Hologic (NASDAQ:HOLX) jumps 7% premarket on light volume in reaction to its upward revision of Q4 guidance driven by strong sales of COVID-19 tests and Panther instruments.
The company forecasts revenue of $1,225M – $1,275M, up 54 – 60% from a year ago and up from its outlook of $925M – 1.025M provided in July.
The increased revenue is also expected to drive non-GAAP EPS significantly above prior guidance of $0.95 – 1.15.
https://seekingalpha.com/news/3613274-hologic-up-7-on-bullish-q4-outlook
The USPTO has granted a motion from Broad Institute for priority benefit over Emmanuelle Charpentier (CVC) in an interference between the University of California, the University of Vienna, CVC and the Broad Institute, Inc. over certain Broad patents covering CRISPR/Ca9 gene editing technology, patents that Editas Medicine (NASDAQ:EDIT) exclusively licenses.
As a result, Broad will enter the priority phase of the interference as “senior party” while CVC will be “junior party” for the purposes of determining who was the first inventor. The senior party is considered the entity that filed an earlier patent application and is assumed to be the prior inventor. The junior party has the burden of proving that it is the first inventor.
Broad has been in a dispute over CRISPR/Cas9 patents with UC-Berkeley (Jennifer Doudna and French researcher Charpentier co-discovered the gene editing technology) and the University of Vienna (where Charpentier used to work) for almost four years. Doudna’s group actually filed first, but Editas co-founder Feng Zhang submitted a request, including a modest fee, for priority review of Broad’s patents, an apparent established option for patent filers. The parties have been fighting ever since.
https://seekingalpha.com/news/3613266-editas-medicine-up-5-on-favorable-crispr-cas9-patent-ruling
Vesper Healthcare Acquisition has filed to raise $400M in an IPO, with listing on the Nasdaq under the symbol “VSRU.” Goldman Sachs and JPMorgan are underwriting.
Ex-Allergan CEO Brent Saunders is leading the effort, and he’s brought along Manisha Narasimhan, who was SVP of strategic initiatives, portfolio innovation, and investor relations at Allergan.
The focus of Saunders’ SPAC will be medical aesthetics, eyecare, longevity and wellness categories, though it may pursue targets in any industry.
Saunders became CEO of Allergan in 2014 after his generics firm Actavis purchased the company. He departed after the sale to AbbVie (NYSE:ABBV).
https://seekingalpha.com/news/3613269-allergans-ex-ceo-brent-saunders-launching-blank-check-company
AstraZeneca’s (NYSE:AZN) CEO Pascal Soriot has said that the company is still aiming for the Oxford COVID-19 vaccine to be ready by this year-end.
Pascal Soriot told during an an online conference that it is unclear how long the trial will be paused in response to a recent adverse event, but a 2020 approval is still on the cards.
The Company expects to have a set of data to submit before year end. Depending on how quickly regulators review the filing, that could enable AstraZeneca to win approval this year.
Soriot said that the decision to resume the coronavirus vaccine trials rests with a group of independent experts who are working to understand if the volunteer’s condition was coincidental or a result of the vaccine.
AZN suspended late-stage trials of its COVID-19 vaccine this week after an illness in a participant in Britain. The patient was reportedly suffering from symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
Other COVID-19 players: Moderna (NASDAQ:MRNA), Novavax (NASDAQ:NVAX), Sanofi (NASDAQ:SNY), Merck (NYSE:MRK), BioNTech (NASDAQ:BNTX), J&J (NYSE:JNJ), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE).
Verona Pharma is starting a pilot study of its inhaled respiratory diseases drug ensifentrine in patients hospitalised with COVID-19.
The Anglo-American biotech is already developing ensifentrine in chronic obstructive pulmonary disease (COPD), but the company believes it could also help to relieve respiratory symptoms associated with viruses such as SARS-CoV-2.
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound.
Verona said that clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown that ensifentrine improved oxygenation, reduced inflammation in the lungs and enhanced mucus clearance.
Ensifentrine, which the company noted has been well tolerated in clinical trials involving more than 1,300 people to date, is a dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4).
The randomised double-blind pilot study will test efficacy and safety of ensifentrine delivered via pressurised metered-dose inhaler (pMDI).
It will involve around 45 hospitalised patients with COVID-19 at a single centre at the University of Alabama at Birmingham.
Patients will be randomised to receive 2mg of pMDI ensifentrine or placebo, twice-daily for up to 29 days or until discharge if this occurs before 29 days. The clinical status of all patients will be evaluated at day 29 and day 60.
The primary endpoint is the proportion of patients recovered from COVID-19 and no longer hospitalised at day 29.
Secondary endpoints will be safety and tolerability, improvements in clinical status, time to recovery, supplemental oxygen use, and the proportion of patients needing mechanical ventilation and mortality.
Mike Wells, a pulmonologist and principal investigator at the University of Alabama in Birmingham, said: “Therapies are urgently needed to treat patients hospitalised with COVID-19.
“Ensifentrine has demonstrated impressive effects on improving lung function and symptoms in patients with obstructive lung diseases, along with notable anti-inflammatory effects following inhaled dosing in clinical trials to date.
“Combined with positive safety results, ensifentrine has the potential to significantly benefit patients suffering from COVID-19.”
Exelixis made its name developing small-molecule drugs for cancer, so a new pair of deals focused on antibody-drug conjugates reinforces a recent change of direction for the biotech.
California-based Exelixis has four small-molecule drugs already on the market, but over the last couple of years it has been expanding its position in biologics R&D – with a particular focus on ADC drugs – under CEO Michael Morrissey.
While they have been around for some years, ADCs – which pair antibodies with a drug payload designed to boost their efficacy – are gathering momentum in biopharma drug development as early issues with stability and toxicity have been ironed out.
The latest partnerships are with Swiss startup NBE-Therapeutics and Catalent Pharma, and boost Exelixis’ ADC capabilities in multiple areas.
The deal with NBE includes a $25 million upfront payment to the Swiss firm and kicks off a two-year alliance that will cover multiple cancer targets, with Exelixis funding the R&D effort. It also gives Exelixis access to NBE’s expertise in conjugation ‘linkers’ used to join the antibody and drug portions of an ADC, as well as new payloads based on anthracycline molecules.
The three-year partnership with Catalent meanwhile adds another linker technology – called SMARTag – and starts with a $10 million upfront fee as well as R&D funding.
Both deals give Exelixis an exclusive option to license ADC candidates at the preclinical stage, before they are submitted for approval to start human trials, and can be extended if the parties agree.
Last year, Exelixis paid $7.5 million for a license to an ADC developed by Iconic Therapeutics – called ICON-2 – which targets the tissue factor (TF) pathway thought to contribute to the progression and spread of tumours. The ADC is due to start testing in humans this year.
Earlier deals included a collaboration with Invenra on ‘multispecific’ antibodies that can target more than one target simultaneously, which was signed in 2018.
Last year Exelixis expanded that multidrug agreement, which was set up initially with a $2 million upfront payment, another $2 million of payments tied to the start of new discovery projects, and up to $131.5 million in milestones.
“Exelixis is pursuing both internal drug discovery and external business development approaches to build a pipeline with the potential to make a difference for patients with cancer,” said Peter Lamb, the biotech’s chief scientific officer.
The shift into biologics comes after Exelixis has built a portfolio of orally active cancer drugs headed by two based on tyrosine kinase inhibitor cabozantinib – Cabometyx for kidney and liver cancers and Cometriq for thyroid cancer – which together are making blockbuster sales.
It also developed MEK inhibitor Cotellic (cobimetinib) – sold by Roche for BRAF-positive melanoma – and Daiichi Sankyo-partnered hypertension drug Minnebro (esaxerenone).
Having raised a truly phenomenal amount of venture cash over the past five years it appears that Grail might finally be making the leap to the public markets. The liquid biopsy developer has filed to raise $100m in a Nasdaq IPO – a float that will almost certainly see the company bank much more, perhaps in the region of $500m, according to one estimate. The cash will help fund the US launch of Grail’s long-awaited pan-cancer blood test, expected next year. Called Galleri, this is to be sold as an unapproved lab-developed test, to screen asymptomatic people aged over 50 – a setting in which no pan-cancer liquid biopsy is yet available. US approval could follow in 2023, putting Galleri three years behind similar assays from Guardant Health and Roche. A second blood test, in the more familiar setting of diagnosing patients for whom there is a clinical suspicion of cancer could also launch next year. Lastly, a test using blood or tissue is in development to detect residual disease post-treatment. Investors will want these to succeed as soon as possible since Grail is not yet profitable; in the first six months of 2020, Grail made a net loss of more than $136m, a 16% increase year-on-year.
| Grail’s VC funding | |||
|---|---|---|---|
| Date | Round | Investment ($m) | Investors |
| May 2020 | Series D | 390.0 | Canada Pension Plan Investment Board; Existing shareholders; Illumina; PSP Investments; Undisclosed investors |
| Dec 2019 | Undisclosed | 125.0 | Undisclosed investors |
| May 2018 | Series C | 300.0 | 6 Dimensions Capital; Ally Bridge Group; Blue Pool Capital; China Merchants Securities; CRF Investment; Hillhouse Capital Group; Huangpu River Capital; ICBC International; Sequoia Capital; Wuxi Nextcode |
| Jan 2018 | Series B (second close) | 314.7 | Undisclosed investors |
| Mar 2017 | Series B | 900.0 | Amazon; Arch Venture Partners; Bristol Myers Squibb; Celgene; Johnson & Johnson Development Corporation; Mckesson Ventures; Merck & Co; Tencent Holdings; Varian |
| Jan 2016 | Series A | 100.0 | Arch Venture Partners; Bezos Expeditions; Bill & Melinda Gates Foundation; Illumina; Sutter Hill Ventures |
| Total | 2,129.7 | ||
| Source: EvaluateMedTech. |
https://www.evaluate.com/vantage/articles/news/snippets/grail-seeks-float-last
