The coronavirus pandemic continues to plague the world and vaccine updates gain more significance in the sector with each passing day. Additionally, quite a few regulatory and pipeline updates in the past week from the biotech sector are in focus.
: Recap of the Week’s Most Important Stories : Regulatory and Pipeline Updates From Amgen Amgen ( AMGN Quick Quote AMGN - Free Report) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for pipeline candidate, sotorasib, an investigational KRASG12C inhibitor. The company is seeking approval of the candidate for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Earlier, Amgen and partner AstraZeneca announced that the late-stage study, SOURCE, on tezepelumab in patients with severe, oral corticosteroid-dependent asthma failed to achieve the primary endpoint. The 48-week study assessed the efficacy and safety of tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC). The phase III study, SOURCE, did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo.
Last week, Amgen announced that the FDA has approved Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA).
Amgen currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Moderna Gets EUA for COVID-19 Vaccine Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) announced that the FDA has granted an Emergency Use Authorization (EUA) to its COVID-19 vaccine, mRNA-1273. The vaccine has been authorized for use in individuals 18 years of age or older. The company will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. The EUA comes close on the heels of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation for the same. From the panel, 20 members voted in support of the EUA, while there was no vote against it. : Ligand Enters Into Collaboration With Glaxo Ligand Pharmaceuticals ( LGND Quick Quote LGND - Free Report) announced a collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline. The collaboration will utilize the Icagen discovery technology to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases.
Per the terms, Ligand will receive an upfront payment of $7 million. It is also eligible for milestone payments of up to $154.5 million along with tiered royalties on net sales of any drug from the collaboration that is commercialized by Glaxo. Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and Glaxo collaborating to identify candidates for entry into IND-enabling studies. Glaxo has the exclusive option to license any identified inhibitor and will be responsible for the further development and commercialization of any drug candidate identified through the collaboration.
: BioCryst Declines on Galidesivir Update BioCryst Pharmaceuticals, Inc.’s ( BCRX Quick Quote BCRX - Free Report) shares were down after it announced that it expects the National Institute of Allergy and Infectious Diseases (NIAID) to discontinue funding the development of its antiviral galidesivir for COVID-19.
Data from part 1 of a clinical study of its broad-spectrum antiviral, galidesivir, showed that there was no clinical efficacy benefit with galidesivir treatment compared to placebo treatment. The candidate was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. Per the company, the study was not designed or sized to demonstrate clinical efficacy.
Consequently, based on the company’s ongoing discussions with the NIAID, part of the National Institutes of Health, a major funding partner for the program, BioCryst expects NIAID to continue their support for the development of galidesivir with a focus on biodefense threats, such as Marburg virus disease, and not COVID-19.
: Vertex Collaborates With Skyhawk Vertex Pharmaceuticals Incorporated ( VRTX Quick Quote VRTX - Free Report) entered into a strategic research collaboration and licensing agreement with Skyhawk Therapeutics, Inc. for the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases. Per the agreement, Vertex will make an upfront payment of $40 million to Skyhawk. Skyhawk will grant Vertex options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Vertex’s exercising of its options, it will be responsible for further development and commercialization. Skyhawk is also eligible to receive up to $2.2 billion in potential milestone payments, as well as potential royalties on future sales. : Pfizer/BioNTech’s Vaccine Wins Authorization Pfizer ( PFE Quick Quote PFE - Free Report) and partner BioNTech ( BNTX Quick Quote BNTX - Free Report) announced that the European Commission (EC) has granted a conditional marketing authorization (CMA) to their COVID-19 vaccine, BNT162b2, for individuals 16 years of age and older. The vaccine will be marketed in the EU under the brand name, COMIRNATY. The CMA follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP) positive opinion to authorize the vaccine. Performance
The Nasdaq Biotechnology Index gained 1.91% in the last five trading sessions. Among the biotech giants, Vertex gained 2.66% during this period. Over the past six months, shares of Alexion have rallied 31.55%. (See the last biotech stock roundup here:
) Biotech Stock Roundup: ALXN Up on Acquisition News, PFE/BNTX Get EUA for Vaccine & & More What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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