Jefferies is positive on the stock with a Buy rating. The target price remains set at GBX 1950.
Wednesday, February 3, 2021
Biocryst Rapivab expanded use application approved by FDA
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for RAPIVAB® (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.
“Influenza can have serious and deadly consequences and we are very pleased that the FDA has extended the approved indication for RAPIVAB to include patients as young as six months. These patients can be among those at greatest risk for severe outcomes and RAPIVAB is an important antiviral with proven benefits,” said Dr. William Sheridan, chief medical officer of BioCryst.
Humanigen, Avid Bio Agree on manufaacturing COVID Therapy Lenzilumab for Potential EUA Filing
Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (“Avid”) and Humanigen, Inc. (NASDAQ:HGEN) (“Humanigen”) today announced that they have entered into a manufacturing services agreement to expand production capacity for lenzilumab™, Humanigen’s therapeutic candidate in development for COVID-19. Lenzilumab is an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm” associated with COVID-19. Humanigen has completed enrollment of its 520 patient Phase 3 clinical trial of lenzilumab in hospitalized COVID-19 patients.
Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen’s regulatory and potential commercial activities. This collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization (EUA) and subsequent Biologics License Application (BLA) later this year.
“Having recently completed enrollment in our Phase 3 clinical trial of lenzilumab, we are also focusing on scalable manufacturing capacity to help ensure access in advance of a potential EUA filing,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
“As the COVID-19 pandemic continues to rage in the U.S. and around the world, it is essential that life science companies like Avid and Humanigen align our areas of expertise to speed the development and commercialization of valuable therapeutics that can make a difference in the lives of patients. At Avid, we are proud to play our part in these important efforts,” said Timothy Compton, chief commercial officer of Avid. “Lenzilumab is an exciting COVID-19 therapeutic candidate and the type of complex biologic for which Avid possesses decades of manufacturing success. We are pleased to be trusted by Humanigen to provide the critical CDMO services that will be essential for achieving the company’s regulatory and commercialization goals for lenzilumab.”
Humana Q4, 2020 results, outlook
Quarterly Results
Earnings per share fell 200.88% over the past year to ($2.30), which beat the estimate of ($2.36).
Revenue of $18,960,000,000 rose by 16.35% year over year, which beat the estimate of $18,770,000,000.
Guidance
The upcoming fiscal year's EPS expected to be between $21.25 and $21.75.
https://www.benzinga.com/news/earnings/21/02/19462142/humana-q4-earnings-insights
Glaxo sees lower profit this year, split plans on track
Britain’s GSK forecast a dip in earnings this year as it grapples with COVID-19 disruptions and invests in its pipeline of new drugs, and said its plans to split into two businesses were on track.
The world’s biggest vaccine maker by sales said on Wednesday it expected adjusted earnings to fall by a mid- to high-single digit percentage at constant exchange rates.
Turnover for the fourth-quarter of 2020 fell 2% to 8.74 billion pounds ($11.9 billion) and adjusted earnings came in at 23.3 pence per share, both slightly higher than analysts’ average forecast.
While the COVID-19 pandemic has boosted demand for GSK’s over-the-counter painkillers, it has disrupted other parts of its business as patients have made fewer trips to doctors.
Earlier on Wednesday, GSK said it was teaming up with German biotech firm CureVac to develop a COVID-19 vaccine to target several variants of the virus with one shot.
Rather than developing its own COVID-19 shot, GSK has so far focused on supplying its vaccine booster, or adjuvant, to other drugmakers. But it has had two big setbacks, as a project with Sanofi was delayed, while China’s Clover ended its deal with GSK on Monday.
Meanwhile, companies using new technologies that don’t require adjuvants, including Pfizer/BioNTech and Moderna, are already rolling out COVID-19 vaccines.
GSK last year launched a two-year programme to split in two after the merger of its over-the-counter products business into a venture with Pfizer that created a market leader with brands from Sensodyne toothpaste to Panadol painkillers. That will be split from its drug making business.
Jazz Pharmaceuticals to Acquire GW Pharma
Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.
GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company's lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS),
Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.
The two companies will host a conference call today at
A replay of the conference call will be available through
AbbVie Earnings Top Estimates, Guidance Strong
Early Wednesday, AbbVie stock rose after the pharmaceutical company reported adjusted profit of $2.92 per share on $13.86 billion in sales for its fourth quarter.
On average, analysts polled by FactSet expected AbbVie (ABBV) to earn $2.85 per share, on an adjusted basis, and to report nearly $13.7 billion in sales.
In the year-earlier period, AbbVie earnings were $2.21 a share on $8.7 billion in sales.
For the year ending in 2021, AbbVie guided to EPS of $12.32-$12.52. The Street expected AbbVie earnings of $12.20 per share and $54 billion in sales.
https://www.investors.com/news/technology/abbvie-stock-abbvie-earnings-q4-2020/
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