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The Daily Biotech Pulse: FDA Nod For Amphastar's Generic Glucagon, Arcturus Sinks On Vaccine Data, Decision Day For Osmotica

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Shanthi Rexaline
·6 min read
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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. 28)

  • Aclaris Therapeutics Inc (NASDAQ: ACRS)

  • Allakos Inc (NASDAQ: ALLK)

  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)

  • Arvinas Inc (NASDAQ: ARVN)

  • Atea Pharmaceuticals, Inc. (NASDAQ: AVIR)

  • AtriCure Inc. (NASDAQ: ATRC)

  • BIO-TECHNE Corp (NASDAQ: TECH)

  • BridgeBio Pharma Inc (NASDAQ: BBIO)

  • Cellectis SA (NASDAQ: CLLS)

  • Crispr Therapeutics AG (NASDAQ: CRSP)

  • Curis, Inc. (NASDAQ: CRIS)

  • Edwards Lifesciences Corp (NYSE: EW)

  • ESSA Pharma Inc (NASDAQ: EPIX)

  • Eton Pharmaceuticals Inc (NASDAQ: ETON)

  • Evelo Biosciences Inc (NASDAQ: EVLO)

  • Evogene Ltd (NASDAQ: EVGN)

  • Inari Medical Inc (NASDAQ: NARI)

  • Integra Lifesciences Holdings Corp (NASDAQ: IART)

  • Intellia Therapeutics Inc (NASDAQ: NTLA)

  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)

  • Kodiak Sciences Inc (NASDAQ: KOD)

  • Kymera Therapeutics Inc (NASDAQ: KYMR)

  • Lumos Pharma Inc (NASDAQ: LUMO)

  • Medicenna Therapeutics Corp (NASDAQ: MDNA)

  • Myovant Sciences Ltd (NYSE: MYOV) - announced a licensing deal with Pfizer Inc. (NYSE: PFE) for up to $4.2 billion

  • Natera Inc (NASDAQ: NTRA)

  • Neuronetics Inc (NASDAQ: STIM)

  • NGM Biopharmaceuticals Inc (NASDAQ: NGM)

  • Novocure Ltd (NASDAQ: NVCR)

  • Organogenesis Holdings Inc (NASDAQ: ORGO)

  • Pacific Biosciences of California Inc (NASDAQ: PACB)

  • Praxis Precision Medicines Inc (NASDAQ: PRAX)

  • Precigen Inc (NASDAQ: PGEN)

  • SAGE Therapeutics Inc (NASDAQ: SAGE)

  • Sangamo Therapeutics Inc (NASDAQ: SGMO)

  • Silverback Therapeutics Inc (NASDAQ: SBTX)

  • Spero Therapeutics Inc (NASDAQ: SPRO)

  • Vericel Corp (NASDAQ: VCEL)

  • XOMA Corp (NASDAQ: XOMA)

  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 28)

  • AbCellera Biologics Inc (NASDAQ: ABCL)

  • Aprea Therapeutics Inc (NASDAQ: APRE) - announced negative Phase 3 data for its eprenetapopt with Bristol-Myers Squibb Co's (NYSE: BMY) chemo medication Vidaza in TP53 mutant myelodysplastic syndromes

  • Gilead Sciences, Inc. (NASDAQ: GILD)

  • Inhibikase Therapeutics Inc (NASDAQ: IKT) (went public Wednesday)

  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)

  • Liquidia Corp (NASDAQ: LQDA)

  • Opthea Spon American Depositary Receipts Representing 8 Ord Shs (NASDAQ: OPT)

  • Pharming Group N.V. (NASDAQ: PHAR) (went public Wednesday)

  • Qualigen Therapeutics Inc (NASDAQ: QLGN)

  • Virios Therapeutics LLC (NASDAQ: VIRI)

  • Yumanity Therapeutics Inc (NASDAQ: YMTX)

Stocks In Focus Amphastar Gets FDA Approval For Generic Glucagon Injection To Treat Very Low Blood Sugar Levels

The FDA announced approval of Amphastar Pharmaceuticals Inc's (NASDAQ: AMPH) generic glucagon for injection USP, 1mg/vial packaged in emergency kit for the treatment of hypoglycemia, which may occur in patients with diabetes mellitus.

In premarket trading, the stock was up 18.72% to $22.58.

Novo Nordisk Files For EU Label Expansion For Diabetes Drug

Novo Nordisk A/S (NYSE: NVO) announced the submission of a label extension application to the European Medicines Agency for Ozempic, a once-weekly glucagon-like peptide-1 analogue, to introduce a new dose of 2mg. Ozempic is currently approved in the EU in 0.5mg and 1mg doses for the treatment of type 2 diabetes in adults.

The stock was up 1.27% to $71.14 in premarket trading Tuesday.

Arcturus Releases Phase 1/2 Vaccine Data, Gets Singaporean Regulatory Nod For Commencing Phase 2 Study

Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) said it has received approval from the Singapore Health Science Authority to proceed with a Phase 2 study of ARCT-021, its coronavirus vaccine candidate.

Phase 1/2 data demonstrated favorable tolerability, with immunogenicity observed in 100% of vaccinated subjects receiving 7.5 µg single dose & 5 µg single and prime-boost regimens, the company said.

Responder peak geometric mean neutralizing antibody titers of 32, 33 and 46 were observed following 5 µg single dose, 7.5 µg single dose and 5 µg prime-boost participants, respectively.

This compares to antibody titers of 12 to 1,818 observed in convalescent sera.

The Phase 2 study will enable selection of the optimal ARCT-021 vaccination regimen for Phase 3 registrational studies, it added.

The company expects to report interim Phase 2 data in early 2021 providing support for the anticipated initiation of a global Phase 3 study in the second quarter of 2021.

The stock plunged 37.46% to $57.80 in premarket trading.

Related Link: The Week Ahead In Biotech (Dec. 27-Jan. 2): Data Releases, Regulatory Filings To Move Stocks

Mirum's CEO Buys Shares

Mirum Pharmaceuticals Inc (NASDAQ: MIRM) shares rose in reaction to a SEC filing that revealed that the company's CEO Christopher Peetz bought 5,000 shares of the company.

The stock was up 6.14% premarket to $18.85.

Zai Lab's Licensed Ovarian Cancer Drug Eligible For Reimbursement In China

Zai Lab Ltd – ADR (NASDAQ: ZLAB) said Zejula has been included in the updated National Reimbursement Drug List released by China's National Healthcare Security Administration.

Zejula has been included in the NRDL as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

"NHSA reimbursement will help make ZEJULA affordable to many patients in need across China," said William Liang, Zai Lab's chief commercial officer.

In 2016, the company licensed the drug from Tesaro, which was subsequently acquired by GlaxoSmithKline plc (NYSE: GSK). Zai Lab has the rights for the drug in Mainland China, Hong Kong and Macau.

Nevro Submits Premarket Approval Supplement Seeking Nod For Therapy To Treat Painful Diabetic Neuropathy

Nevro Corp (NYSE: NVRO) said it has submitted a premarket approval supplement to the FDA to seek approval of its Senza System for the treatment of chronic pain associated with painful diabetic neuropathy, or PDN.

"This submission is a significant milestone in the evaluation of Nevro's proprietary HF10 high frequency spinal cord stimulation therapy to address the many PDN patients who are unable to find relief with currently available pharmacologic options," said Keith Grossman, Nevro's CEO.

Assuming a six-month review period and a regulatory nod, the company expects to market Senza System and HF10 therapy for treatment of chronic pain in PDN patients in the second half of 2021.

Alkermes' Schizophrenia Drug NDA Resubmission Accepted For Review

Alkermes Plc (NASDAQ: ALKS) said the FDA has acknowledged the receipt of its NDA resubmission for ALKS 3831 for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new PDUFA date of June 1, 2021.

The stock was adding 9.6% premarket Tuesday to $23.29. 

On The Radar PDUFA Dates

The FDA is scheduled to rule on Osmotica Pharmaceuticals PLC's (NASDAQ: OSMT) NDA for Ontinua (arbaclofen) ER for treating spasticity in patients with multiple sclerosis. The investigational asset had faced an earlier rejection in 2016 due to manufacturing issues at clinical trial sites.

Related Link: 5 Biotech Stocks That Generated 1,000%+ Returns In 2020

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