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Sunday, November 14, 2021

Biotech week ahead, Nov. 15

 Biotech stocks declined for the second straight week amid a broader market pullback, along with earnings news from small- and micro-cap companies and presentations at multiple conferences.

Among the biggest news of the week is Johnson & Johnson's 

JNJ +1.15%
 (Get Free Alerts for JNJ) announcement regarding the spin-off of its Consumer Health business.

Eton Pharmaceuticals, Inc. 

ETON +3.08%
 (Get Free Alerts for ETON)'s topiramate oral solution received approval from the Food and Drug Administration for certain types of seizures in patients two years of age and older and as a preventative treatment of migraine in patients 12 years of age and older.

Azurity Pharma, the sponsor of the new drug application, had purchased topiramate, along with two other neurology candidates from Eton. Eton is eligible to receive a $5 million milestone payment and also royalties on sales.

Oncorus, Inc. 

ONCR -45.59%
 was among the biggest decliners of the week following the company's presentation of early-stage data for a cancer immunotherapy candidate at the Society for Immunotherapy of Cancer conference.

Here are the key upcoming catalysts that a biotech investor should focus on in the unfolding week:

Conferences

Society For Immunotherapy of Cancer: Nov. 10-14 (hybrid event, to be held in Washington D.C. and to be available virtually)

American Association for the Study of Liver Diseases, AASLD, The Liver Meeting 2021: Nov. 12-15 (virtual meeting)

American Hear Association, or AHA, Scientific Sessions: Nov. 13-15

Guggenheim Healthcare Talks: 3rd Annual Neuro/Immunology Conference: Nov. 15-16 (virtual)

The Stifel 2021 Virtual Healthcare Conference: Nov. 15-17

The 34th International Papillomavirus Conference: Nov. 15-19 (virtual)

Jefferies London Healthcare Conference: Nov. 16-17 (in London) and Nov. 18-19 (virtual)

2021 Society For Neuro-Oncology, SNO, Annual Meeting: Nov. 18-21 (in Boston)

The American Society For Dermatologic Surgery, or ASDS, virtual Annual Meeting: Nov. 19-21

PDUFA Dates

The FDA is scheduled to rule on BioMarin Pharmaceutical Inc.'s 

BMRN +0.36%
 NDA for vosoritide, an investigational, once daily injection for treating children with achondroplasia, the most common form of disproportionate short stature in humans. The PDUFA date is set for Saturday, Nov. 20.

Clinical Readouts/Presentations

Standalone Releases

Kezar Life Sciences, Inc. 

KZR +5.81%
: interim Phase 2 data for KZR-616 in lupus and data for KZR-261 (Monday, at 4:30 pm)

ProQR Therapeutics N.V. 

PRQR -0.38%
: updated data from the Phase 1/2 InSight extension study of Sepofarsen in Leber congenital amaurosis type 10 (Thursday)

Plus Therapeutics, Inc. 

PSTV -0.58%
: Phase 1 data for Rhenium-186 NanoLiposome in glioblastoma multiforme (Thursday)

AASLD Presentations

CymaBay Therapeutics, Inc. 

CBAY +2.08%
: Phase 3 data for seladelpar in patients with primary biliary cholangitis

AHA Presentations

Milestone Pharmaceuticals Inc. 

MIST +7.68%
: new analyses on the impact of etripamil on heart rate in patients with paroxysmal supraventricular tachycardia (Sunday)

PhaseBio Pharmaceuticals, Inc. 

PHAS -3.65%
: prespecified interim analysis of pivotal REVERSE-IT Phase 3 trial of bentracimab for the reversal of the antiplatelet effects of ticagrelor in patients who present with uncontrolled major bleeding or who require surgery or invasive procedure (Monday)

Amarin Corporation plc 

AMRN -1.22%
: main results of the Phase 3 PREPARE-IT2 study of Vascepa vs placebo in outpatients With Covid-19 (Monday)

International Papillomavirus Conference Presentations

Vaccitech plc 

VACC -0.47%
: safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200

SNO Meeting Presentations

Candel Therapeutics, Inc. 

CADL +2.28%
: initial safety data on CAN-2409 in combination with Bristol-Myers Squibb Company's 
BMY +0.41%
 Opdivo from a phase 1 clinical trial in high-grade glioma

Chimerix, Inc. 

CMRX +2.35%
: clinical efficacy of ONC201 in recurrent H3 K27M-mutant diffuse midline glioma patients (Saturday)

ASDS Meeting Presentation

Dermata Therapeutics, Inc. 

DRMA -0.59%
: efficacy and safety results for its Phase 1b proof of concept study evaluating a single application of DMT410 to treat multiple aesthetic skin conditions (Friday)

Earnings

UroGen Pharma Ltd. 

URGN +1.7%
 (Monday, before the market open)
Milestone Scientific Inc. 
MLSS -0.42%
 (Monday, before the market open)
Trevena, Inc. 
TRVN +4.41%
 (Monday, before the market open)
Kala Pharmaceuticals, Inc. 
KALA -0.96%
 (Monday, before the market open)
Vascular Biogenics Ltd. 
VBLT +0.4%
 (Monday, before the market open)
DarioHealth Corp. 
DRIO -2.63%
 (Monday, before the market open)
Gamida Cell Ltd. 
GMDA +3.69%
 (Monday, before the market open)
Protalix BioTherapeutics, Inc. 
PLX +2.73%
 (Monday, before the market open)
AcelRx Pharmaceuticals, Inc. 
ACRX -0.28%
 (Monday, before the market open)
Athersys, Inc. 
ATHX -10.16%
 (Monday, before the market open)
Aytu Biopharma, Inc. 
AYTU +2.07%
 (Monday, after the close)
Pulse Biosciences, Inc. 
PLSE +0.23%
 (Monday, after the close)
INVO Bioscience, Inc. 
INVO +0%
 (Monday, after the close)
Evofem Biosciences, Inc. 
EVFM +1.39%
 (Monday, after the close)
Biocept, Inc. 
BIOC +3.4%
 (Monday, after the close)
ImmuCell Corporation 
ICCC +0.22%
 (Monday, after the close)
Eton Pharmaceuticals, Inc. 
ETON +3.08%
 (Get Free Alerts for ETON) (Monday, after the close)
Syndax Pharmaceuticals, Inc. 
SNDX +1.64%
 (Monday, after the close)
OptiNose, Inc. 
OPTN -1.57%
 (Monday, after the close)
Osmotica Pharmaceuticals plc 
OSMT -2.96%
 (Monday, after the close)
Mirum Pharmaceuticals, Inc. 
MIRM -0.5%
 (Monday, after the close)
Ra Medical Systems, Inc. 
RMED -2.4%
 (Monday, after the close)
Rockwell Automation, Inc. 
ROK +1.48%
 (Monday, after the close)
Precipio, Inc. 
PRPO +6.42%
 (Monday, after the close)
TFF Pharmaceuticals, Inc. 
TFFP +2.09%
 (Monday, after the close)
MediWound Ltd. 
MDWD +4.39%
 (Tuesday, after the close)
PAVmed Inc. 
PAVM -1.17%
 (Tuesday, after the close)
EDAP TMS S.A. 
EDAP +1.04%
 (Wednesday, after the close)

IPOs

IPO Quiet Period Expiry

Context Therapeutics Inc. 

CNTX +3.44%

Minerva Surgical, Inc. 
UTRS +0.1%

Xilio Therapeutics, Inc. 
XLO -6.69%

Ventyx Biosciences, Inc. 
VTYX -0.43%

https://www.benzinga.com/general/biotech/21/11/24077175/the-week-ahead-in-biotech-nov-14-nov-20-biomarin-fda-decision-tapering-earnings-news-flow-confere

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Colo. Gov frustrated with 'convoluted messaging out of the CDC and FDA'

 Colorado Gov. Jared Polis (D) on Sunday said he is frustrated with the “convoluted messaging” about booster shots coming from the Centers of Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), as his state currently grapples with a spike in COVID-19 cases.

Asked by host Margaret Brennan on CBS’s “Face the Nation” if he is disappointed that the CDC has not been clear in its guidance for when Americans should get their booster shots, Polis said he is “very frustrated” with the information coming from the two top health agencies.

“I've been very frustrated with the convoluted messaging out of the CDC and the FDA,” Polis told Brennan, before airing an endorsement for booster shots six months after becoming fully vaccinated.

“Everybody should get the booster after six months. The data is incredibly clear that it increases your personal protection level,” Polis said.

Americans were left confused last month when CDC officials appeared to disagree in their rulings on booster shots.

A CDC panel in September said it was recommending a third dose of Pfizer’s vaccine for people 65 years old and older, nursing home residents and those ages 18 through 64 who have underlying health conditions.

The panel was mulling including people in potentially high-exposure risk occupations in that group, but ultimately decided against it because they said there was not enough evidence showing that inoculated people under the age of 50 had waning protection against severe disease and hospitalization.

The FDA one day earlier had released a statement saying it was authorizing the Pfizer booster shot for individuals 65 and older and those 18 through 64 years old who are at high risk of severe COVID-19 illness and whose work has a potential high-risk of exposure, the last of which was not included in the CDC panel’s recommendation.

One day after the CDC panel ruled, however, agency Director Rochelle Walensky broke with the advisory committee and authorized the booster shot for the broader group, which included those in potentially high-risk environments.

Polis’ comments come as Colorado is facing a surge in COVID-19 cases, driven largely by the highly infectious delta variant.

He said that while his state was “largely spared” from the “delta spike” over the summer, Colorado is “getting it now.”

He added that the variant is “incredibly effective, like a heat seeking missile, at seeking out the unvaccinated, infecting them, hospitalizing them in large numbers and killing them in certain- in certain- far too often.”

Polis issued an executive order on Thursday that allows booster shots for all adults in Colorado.

Polis’ order declared the entire state at high risk for exposure or transmission of COVID-19 to make shots available to adults six months after their second dose of either Pfizer or Moderna’s vaccine, or two months after receiving the Johnson & Johnson vaccine.

https://thehill.com/homenews/sunday-talk-shows/581473-polis-frustrated-with-convoluted-messaging-out-of-the-cdc-and-fda

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Gottlieb pans 'confusing' CDC booster messaging

 Former Food and Drug Administration Commissioner Scott Gottlieb on Sunday said the Center for Disease Control and Prevention’s (CDC) “confusing messaging” around COVID-19 booster shots “may end up being one of the biggest missed opportunities in this pandemic.”

Asked by host Margaret Brennan on CBS’s “Face the Nation” why the CDC is not instructing Americans to get their booster shots now, Gottlieb said the trend in waning vaccine protection is “unmistakable,” before airing an endorsement for individuals to go out and get their third shot. 

“We now see very clear evidence of declining vaccine effectiveness over time. There's different reasons why that may be the case, but the trend is unmistakable. And this has been apparent since the end of the summer, now it's very clear,” Gottlieb said.

“Anyone who's eligible for a booster, and most Americans probably are eligible for a booster at this point, should be going out and seeking it,” he added.

Americans were left confused in September when CDC officials appeared to disagree on who was eligible for a COVID-19 booster shot.

The agency’s advisory committee announced that it was recommending a third dose of the Pfizer-BioNTech vaccine for individuals 65 years and older, nursing home residents and people ages 18 through 64 who have underlying health conditions.

The panel was considering including individuals in potentially high-exposure risk occupations to that list, but it ultimately decided not to because they said there was not enough evidence illustrating that protection in vaccinated people younger than 50 years old was decreasing against severe disease and hospitalization.

One day later, however, CDC Director Rochelle Walensky bucked the panel’s recommendation and authorized the booster shot for the larger group, which included those in potentially high-risk environments.

Pressed on why he considers the booster messaging from the health agency to be the biggest misstep during the pandemic, Gottlieb, who sits on the board of Pfizer, said administering third shots could have helped address the delta wave earlier.

“I think when we look back, this may be a very big missed opportunity to try to get ahead of this Delta wave, again, because this is going to be the fastest way that we can increase the total immunity in the population,” Gottlieb said.

He noted that officials, in addition to tracking total immunity in the population must keep an eye on “depth of immunity,” which refers to “how many people have a lot of residual immune protection against this virus and are going to be what we call a dead-end host and not going to be someone who can catch and spread this virus.”

"And the fastest way to turn someone into a dead-end host is to get them fully vaccinated. There's a lot of people with declining vaccine effectiveness right now who can both catch and spread this virus. If we give them a booster, we restore the full effectiveness of that vaccine,” Gottlieb said.

"If you go out and start vaccinating someone right now for the first time, it might take five or six weeks for them to get full immunity in many parts of the country. This delta wave will be over in five or six weeks, so we need to do what we can right now,” he added.

https://thehill.com/homenews/sunday-talk-shows/581478-gottlieb-pans-confusing-cdc-booster-messaging

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Chinese court rules against Kangmei in 'milestone' class action case

 

A Chinese court ruled on Friday against Kangmei Pharmaceutical Co and some of its former executives, handing victory to investors in China's first class-action lawsuit against corporate fraud.

The ruling by the Intermediate People's Court of Guangzhou was hailed by China's securities regulator as a "milestone" event in the country's capital markets.

Under the ruling, Kangmei must pay 55,326 investors a total of 2.46 billion yuan ($385.51 million) to reimburse their losses. Former Chairman Ma Xingtian and his wife, as well as four former executives, are liable for the obligations.

Kangmei was engaged in intentional and systematic financial cheating worth 30 billion yuan ($4.60 billion) between 2016 and 2018, the China Securities Regulatory Commission (CSRC) has concluded.

CSRC said in a statement that the costly penalty against the executives holds the "top evils" responsible, and will help intimidate capital-market wrong-doers.

Kangmei could not immediately be reached for comment on the ruling.

China, which vows "zero tolerance" against accounting fraud, launched the country's first class-action lawsuit https://www.reuters.com/article/china-markets-classaction-idUSL4N2M93GB against Kangmei last April.

CSRC said that in addition to Friday's ruling, the Foshan Procuratorate is launching criminal charges against former Kangmei Chairman Ma.

https://www.marketscreener.com/quote/stock/KANGMEI-PHARMACEUTICAL-CO-6498032/news/Chinese-court-rules-against-Kangmei-in-milestone-case-37001362/

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Black Friday Smartphone Deals: Top Early Samsung Galaxy, Google Pixel, Apple iPhone, OnePlus & More

 Save on a wide selection of smartphone deals at the early Black Friday sale, together with Apple iPhone 13, Google Pixel 6 & Samsung Galaxy S21 savings

Here’s our round-up of the top early smartphone deals for Black Friday, featuring the latest offers on the OnePlus 9, Google Pixel 5 & other Apple and Android cell phones. Find the full selection of deals using the links below.

Best Cell Phone Deals:

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Black Friday Bowflex Deals: Early Treadmill, Elliptical, Spin Bike & More Gym

 Early Black Friday Bowflex deals have landed, check out the best early Black Friday dumbbell, kettle bell & more sales listed below

Here’s our review of all the best early Bowflex deals for Black Friday, together with offers on SelectTech adjustable dumbbells, benches and more. Shop the latest deals using the links below.

Best Bowflex Deals:

Best Exercise Equipment Deals:

Want some more deals? We recommend checking Walmart’s Black Friday deals and Amazon’s Black Friday page to enjoy hundreds more live deals right now. Deal Tomato earns commissions from purchases made using the links provided.

https://www.marketscreener.com/news/latest/Black-Friday-Bowflex-Deals-2021-Early-Treadmill-Elliptical-Spin-Bike-More-Gym-Equipment-Savin--37019173/

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