The Daily Biotech Pulse: Merck Shelves 2 COVID-19 Studies, Bristol-Myers Squibb Gets European Regulatory Nod, InspireMD's Reverse Split

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 April 14)

• 10x Genomics, Inc. TXG
• Affimed N.V. AFMD
• Bio-Techne Corporation TECH - announced out-licensing of antibody treatment candidate to Xencor, Inc. XNCR
• BioNTech SE BNTX - reacted to increased EU orders for its COVID-19 vaccine in the wake of the Johnson & Johnson JNJ setback 
• Globus Medical, Inc. GMED
• Medpace Holdings, Inc. MEDP
• Medtronic plc MDT
• Merit Medical Systems, Inc. MMSI
• Natus Medical Incorporated NTUS
• NuVasive, Inc. NUVA
• PLx Pharma Inc. PLXP
• PPD, Inc. PPD - moved on rumors of a potential buyout by Thermo Fisher Scientific Inc. TMO
• ShockWave Medical, Inc. SWAV
• Supernus Pharmaceuticals, Inc. SUPN
• Zimmer Biomet Holdings, Inc. ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 14)

• Bellerophon Therapeutics, Inc. BLPH
• Celyad Oncology SA CYAD
• Design Therapeutics, Inc. DSGN
• Kronos Bio, Inc. KRON
• Lixte Biotechnology Holdings, Inc. LIXT
• Metacrine, Inc. MTCR
• Millendo Therapeutics, Inc. MLND
• Nabriva Therapeutics plc NBRV
• Osmotica Pharmaceuticals plc OSMT
• Reviva Pharmaceuticals Holdings, Inc. RVPH
• Titan Pharmaceuticals, Inc. TTNP

Stocks In Focus

Regenxbio Doses First Patient In Gene Therapy Study

REGENXBIO Inc. RGNX said it dosed the first patient in Cohort 3 of the ongoing Phase I/2 trial of RGX-121 for the treatment of Mucopolysaccharidosis Type II, also known as Hunter Syndrome, in patients up to five years old.

RGX-121 is an investigational one-time gene therapy designed to deliver the gene that encodes the iduronate-2-sulfatase enzyme using the AAV9 vector. RGX-121 is administered directly to the central nervous system.

The stock gained 5.4% to $37.25 in after-hours trading.

Novavax Confirms Participation In Combination COVID-19 Vaccine Study In UK

Novavax, Inc. NVAX said it is participating in a newly expanded investigator-initiated Phase 2 clinical trial called "Comparing COVID-19 Vaccine Schedule Combinations – Stage 2," dubbed Com-COV2, to be conducted by the University of Oxford and supported by the U.K. Vaccines Taskforce.

Novavax's recombinant protein vaccine candidate NVX-CoV2373 is one of four COVID-19 vaccines that will be studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19.

The stock was up 2.18% premarket to $205.72.

Pacira Initiates Legal Proceedings Against Publication

Pacira BioSciences, Inc. PCRX said it has filed a lawsuit against the American Society of Anesthesiologists and various other defendants, seeking pecuniary damages and the retraction of three articles that it said create the false and misleading impression that its Exparel is not an effective analgesic.

The stock was down 1.35% to $68.49 in premarket trading Thursday.

Bristol-Myers Squibb Announces European Approval For Kidney Cancer Combo Treatment 

Bristol-Myers Squibb BMY said the European Commission has approved its Opdivo in combination with Exelixis, Inc.'s EXEL Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.

Merck Pulls Plug On COVID-19 Asset, Shelves Study of Another In Hospitalized COVID-19 Patients

Merck MRK and partner Ridgeback Biotherapeutics said a decision has been made to proceed with the Phase 3 portion of MOVe-OUT in outpatients with COVID-19 evaluating the 800 mg dose of molnupiravir twice daily.

Yet the companies have decided not to proceed with the Phase 3 study of molnupiravir in hospitalized patients, as data from MOVe-IN indicate that molnupiravir is unlikely to demonstrate a clinical benefit in this population.

Separately, Merck announced the discontinuation of development of MK-7110 for the treatment of hospitalized patients with COVID-19. The company acquired MK-7110 in December 2020 through its acquisition of OncoImmune.

Related Link: The Week Ahead In Biotech (April 11-17): Avenue Therapeutics FDA Decision and Conference Presentations In The Spotlight

Roche Reports Positive Long-Term Phase 2/3 Data For Spinal Muscular Dystrophy Treatment In Infants

Roche Holding AG RHHBY announced new two-year data from Part 2 of FIREFISH, a Phase 2/3 global study evaluating Evrysdi in infants ages 1-7 months at enrollment with symptomatic Type 1 spinal muscular atrophy.

The data shows Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support.

The study also showed Evrysdi continued to improve survival, improve ability to feed orally and reduce the need for permanent ventilation. Exploratory data suggested Evrysdi continued to improve the ability to swallow and reduce hospitalizations compared to the natural course of Type 1 SMA. Safety for Evrysdi was consistent with its established safety profile.

Neuronetics Names Robert Cascella As Chairman

Neuronetics, Inc. STIM announced that Brian Farley will retire from its board and his role as chairman following its annual shareholder meeting scheduled for May 27. The company named Robert Cascella, who joined the board on April 1, as chairman of its board following Farley's retirement. The board will now have seven members.

InspireMD Announces 1-For-15 Reverse Split

InspireMD, Inc. NSPR announced a 1-for-15 reverse split of its common stock effective April 26. Beginning on April 27, the stock will trade on the NYSE American on a split-adjusted basis.

The stock was down 9.15% premarket at 50 cents. 

Compass Announces Publication Of Positive Results For Depression Drug

COMPASS Pathways plc CMPS announced publication of the results of an exploratory study in the New England Journal of Medicine showing signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram for major depressive disorder.

COMP360 is Compass' proprietary formulation of synthetic psilocybin.

AbCellera Announces Collaboration Agreement For Antibody Drug Discovery

AbCellera Biologics Inc. ABCL and Empirico announced  a strategic multi-target discovery collaboration.

Through each company's proprietary technologies, the multi-target collaboration leverages hyper-scale datasets, machine learning and advanced computation to both identify high-value, genetically validated drug targets and discover novel therapeutic antibodies, the companies said.

Under the terms of the agreement, Empirico will have the rights to develop and commercialize novel antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive downstream clinical and commercial milestone payments and royalties on net sales of products from Empirico.

Abcellera shares were up 2.65% to $29 in premarket trading Thursday.

On The Radar

Clinical Readouts

Chinook Therapeutics, Inc. KDNY will present at the the International Society of Nephrology's World Congress of Nephrology with Gd-IgA1 biomarker data in healthy volunteers from Parts 1 and Part 2 of the ongoing Phase 1 study of BION-1301 in immunoglobin A nephropathy, as well as data from the Phase 1 intravenous to subcutaneous bioavailability study in healthy volunteers.

Earnings

• Affimed N.V. AFMD (before the market open)
• Centogene N.V. CNTG Centogene N.V. CNTG (before the market open)
• Adamis Pharmaceuticals Corporation ADMP

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