Biotech week ahead, Nov. 1

 Biotech stocks rose a third week running in the week ending Oct. 29 amid positive reaction to earnings. Big pharma earnings were mostly better than expected.

Merck & Co, Inc. 

MRK +1.78%

 (Get Free Alerts for MRK) led the gains among large-cap pharma companies, with a weekly gain of over 8%, thanks to its third-quarter results that were notably above expectations. Investor optimism can also be attributed to expectations concerning its COVID-19 antiviral treatment being developed with Ridgeback.

Meanwhile, Gilead Sciences, Inc. 

GILD -3.65%

 (Get Free Alerts for GILD) shares came under pressure after the biopharma tempered its forecasts for non-COVID-19 sales.

Regulatory decisions for the week were mixed. 

Eyenovia, Inc. 

EYEN -3.54%

's MydCombi new drug application was shot down with a complete response letter, while Clearside Biomedical, Inc. NASDAQLSD & Bausch Health Companies Inc. 

BHC +1.72%

 received a regulatory nod for their Xipere for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.

On a positive vaccine-related news flow Pfizer, Inc. 

PFE +1.23%

-BioNTech SE 

BNTX -1.77%

 received Food and Drug Administration authorization for their COVID-19 vaccine for use in the pediatric population.

HCW Biologics Inc. 

HCWB -5.5%

 was among the biggest advancers of the week after it was given the nod for proceeding with the Phase 1b trial of its pancreatic cancer treatment candidate. On the other hand, Cortexyme, Inc. 

CRTX -7.43%

 fell about 80% for the week following a failed Alzheimer's trial.

News on initial public offerings exelarated, with three biotechs pricing their offerings and listing on Wall Street.

Here are the key catalysts that are scheduled for the unfolding week:

Healthcare Conferences:

Psych Congress: Oct. 29-Nov. 1, in San Antonio (hybrid)
North American Cystic Fibrosis Conference, or NACFC: Nov. 2-5 (virtual)
International Society for Affective Disorders, or ISAD, Conference: Nov. 3-4 (virtual)
4th Inflammatory Skin Disease Summit: Nov. 3-6, in New York
American College of Rheumatology, or ACR, Convergence 2021: Nov. 3-9 (virtual)
Neuroscience Education Institute, or NEI, Congress: Nov. 4-7, in Colorado Springs, Colorado (hybrid)
The American Society of Nephrology, or ANS, Kidney Week 2021: Nov. 4-7 (virtual)

PDUFA Dates

The FDA is scheduled to rule on Eton Pharmaceuticals, Inc. 

ETON -0.35%

's NDA for topiramate oral solution as a treatment option for three indications – as a monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years of 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 of migraine in patients 12 years of age and older.

The original PDUFA date of Aug. 6 was extended by three months to provide the regulator time to review a recent amendment to the application by Azurity Pharma. Azurity had purchased topiramate, along with two other neurology candidates from Eton. Eton is eligible to receive a $5 million milestone payment, contingent on regulatory approval, and royalties on sales. The new PDUFA date is Nov. 6.

Clinical Readouts/Presentations

Inflammatory Skin Disease Summit Presentations

RAPT Therapeutics, Inc. 

RAPT -3.66%

: additional efficacy results from a Phase 1b monotherapy trial of RPT193 in patients with moderate-to-severe atopic dermatitis (Wednesday, at 5 pm – 5:30 pm)

NACFC Presentations

Calithera Biosciences, Inc. 

CALA -0.52%

: data from the Phase 1b trial of CB-280, Calithera's investigational arginase inhibitor for the treatment of cystic fibrosis (poster presentation available on Monday, and poster session with presenting authors available via live video chats on Wednesday, at 1:10 pm-1:50 pm)

ANS Meeting Presentations

Talaris Therapeutics, Inc. 

TALS +7.24%

: data from continued long-term follow-up of patients treated in the Phase 2 study of FCR001, as well as findings from urinary cell mRNA profiling of a subgroup of those Phase 2 patients (Thursday, at 1 pm to 3 pm)

GlaxoSmithKline plc 

GSK +0.51%

: late-breaking Phase 3 data for daprodustat as a potential treatment for patients with anemia due to chronic kidney disease in both dialysis and non-dialysis populations (Friday, 1:30 pm)

Alnylam Pharmaceuticals, Inc. 

ALNY -1.59%

: full results from the ILLUMINATE-C Phase 3 study of lumasiran in Primary hyperoxaluria type 1

Equillium, Inc. 

EQ +7.13%

: an Interim subgroup analysis from a Phase 1b study of itolizumab in systemic lupus patients with proteinuria

Chinook Therapeutics, Inc. 

KDNY -0.09%

: initial results of a Phase 1/2 study of BION-1301 in patients with IgA nephropathy

Vera Therapeutics, Inc. 

VERA +9.69%

: data for the company's lead product candidate, atacicept, from the Phase 2a JANUS clinical trial in patients with IgA nephropathy

DiaMedica Therapeutics Inc. 

DMAC -1.25%

: late-breaking data from the Phase 2 REDUX trial of DM199 in chronic kidney disease (Thursday, 1 pm)

Dicerna Pharmaceuticals, Inc. 

DRNA -2.98%

: data from the PHYOX2 trial of nedosiran, an investigational RNAi candidate for the treatment of primary hyperoxaluria

ACR Convergence Presentations

Tonix Pharmaceuticals Holding Corp. 

TNXP -0.16%

: Positive results of a Phase 3 efficacy and safety trial of TNX-102 SL for the treatment of fibromyalgia (Saturday, at 11:45 am-12 pm)

Earnings

Monday

Hologic, Inc. 

HOLX +0.89%

 (after the close)
Neurocrine Biosciences, Inc. 

NBIX +3.46%

 (after the close)

Tuesday

Sage Therapeutics, Inc. 

SAGE -1.94%

 (before the market open)
Pfizer Inc. 

PFE +1.23%

 (before the market open)
Myriad Genetics, Inc. 

MYGN -3.81%

 (before the market open)
Incyte Corporation 

INCY +1.89%

 (before the market open)
Integra LifeSciences Holdings Corporation 

IART -0.82%

 (before the market open)
Esperion Therapeutics, Inc. 

ESPR +1.02%

 (before the market open)
Catalent, Inc. 

CTLT +1.73%

 (before the market open)
Bio-Techne Corporation 

TECH +1.63%

 (before the market open)
Avanos Medical, Inc. 

AVNS -0.16%

 (before the market open)
Pulmonx Corporation 

LUNG -1.82%

 (after the close)
Amgen Inc. 

AMGN -0.08%

 (after the close)
Deciphera Pharmaceuticals, Inc. 

DCPH -3.11%

 (after the close)
Exelixis, Inc. 

EXEL -1.15%

 (after the close)
Exact Sciences Corporation 

EXAS -1.58%

 (after the close)
Halozyme Therapeutics, Inc. 

HALO -0.31%

 (after the close)
Inspire Medical Systems, Inc. 

INSP +3.75%

 (after the close)
Pacific Biosciences of California, Inc. 

PACB -0.79%

 (after the close)
MacroGenics, Inc. 

MGNX -1.86%

 (after the close)
REGENXBIO Inc. 

RGNX -2.98%

 (after the close)
Ultragenyx Pharmaceutical Inc. 

RARE -1%

 (after the close)
Vertex Pharmaceuticals Incorporated 

VRTX +1.61%

 (after the close)
Related Link: Novavax Rips Higher After Completing Regulatory Filing For Authorization Of COVID-19 Vaccine In UK

Wednesday

Agios Pharmaceuticals, Inc. 

AGIO -2.89%

 (before the market open)
Amneal Pharmaceuticals, Inc. 

AMRX +0.73%

 (before the market open)
Horizon Therapeutics Public Limited Company 

HZNP +1.75%

 (before the market open)
Amarin Corporation plc 

AMRN +2.14%

 (before the market open)
Intercept Pharmaceuticals, Inc. 

ICPT -3.05%

 (before the market open)
Ionis Pharmaceuticals, Inc. 

IONS +2.15%

 (before the market open)
Pacira BioSciences, Inc. 

PCRX +0.36%

 (before the market open)
Syneos Health, Inc. 

SYNH +2.83%

 (before the market open)
United Therapeutics Corporation 

UTHR -0.73%

 (before the market open)
Praxis Precision Medicines, Inc. 

PRAX -3.75%

 (before the market open)
Viking Therapeutics, Inc. 

VKTX -2.51%

 (after the close)
Outset Medical, Inc. 

OM +0.04%

 (after the close)
Zymergen Inc. 

ZY +1.92%

 (after the close)
Heron Therapeutics, Inc. 

HRTX +0.18%

 (after the close)
Ortho Clinical Diagnostics Holdings plc 

OCDX +1.18%

 (after the close)
Supernus Pharmaceuticals, Inc. 

SUPN +1.12%

 (after the close)
Sarepta Therapeutics, Inc. 

SRPT -0.15%

 (after the close)
QIAGEN N.V. 

QGEN +2.46%

 (after the close)
Penumbra, Inc. 

PEN -0.45%

 (after the close)
ICU Medical, Inc. 

ICUI +1.69%

 (after the close)
Corcept Therapeutics Incorporated 

CORT +1.35%

 (after the close)
AtriCure, Inc. 

ATRC -0.42%

 (after the close)
Adaptive Biotechnologies Corporation 

ADPT -3.3%

 (after the close)
10x Genomics, Inc. 

TXG -1.92%

 (after the close)

Thursday

Zimmer Biomet Holdings, Inc. 

ZBH -1.64%

 (before the market open)
Regeneron Pharmaceuticals, Inc. 

REGN +2.36%

 (before the market open)
NeoGenomics, Inc. 

NEO -0.02%

 (before the market open)
Moderna, Inc. 

MRNA -0.78%

 (before the market open)
Lantheus Holdings, Inc. 

LNTH +2.18%

 (before the market open)
Ironwood Pharmaceuticals, Inc. 

IRWD -0.31%

 (before the market open)
Intellia Therapeutics, Inc. 

NTLA -2.3%

 (before the market open)
Sangamo Therapeutics, Inc. 

SGMO -2.52%

 (before the market open)
Jounce Therapeutics, Inc. 

JNCE +2.57%

 (before the market open)
Fulcrum Therapeutics, Inc. 

FULC -5.83%

 (before the market open)
Chimerix, Inc. 

CMRX -3.85%

 (before the market open)
Provention Bio, Inc. 

PRVB +0.16%

 (before the market open)
Aerie Pharmaceuticals, Inc. 

AERI +4.32%

 (after the close)
Aligos Therapeutics, Inc. 

ALGS -1.97%

 (after the close)
Allogene Therapeutics, Inc. 

ALLO +0.52%

 (after the close)
Global Blood Therapeutics, Inc. 

GBT +0.52%

 (after the close)
Caladrius Biosciences, Inc. 

CLBS +3.6%

 (after the close)
Bionano Genomics, Inc. 

BNGO -0.97%

 (after the close)
Kura Oncology, Inc. 

KURA -2.84%

 (after the close)
Y-mAbs Therapeutics, Inc. 

YMAB -4.51%

 (after the close)
Zogenix, Inc. 

ZGNX +1.19%

 (after the close)
Vir Biotechnology, Inc. 

VIR -2.28%

 (after the close)
Quidel Corporation 

QDEL +0.08%

 (after the close)
Puma Biotechnology, Inc. 

PBYI -2.11%

 (after the close)
Novavax, Inc. 

NVAX -1.19%

 (after the close)
Nektar Therapeutics 

NKTR -6.01%

 (after the close)
Natera, Inc. 

NTRA -2.24%

 (after the close)
Insulet Corporation 

PODD +0.01%

 (after the close)
Illumina, Inc. 

ILMN +0.37%

 (after the close)
Guardant Health, Inc. 

GH -1.18%

 (after the close)
Iovance Biotherapeutics, Inc. 

IOVA -3.72%

 (after the close)
Collegium Pharmaceutical, Inc. 

COLL -2.73%

 (after the close)
Globus Medical, Inc. 

GMED +0.4%

 (after the close)
Glaukos Corporation 

GKOS -0.13%

 (after the close)
Fate Therapeutics, Inc. 

FATE -3.89%

 (after the close)
Endo International plc 

ENDP +0.47%

 (after the close)
Emergent BioSolutions Inc. 

EBS -2.17%

 (after the close)
Axonics, Inc. 

AXNX +0.25%

 (after the close)
Arena Pharmaceuticals, Inc. 

ARNA -1%

 (after the close)

Friday

Elanco Animal Health Incorporated 

ELAN -0.06%

 (before the market open)

IPO Calendar

IPO Pricing

Hamburg, Germany-based Evotec SE NASDAQEVO has filed a preliminary prospectus with the SEC for a 22-million ADS initial public offering at a price of $26.16 per ADS. Each ADS represents one-half of one ordinary share. The per-ADS pricing is based on the closing price of the company's ordinary shares on the Frankfurt Stock Exchange Friday and assuming an exchange rate of $1.163 per euro. The company is a drug discovery and development partner for the pharmaceutical and biotechnology industry. The shares are expected to be listed on the Nasdaq under the ticker symbol "EVO."

Mainz Biomed B.V. NASDAQMYNZ is planning to offer 2 million ordinary shares in an IPO, with the offering expected to be priced between $4 and $6. The molecular genetics cancer diagnostic company has applied for listing its shares on the Nasdaq under the ticker symbol "MYNZ."

Belgium-based MDxHealth SA NASDAQMDXH is offering 3.75 million ADSs in an IPO, assuming an offer price of $13.46 per ADS. Each ADS represents ten ordinary shares. The commercial-stage precision diagnostics company has applied to list the ADSs on the Nasdaq under the ticker symbol "MDXH."

Nuvectis Pharma, Inc. NASDAQNVCT, a New Jersey-based biopharma focused on the development of precision medicines for the treatment of serious unmet medical needs in oncology, is planning a 2.3-million share IPO. The company expects the offering to be priced between $12 and $14 and has applied for listing its shares on the Nasdaq under the ticker symbol "NVCT."

IPO Quiet Period Expiry

Theseus Pharmaceuticals, Inc. 

THRX +6.53%

Cognition Therapeutics, Inc. 

CGTX -0.49%

IsoPlexis Corporation 

ISO +9.54%

Pyxis Oncology, Inc. 

PYXS +0.3%

https://www.benzinga.com/general/biotech/21/10/23778169/the-week-ahead-in-biotech-oct-31-nov-6-earnings-pick-up-pace-eton-awaits-seizure-drug-approval-ki

American Cancels 1,500 Flights Over Weekend, Denies Any Relation To Vaccine Mandate

 By Zachary Stieber of Epoch Times

American Airlines canceled over 1,500 flights between Oct. 29 and Oct. 31, blaming staff shortages and inclement weather. In addition to 340 flights being canceled on Friday, 540 were canceled on Saturday, and 650 were canceled on Sunday, a spokeswoman for the Texas-based airline told The Epoch Times in an email.

In a letter to employees obtained by The Epoch Times, American’s Chief Operating Officer David Seymour blamed “severe winds” in the Dallas-Fort Worth area with creating the situation.

“With additional weather throughout the system, our staffing begins to run tight as crew members end up out of their regular flight sequences,” he said. “To make sure we are taking care of our customers and providing scheduling certainty for our crews, we have adjusted our operation for the last few days this month by proactively canceling some flights.”

American projects having the issues resolved soon.

The spokeswoman said that the problems aren’t related to the company’s COVID-19 vaccine mandate. Capt. Dennis Tajer, a spokesman for the Allied Pilots Association, which represents American pilots, also said the cancellations are not linked to the vaccination requirements. Weather was the catalyst, but management failure also contributed, Tajer told The Epoch Times in an email.

“Management is failing at the most fundamental part of running an airline. Connecting crews to the airplane. Our employees are suffering this failure as much as passengers as crews are stuck out into their days off while scrambling to find hotels,” he said.

“Mother nature generates a storm and management’s failure to properly schedule creates storms days after,” he added.

Of the flights canceled on Saturday, all but around a dozen were due to the inability to connect workers to airplanes, Tajer said.

American announced the COVID-19 vaccine mandate on Oct. 1.

“While we are still working through the details of the federal requirements, it is clear that team members who choose to remain unvaccinated will not be able to work at American Airlines,” Doug Parker, American Airlines chief executive, said in a memorandum that day.

Executives at the company later said employees must be fully vaccinated by Nov. 24 or be fired.

Most U.S.-based airlines have imposed mandates, some in response to President Joe Biden’s plans to force private businesses to either get proof of vaccination from employees or require them to undergo weekly COVID-19 testing.

The head of the pilots association warned the White House and Congress last month that mandates could trigger chaos in the near future.

Southwest Airlines canceled thousands of flights earlier this month, leaving many travelers stranded for days. The airline claimed the problems were mostly due to unfavorable weather and not related to the mandate it imposed, though other airlines didn’t suffer problems at the same time and it later delayed a plan to put workers who don’t comply with the vaccination requirements on unpaid leave.

In addition to the weekend cancellations from American, the airline delayed hundreds of flights between Friday and Sunday, according to the tracking site FlightAware. That included 73 delays early Oct. 31.

American said nearly 1,800 flight attendants who were on leave would be returning to work soon and that it was hiring over 600 more flight attendants, in addition to working to hire 4,000 workers for other positions.

“The hiring of pilots and within tech ops continues to take place, and we already began ramping up hiring in reservations so more team members will be in place for the holiday season,” it said.

https://www.zerohedge.com/weather/american-cancels-1500-flights-halloween-weekend-denies-denies-any-relation-vaccine-mandate

Sanders working to get prescription drug price provision in social spending bill

 Progressive U.S. Senator Bernie Sanders said on Sunday that he was still working on getting a provision to lower prescription drug prices into the social spending bill pending in the U.S. Congress before a vote by the House of Representatives. 

  President Joe Biden was dealt a setback on Thursday as the House abandoned plans for a vote on an infrastructure bill before his departure to Europe for an international summit with other world leaders, with progressive Democrats seeking more time to consider his call for a separate $1.75 trillion plan to address climate measures, preschool and other social initiatives. 

  A proposal that would allow the U.S. government's Medicare health plan for seniors to negotiate prescription drug prices to make them cheaper was not included in the social spending bill. 

  "I spent all of yesterday on the telephone... We are continuing that effort (to include the prescription drug price provision in the bill)", Sanders told CNN in an interview on Sunday. 

  "It is outrageous that we continue to pay the highest prices in the world for prescription drugs," added Sanders, who has championed that cause for years. 

  Biden had sought to unite his fellow Democrats behind the climate and social spending plan with personal appeals on Thursday, and had pressed for a Thursday vote on the $1 trillion infrastructure bill, another main plank of his domestic agenda. 

  He hoped a framework on the larger measure would convince progressive House Democrats to support the infrastructure bill, but their insistence that the two move together led House leaders to abandon a planned vote. 

  The plan also did not include paid family leave or a tax on billionaires with some constituencies angered by the absence of key Biden administration pledges from the bill. 

https://finance.yahoo.com/news/sanders-working-prescription-drug-price-144254271.html