iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB), (ABCL) – The Daily Biotech Pulse: United States to buy 500 million doses of Pfizer-BioNTech vaccine for donation, Verona Out-Licenses Drug COPD, Nautilus Lists through SPAC deal
Here is an overview of the main developments in the field of biotechnology over the past 24 hours:
Climb the summits
(Biotech stocks hit 52-week highs on June 9)
- Aethlon Medical, Inc. (NASDAQ: AEMD) (moved to a report highlighting the effectiveness of its hemopurifier in treating COVID-19)
- Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)
- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO)
- Alkermes plc (NASDAQ: ALKS)
- AngioDynamics, Inc. (NASDAQ: ANGO)
- Intra-Cellular Therapies, Inc. (NASDAQ: ITCI)
- Jazz Pharmaceuticals plc (NASDAQ: JAZZ)
- Novo Nordisk A / S (NYSE: NVO)
- Oramed Pharma inc. (NASDAQ: ORMP)
- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK)
- Protagonist Therapeutics, Inc. (NASDAQ: PTGX)
- Sesen Bio, Inc. (NASDAQ: SESN)
None of the biopharma / medical devices / molecular diagnostics stocks listed on the NYSE or Nasdaq hit their lowest level in 52 weeks on Wednesday.
Focus on actions
500 million doses of Pfizer, BioNTech vaccine for countries in need
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) has announced plans to provide the U.S. government at a non-profit price with 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 US government will in turn donate doses of Pfizer-BioNTech vaccine to low- and lower-middle-income countries and the organizations that support them.
As part of this plan, the United States will allocate vaccine doses to 92 low and lower middle income countries and economies, as defined by Gavi’s COVAX advance market engagement and the Union’s 55 member states. African.
Verona Licenses Greater China Rights to Chronic Obstructive Pulmonary Disease Drug
Verona Pharma plc (NASDAQ: VRNA) and Nuance Pharma Limited announced that the companies have entered into an agreement granting Shanghai-based Nuance the rights to develop and market ensifentrine in Greater China.
Ensifentrin is an experimental inhaled double inhibitor of phosphodiesterase 3 and 4 enzymes which allows it to combine bronchodilator and anti-inflammatory effects into a single compound.
Verona Pharma is leading a global Phase 3 program evaluating ensifentrin for the maintenance treatment of chronic obstructive pulmonary disease with sites in the United States, Europe and South Korea.
Verona Pharma will receive a $ 25 million upfront cash payment and a $ 15 million stake 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 double-digit tiered royalties as a percentage of net sales in Greater China.
The stock was up 18.39% to $ 7.69 in pre-market Thursday.
Flexion appoints new chief medical officer
Flexion Therapeutics, Inc. (NASDAQ: FLXN) announced the appointment of William Andrews as Chief Medical Officer, effective July 1.
“Will brings an impressive combination of medical, clinical, regulatory and business development skills, complemented by the extensive business experience he has gained from launching seven products throughout his career,” said Michael Clayman, CEO of Flexion Therapeutics.
The stock fell 0.88% to $ 90 after-market.
Related Link: The Week Ahead in Biotechnology: FDA Rulings on Biogen, Alexion, and Vertex, Multiple Conference Presentations on the Bridge
ObsEva to present positive phase 2a data for ebopiprant in preterm labor
ObsEva SA (NASDAQ: 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 stated, data from Prolong demonstrated that ebopiprant was well tolerated and showed early evidence of efficacy in pregnant women in spontaneous preterm labor and supports advancement in an adaptive phase 2b / 3 study, a declared the company. The company plans to launch a phase 2b / 3 adaptive dosing study in the fourth quarter.
The stock rose 3.31% to $ 3.12 in pre-market Thursday.
Bristol-Myers Squibb reports positive results in late stage cell therapy to treat large B-cell lymphoma
Bristol-Myers Squibb Company (NYSE: BMY) announced the first positive results of the Phase 3 Transform study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma compared to treatment with rescue followed by high-dose chemotherapy and hematopoietic stem cell transplantation.
The results of a pre-defined interim analysis conducted by an independent review panel showed that the study met its primary endpoint of demonstrating a clinically significant 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.
Overall survival data were immature at the time of this interim analysis. The safety results were consistent with Breyanzi’s known safety profile for the third-line treatment of LBCL.
The stock rose 0.23% to $ 65.55 in pre-market Thursday.
MannKind Announces Collaboration to Study Inhaled Formulation for Treatment of Pulmonary Fibrosis
MannKind Company (NASDAQ: MNKD) and Thirona Bio have announced a transaction that aims to advance the development of a new compound with the potential for multiple indications.
FBM5712 is a new small molecule inhibitor of ALK-5 kinase, developed by Thirona as a topical product to prevent and / or reduce cutaneous fibrosis.
Under the terms of the collaboration agreement, the companies will assess the therapeutic potential of Thirona’s FBM5712 for the treatment of pulmonary fibrosis.
MannKind will formulate FBM5712 as a dry powder. If the initial studies show promise, MannKind may exercise certain rights to apply for a full license of the compound for clinical development and commercialization for the treatment of fibrotic lung disease.
In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing.
MannKind stock rose 1.47% to $ 4.14 in pre-market Thursday.
ALX and Lilly Strike Clinical Trial Collaboration for Combination Therapy for Gastroesophageal Cancer
ALX Oncology (NASDAQ: ALXO) announced an agreement to collaborate and provide clinical trials with Eli Lilly and company (NYSE: LLY) to evaluate the combination of ALX148 and Lilly’s Cyramza for the treatment of patients with HER2-positive gastric cancer or cancer of the gastroesophageal junction.
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 after treatment. by therapy and chemotherapy targeting HER2. Lilly will supply ramucirumab for this trial.
Financial details of the collaboration agreement were not disclosed.
Aligos to Show Positive Phase 1 Results for Hepatitis B Virus Treatment Candidate
Aligos Therapeutics, Inc. (NASDAQ: ALGS) has announced that it will present a poster describing data from the ongoing ALG-000184-201 study at the HBV-TAG 2021 conference, which will be held virtually June 11-12, 2021.
The experimental treatment was well tolerated and 100 mg of ALG-000184 administered over 14 days resulted in a mean reduction in hepatitis B virus DNA of 2.9 log10 IU / mL, the company said.
AbCellera wins on insider buying
AbCellera Biologics Inc. (NASDAQ: ABCL) Shares rose after two documents revealed that the company’s CFO Andrew Booth and general counsel Tryn Stimart bought shares in the company by exercising stock options.
The stock gained 3.82% to $ 24.75 after-market.
On the radar
Clinical readings / presentations
Precigen, Inc. (NASDAQ: PGEN) will present interim data from the AG019 phase 1b / 2a clinical trial in type 1 diabetes at the Federation of Clinical Immunological Societies meeting.
Initial Public Offering
Nautilus Biotechnology, Inc., a company specializing in a platform for analyzing monomolecular proteins to quantify the proteome, has announced the completion of its merger with Arya Sciences Acquisition Corp III (NASDAQ: ARYA), a SPAC sponsored by Perceptive Advisors.
The combined company, Nautilus Biotechnology, Inc., will begin trading its common shares under the symbol “NAUT” on the Nasdaq.
Related Link: Attention Biotech Investors: Mark Your Calendar for June PDUFA Dates
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