The Daily Biotech Pulse: Novavax Vaccine Supply Deal, Orphan Drug Designation For Travere, COVID-19 Boost For Quidel, Opko

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 Feb. 19)

• Angion Biomedica Corp ANGN
• Antares Pharma Inc ATRS
• Applied Molecular Transport Inc. AMTI
• Avanos Medical Inc AVNS (reacted to its fourth-quarter results)
• Celldex Therapeutics, Inc. CLDX
• Cellular Biomedicine Group Inc CBMG
• Cleveland BioLabs, Inc. CBLI
• Endo International PLC ENDP
• Immunome Inc IMNM ( reacted to discovery of antibodies against coronavirus variants)
• Mereo BioPharma Group plc – ADR MREO
• Nantkwest Inc NK
• Onconova Therapeutics Inc ONTX
• Processa Pharmaceuticals Inc PCSA
• Prothena Corporation PLC PRTA
• Rigel Pharmaceuticals, Inc. RIGL( announced a licensing and collaboration deal with Eli Lilly And Co LLY)
• Silence Therapeutics ADR Representing 3 Ord Shs SLN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 19)

• Avidity Biosciences Inc RNA
• Biophytis SA ADR BPTS (received regulatory nod in France and Belgium for expansion of patient recruitment for Part 2 of the Phase 2/3 COVID-19 study)
• Bioventus Class A Ord Shs (Proposed) BVS
• Pharming Group N V ADS each representing 10 Ord Shs PHAR
• Sana Biotechnology Inc SANA
• Uniqure NV QURE
• Vallon Pharmaceuticals Inc VLON

Stocks In Focus

Novavax Strikes $1B-dose Vaccine Supply Deal With Gavi

Novavax, Inc. NVAX announced a memorandum of understanding with Gavi to provide 1.1 billion cumulative doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility.

COVAX is a vaccine partnership co-led by the CEPI, Gavi and the WHO, which are working along with developed and developing country vaccine manufacturers, UNICEF, the World Bank, civil society organizations and others to guarantee fair and equitable access to the vaccine for every country in the world.

COVAX currently includes more than 190 participating economies.

The stock rallied 10.07% to $292 in after-hours trading.

Travere' Rare Kidney Disorder Drug Gets Orphan Drug Designation

Travere Therapeutics Inc TVTX said the European Commission has granted orphan designation to sparsentan for the treatment of IgA nephropathy, a rare kidney disorder and a leading cause of end-stage kidney disease.

Sparsentan is currently being evaluated in a pivotal Phase 3 clinical study for the treatment of IgAN, as well as a pivotal Phase 3 clinical study for the treatment of focal segmental glomerulosclerosis.

Topline data from the interim proteinuria assessment in the ongoing PROTECT Study of sparsentan in IgAN remain on track to be reported in the third quarter, Travere said.

The stock was up 2.69% to $30.50 in after-hours trading.

Pfizer/BioNTech Submit New Data to FDA Showing Stability of Coronavirus Vaccine at Standard Freezer Temperature

Pfizer Inc. PFE and BioNTech SE – ADR BNTX announced the submission of new data to the FDA, demonstrating the stability of their COVID-19 vaccine when stored at -25 degrees centigrade to -15 degrees centigrade, temperatures more commonly found in pharmaceutical freezers and refrigerators.

The data have been submitted to the FDA to support a proposed update to the U.S. emergency use authorization prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer, they said.

Viveve Expects Q4 Revenues to Exceed Consensus

Viveve Medical Inc VIVE announced preliminary fourth-quarter revenues of $1.9 million, above the $1.65-million consensus estimate. Additionally, the company said it expects a continued reduction in operating expenses, and a strengthened cash position following the close of its recent upsized financing of $27.6 million.

It is positioned with the capital resources to support operations through year-end 2022, including the planned completion of its pivotal U.S. PURSUIT trial in stress urinary incontinence.

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

Precision Announces Publication of Positive Long-term Animal Testing Data For Gene Editing Technology In Lowering Cholesterol

Precision BioSciences Inc DTIL announced the publication of a paper in Molecular Therapy describing three-year follow-up data showing long-term stable reduction of low-density lipoprotein cholesterol levels in non-human primates following in vivo gene editing of the PCSK9 gene with its proprietary ARCUS genome editing platform.

The stock was adding 1.50% to $11.50 in premarket trading Friday.

Immunocore's Tebentafusp Gets Breakthrough Therapy Designation For Treating Melanoma of Eye

Immunocore Holdings PLC – ADR IMCR said the FDA granted breakthrough therapy designation for tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

Dr. Reddy's Begins Rolling Submission For Regulatory Review of Russia-developed COVID-19 Vaccine In India

Dr.Reddy's Laboratories Ltd RDY said it has initiated the process with the Drugs Controller General of India for emergency use authorization of human adenoviral vector-based platform vaccine candidate, Sputnik V.

The company said as part of the review process, it will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by Feb. 21.

Sputnik V is developed by Russia's Gamaleya National Research Institute of Epidemiology.

Oncorus Rises On Insider Buying

Oncorus Inc ONCR shares rallied after a Form-4 filing with the SEC revealed James Flynn, one of the directors of the company's board, bought 300,000 shares in the company in three transactions, priced at $19 apiece.

In after-hours trading, the stock was up 6.49% to $17.24.

Landos Gains On Disclosure of Fund Stake

Landos Biopharma Inc LABP shares advanced after a 13D filing showed that Perceptive Advisors LLC beneficially owned 17.96 million shares in the company, giving it a stake of 45.9%.
The stock gained 5.47% to $15.05 in after-hours trading.

Earnings

Quidel Corporation'sQDEL fourth-quarter revenues climbed 432% year-over-year to $809.2 million, with bulk of the revenues coming from COVID-19 products. Non-GAAP EPS climbed from $1 in 2019 to $11.07 in 2020, while analysts, on average, estimated $10.14 per share.

In after-hours trading, the stock moved down 5.76% to $198.

Opko Health Inc. OPK said its fourth-quarter revenues more than doubled from $224.3 million in 2019 to $494.6 million in 2020. The company reversed to a profit of 5 cents per share from a loss of 18 cents per share. The consensus estimate called for EPS of 4 cents.

In after-hours trading, the stock lost 4.11% to $5.14.

Offerings

Clearpoint Neuro Inc CLPT priced its underwritten public offering of 1.85 million shares of its common stock at a price of $23.50 per share. All the shares are being offered by the company. The offering is expected to close on Feb. 23, subject to customary closing conditions.

The stock slipped 4.65% to $24.60 in after-hours trading.

On The Radar

Clinical Readouts

Insmed Incorporated INSM will release topline data from its Phase 1 healthy volunteer trial of treprostinil palmitil inhalation powder, which is being evaluated for the treatment of patients with pulmonary arterial hypertension and other rare and serious pulmonary disorders.