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

Down In The Dumps

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

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

Stocks In Focus

Supernus ADHD Treatment Aces Late-Stage Trial

Supernus Pharmaceuticals Inc (NASDAQ: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 (NASDAQ:VYGR) said the FDA has notified its licensor Neurocrine Biosciences, Inc. (NASDAQ: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. (NYSE: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. (NYSE:PFE) and BioNTech SE - ADR (NASDAQ: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 (NASDAQ: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. (NASDAQ: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. (NASDAQ: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 (OTC: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 (NASDAQ:HALO) Enhanze technology.

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

Translate Bio Inc (NASDAQ: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 (NASDAQ:RGNX) said it has agreed to sell a portion of the royalty rights due from Novartis AG (NYSE: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 (NASDAQ: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