Opko Health announced the initiation of a Phase 2 trial of Rayaldee as a treatment for mild-to-moderate COVID-19. After rising in the pre-market trading hours, Opko stock was down 0.63% at the close on Tuesday.
Opko Health’s (OPK) Rayaldee is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3 and was launched in 2016 for treating secondary hyperparathyroidism in adults with stage 3 or 4 CKD (chronic kidney disease) and vitamin D insufficiency.
The company announced that the trial (called REsCue) will be a randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (calcifediol) extended-release capsules to treat symptomatic patients infected with SARS-CoV-2.
The trial, which will be conducted at multiple COVID-19 outpatient clinics in the US, is expected to enroll about 160 subjects, many with stage 3 or 4 CKD who are at higher risk for developing more severe illness. Opko expects to report top-line results from the Phase 2 trial before the end of this year.
Yesterday, Barrington analyst Michael Petusky reiterated a Buy rating and a price target of $7 for Opko Health stating, “OPKO’s lab business has greatly benefitted from its ability to land COVID‐19 related PCR [polymerase chain reaction] and antibody serology testing agreements since the crisis began to impact the U.S. in Q1.”
“To date, the company has provided COVID‐19 testing to the general public through its relationships with several states and cities, has signed major partnerships with Rite Aid and CVS, and also has secured several high profile deals with major sports organizations including the NFL, the NBA and Major League Soccer.” (See OPK stock analysis on TipRanks)
The Street has a Strong Buy consensus for Opko Health based on 4 recent Buy ratings. The stock has risen an impressive 114% so far in 2020 and the average analyst price target of $8.00 indicates a further upside of about 154% in the coming months.
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Powerful Vatican Cardinal Becciu resigns amid scandal
ROME (AP) — The powerful head of the Vatican’s saint-making office, Cardinal Angelo Becciu, resigned suddenly Thursday from the post and renounced his rights as a cardinal amid a financial scandal that has reportedly implicated him indirectly.
The Vatican provided no details on why Pope Francis accepted Becciu’s resignation in a statement late Thursday. In the one-sentence announcement, the Holy See said only that Francis had accepted Becciu’s resignation as prefect of the Congregation for the Causes of Saints “and his rights connected to the cardinalate.”
Becciu, the former No. 2 in the Vatican’s secretariat of state, has been reportedly implicated in a financial scandal involving the Vatican’s investment in a London real estate deal that has lost the Holy See millions of euros in fees paid to middlemen.
The Vatican prosecutor has placed several Vatican officials under investigation, as well as the middlemen, but not Becciu. Becciu has defended the soundness of the original investment and denied any wrongdoing, and it’s not clear whether the scandal itself was behind his resignation or possibly sparked a separate line of inquiry.
But the late-breaking news of his resignation, the severity of his apparent sanction, the Vatican’s tight-lipped release and the unexpected downfall of one of the most powerful Vatican officials all suggested a shocking new chapter in the scandal, which has convulsed the Vatican for the past year.
The last time a cardinal’s rights were removed was when American Theodore McCarrick renounced his rights and privileges as a cardinal in July 2018 amid a sexual abuse investigation. He was subsequently defrocked altogether by Francis last year for sexually abusing adults as well as minors.
Before him, the late Scottish Cardinal Keith O’Brien in 2015 relinquished the rights and privileges of being a cardinal after unidentified priests alleged sexual misconduct. O’Brien was, however, allowed to retain the cardinal’s title and he died a member of the College of Cardinals, the elite group of churchmen whose main job is to elect a pope.
In the Vatican statement, the Holy See identified Becciu as “His Eminence Cardinal Angelo Becciu,” making clear he remained a cardinal but without any rights.
At 72, Becciu would have been able to participate in a possible future conclave to elect Francis’ successor. Cardinals over age 80 can’t vote. But by renouncing his rights as a cardinal, Becciu has relinquished his rights to take part.
Becciu was the “substitute,” or top deputy in the secretariat of state from 2011-2018, when Francis made him a cardinal and moved him into the Vatican’s saint-making office. He straddled two pontificates, having been named by Pope Benedict XVI and entrusted with essentially running the Curia, or Vatican bureaucracy, a position that gave him enormous influence and power.
The financial problems date from 2014, when the Vatican entered into a real estate venture by investing over $200 million in a fund run by an Italian businessman. The deal gave the Holy See 45% of the luxury building at 60 Sloane Ave. in London’s Chelsea neighborhood.
The money came from the secretariat of state’s asset portfolio, which is funded in large part by the Peter’s Pence donations of Catholics around the world for the pope to use for charity and Vatican expenses.
The Holy See decided in November 2018, after Becciu had left the secretariat of state, to exit the fund, end its relationship with the businessman and buy out the remainder of the building. It did so after Becciu’s successor determined that the mortgage was too onerous and that the businessman was losing money for the Vatican in some of the fund’s other investments.
The buyout deal, however, cost the Holy See tens of millions of euros more and sparked the Vatican investigation that has so far implicated a half-dozen Vatican employees.
Becciu has insisted he wasn’t in power during the 2018 buyout deal and always acted in the sole interests of the Holy See. In the Vatican prosecutor’s initial warrant, Becciu is not named, and it remains unclear if his role in managing the secretariat of state’s vast asset portfolio was connected with the resignation.
His former boss, Secretary of State Pietro Parolin, has said the whole matter was “opaque” and needed to be clarified. Francis, for his part, has vowed to get to the bottom of what he has said was evidence of corruption in the Holy See.
Francis would meet regularly with Becciu in the Italian’s role as prefect of the saint-making office, since every month or two he would present lists of candidates for possible beatification or canonization for Francis to approve.
In addition, since the beginning of his pontificate, Francis had an annual luncheon date at Becciu’s apartment along with 10 priests on the Thursday of Holy Week leading up to Easter. The Vatican always reported the get-togethers were a chance for the pope to chat informally with Becciu and priests of his diocese on the day the church celebrates the institution of the priesthood.
The luncheon didn’t happen this year amid the Vatican’s coronavirus lockdown.
Novavax Kicks Off 10,000 Patient Covid Vaccine Study in U.K.
(Bloomberg) — Novavax Inc. climbed as much as 6.7% in extended trading on plans to start enrolling participants for a late-stage study of its experimental shot for the novel coronavirus in 10,000 patients in the U.K.The company joins the ranks of AstraZeneca Plc, Pfizer Inc. with German partner BioNTech SE and Moderna Inc. as its vaccine enters the final stretch on the path toward regulatory approval. There are roughly 38 shots being tested in humans around the world and more than 140 others in earlier stages of study, according to the World Health Organization’s estimates.Half of the people enrolled in Novavax’s placebo-controlled trial will get two shots of NVX-CoV2373 with Matrix-M, the biotech company’s adjuvant meant to make the immunizing shot more powerful. At least a quarter of study participants will be seniors, and priority will be given to enrolling racial and ethnic minorities hardest hit by the virus.The study has a two-pronged target to show effectiveness in those with symptoms of the disease or in moderate to severe Covid-19 patients, and achieving either goal may be enough to get a regulatory nod. Up to 400 people in the study will also get a seasonal flu vaccine to gauge the potential of administering a Covid shot alongside a flu shot.Novavax shares rose as much as 6.7% to $109.31 in postmarket trading in New York. The Gaithersburg, Maryland-based company secured a $1.6 billion U.S. contract in July on top of $388 million in funding from the Coalition for Epidemic Preparedness Innovations in May.“We have three shots on goal,” Gregory Glenn, the company’s president of research and development, said in a phone call, referring to other Covid-19 trials. Planning is also underway for a larger, 30,000 person study in the U.S. that will start enrolling in mid-October, while a smaller Phase 2b study in South Africa is ongoing.As drug developers large and small race to come up with an effective inoculation, Novavax has seen its stock price climb nearly 2,500% this year on its rapid progress against the disease. Since revealing a first look at Novavax’s shot in people in August, the stock has given back roughly 40% of that surge in shares. Day trader interest in vaccine and Covid-19 medicines faded from frenzied levels earlier this year as virus rates in the U.S. eased over the summer. So-called biotech tourists may also lose interest as a company gets closer to commercialization.(Updates to add shares)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Kenya anti-graft agency slams procurement of COVID-19 equipment
By Humphrey Malalo
NAIROBI (Reuters) – Kenya’s anti-corruption agency has documented evidence of “criminal” behaviour by officials over the procurement of COVID-19 emergency equipment, said a report presented to the Senate.
The Ethics and Anti-Corruption Commission began investigating allegations of graft in June over the procurement and supply of COVID-19 equipment by the Kenya Medical Supplies Authority. The commission said there was “irregular expenditure” of 7.8 billion Kenyan shillings ($71.96 million).
The revelations come at a time when medical staff in the East African nation have gone on a series of strikes over low pay and poor-quality protective equipment to treat COVID-19 patients. [nL4N2FN1WR]
“The investigation established criminal culpability on the part of public officials in the purchase and supply of COVID-19 emergency commodities at Kenya Medical Supplies Authority (KEMSA) that led to irregular expenditure of public funds,” the commission said in a report it sent to lawmakers on Wednesday.
The watchdog shared its preliminary findings with the Director of Public Prosecutions and has recommended charges against some officials and a system-wide review at the procurement authority to “seal corruption loopholes in future.”
A spokeswoman from the Health Ministry was unavailable for comment. KEMSA is a state-run agency which comes under the ministry.
The head of KEMSA was suspended last month over allegations that it had procured low quality items and inflated prices of others.
In a separate report seen by Reuters on Thursday, the Public Procurement Regulatory Authority catalogued instances of alleged inflation of prices for products procured by KEMSA.
Paracetamol tablets sold at 40 shillings per pack were bought for 66.50 shillings during the pandemic, while alcohol-based sanitizers priced at 313 shillings were purchased at 495 shillings, the report said.
“There was no evidence of indicative price indices obtained through market survey,” the report said.
It also alleged that most “tenders were retrospectively negotiated and evaluated after the deliveries” and “some of the negotiated prices were not as per the prices as proposed.”
Last month, police teargassed protesters in Nairobi during a demonstration against alleged corruption in the procurement of protective gear meant for defence against COVID-19.
Health workers in Kenya have posted images on social media showing what they claim is inadequate protective equipment provided to them, such as porous dust overalls that would not prevent the spread of the virus.
($1 = 108.4000 Kenyan shillings)
(writing by Omar Mohammed; editing by Katharine Houreld and Alexandra Hudson)
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