The Daily Biotech Pulse: US To Procure 500M Pfizer-BioNTech Vaccine Doses For Donation, Verona Out-Licenses COPD Drug, Nautilus Lists Through SPAC Deal - iShares Biotechnology ETF (NASDAQ:IBB)

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 June 9)

Aethlon Medical, Inc. AEMD (moved on a report highlighting efficacy of its Hemopurifier in COVID-19 treatment)
Alexion Pharmaceuticals, Inc. ALXN
Agios Pharmaceuticals, Inc. AGIO
Alkermes plc ALKS
AngioDynamics, Inc. ANGO
Intra-Cellular Therapies, Inc. ITCI
Jazz Pharmaceuticals plc JAZZ
Novo Nordisk A/S NVO
Oramed Pharmaceuticals Inc. ORMP
Paratek Pharmaceuticals, Inc. PRTK
Protagonist Therapeutics, Inc. PTGX
Sesen Bio, Inc. SESN

Down In The Dumps

None of the NYSE or Nasdaq-listed biopharma/medical devices/molecular diagnostics stock hit 52-week lows Wednesday.

Stocks In Focus

500M Doses Of Pfizer, BioNTech Vaccine Destined For Countries In Need

Pfizer Inc. PFE and BioNTech SE BNTX announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine — 200 million doses in 2021 and 300 million doses in the first half of 2022.

The U.S. government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them.

As part of the plan, the U.S. will allocate the vaccine doses to 92 low- and lower middle-income countries and economies as defined by Gavi's COVAX Advance Market Commitment and the 55 member states of the African Union.

Verona Out-Licenses Greater China Rights To Chronic Obstructive Pulmonary Disease Drug

Verona Pharma plc VRNA and Nuance Pharma Limited announced the companies have entered into an agreement granting Shanghai-based Nuance the rights to develop and commercialize ensifentrine in Greater China.

Ensifentrine is an investigational inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that enables it to combine both bronchodilator and anti-inflammatory effects in one compound.

Verona Pharma is conducting a global Phase 3 program evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease with sites in the U.S., Europe and South Korea.

Verona Pharma will receive an upfront payment of $25 million in cash and equity interest valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma.

Verona Pharma is also eligible to receive future milestone payments of up to $179 million and tiered double-digit royalties as a percentage of net sales in Greater China.

The stock was rallying 18.39% to $7.69 in premarket trading Thursday.

Flexion Appoints New Chief Medical Officer

Flexion Therapeutics, Inc. FLXN announced the appointment of William Andrews as chief medical officer, effective July 1.

"Will brings an impressive combination of medical, clinical, regulatory and corporate development skills, complemented by deep commercial experience he gained launching seven products throughout his career," said Michael Clayman, CEO of Flexion Therapeutics.

The stock fell 0.88% to $90 in after-hours trading.

ObsEva To Present Positive Phase 2a Data For Ebopiprant In Preterm Labor

ObsEva SA OBSV announced the presentation of clinical data from the Prolong Phase 2a proof-of-concept study of ebopiprant for the treatment of spontaneous preterm labor at the Royal College of Obstetricians and Gynecologists Virtual World Congress 2021.

As previously disclosed, the Prolong data demonstrated that ebopiprant was well-tolerated and showed early evidence of efficacy in pregnant women with spontaneous preterm labor and supports the advancement into a Phase 2b/3 adaptive study, the company said. The company expects to initiate a Phase 2b/3 adaptive dose-ranging study in the fourth quarter.

The stock was up 3.31% at $3.12 in premarket trading Thursday.

Bristol-Myers Squibb Announces Positive Late-Stage Results For Cell Therapy To Treat Large B-Cell Lymphoma

Bristol-Myers Squibb Company BMY announced positive topline results from the Transform Phase 3 study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma versus salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant.

Results of a pre-specified interim analysis conducted by an independent review committee showed the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care.

The overall survival data was immature at the time of this interim analysis. Safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting.

The stock was up 0.23% to $65.55 in premarket trading Thursday.

MannKind Announces Collaboration For Study Of Inhaled Formulation of Lung Fibrotic Treatment

MannKind Corporation MNKD and Thirona Bio announced a transaction that is intended to advance the development of a novel compound with the potential for multiple indications.

FBM5712 is a novel small molecule inhibitor of the ALK-5 kinase, which is being developed by Thirona as a topical product intended to prevent and/or reduce skin fibrosis.

Under the terms of the collaboration agreement, the companies will evaluate the therapeutic potential of Thirona's FBM5712 for the treatment of pulmonary fibrosis.

MannKind will formulate FBM5712 as a dry powder formulation. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases.

In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona's Series A financing.

MannKind shares were up 1.47% to $4.14 in premarket trading Thursday.

ALX, Lilly Strike Clinical Trial Collaboration For Combo Therapy For Gastroesophageal Cancer

ALX Oncology ALXO announced a clinical trial collaboration and supply agreement with Eli Lilly and Company LLY to evaluate the combination of ALX148 and Lilly's Cyramza for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer.

Under the terms of the agreement, ALX will conduct a randomized Phase 2/3 study to evaluate the efficacy of ALX148 in combination with ramucirumab, trastuzumab and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Lilly will supply ramucirumab for this trial.

The financial details of the collaboration agreement were not disclosed.

Aligos To Present Positive Phase 1 Results For Hepatitis B Virus Treatment Candidate

Aligos Therapeutics, Inc. ALGS said it will present a poster describing data from the ongoing Study ALG-000184-201 at the HBV-TAG 2021 Conference, taking place virtually June 11-12, 2021.

The investigational therapy was well-tolerated, and 100 mg of ALG-000184 given over 14 days resulted in a mean reduction in hepatitis B virus DNA of 2.9 log10 IU/mL, the company said.

AbCellera Gains On Insider Buying

AbCellera Biologics Inc. ABCL shares rose after two filings revealed that the company's CFO Andrew Booth and chief legal officer Tryn Stimart bought shares in the company by exercising stock options.

The stock gained 3.82% to $24.75 in after-hours trading.

On The Radar

Clinical Readouts/Presentations

Precigen, Inc. PGEN will present at the Federation of Clinical Immunology Societies meeting with interim data from the AG019 Phase 1b/2a clinical trial in Type 1 diabetes.

IPO

Nautilus Biotechnology, Inc., a company specializing in a single-molecule protein analysis platform for quantifying the proteome, announced the completion of its business combination with Arya Sciences Acquisition Corp III ARYA, a SPAC sponsored by Perceptive Advisors.

The combined company, Nautilus Biotechnology, Inc., will commence trading shares of its common stock under the ticker symbol "NAUT" on the Nasdaq.

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