Y-mAbs Completes Pre-BLA Meeting with FDA for Omburtamab

 Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it recently completed a Pre-Biologics License Application (“pre-BLA”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma. The Company expects to resubmit the BLA for omburtamab by the end of the first quarter 2022.

A data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial Sloan Kettering (“MSK”), where 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab, showed that patients had a median survival of 50.0 months, with the final median not yet being reached. The Company intends to submit the complete clinical data package in the BLA and announce the data later this year.

https://finance.yahoo.com/news/y-mabs-announces-completion-pre-140000401.html

Why Neurocrine Biosciences Is Trading Higher

 Neurocrine Biosciences Inc 

NBIX +6.82%

 (Get Free Alerts for NBIX) reported Q4 Ingrezza sales of $301 million, +25% Y/Y, with total prescriptions up 32%

• Overall sales increased $312.0 million 26%, missing the consensus of $316.79 million.
• Ingrezza (valbenazine) is indicated for adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
• "As we exited last year with restored growth for INGREZZA, investments we are making this year will further accelerate our ability to help many more patients with tardive dyskinesia who remain undiagnosed and untreated. Additionally, we now have 12 clinical programs in mid-to-late-stage studies, many which will generate important data readouts over the next two years," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences.
• Q4 adjusted net income and EPS were $4 million and $0.04, respectively, compared with $87 million and $0.89, respectively, for Q4 FY20, driven by the $100 million upfront fee paid to Sosei Heptares under exclusive license agreement.
• On December 31, 2021, the Company held cash, cash equivalents, and marketable securities of $1.3 billion.
• Guidance: For FY22, Neurocrine expects Ingrezza sales of $1.25 billion - $1.35 billion.

https://www.benzinga.com/general/biotech/22/02/25568826/why-neurocrine-biosciences-are-trading-higher-today

Seagen delivers a triple blow

 A painful cut to guidance by one of the sector’s success stories is far from what biotech needs right now. But this is exactly what Seagen delivered, yesterday taking the axe to sales forecasts for all three of its top cancer drugs. The best the sellside could muster was that the company tends to guide conservatively, but this provided little comfort: Seagen's stock tanked 15% at the open today, slicing more than $3bn from its valuation. The biggest disappointment came with the Her2 kinase inhibitor Tukysa; guidance implies that sales might have already peaked after a mere two years on the market. The breast cancer drug is struggling to compete against astonishingly good data from Daiichi and Astrazeneca’s Enhertu, and the bull case for Tukysa – that strong CNS activity would continue to drive use in patients with brain metastases – is starting to feel like sheer optimism. Investors will have to hope that Seagen is laying out the worst-case scenario for 2022, but there are more risks to long-term numbers on the horizon. Several clinical readouts are looming that have the potential to take the company's products into new markets, and positive outcomes could not be more crucial. 

Swinging the axe: Seagen's sales vs expectations
	Annual sales ($m)
	2020 (actual)		2021 (actual)	2021 (consensus)		2022 guidance	2022 consensus		2026 consensus
Padcev	222		340	323		435-455	544		2,323
Tukysa	120		334	324		315-355	534		1,535
Adcetris	659		706	700		730-755	804		1,387
Source: Evaluate Pharma, company statements.

 

Looking for long-term potential: key readouts for Seagen
Padcev (currently approved in 3rd-line metastatic urothelial cancer)
EV-103/Keynote-869	Cohort H, Padcev monotherapy, neoadjuvant MIBC	Asco-GU February 17-19
	Cohort K, Padcev + Keytruda, 1st-line chemo ineligible metastatic urothelial (potential for AA)	H2'22
EV-302	Padcev + Keytruda, 1st-line metastatic urothelial cancer	2023
Note: EU approval in 2nd-line setting paused for additional CHMP questions related to severe skin reactions. Final decision expected H2'22.
Tukysa (currently approved in 2nd-line metastatic breast cancer, on top of Herceptin and chemo)
Mountaineer	Tukysa +/- Herceptin in previously treated, metastatic Her2+ colorectal cancer	H2'22
Note: MIBC=muscle-invasive bladder cancer; AA= accelerated approval. Source: Company statements, clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/seagen-delivers-triple-blow

Gilead: Remdesivir Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants

 Gilead Sciences, Inc. (Nasdaq: GILD) today released data demonstrating the in vitro activity of Veklury® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Results of Gilead studies are consistent with other in vitro studies independently conducted by researchers from institutions in other countries, including Belgium, Czech Republic, Germany, Poland, and the United States, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron.

The study analyzed in vitro antiviral activity by two methods to understand the susceptibility of ten major SARS-CoV-2 variants to Veklury. The study results showed similar activity of Veklury against the variants and an early ancestral A lineage isolate detected in Seattle, WA (WA1 strain). Specifically, Delta and Omicron variants both remained fully susceptible to Veklury, and these laboratory results demonstrate that Veklury has remained active against all major variants isolated over the past two years.

Veklury directly inhibits viral replication inside host cells by targeting the SARS-CoV-2 RNA-dependent RNA polymerase. On entering the body, Veklury is transformed into the active triphosphate metabolite, which is then incorporated into the viral RNA and stops replication of the virus within the infected cells. The study analyzed nearly 6 million publicly available variant isolate sequences and confirmed that the nsp12 protein, the RNA polymerase target of Veklury, is highly conserved across all variants. Further characterization confirmed that none of the few identified nsp12 mutations prevalent in some of the SARS-CoV-2 variants affects the virus susceptibility to Veklury.

https://finance.yahoo.com/news/veklury-remdesivir-retains-antiviral-activity-130100296.html

Transcript : DexCom, Inc., Q4 2021 Earnings Call, Feb 10, 2022

 https://www.marketscreener.com/quote/stock/DEXCOM-INC-9115/news/Transcript-DexCom-Inc-Q4-2021-Earnings-Call-Feb-10-2022-37848952/

Transcript : Ultragenyx Pharmaceutical Inc., Q4 2021 Earnings Call, Feb 10, 2022

 https://www.marketscreener.com/quote/stock/ULTRAGENYX-PHARMACEUTICAL-15672076/news/Transcript-Ultragenyx-Pharmaceutical-Inc-Q4-2021-Earnings-Call-Feb-10-2022-37849040/

Transcript : Illumina, Inc., Q4 2021 Earnings Call, Feb 10, 2022

 https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Transcript-Illumina-Inc-Q4-2021-Earnings-Call-Feb-10-2022-37849045/