for letting us know … any tragic case,” Walensky responded.

The emails were partially redacted; one was fully redacted.

Read more here...

Tyler Durden Sun, 06/26/2022 - 15:30

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