The Daily Biotech Pulse: Vir-GlaxoSmithKline COVID-19 Antibody Treatment Approved, Zosano Spikes On Long-Term Migraine Drug Data, Decision Day For Eton, 2 IPOs

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 May 26)

I-Mab IMAB
Nuvation Bio Inc. NUVB
PDS Biotechnology Corporation PDSB
Pieris Pharmaceuticals, Inc. PIRS
PLx Pharma Inc. PLXP
West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 26)

Assembly Biosciences, Inc. ASMB
Axcella Health Inc. AXLA
Black Diamond Therapeutics, Inc. BDTX
Bolt Biotherapeutics, Inc. BOLT
Coherus BioSciences, Inc. CHRS
Evofem Biosciences, Inc. EVFM
Impel NeuroPharma, Inc. IMPL
IMV Inc. IMV
Intercept Pharmaceuticals, Inc. ICPT
Ionis Pharmaceuticals, Inc. IONS
Kiniksa Pharmaceuticals, Ltd. KNSA
Larimar Therapeutics, Inc. LRMR (reacted to a clinical hold imposed on Phase 1 study of CTI-1601 in Friedreich ataxia)
Spruce Biosciences, Inc. SPRB
Travere Therapeutics, Inc. TVTX (flagged a delay in regulatory filing for drug to treat kidney scarring)
Viking Therapeutics, Inc. VKTX

Stocks In Focus

Vir-GlaxoSmithKline's Antibody Treatment Approved For Mild-To-Moderate COVID-19

GlaxoSmithKline plc GSK and Vir Biotechnology, Inc. VIR said the FDA granted an emergency use authorization for sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients12 years of age and older weighing at least 40 kg who have tested positive for SARS-CoV-2 and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks, the companies said.

Vir shares rallied 9.27% to $50 in after-hours trading.

Legend Biotech's Out-Licensed Multiple Myeloma Cell Therapy Accepted For Priority Review By FDA

Legend Biotech Corporation LEGN sad the FDA has accepted for priority review the biologics license application submitted by Johnson & Johnson's JNJ Janssen unit for ciltacabtagene autoleucel, or Cilta-cel, an investigational B-cell maturation antigen-directed chimeric antigen receptor T cell therapy being evaluated for relapsed and/or refractory multiple myeloma.

Legend Biotech out-licensed the cell therapy to Janssen based on a 2017 collaboration agreement.

The Prescription Drug User Fee Act target action date has been set for November 29.

Legend shares gained 3.3% to $38.78 in after-hours trading.

Ironwood Settles With Teva Over Generic Versions Of Irritable Bowel Syndrome Treatment

Ironwood Pharmaceuticals, Inc. IRWD announced that, along with its partner AbbVie Inc. ABBV, it has agreed to provide a license to Teva Pharmaceutical Industries Limited's TEVA abbreviated new drug application seeking approval to market a generic version of 72 mcg Linzess prior to the expiration of the companies' applicable patents.

Linzess is an FDA-approved treatment for irritable bowel syndrome and chronic idiopathic constipation.

With this agreement, the companies have settled with the filers of all known ANDAs to date seeking approval to market generic versions of LInzess. Teva will be granted a license to market its 72 mcg generic version of Linzess in the U.S. beginning March 31, 2029. The earliest licensed entry of any generic Linzess, 72 mcg, 145 mcg or 290 mcg in the U.S. is March 2029.

Ocugen To Apply For Emergency Use Authorization For Covaxin In June

Ocugen, Inc. OCGN confirmed its plan to submit its emergency use authorization application for Covaxin to the FDA in June.

The announcement assumes significance due to the fact that the FDA, in updated guidelines for emergency use authorization, said it will deny processing of authorization through this route except in cases where the companies have already engaged with the agency.

The stock slipped 0.91% to $7.59 in after-hours trading.

Pfizer, Myovant Announce FDA Nod For Myfembree In Uterine Fibroids

Pfizer, Inc. PFE and Myovant Sciences MYOV announced FDA approval for once-daily Myfembree, relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg, for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.

The companies said they will jointly commercialize Myfembree in the U.S. Myfembree is expected to be available in June.

Pfizer shares edged down 0.15% to $38.86 in after-hours trading and Myovant receded 0.34% to $23.60.

Zosano Announces Publication Of Positive Results From Long-Term Use Of Migraine Drug

Zosano Pharma Corporation ZSAN announced that an article titled, "Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine" was published in the Journal of Headache and Pain

This open-label, multicenter observational study was designed to evaluate the safety and efficacy of the repeated use of Qtrypta in adults with migraine who had historically experienced at least two migraine attacks per month.

The tolerability and efficacy results in this long-term study were consistent with the results observed in the Phase 2/3 ZOTRIP study.

The FDA had handed down a complete response letter for Zosano's NDA for Qtryptain in December.

In after-hours trading, the stock jumped 26.34% to 94 cents.

Lantheus' Prostate Cancer PET Imaging Agent Approved By FDA

Lantheus Holdings, Inc. LNTH announced FDA approval for Pylarify, an F 18-labeled prostate-specific membrane antigen targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer. Pylarify is the first and only commercially available approved PSMA PET imaging agent for prostate cancer.

The product will be immediately available in parts of the mid-Atlantic and southern regions and availability is expected to rapidly expand over the next six months with broad availability across the U.S. anticipated by year's end.

The shares were jumping 22.3% to $23.86 in premarket trading Thursday.

Sanofi, GSK Commence Late-Stage COVID-19 Vaccine Study

Sanofi SNY and GlaxoSmithKline announced the commencement of a Phase 3 clinical study to assess the safety, efficacy and immunogenicity of the companies' adjuvanted recombinant-protein COVID-19 vaccine candidate.

The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the U.S., Asia, Africa and Latin America.

Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved/authorized in the fourth quarter of 2021, the companies said. Manufacturing will begin in the coming weeks to enable rapid access to the vaccine should it be approved.

Bausch Health To Reduce Debt By $100M

Bausch Health Companies Inc. BHC announced it will reduce debt by $100 million through the redemption of outstanding senior notes using cash generated from operations.

The stock was seen adding 0.44% to $32.10 in premarket trading Thursday.

Novartis Kickstarts Phase 2/3 Study Of COVID-19 Treatment Candidate

Novartis AG NVS and Molecular Partners AG MLLCF announced the start of a Phase 2 and 3 study to explore the use of the latter's novel DARPin therapeutic candidate ensovibep for the treatment of COVID-19.

Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.

Selecta Biosciences Gains On Insider Buying

Selecta Biosciences, Inc. SELB disclosed in two separate filings that its chief medical officer Peter Traber bought 17,500 shares, and Timothy Springer, a director of the board, purchased 1.9 million shares.

The stock gained 3.17% to $4.23 in after-hours trading.

Precision Appoints Alex Kelly As Permanent CFO

Precision BioSciences, Inc. DTIL announced the appointment of Alex Kelly as chief financial officer. Kelly joined Precision BioSciences in October as chief corporate affairs officer and has served as the company's interim CFO since December 2020.

Offerings

Reviva Pharmaceuticals Holdings, Inc. RVPH priced its upsized underwritten public offering of 8 million shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying investor warrants to purchase up to 6 million shares of common stock.

Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one investor warrant to purchase 0.75 shares of common stock at a combined effective price of $3.75. The investor warrants will be immediately exercisable at an exercise price of $4.125 per share of common stock and will expire five years from the date of issuance.

The stock fell 3.62% to $4.26 in after-hours trading.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Eton Pharmaceuticals, Inc.'s (NASDAQ: ETON NDA for dehydrated alcohol injection for the treatment of methanol poisoning.

Adcom Meeting

FDA's Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to discuss Provention Bio, Inc.'s PRVB BLA for teplizumab intravenous infusion for the delay or prevention of clinical type 1 diabetes mellitus in at-risk individuals.

Earnings

Medtronic plc MDT (before the market open)
RedHill Biopharma Ltd. RDHL (before the market open)
Can-Fite BioPharma Ltd. CANF (before the market open)
AnPac Bio-Medical Science Co., Ltd. ANPC (before the market open)
Ascendis Pharma A/S ASND (after the close)

IPOs

Day One Biopharmaceuticals, Inc., a clinical-stage biopharma dedicated to developing and commercializing targeted therapies for patients of all ages with genetically defined cancers, priced its initial public offering of 10 million shares of its common stock at a public offering price of $16 per share.

All of the shares are being offered by Day One. The gross proceeds from the offering are expected to be $160 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "DAWN." The offering is expected to close on June 1 subject to the satisfaction of customary closing conditions.

Singular Genomics Systems, Inc., a company focused on delivering genomic technologies for the advancement of science and medicine, priced its upsized IPO of 10.2 million shares of its common stock at a price of $22 per share. All of the shares of common stock are being offered by Singular Genomics.

The gross proceeds from the offering are expected to be $224.4 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "OMIC."

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