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Gilead Sciences Inc. GILD, +1.22% said late Friday that its CAR-T cell therapy had received approval from the Food and Drug Administration as a treatment for adult patients with relapsed or refractory mantle cell lymphoma. Shares of Gilead were up 0.6% in trading on Monday. The list price for Tecartus is $373,000 for a one-time infusion, according to a Gilead spokesperson, who noted by email that 87% of patients who receive a single dose report a response to the therapy. The "approval should also help quell at least in part any concerns that part two of the first wave of COVID-19 cases or the vaccine development race is distracting the FDA from approving important cancer medications," Mizuho Securities analyst Salim Syed wrote in a note to investors on Friday. Gilead's stock has gained 14.1% so far this year, while the S&P 500 SPX, +0.74% has declined 0.4%.
Bloomberg) -- The first large study of a Covid-19 vaccine in the U.S. began with the dosing of a single patient Monday morning in Savannah, Georgia, the opening shot for testing by Moderna Inc. and the National Institutes of Health that will weigh the vaccine’s safety and efficacy in 30,000 people.
The Moderna vaccine, backed by $955 million in government funding, will be tested at 89 U.S. sites. It uses messenger RNA, a synthetic form of genetic material from the virus designed to nudge the body’s immune system into attack mode. If the trial is successful, the company is on track to make 500 million doses of its vaccine in 2021, Moderna Chief Executive Officer Stephane Bancel said on a conference call with government officials.
Early results from the Moderna trial could be available in November or December, Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said on the call. But he called it “conceivable” that results could come as early as October if the trial enrolls very quickly in places with high case loads.
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Consideration - no coupon
The trial is designed to show that the vaccine is at least 60% effective in preventing Covid-19, Fauci said.
Francis Collins, the head of the NIH, said making sure the trial’s participants come from diverse backgrounds is “essential.” The NIH will be tracking the diversity of the trial weekly to make sure it is attracting patients representative of those in the U.S. who are being hit hardest by the virus, he said.
“We really are going to depend upon that sense of volunteerism from individuals from every different corner of society” Collins said on the call.
Collins also said the government will be advised on the tricky question of who might get the vaccine first by a special panel of the National Academy of Medicine, a private, nonprofit organization of doctors and researchers.
At least three other Phase 3 trials aren’t far behind, Collins said. The next three Phase 3 trials will be undertaken on vaccines from the University of Oxford, Johnson & Johnson and Novavax Inc. working within the government’s “Warp Speed” push. Separately, an upcoming trial of Pfizer Inc. and BioNTech SE’s shot is also nearing late-stage study.
J&J launched its Phase 1 clinical trials in the U.S. on Monday, and started in Belgium on Wednesday, according to the company.
Cambridge, Massachusetts-based Moderna climbed as much as 11% Monday after announcing on Sunday that it’s getting $472 million in a second round of U.S. funding for its late-stage trial. The shares were up 7.6% in New York trading at 11:58 a.m.
Moderna’s vaccine, co-developed with the NIH, is one of more than 160 in development to prevent the spread of the disease, and the World Health Organization estimates about 25 different inoculations are currently in human trials.
Government support for the vaccine “increases our confidence in its success,” BMO analyst George Farmer wrote in a note to clients. Goldman analysts led by Salveen Richter called Moderna “a leading contender” to bring a vaccine to the market, potentially before the end of the year.
Gilead Sciences Inc. (GILD) said that its biotech subsidiary Kite has received accelerated approval by the U.S. Food and Drug Administration (FDA) for the use of Tecartus as a treatment in adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Tecartus, which is a chimeric antigen receptor (CAR) T cell therapy, will be produced in Kite’s commercial manufacturing facility in California. MCL is a rare form of lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. MCL is highly aggressive following relapse, with many patients progressing following therapy.
“Kite is committed to bringing the promise of CAR T therapy to patients with hematological cancers, and as such, we are proud to launch our second cell therapy,” said Kite CEO Christi Shaw. “We look forward to partnering with the lymphoma community to deliver this potentially transformative therapy to patients with relapsed or refractory MCL.”
The approval of the one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of an open-label study in which 87% of patients responded to a single infusion of Tecartus, including 62% of patients showing a complete response (CR). Among patients evaluated for safety, 18% experienced grade 3 or higher cytokine release syndrome (CRS) and 37% experienced grade 3 or higher neurologic toxicities.
Five-star analyst Evan Seigerman at Credit Suisse on July 24 upgraded Gilead to Hold from Sell with a $75 price target based mainly on the potential opportunity and contribution of remdesivir - the company’s experimental antiviral for the treatment of Covid-19 - on earnings this year. The analyst expects remdesivir will help the revenue trajectory in 2H.
“While the company will have at least 2M treatment courses by year-end - we do not expect $6B in incremental revenue (a portion was donated at no cost and other supply was used in trials),” Seigerman wrote in a note to investors. “We forecast a modest $1.9B, increasing to $5B in 2021 (treatment + stockpiling, even with other therapeutics expected and the potential for vaccines by 2021).”
Seigerman expects Gilead at its 2Q results, which are scheduled to be released on July 30, to update guidance to include revenues from remdesivir.
“We could see an uptick in R&D numbers for 2Q given the investment in remdesivir (even ahead of projected revenues in 3Q/4Q),” Seigerman added. “We’re not changing our numbers ahead of the quarter, but rather highlighting potential areas of softness heading into the print.”
The rest of the Street is cautiously optimistic on the stock with a Moderate Buy consensus based on 8 Buy ratings, 12 Holds and 2 Sells.
July 27 (Reuters) - Moderna Inc said on Monday it has started a U.S. government-backed late-stage trial evaluating its COVID-19 vaccine candidate, mRNA-1273, in about 30,000 adults who do not have the respiratory illness caused by the new coronavirus.
The main goal of the study will be prevention of the symptomatic COVID-19 disease, the company said. (Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)
Yawning, you sound nervous... this will be the 3rd Times MRNA has ran to 80 plus dollars!!!!!!
Enjoy the show this morning
Game Changer MRNA Longs.......
Read my last post then ad this on top!!!!
Exciting times ahead $$$$$
Can u say MERGER!!!!!!!
Alert alert alert!!!!!
Reuters) - Moderna Inc said on Sunday it has received an additional $472 million from the U.S. government's Biomedical Advanced Research and Development Authority (BARDA) to support development of its novel coronavirus vaccine.
The drug maker said the additional funding will support its late-stage clinical development including the expanded Phase 3 study of Moderna's vaccine candidate.
(Reporting by Maria Ponnezhath in Bengaluru; Editing by Will Dunham)
Over a Year plus here too rich
All eyes are on the drug manufacturers that are racing to develop the first safe and efficacious coronavirus vaccine. Global COVID-19 cases have crossed the 15 million mark, with at least 634,000 deaths worldwide. In the United States alone, 4.1 million cases have been reported with at least 144,000 deaths, as of July 24. With cases rising every day, the country is limited in its ability to fully stop the spread of the virus until there's a vaccine on the market.
Currently, 198 coronavirus vaccines are in development with 19 in clinical testing. Among them, Moderna (NASDAQ:MRNA) has commanded much of the attention. Vaccine development typically takes many years, but due to the urgency and the rising cases, the process has been expedited. In April, the Biomedical Advanced Research and Development Authority awarded Moderna with $483 million in funding to accelerate the development of its vaccine. Moderna stepped into the spotlight on July 14 when it announced positive news with its interim results from its phase 1 trial for its COVID-19 vaccine candidate.
Vials labeled COVID-19 vaccine
IMAGE SOURCE: GETTY IMAGES.
The vaccine race is on
The results of the analysis of Moderna's open-label phase 1 study of its mRNA-1273 vaccine candidate were published in The New England Journal of Medicine. Moderna's potential coronavirus RNA-based vaccine aims to provide immunity through the introduction of genetic material or RNA. Biotech and pharma companies are developing COVID-19 vaccine candidates across nine different categories and an RNA-based vaccine is just one. This interim analysis "evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57."
The results showed that the vaccine was safe and successfully neutralized antibodies in all participants, meaning it prevented infection from novel coronavirus. Moderna's phase 2 trial, the study of which started on May 29, is in the process that will evaluate the vaccine further. Through phase 2, Moderna wants to "assess the safety, reactogenicity, and immunogenicity of two mRNA-1273 vaccinations administered 28 days apart."
Moderna will start its phase 3 'Cove' study involving 30,000 participants on July 27 with a partnership with technology firm Medidata. The main goal of the phase 3 trial is to check if the "primary endpoints of prevention of symptomatic Covid-19 disease are achieved in the vaccine-treated group."
The company has completed manufacturing the vaccines required for phase 3. It is already gearing up to deliver 500 million and 1 billion doses annually, even before phase 3 has begun, which is a bold move considering that many things can still go wrong.
This biotech company's shares could skyrocket if it wins the vaccine race. But keep in mind, besides the COVID-19 vaccine which is in trial phases, Moderna doesn't have any other approved products in the market. Currently, it has many vaccines in its pipeline for development that are either in phase 1 or pre-clinical stage.
Other pharma companies are also sprinting to develop the first safe and efficacious coronavirus vaccine, including AstraZeneca (NYSE:AZN), which is in the process of conducting a phase 2/3 trial now, along with a partnership with the University of Oxford.
Meanwhile, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have received a "fast track" designation from the U.S. Food and Drug Administration for two vaccine candidates in ongoing phase 1/2 clinical studies in the U.S. and Germany. Johnson and Johnson (NYSE:JNJ) is also working on a potential vaccine for COVID-19 and expects to begin the phase 1/2a clinical trial by the second half of July.
The New York Times reported while Johnson and Johnson and AstraZeneca assured lawmakers that they would manufacture millions of doses of the vaccine without any profit, Moderna made no such promise.
What investors can expect
Moderna's shares have soared by 256% year to date, with the S&P 500 falling by nearly 1%. Hopes rose after its positive results from the phase 1 trial, pulling the stock up 32% in the week ended July 17. For the same period, shares of AstraZeneca, Pfizer, and BioNTech have gained 14.7%, 9.6%, and 2.9%, respectively.
Biotech stocks performance for the week ended July 17
IMAGE SOURCE: Y CHARTS.
There are also a lot of risks involved, including further trials, regulatory approvals, and a competitor beating Moderna to market with an approved vaccine. With the world desperately waiting for a vaccine, any company succeeding in their coronavirus vaccine endeavor would be the best news of the year, but not for Moderna's shares if they fail to win the race.
A basket of carefully selected biotech stocks involved in coronavirus vaccine development could pay off significantly for aggressive investors who are willing to handle the risk of any unfavorable news. That said, Moderna's promising phase 1 results make it a good coronavirus stock to buy before the release of its phase 3 trial results.
Gilead Sciences Inc. (NASDAQ: GILD) is expected to reveal its second-quarter results on Thursday after the close. The consensus forecast calls for $1.48 in EPS, as well as $5.34 billion in revenue. The stock closed at $73.64 per share. The consensus price target is $81.42, and the 52-week trading range is $60.89 to $85.97.
There's been a lot of talk lately that Canadian pot giants Aurora Cannabis (NYSE:ACB) and Aphria (NASDAQ:APHA) have been discussing a potential merger. With competition in the industry on the rise and a potentially tough road ahead in the sector amid the COVID-19 pandemic, a merger is one way the two companies could strengthen their footprint in Canada and be in a better position to succeed over the long term.
Let's take a look at whether a deal between the two companies is inevitable and what that might mean for investors.
Discussions were in "advanced" stages
According to BNN Bloomberg, in mid-month, Aurora and Aphria "held advanced talks" about a possible deal.
The talks did end up breaking down, but not before they went into the details, including that Aphria shareholders would come away with a majority (51%) stake of the new company and that Aphria's current CEO, Irwin Simon, would be in charge of the new entity.
Two people shaking hands on a deal.
IMAGE SOURCE: GETTY IMAGES.
Why the deal makes a lot of sense
A merger would give the combined company close to one-third market share in Canada and a presence in 25 countries around the world. And the two companies have reportedly already been able to identify approximately 200 million Canadian dollars in cost savings from working together. That's no small figure given that in Aurora's third-quarter results, which the company released back on May 14, the pot producer incurred a net loss of CA$137.4 million.
It makes sense that Aphria's CEO would be leading the new company, given the Ontario-based pot producer's low-cost operations and focus on profitability. The company has reported a profit in three of its last four quarters, while Aurora's been profitable in just one of its past four quarterly results.
Another reason the two could come together: They're both without a big partner from another industry. Unlike their common rival, Canopy Growth, which has a 38.6% investment from Constellation Brands, neither Aphria nor Aurora are able to tap into the deep pockets of a larger partner. By joining forces together, they add more resources to the mix and create more stability for their investors, and they don't need to worry about a large investor nixing the deal.
Why the deal may be inevitable
A deal between the two companies didn't end up materializing, but although the talks appear to be off for now, that doesn't mean they'll stay that way. If the two companies went into the details of discussing who would be in charge and even looked for synergies that would result from working together, that suggests there's real interest there. And the longer the pandemic goes on, weighing down the economy and also the industry, the more pressure there will likely be to make a deal happen.
Back in February, investment bank Ello Capital noted that Aurora was in horrible shape and that it had perhaps a couple of months of liquidity left.
In its third quarter, Aurora reported cash and cash equivalents of CA$230.2 million, but it burned through CA$288.3 million over the course of its day-to-day operating activities during the past nine months.
Aphria's in a much stronger position. When it released its Q3 results on April 14, it reported cash and cash equivalents of CA$515.1 million. And it was also burning far less cash from its operations -- just CA$124.4 million over a nine-month period.
Aphria's strong cash position looks like it could give the company the upper hand right now. If Aurora continues to struggle and burn cash, it may become more desperate to work out a deal. And all it takes is one side in a negotiation to get desperate for a deal to come together quickly, which is what could very well happen if Aurora's financial position deteriorates as the year goes on.
What this means for investors
A deal involving these two Canadian pot producers will instantly create an industry leader, one that would be poised to take advantage of the U.S. market once marijuana is legal across the country. A combined entity would also make for a more stable investment over the long run, as it would have greater resources and market share.
As of today, however, all of that means nothing. Talks are just talks, and investing in a company because of a potential deal can be risky. Things can change quickly in the industry, and a better partner for a merger or acquisition -- for either company -- could emerge, putting these discussions to a definitive end.
However, whether it's Aurora and Aphria or another pair of cannabis companies, it's likely that a large deal will happen at some point over the course of the next 12 months. Marijuana companies are struggling, and as it becomes more difficult to raise cash and expand, consolidation will be much more attractive.
Moderna Inc said on Friday its formula used in developing a COVID-19 vaccine was not covered under patents owned by Arbutus Biopharma.
An administrative court run by the U.S. Patent and Trademark Office on Thursday rejected Moderna's arguments to invalidate a U.S. patent owned by Arbutus, sparking worries over its efforts to develop next-generation vaccines, including a coronavirus vaccine.
Moderna said the court's ruling relates to actions it took in response to "longstanding aggressive posture" taken by Arbutus against developers of nucleic acid-based therapeutics and began well before the development of mRNA-1273, its COVID-19 vaccine candidate.
Moderna shares were up slightly in extended trading, while Arbutus shares closed down 20% on Friday.
(Reporting by Vishwadha Chander in Bengaluru; Editing by Anil D'Silva)
We’ll get through this my friend. Can’t have you getting Down too!!!! Need your DD to keep momentum going. Stay MRNA strong my friend.
We’ve been here before
Moderna Inc's (NASDAQ: MRNA) coronavirus vaccine in development — mRNA-1273 — continues to inspire confidence among sell-side analysts.
The Moderna Analyst: SVB Leerink analyst Mani Foroohar initiated coverage of Moderna with a Market Perform rating and $65 price target.
The Moderna Thesis: The intense unmet need and the political will to get one or more vaccines approved are likely to sway regulators into showing substantial flexibility for vaccine candidates against SARS-CoV-2, the virus that causes COVID-19, Foroohar said in a Thursday initiation note. (See his track record here.)
"As a result, odds of approval for MRNA-1273 and competing therapies are high, even if pivotal clinical datasets show some inadequacies or inconsistencies," the analyst said.
Initial demand for the vaccine should be robust, he said.
SVB Leerink's base case estimates are modestly above the consensus for 2021.
Medium- and long-term expectations are unlikely to be met unless Moderna shows a best-in-class profile, Foroohar said.
This is an unlikely proposition for Moderna, given its many competitors, including big biopharma players pursuing mRNA strategies similar to Moderna's, the analyst said.
SVB Leerink also sees commoditization risk even in the face of excellent data, as many companies are entering the market in a short time — and considering the early price point implied by Pfizer Inc. (NYSE: PFE)/BioNTech SE's – ADR supply agreement with the U.S. government.
This scenario implies a price target of $19 per share attributable to Moderna's vaccine program, Foroohar said.
While being optimistic about Moderna's mRNA-1273, the analyst said he's uncomfortable with Moderna's valuation, even after ascribing value to a dozen programs, many of which are quite early.
"Without major pipeline catalysts to counterbalance competitive risk to MRNA-1273, we view risk/reward as unappealing at this valuation."
MRNA Price Target: Moderna shares were trading down 3.17% at $80.59 at last check Thursday.
Yessss sir $$$$$$$$$$
Gilead Sciences, Inc. GILD announced that it will acquire a 49.9% equity interest in Tizona Therapeutics, Inc., a privately-held developer of first-in-class cancer immunotherapies, for $300 million. In addition, Gilead will have an exclusive option to buy the rest of the company for up to $1.25 billion. This option will include an option exercise fee and potential future milestone payments.
Shares of the company have increased 20.5% year to date compared with the industry’s growth of 10.6%.
Tizona develops first-in-class medicines to bring in transformations for people suffering from cancer. Its lead pipeline candidate is TTX-080. TTX-080 is a potential first-in-class medicine that targets HLA-G. The characteristic of HLA-G is that it can address tumors that do not respond to current anti-PD-(L)1 treatments. It also deepens responses in tumors that are sensitive to anti-PD-(L)1 therapies.
However, Gilead can exercise this option to acquire the remainder of Tizona following the readout of a phase Ib study of the latter’s investigational antibody, TTX-080, or earlier, if the former decides to do so.
The investigational new drug (IND) application for TTX-080 has been cleared by the FDA. Tizona plans to initiate a phase I study evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.
Gilead will have the right to appoint two individuals to Tizona's board of directors upon the closing of the transaction. The deal is expected to close in the third quarter of 2020.
Tizona's investigational first-in-class anti-CD39 antibody, TTX-030, developed in partnership with AbbVie ABBV, will be divested before the closing of this transaction. TTX-030 is not part of this agreement.
By acquiring a stake in Tizona, Gilead plans to build a strong and diverse immuno-oncology pipeline as the former is developing first-in-class cancer immunotherapies that address tumors that do not respond to current checkpoint inhibitors. Thus, this could be an excellent opportunity for Gilead to develop novel therapies that will improve the treatment of cancer.
Wise beyond your year’s my friend!!!!
Been here since 2 dollars....I’m out $$$$$
GLTA here. Just couldn’t pass my account up
God bless you all
Carnival (CCL) CEO Arnold Donald is hopeful that cruising around the world isn’t too far off into the distance.
Donald told Yahoo Finance on Tuesday during the All Markets Summit Extra sailing in Germany is about to commence in August and Italy may be next. It remains unclear when cruising in the U.S. will restart as the industry works tirelessly to implement new safety protocols to protect against COVID-19.
Carnival’s voyage to the gates of the road to recovery has been turbulent to say the very least.
In March, Carnival’s Diamond Princess and Grand Princess ships were the faces of the COVID-19 outbreak. Thousands of passengers were trapped on the quarantined ships, with many live broadcasting their experiences on Twitter and Instagram. COVID-19 infections and deaths among passengers on the two ships mounted in March.
It’s estimated that more than 700 people were infected with COVID-19 from the Diamond Princess. Nine people are believed to have died.
“We are doing what we need to do” to start cruising, said Donald. “Our priority is public health... there is so much yet to learn about COVID-19.”
To be sure, Donald and his executive team have thrown the kitchen sink at keeping the cruise line giant afloat long enough that it sails into calmer waters, perhaps later in 2021.
Since the spring, Carnival has taken swift action to shore up its balance sheet. The company has raised a total of $10 billion in liquidity through a mix of debt and equity. In the process, Carnival now counts Saudi Arabia’s sovereign wealth fund as an 8.2% shareholder after it bought a stake in the company via a public share offering.
Meantime, Carnival has slashed $7 billion in annualized operating expenses through staff reductions and cut capacity by 9% via ship sales and the recycling of older vessels.
Assuming no revenue, Carnival believes it has enough liquidity to last it the next 12 months. The company has said it has more capacity to raise debt if needed.
The verdict is out on whether Carnival will require that one (or two) final financial lifeline. Earlier this month, the CDC extended its ‘no sail’ order for U.S. cruises to September 30 from July 24. No serious discussions with the CDC on the resumption of cruising in the U.S. has begun, Donald told investors on an earnings call a few weeks ago.
Carnival cruise line ship Carnival Magic is docked at Port Canaveral, Saturday, April 4, 2020, in Cape Canaveral, Fla. (AP Photo/John Raoux)
Carnival cruise line ship Carnival Magic is docked at Port Canaveral, Saturday, April 4, 2020, in Cape Canaveral, Fla. (AP Photo/John Raoux)
Carnival shares are down about 70% this year, according to Yahoo Finance Premium data. The stock trades at a nearly 46% discount to book value.
Despite the uncertainty on the future of cruising post pandemic, there are faint glimmers of hope emerging on the horizon. Carnival’s AIDA brand — which caters to cruise-goers in Germany — has received clearance to sail again, Donald pointed out. It’s likely some European countries such as Italy will give the green light on cruising soon. Carnival’s bookings for 2021 are surprisingly within historical ranges (at lower prices, however, amid discounts), with 60% of reservations from new cruisers.
Investors of Moderna (MRNA) slept soundly last weekend, as shares ended each session in the green during the week. Saving the best for last, on Friday July 17, Moderna posted a 16% uptick after it was revealed that the European Union (EU) might purchase Moderna’s experimental COVID-19 vaccine. The latest surge has sent the stock to a record high, having added 310% of muscle since the turn of the year.
With a Phase 2 study currently in progress, and a Phase 3 trial of mRNA-1273 set to begin on July 27, Oppenheimer analyst Hartaj Singh sees a rocky path ahead, yet remains optimistic.
“MRNA's valuation, in our view, is reflecting an approval and fast uptake of mRNA-1273, in line with other historical biotech comps. Pricing dynamics, potential donation of free vaccine and distribution of mRNA-1273 are non-trivial issues. We believe these can be navigated, but transit could be choppy. As the leader in the COVID-19 vaccine space, we continue to find MRNA attractive,” said the 5-star analyst.
Should mRNA-1273 gain approval, which is by no means a certainty and given a 50% probability of success by Singh, it is expected to generate sales of $5 billion by 2023. However, in order for that to become a reality, there are “many hurdles that MRNA needs to navigate over the next 3-6 months.”
These hurdles include the drug’s pricing. Other big pharma names such as Johnson & Johnson and AstraZeneca have said they might distribute their vaccines “at cost” while the virus still rages on. Additionally, with Moderna’s use of shareholder capital to produce mRNA-1273 “at risk,” this means “threading the pricing needle for mRNA-1273 will require finesse.” Add into the mix the possibility that the vaccine might be donated to developing countries - like Gilead has done with its viral treatment, remdesivir - and pricing becomes further complicated.
Lastly, there are the distribution logistics. Singh believes Moderna will “work closely with US governmental and international agencies to distribute mRNA-1273 in an equitable manner,” and might even search for a partner to work with on the commercial side.
Despite the variables, all in all, Singh concludes these are “high-quality problems, and we continue to find MRNA attractive.”
Therefore, Singh reiterated an Outperform rating along with a $108 price target. There’s 33% upside in the cards, should Singh’s target be met over the next 12 months.
Gilead Sciences (NASDAQ:GILD) announced Tuesday it's paying $300 million for a 49.9% ownership stake in Tizona Therapeutics and an option to acquire the company outright later for up to $1.25 billion in fees and potential milestone payments.
The deal provides the privately owned company with financing to support the development of TTX-080, a potential first-in-class immunotherapy targeting HLA-G, an immune checkpoint molecule expressed in multiple tumor types. A phase 1 study of HLA-G as monotherapy and in combination with existing treatments is set to begin enrolling patients this quarter.
A business person speaks through a megaphone.
IMAGE SOURCE: GETTY IMAGES.
If successful, TTX-080 could offer an alternative treatment for patients who don't respond to checkpoint inhibitors targeting the immune checkpoint PD-1, including the blockbuster drugs Opdivo and Keytruda. TTX-080 may enhance the efficacy of PD-1 inhibitors, suggesting there's also a potential pathway to improving the standard of care in eligible solid tumor cancer patients.
The biotech giant will be able to exercise its option to acquire the remaining equity of Tizona Therapeutics "following the completion of Phase 1b studies for TTX-080, or earlier."
Management expects this deal to close in the third quarter, after Tizona has spun-out its other drug in development, TTX-030, as a separate company. An anti-CD39 antibody, TTX-030 is being developed in partnership with AbbVie (NYSE:ABBV).
(Updated - July 21, 2020 8:32 AM EDT)
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will invest $300 million to acquire a 49.9 percent equity interest in Tizona Therapeutics, Inc., a privately held company developing first-in-class cancer immunotherapies. Gilead will also receive an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion, including an option exercise fee and potential future milestone payments.
Gilead can exercise its option to acquire the remainder of Tizona following the readout of a Phase 1b study of Tizona’s investigational antibody, TTX-080, or earlier if Gilead decides to do so. TTX-080, discovered by Tizona, is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. The expression pattern of HLA-G often appears distinct from that of PD-(L)1, suggesting potential utility to address tumors that do not respond to current anti-PD-(L)1 treatments and to deepen responses in tumors that are sensitive to anti-PD-(L)1 therapies.
The U.S. Food and Drug Administration has cleared Tizona’s Investigational New Drug (IND) application for TTX-080, and in the third quarter of this year, Tizona plans to initiate a Phase 1 clinical trial evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.
“Tizona is pursuing first-in-class cancer immunotherapies that could make an important difference in oncology by helping patients who don’t respond to current checkpoint inhibitors,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “This agreement with Tizona adds to the significant progress we’ve made in the first half of this year in building out a strong and diverse immuno-oncology pipeline. We now have multiple opportunities to develop novel therapies that will improve the treatment of cancer.”
“Gilead’s support will enable Tizona to accelerate and broaden our TTX-080 clinical program while also enabling us to rapidly advance our rich, first-in-class preclinical portfolio and target validation efforts,” said Scott Clarke, Chief Executive Officer, Tizona. “Our mission is dedicated to translating novel scientific insights into first-in-class immunotherapies and Gilead is a partner that shares our passion for science and delivering breakthrough innovation to people with cancer.”
Terms of the Agreement
Under the terms of the agreement, Tizona equity holders will receive $300 million upon closing. Gilead will obtain a 49.9 percent equity stake and an exclusive option to purchase the remaining equity exercisable following the completion of Phase 1b studies for TTX-080, or earlier if Gilead chooses. Tizona equity holders will be eligible to receive up to $1.25 billion in an option exercise fee and potential future milestone payments. Gilead will also provide funding to support Tizona’s ongoing research and development to advance its novel pipeline.
The transaction is expected to close in the third quarter of this year and is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Gilead will have the right to appoint two individuals to Tizona’s Board of Directors upon closing of the transaction.
Tizona will spin off TTX-030, the company’s investigational, first-in-class anti-CD39 antibody partnered with AbbVie, into a separate entity prior to closing of this transaction. TTX-030 is not subject to this agreement.
TTX-080 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.
Cowen is acting as financial advisor and Ropes & Gray is acting as legal counsel to Gilead. Latham & Watkins is acting as legal counsel and Squire Patton Boggs is acting as IP counsel to Tizona.
mRNA did this less than two months ago. Then MRNA printed 95 dollars a share. This is normal here as of late. Until phase 3 is released,,,, it’s going to have ups and downs. Hang tight, if there’s NEWS you know I’ll post it. Been doing it for months. If your Green and need to sell for profits...... Can’t blame you...... take it.
GLTA except Shorty!!!!
Absolutely my friend!!!! Spot on $$$$
Yep RSI is above 90.... don’t forget about it being shorted !!!!!!!!
We’re ready to go mRNA longs$$$$$$
Just remember they’ve been bailed out 50 milly plus from Saudi Investor’s... don’t listen to the haters. B patient my friend. It’s worth it in the long run
Patients is key here. Vaccine is made, airline takes off again... been here since 7.40. I truly believe we’ll b flying high soon.
GLTA except Shorty!!!!
Poor kitty cat!!! Tried helping you
Easily my friend. Patients is key! Well b back very very soon
Not a bad shake today.. to be expected cause of ,,,,,neutral ,,,,,, but or sell according to JPMORGAN!
Back up we go$$$$$$$
The U.S. Food and Drug Administration (FDA) granted Gilead Sciences (NASDAQ:GILD) emergency use authorization for its COVID-19 treatment, remdesivir, in May. The company donated its initial stock of the drug, but recently set a price and is now transitioning to selling the treatment. Gilead's investment has been steep. The company estimates it will have spent $1 billion by the end of the year. But at $2,340 per patient for a five-day treatment course, and considering a Journal of Virus Eradication report estimating it costs less than a dollar to produce a one-day dose of remdesivir, it's likely Gilead will make a profit.
There is a lot to Gilead besides coronavirus work. The biotech company's HIV drug sales are growing, led by blockbuster Biktarvy. The drug's revenue more than doubled in the first quarter, and Gilead said that in the U.S., Biktarvy is the No. 1 prescribed HIV treatment. Looking ahead, rheumatoid arthritis drug filgotinib may be another growth driver. The FDA is currently reviewing the drug and may issue a decision at any time. Gilead has already prepared for a second-half launch and hopes for approval in Europe and Japan by the end of the year.
Gilead's shares actually peaked on April 30, with a 29% gain from the start of the year. As attention turned to vaccine makers, the shares lost some steam, ultimately delivering an 18% increase for the first half. Gains moving forward might be slower than those of certain vaccine makers, but the overall path higher should be smoother.
Panic seller’s kicking themselves now
MRNA too strong$$$$$$$
Moderna, which is applying similar technology as Pfizer (PFE) - Get Report and BioNTech (BNTX) - Get Report to develop a vaccine, received fast-track approval from the Food and Drug Administration for its Covid-19 vaccine candidate in May.
For its part, Moderna will begin a Phase 3 trial on July 27 that is expected to include some 30,000 participants. The participants will help compare its vaccine with placebo injections of the vaccine and determine whether it continues to show a buildup of antibodies needed to fend off the coronavirus.
Moderna has been focused on testing a vaccine that will not only prevent infection from SARS-CoV-2, the virus that causes Covid-19, but also prevent severe cases of the disease that require hospitalization.
Futures are low.... mrna going high
One in the same my friend $$$$$
Nothing wrong with that my friend!!
Let us see what tomorrow has in store for us $$$$$$
That’s great. Hopefully kitty cat will follow your lead and get a better position. Looking forward to Monday and what’s in store for GAXY $$$$$$
GLTA
Yawn !!!!!!!!!!