The Daily Biotech Pulse: Supernus Issues Positive ADHD Readout, Sorrento Files For Emergency Use Authorization For Rapid COVID-19 Test, Inhibikase To Make Wall Street Debut

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. 22)

• Aclaris Therapeutics Inc ACRS
• Adaptive Biotechnologies Corp ADPT
• Allakos Inc ALLK
• Allovir Inc ALVR
• Alpine Immune Sciences Inc ALPN
• Amicus Therapeutics, Inc. FOLD
• Arrowhead Pharmaceuticals Inc ARWR
• Arvinas Inc ARVN
• Atea Pharmaceuticals, Inc. AVIR
• Athira Pharma Inc ATHA
• AtriCure Inc. ATRC
• Beam Therapeutics Inc BEAM
• BioNTech SE – ADR BNTX
• Bioanalytical Systems, Inc. BASI
• BIO-TECHNE Corp TECH
• BioLife Solutions Inc BLFS
• Blueprint Medicines Corp BPMC
• BridgeBio Pharma Inc BBIO
• C4 Therapeutics Inc CCCC
• CareDx Inc CDNA
• Corcept Therapeutics Incorporated CORT
• Denali Therapeutics Inc DNLI
• Edap Tms SA EDAP
• Edwards Lifesciences Corp EW
• Eidos Therapeutics Inc EIDX
• ESSA Pharma Inc EPIX
• EXACT Sciences Corporation EXAS
• Glaukos Corp GKOS
• Guardant Health Inc GH
• Integra Lifesciences Holdings Corp IART
• Intuitive Surgical, Inc. ISRG
• Kodiak Sciences Inc KOD
• Kymera Therapeutics Inc KYMR
• Mersana Therapeutics Inc MRSN
• MiMedx Group Inc MDXG
• Nantkwest Inc NK
• Natera Inc NTRA
• NeoGenomics, Inc. NEO
• Neuronetics Inc STIM
• OncoSec Medical Inc ONCS
• Organogenesis Holdings Inc ORGO
• Orphazyme A S ADR ORPH
• Otonomy Inc OTIC
• Oxford Immunotec Global PLC OXFD
• Pacific Biosciences of California Inc PACB
• PLx Pharma Inc PLXP
• PRA Health Sciences Inc PRAH
• Precigen Inc PGEN
• Prelude Therapeutics Inc PRLD
• Profound Medical Corp PROF
• Pulmonx Corp LUNG
• PTC Therapeutics, Inc. PTCT
• SAGE Therapeutics Inc SAGE
• Sanara Medtech Inc SMTI
• Sangamo Therapeutics Inc SGMO
• Sarepta Therapeutics Inc SRPT
• Seelos Therapeutics Inc SEEL
• Sigilon Therapeutics, Inc. SGTX
• Shockwave Medical Inc SWAV
• Spero Therapeutics Inc SPRO
• SpringWorks Therapeutics Inc SWTX
• Surface Oncology Inc SURF
• Summit Therapeutics Inc SMMT
• Syros Pharmaceuticals Inc SYRS
• TG Therapeutics Inc common stock TGTX
• Turning Point Therapeutics Inc TPTX
• Twist Bioscience Corp TWST
• Ultragenyx Pharmaceutical Inc RARE
• Vascular Biogenics Ltd VBLT
• Vericel Corp VCEL
• Vistagen Therapeutics Inc VTGN
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 22)

• Gilead Sciences, Inc. GILD
• Histogen Inc HSTO
• Immunome Inc IMNM
• Soligenix, Inc. Common Stock SNGX
• Virios Therapeutics LLC VIRI (listed on Thursday)

Stocks In Focus

Supernus ADHD Treatment Aces Late-Stage Trial

Supernus Pharmaceuticals Inc SUPN announced positive top-line results from the Phase 3 study of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder.

At a daily dose of up to 600 mg, the trial met the primary endpoint with robust statistical significance compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator symptom rating scale, the company said.

The study also met the key secondary efficacy endpoint, with statistical significance in the change from baseline of the clinical global impression – severity of Illness scale at week six, Supernus said. 

SPN-812 is being reviewed by the FDA to treat ADHD in pediatric populations ages six to 17. The company plans to meet with the FDA in January to discuss a CRL the agency issued for the NDA.

The stock was up 28.24% premarket Wednesday at $28.88. 

FDA Imposes Clinical Hold On Study of Voyager's Out-Licensed Parkinson's Disease Gene Therapy

Voyager Therapeutics Inc VYGR said the FDA has notified its licensor Neurocrine Biosciences, Inc. NBIX that the RESTORE-1 Phase 2 clinical trial of NBIb-1817, an intracerebral AAV-based investigational gene therapy in development for the treatment of Parkinson's disease, has been placed on clinical hold.

The clinical hold follows Neurocrine's submission of an IND safety report related to the observation of MRI abnormalities in some RESTORE-1 study participants.

Neurocrine Biosciences and Voyager will work closely with the FDA and the DSMB to determine the next steps for the RESTORE-1 clinical trial, Voyager said.

Neurocrine licensed the investigational asset from Voyager.

Voyager shares were down 10.08% to $8.12 in premarket trading.

Merck Signs $356M COVID-19 Treatment Supply Deal With The US

Merck & Co., Inc. MRK said it has entered into an agreement with the U.S. government to support the development, manufacture and initial distribution of an investigational biological therapeutic, codenamed CD24Fc and to be named MK-7110, upon approval or emergency use authorization emergency use authorization from the FDA.

Merck acquired MK-7110, an investigational asset being evaluated for severe and critical COVID-19 patients, through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.

Under the agreement, Merck will receive up to approximately $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the government through June 30, 2021.

In premarket trading Wednesday, Merck shares were rising 0.71% to $79.98. 

Related Link: The Week Ahead In Biotech: Light Calendar In Abbreviated Week Features 1 IPO, 1 FDA Decision

Pfizer-BioNTech To Supply Additional 100M Doses of Coronavirus Vaccine To US Government For $1.95B

Pfizer Inc. PFE and BioNTech SE - ADR BNTX announced a second agreement with the U.S. government to supply an additional 100 million doses of the companies' COVID-19 Vaccine from production facilities in the U.S. The companies expect to deliver the full 200 million doses to Operation Warp Speed by July 31, 2021. The U.S. government will pay $1.95 billion for the additional 100 million doses.

Sorrento Applies For Emergency Use Authorization Of Rapid COVID-19 Antigen Test

Sorrento Therapeutics Inc SRNE said it has submitted an emergency use application to the FDA for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients.

In premarket trading Wednesday, the stock was rallying 9.42% to $7.90. 

Harvard Bioscience Refinances Debt With New Credit Facility

Harvard Bioscience, Inc. HBIO announced refinancing of its debt with the closing of a new $65-million credit facility. Proceeds from the new facility will be used to retire existing debt and pay related fees and expenses, the company said.

The refinancing significantly reduces borrowing costs while increasing operating flexibility through less restrictive financial covenants and access to higher levels of revolver borrowings, Harvard Biosciences said. 

The stock was rising 9.95% to $4.75 in premarket trading Wednesday.

Spectrum Pharma Reports Mixed Results For Lung Cancer Study, Plans To File For Approval With Cohort 2 Data From Midstage Trial

Spectrum Pharmaceuticals, Inc. SPPI said the FDA has agreed to the submission of an NDA based on data from Cohort 2 of the Phase 2 ZENITH20 clinical trial that is evaluating poziotinib in a once-daily 16 mg dose in previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

The company also reported that its pre-specified primary endpoint was not met in Cohort 3, which consisted of first-line NSCLC patients with EGFR exon 20 insertion mutations, who were administered 16 mg once daily.

Spectrum also reported that preliminary data from patients receiving 8 mg of poziotinib twice daily demonstrated meaningful improvement in tolerability as measured by adverse events and dosing interruptions.

The company said it is preparing for a regulatory filing in 2021.

In premarket trading, the stock was down 9.17% to $3.86.

Roche's Breast Cancer Combo Treatment Approved In Europe

Roche Holdings AG Basel ADR Common Stock RHHBY said the European Commission has approved Phesgo, a fixed-dose combination of monoclonal antibodies Perjeta and Herceptin, with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer.

The Perjeta and Herceptin combination is administered by a single subcutaneous injection utilizing Halozyme Therapeutics, Inc.'s HALO Enhanze technology.

Translate Bio's CFO to Depart By Year's End

Translate Bio Inc TBIO said CFO John Schroer is leaving the company, effective year-end 2020. The company's corporate controller Robert Prentiss will serve as principal accounting officer on an interim basis while a formal search process to appoint a new CFO is conducted, the company said. 

Regenxbio To Sell Portion Of Zolgensma Royalty Revenues For $200M

Regenxbio Inc RGNX said it has agreed to sell a portion of the royalty rights due from Novartis AG NVS for the sale of Zolgensma to Healthcare Royalty Management for $200 million. Regenxbio said it expects the transaction to provide immediate non-dilutive capital to pursue development of gene therapy candidates and completion of internal manufacturing capabilities.

Zolgensma is a treatment option for spinal muscular dystrophy based on Regenxbio's NAV technology.

Offerings

Cellectar Biosciences Inc CLRB said it intends to offer shares of its common stock and common stock equivalents in an underwritten public offering.

Concurrently with the completion of the public offering, the company plans to sell to certain investors in a private placement, shares of common stock and convertible preferred stock at a price equal to the public offering price.

The stock was plunging 29.96% to $1.94 in premarket trading Wednesday.

On The Radar

IPOs

Atlanta-based Inhibikase Therapeutics Inc. priced its initial public offering of 1.8 million shares of its common stock at $10 per share compared to the initially estimated range of $10-$12 per share, for raising gross proceeds of $18 million. The shares will be listed on the Nasdaq under the ticker symbol IKT. Inhibikase is a clinical stage pharmaceutical company developing therapeutics for Parkinson's disease.
Related Link: Sarepta, Amicus Top Biotech Picks Ahead Of Key Binary Events: Analyst