Why Horizon Therapeutics, Selecta Biosciences Are Moving In Synch

Shares of Horizon Therapeutics PLC HZNP 3.53%, which focuses on rare and rheumatic diseases, surged higher Thursday despite an absence of announcements from the biopharma.

What Happened: Horizon shares moved in sympathy with Selecta Biosciences Inc SELB 33.87%, which announced an adverse mid-stage clinical data readout for SEL-212.

Selecta's Phase 2 study compared SEL-212 to Horizon's Krystexxa, which is the approved uricase in the U.S. for the treatment of chronic refractory gout.

SEL-212 combines Selecta's ImmTOR immune tolerance platform and a therapeutic uricase enzyme, and the company has out-licensed it to Swedish Orphan Biovitrum AB.

Krystexx came into Horizon's stable with its 2015 acquisition of Creata Holdings, which acquired the asset from its original developer Savient Pharma in 2013.

Savient had received the FDA nod for Krystexxa in Sept. 2010.

"SEL-212 showed a numerically higher response rate on the primary endpoint during months three and six combined, but did not meet the primary endpoint of statistical superiority," Selecta said, in the announcement of the topline data for the Phase 2 study dubbed COMPARE.

SEL-212 led to a statistically significant greater overall reduction in mean SUA levels relative to Krystexxa, Selecta said.

Why It's Important: Krystexxa fetched Horizon $75.2 million — or roughly 20% of its total revenue of $379.3 million — in the second quarter ended June 30. 

The setback to the next-gen competing drug-in-development is a clear near-term positive for Horizon.

Selecta said it now looks ahead to evaluate SEL-212 in an ongoing double-blind, placebo-controlled Phase 3 DISSOLVE program.

HZNP, SELB Price Action: Horizon shares gained 3.53% to end Thursday's session at $80.42. 

Selecta shares lost 33.87% and closed the session at $1.64. 

https://www.benzinga.com/general/biotech/20/10/17740755/why-horizon-therapeutics-selecta-biosciences-are-moving-in-sympathy

Oct. FDA, CDC Meetings On Covid Vaccines Set Stage For Emergency Use Authorization

Even as the world — and investors — await a coronavirus vaccine, the timeline has become increasingly hard to gauge given clinical setbacks and the risks inherent with fast development. 

An analyst at Canaccord Genuity said a year-end timeline looks a possibility, going by two key events scheduled for this month. 

Upcoming FDA, CDC Meetings: With five SARS-CoV-2 vaccine candidates in pivotal Phase 3 trials, two meetings scheduled for late October could be the key, Canaccord analyst Arlinda Lee said in a note. 

The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet between 10 a.m. and 5 p.m. on Oct. 22 to discuss the development, authorization and/or licensure of vaccines to prevent COVID-19.

Also on tap is the CDC's Advisory Committee on Immunization Practices meeting. The AICP panel will meet Oct. 28-30, which is one of its customary three yearly meetings to review scientific data and vote on vaccine recommendations.

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

The Late-Stage Coronavirus Vaccine Programs: AstraZeneca plc's AZN 0.91% ChAdOx1 nCoV-19, a chimpanzee adenovirus expressing SARS-CoV-2 spike, is in late-stage trials in the U.K., India and South Africa.

The late-stage study in the U.K. was voluntarily paused briefly due to an adverse event in one of the study participants.

The U.S. leg of the study remains halted, with a Reuters report suggesting the FDA has widened the scope of its probe into the halted trial.

Pfizer Inc. PFE 0.82% and BioNTech SE – ADR BNTX 5.03%, which are collaborating on a mRNA vaccine against SARS-CoV-2, recently amended its Phase 3 study protocol to increase the targeted enrollment from 30,000 to 44,000.

The increase was to accommodate a diverse population.

Recently, BioNTech announced plans to acquire Novartis AG's NVS 0.44% GMP-certified manufacturing facility in Germany, which would increase its COVID-19 vaccine production capacity by up to 750 million doses per year.

Johnson & Johnson JNJ 0.98% initiated a Phase 3 study of its coronavirus vaccine candidate JNJ-78436735 on Sept. 23.

JNJ-78436735 is manufactured using J&J's AdVac technology platform, which was used to develop and manufacture its Janssen unit's European Commission-approved Ebola vaccine.

The company has an early 2021 timeline for emergency use authorization. 

Moderna Inc MRNA 1.02% has enrolled over 90% of the targeted enrollment number of 30,000 in the Phase 3 trial of its vaccine candidate mRNA-1273. The company is guiding for emergency use authorization by the end of 2020, although it doesn't expect authorization to come before the end of November.

Novavax, Inc. NVAX 3.18% has an ongoing Phase 3 study of its NVX-CoV2373, a recombinant nanoparticle vaccine, in the U.K.

The company plans to start a late-stage study in the U.S. in October.

https://www.benzinga.com/analyst-ratings/analyst-color/20/10/17742758/october-fda-cdc-meetings-on-coronavirus-vaccines-set-stage-for-emergency-use-author