The Daily Biotech Pulse: FDA Nod For Amgen's Biosimilar, Moderna's Vaccine Vote, Mesoblast Sinks On Data

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Dec. 17)

• Acceleron Pharma Inc XLRN
• Alexion Pharmaceuticals, Inc. ALXN
• AtriCure Inc. ATRC
• Avanos Medical Inc AVNS
• Bioanalytical Systems, Inc. BASI
• BioLife Solutions Inc BLFS
• BridgeBio Pharma Inc BBIO
• Castle Biosciences Inc CSTL
• Certara Ord Shs CERT
• Chimerix Inc CMRX
• Corcept Therapeutics Incorporated CORT
• Chinook Therapeutics Inc KDNY
• Clearpoint Neuro Inc CLPT
• Corcept Therapeutics Incorporated CORT
• Denali Therapeutics Inc DNLI
• Eli Lilly And Co LLY
• Eidos Therapeutics Inc EIDX
• Foghorn Therapeutics Inc. FHTX
• Frequency Therapeutics Inc FREQ
• Genmab 10 Sponsored ADR Ord Shs GMAB
• Glaukos Corp GKOS
• Inhibrx Inc INBX
• Integra Lifesciences Holdings Corp IART
• Kiromic Biopharma Inc KRBP (announced submission of two IND applications to the FDA)
• MannKind Corporation MNKD
• Medpace Holdings Inc MEDP
• MiMedx Group Inc MDXG
• NeoGenomics, Inc. NEO
• Nevro Corp NVRO
• Nkarta Inc NKTX
• Oncorus Inc ONCR
• OncoSec Medical Inc ONCS
• Organogenesis Holdings Inc ORGO
• Otonomy Inc OTIC (announced positive results for Phase 1/2 study of therapy to treat hearing loss)
• PRA Health Sciences Inc PRAH
• Prelude Therapeutics Inc PRLD
• Prevail Therapeutics Inc PRVL
• Sanara Medtech Inc SMTI
• Scopus Biopharma Inc SCPS
• SI-Bone Inc SIBN
• Silverback Therapeutics Inc (NASDAQ: SBTX
• Solid Biosciences Inc SLDB
• Spero Therapeutics Inc SPRO (announced appointment of a new CFO)
• SpringWorks Therapeutics Inc SWTX
• Stoke Therapeutics Inc STOK
• Summit Therapeutics Inc SMMT
• Tarsus Pharmaceuticals Inc TARS
• Ultragenyx Pharmaceutical Inc RARE
• X T L Biopharmaceuticals Ltd XTLB
• Zai Lab Ltd – ADR ZLAB ( reacted to FDA approval for partner MacroGenics Inc's MGNX breast cancer therapy)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 16)

• Galapagos ADR Representing Ord Shs GLPG
• Histogen Inc HSTO (announced filing of an IND for HST-003 for knee cartilage regeneration)
• InMed Pharmaceuticals Inc INM
• Olema Pharmaceuticals Inc OLMA
• Sonnet BioTherapeutics Holdings, Inc. SONN (reacted to its fiscal-year 2020 results)

Stocks In Focus

Mereo Out-licenses Brittle Bone Disease Drug to Ultragenyx For Up to $304M

Mereo BioPharma Group MREO and Ultragenyx announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta.

The agreement provides for Ulltragenyx leading future global development of setrusumab in both pediatric and adult patients, and commercializing it in the U.S. and rest of the world, excluding Europe, Mereo retains commercial rights for Europe.

Ultragenyx will make an upfront payment of $50 million to Mereo and a total of up to $254 million upon achievement of certain clinical, regulatory, and commercial milestones. Ultragenyx will pay tiered double-digit percentage royalties to Mereo on net sales outside of Europe, and Mereo will pay a fixed double digit percentage royalty to Ultragenyx on net sales in Europe.

In after-hours trading, Mereo shares jumped 39.37% to $3.08.

Mesoblast's Stem Cell Therapy Unlikely to Achieve Primary Endpoint In COVID-19 Study

Mesoblast MESO said Data Safety Monitoring Board that performed a third interim analysis of data from a study of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection said the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The committee recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.

The committee, however, said there are no safety concerns.

Mesoblast, which is partnering with Novartis AG NVS in the program, said both companies plan to analyze these results to identify meaningful clinical outcomes that may guide decisions on the development program for remestemcel-L in non-COVID ARDS.

The stock slumped 31.83% to $9.25 in after-hours trading.

Moderna's Vaccine Candidate Endorsed By FDA Panel

Moderna MRNA said the FDA's Vaccines and Related Biological Products Advisory Committee recommended that the regulator grant an emergency use authorization for its investigational vaccine, mRNA-1273, with a 20-0 vote. One member abstained from voting.

Vir, GlaxoSmithKline Commence Phase 3 Trial of Antibody Treatment For COVID-19

Vir Biotechnology Inc VIR and GlaxoSmithKline plc GSK announced that the first patient has been dosed in a new sub-trial of NIH-sponsored Phase 3 trial that is evaluating the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 is a fully human anti-SARS-CoV-2 investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs.

FDA Approves Amgen's Rituxan Biosimilar

Amgen, Inc. AMGN said the FDA approved Riabni, a biosimilar to Roche Holdings AG's RHHBY Rituxan, for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Riabni will be made available in the U.S. in January 2021.

Mannkind Announces Co-promotion Agreement For Hypothyroidism Enzyme Replacement Therapy

Mannkind and Vertice Pharma announced that they have entered into a co-promotion agreement for Thyquidity oral solution through MannKind's specialty sales force. Thyquidity is indicated as a replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism.

Under the terms of the agreement, MannKind's sales force will promote Thyquidity, and Vertice will pay Mannkind a specified quarterly to defray the costs of the additional promotional activity as well as royalties on gross profit resulting from all sales of Thyquidity.

Mannkind shares were up 2.48% to $4.14 in premarket trading.

Oyster Point Submits Regulatory Filing For Dry Eye Disease Drug

Oyster Point Pharma Inc OYST said it has submitted a 505(b)(2) NDA to the FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease.

BioTelemetry to Be Bought By Philips For $72/Share

BioTelemetry Inc BEAT announced a deal to be acquired by Royal Philips for $72.00 per share, implying an enterprise value of $2.8 billion.

In premarket trading Friday, BioTelemetry shares were rallying 18.16% to $73.

Offerings

Vistagen Therapeutics Inc VTGN said it has priced its underwritten public offering consisting of 63 million shares of its common stock at a price of 92 cents per share, and 2 million shares of its Series D convertible preferred stock at $21.16 per share. The company expects to raise $100 million in gross proceeds from the offerings.

The stock was rising 6.95% to 99 cents in premarket trading Friday.

On The Radar

Clinical Readouts

CNS Pharmaceuticals Inc CNSP is scheduled to discuss on a conference call, investigational new drug approval for its lead product candidate, Berubicin, for the treatment of glioblastoma multiforme, and the planned Phase 2 Berubicin clinical trial.

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