- President Donald Trump is taking Regeneron's (NASDAQ:REGN) antibody cocktail after testing positive for COVID-19, a memo from his physician says.
- "Following PCR-confirmation of the President's diagnosis, as a precautionary measure he received a single 8 gram dose of Regeneron's polyclonal antibody cocktail," Dr. Sean P. Conley writes. "He completed the infusion without incident."
- Trump is described as "fatigued but in good spirits".
- First Lady Melania Trump "remains well with only a mild cough and headache".
- The cocktail recently showed benefits in non-hospitalized patients.
- https://seekingalpha.com/news/3619604-trump-taking-regeneron-antibody-cocktail
Friday, October 2, 2020
Trump taking Regeneron antibody cocktail
Pacific Biosciences up as JP Morgan analyst triples price target
- Pacific Biosciences (PACB +11.6%) receives an upgrade to Overweight from Neutral by JPMorgan analyst Tycho Peterson.
- He expects share price to triple to $15, up from his previous target of $5.
- Recent talk with the company's new CEO Christian Henry, left him 'encouraged about the abundant opportunities that lie ahead.'
- He further adds, given Henry's 'impressive track record' along with what he sees as low hanging fruit on the commercial front, Peterson said he feels confident about the new management team's ability to execute on its new strategy.
- A look at the financials and escalating revenue numbers here.
Euro panel probes possible kidney injury from Gilead's remdesivir
The European drugs regulator said on Friday its safety committee was reviewing reports of acute kidney injury in some COVID-19 patients who had been given Gilead Sciences Inc's remdesivir.
The European Medicines Agency (EMA) said at this point it was not clear whether there is a causal relationship between remdesivir and the reports of acute kidney injury. Its committee would review all available data to find that out.
The treatment, one of the first to shorten the recovery time among COVID-19 patients in clinical trials, has been approved for emergency use in several countries including Europe and United States.
Kidney injury can be caused by COVID-19 as well as other factors such as diabetes, the EMA said in a statement.
Nano-X Imaging to demo low-cost system at major show in late November
- Investors on both sides of the aisle should be interested to know that recent IPO Nano-X Imaging (NASDAQ:NNOX) plans to demonstrate its Nanox-ARC system in late November at RSNA 2020, the largest radiology conference in the world with over 50K attendees (at least before COVID-19).
- The company also plans to demonstrate its digital x-ray source, the principal enabler of its low-cost imaging device.
- The stock has almost completed a roundtrip from its August 21 U.S. debut, closing the day at $21.70. Shares rocketed up there, peaking at $66.67 on September 11, before reversing on profit-taking and short sellers taking positions on perceptions of blatant stock promotion. The stock closed today at $23.97.
EU regulator review of AZ’s COVID-19 vaccine imminent
The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports citing people close to the project.
According to Bloomberg, the EMA could announce the start of a “rolling review” of AZD1222 – also known as ChAdOx1 – as early as this week, which would put the vaccine firmly on course to be the first approved for use in Europe.
Reuters meanwhile suggests that the vaccine could be subjected to further delays in the US as the FDA has started sifting through data from earlier trials of vaccines developed by the same scientific team to look for safety signals.
The US arm of a phase 3 trial of AZD1222 has remained on a clinical hold since 6 September, after a subject in the UK was feared to have developed a neurological side effect after receiving the vaccine, but was swiftly restarted elsewhere.
AZ has denied reports that the patient developed transverse myelitis, an inflammation of the spinal cord that has been observed after viral infections as well as some vaccines, but hasn’t revealed the nature of the illness, citing patient confidentiality reasons.
Meanwhile, there have been some inconsistencies between the company’s reporting on the case and that of Oxford University which reportedly prompted a US National Institutes of Health investigation into the incident.
The Reuters report suggests that the FDA’s decision to widen its probe is borne out of caution rather than any strong belief that the vaccine has side effects. However, it says the probe has been made more complicated because data provided by trial investigators is in a different format to that usually required by the agency.
Safety is always of paramount importance in new medicine development, but particularly so with vaccines as they are administered to healthy people. Severe symptoms are also uncommon in people who are infected with the SARS-CoV-2 virus making the risk-benefit calculations even more challenging.
AZ limited its comments on the situation to a brief statement that it is “continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”
According to the World Health Organization (WHO), AZ’s vaccine is already the furthest ahead in a list of 40 vaccines in clinical trials for COVID-19, and that position will be consolidated if the rumour of a rolling review by the EMA is accurate.
Earlier this year, the EMA’s head of vaccines – Marco Cavaleri – suggested that the first approval of a COVID-19 vaccine could come in the EU before the end of 2020.
https://pharmaphorum.com/news/ema-review-of-azs-covid-19-vaccine-imminent-report/
Amag buyers bet big on reversal agent
Covis Pharma is owned by private equity and, if past deals are anything to go by, run by executives more focused on cash flows than R&D. Thus the acquisition of Amag seems something of a departure, considering that the main draw is a project that still requires substantial development. Ciraparantag is a reversal agent believed to be active against heparin as well as the novel, oral anticoagulants Pradaxa, Eliquis, Xarelto and Savaysa. There is a need here: Andexxa, now owned by Alexion after its $1.4bn Portola takeover, is approved against Eliquis and Xarelto, but carries black box warnings; Boehringer Ingelheim’s Praxbind only reverses that company’s Pradaxa. As a small molecule ciraparantag could offer a more convenient, safer and faster-acting option, Amag argued – although this still needs to be proven in phase III. Step forward Covis, which this week agreed to pay almost $500m for Amag, net of debt. Perhaps the hope is that Daiichi Sankyo, which sells Savaysa, will step in as a development partner; the Japanese group previously co-sponsored an earlier trial. The sellside estimates launch in 2023 and sales of $10m by 2026, according to EvaluatePharma. Covis is surely hoping for much more.
US FDA approval tracker: September
Despite a positive panel meeting Mesoblast’s paediatric graft-versus-host disease treatment Ryoncil still received a knockback from the US FDA, featuring as one of three rejections last month. Still, those concerned that the FDA is tightening up will have been relieved that Gavreto received an early green light in Ret fusion-positive NSCLC. Lilly’s Retevmo is already approved in the setting, but comes with a warning about QT prolongation, something Gavreto’s label does not include. Roche will co-commercialise Gavreto with Blueprint in the US after paying $650m up front for rights. Elsewhere, Glaxosnithkline's Nucala became the first biological approved in the US for hypereosinophilic syndrome, some way ahead of Astrazeneca’s Fasenra, which recently started a pivotal study in this setting. Glaxo is still due a decision on dostarlimab, a latecomer to the anti-PD-1 class, in recurrent endometrial cancer; a decision is expected before the year end.
| Notable first-time US approval decisions in September | |||
|---|---|---|---|
| Project | Company | Sales by indication ($m) | Outcome |
| Dostarlimab | Glaxosmithkline | 523 | No decision yet |
| Onureg (CC-486) | Bristol Myers Squibb | 466 | Approved |
| Ryoncil (remestemcel-L) | Mesoblast | 341 | CRL |
| Alkindi Sprinkle | Eton | 266 | Approved |
| Libervant | Aquestive | 197 | CRL |
| Lucassin/terlipressin | Mallinckrodt | 154 | CRL |
| Gavreto (pralsetinib) | Roche/Blueprint | 109* | Approved (~2 mths early) |
| Alaway Preservative Free ophthalmic solution (EM-100) | Eton/Bausch | - | Approved |
| *Forecast doesn’t include Roche numbers. Sources: company releases & EvaluatePharma. | |||
| Supplementary and other notable approval decisions in September | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Fetroja/Cefiderocol | Shionogi | Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia (APEKS-NP) | Approved |
| Trelegy Ellipta | Glaxosmithkline | Asthma (Captain) | Approved |
| Trulicity | Lilly | 3mg and 4.5mg doses for type 2 diabetes (Award-11) | Approved |
| Nucala | Glaxosmithkline | Hypereosinophilic syndrome (NCT02836496) | Approved |
| Kalydeco | Vertex | Cystic fibrosis patients aged 4-6 months (Arrival) | Approved |
| Xeljanz | Pfizer | Children & adolescents with active polyarticular course juvenile idiopathic arthritis (NCT02592434) | Approved |
| Xolair | Novartis | Nasal polyps (Polyp 1 and 2) | No decision yet |
Sources: Sources: company releases & EvaluatePharma. | |||
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