Moderna (MRNA) said on Sunday that it has been awarded up to $472 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support late stage clinical development of its mRNA vaccine candidate (mRNA-1273) against COVID-19.
The U.S. grant will be used to fund the drugmaker’s expanded Phase 3 study of mRNA-1273, which includes 30,000 participants in the U.S and is scheduled to start on July 27. After having already received $483 million from BARDA earlier this year to support early clinical development of the investigational vaccine, the total value of the award is now about $955 million.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.” said Moderna’s CEO Stéphane Bancel. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks."
The primary endpoint of the randomized, placebo-controlled Phase 3 trial will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include the prevention of severe COVID-19 disease as defined by the need for hospitalization and prevention of infection by SARS-CoV-2.
Moderna reiterated that the company remains on track to deliver about 500 million doses per year, and up to 1 billion doses per year, beginning in 2021. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 was secured from investors in the company’s most recent public equity offering in May 2020.
Shares in Moderna have surged 276% so far this year, and Wall Street analysts have a Strong Buy consensus on the stock’s outlook. The $91.87 average price target suggests an additional 25% upside potential lies ahead. (See MRNA stock analysis on TipRanks).
In a bullish note, five-star analyst Hartaj Singh at Oppenheimer on Friday assigned a Buy rating on the stock with a $108 price target suggesting shares have room to gain another 48% over the coming year.
“We do see a tricky period ahead for MRNA as logistics and discussions of commercialization (e.g., pricing) intensify,” Singh wrote in a note to investors on July 24. “We continue to see Moderna as well-positioned to navigate these waters, based on the company's impressive execution in the clinic, thoughtful commentary on the clinical/commercial landscape, and delivered results. Hence, we would buy MRNA.”
Related News:
Pfizer, BioNTech Ink UK Supply Deal For 30M Covid-19 Vaccine Doses
Moderna Soars 16% As Covid-19 Vaccine Shows Strong Immune Response
GSK Buys 10% Stake In Germany’s CureVac To Develop mRNA Vaccines
Sorrento (SRNE) has signed of a letter of intent to buy SmartPharm, to develop a pipeline of gene-encoded antibodies for the potential treatment of COVID-19 and cancer therapeutics.
The biotech company expects that the combination of SmartPharm's DNA gene-encoded in vivo expression technology and its SARS-CoV-2 neutralizing antibodies may potentially provide longer-acting, single injection protection against COVID-19. Financial terms of the deal, which is expected to close in August, were not disclosed.
Sorrento plans to accelerate the development of multiple candidates for in vivo gene-encoded antibodies, starting with its previously announced STI-1499, or COVI-GUARD, which is currently going through preclinical and manufacturing requirements.
In vitro results so far have demonstrated STI-1499's ability to neutralize SARS-CoV-2 infection at low doses, turning it into the company’s lead candidate for potential cost-effective passive protection against COVID-19.
"We are very encouraged by the preclinical data generated thus far by our STI-1499 neutralizing antibody against COVID-19," said Sorrento CEO Henry Ji. "We are excited about the prospect of leveraging SmartPharm's Gene Mab platform in combination with our G-MAB library to produce next-generation gene-encoded antibody candidates against a host of pathogens and cancer cell types. Being able to stimulate the body to produce in vivo our most potent antibodies at optimized manufacturing costs will offer an additional competitive advantage as Sorrento transitions from product development to full scale manufacturing and commercialization."
Sorrento is already working with SmartPharm's gene-encoded monoclonal antibody delivery platform, also known as Gene Mab, to encode and express in vivo proprietary SARS-CoV-2 neutralizing monoclonal antibodies.
If clinical trials are successful, a single administration of STI-1499dpi (DNA plasmid injection) could allow the recipient's own muscle cells to produce the antibody for a prolonged period of time after a single injection, potentially providing extended protection against COVID-19 for periods of time that might provide an alternative to vaccines, the two companies said in the statement.
The move follows last week’s announcement that the U.S. Food and Drug Administration (FDA) had given Sorrento the go ahead to initiate a Phase 2 trial of abivertinib in COVID-19 patients with moderate to severe lung-related symptoms.
Sorrento is confident abivertinib’s potent effect can help it prevent the "cytokine storm," in which the body attacks its own cells on account of the immune system’s overreaction, in COVID-19 patients.
The FDA approval prompted H.C. Wainwright analyst Ram Selvaraju to reiterate a Buy rating on the stock with a $24 price target saying that he believes that Sorrento may be positioning itself as a leader in addressing the pandemic, with multiple potential therapeutic approaches in its pipeline.
“While the clinical development path for abivertinib in lung cancer and its applicability in COVID-19 patient treatment shall need to be clarified, we believe that an accelerated route to the U.S. market for lung cancer treatment and positive Phase 2 data in COVID-19 patients ought to catalyze substantial strategic interest in abivertinib from established pharmaceutical firms,” Selvaraju wrote in a note to investors last week.
Shares in Sorrento are currently trading up a stellar 118% on a year-to-date basis, and analysts have a Moderate Buy consensus on the stock’s outlook. The $24 average analyst price target indicates a promising 229% upside potential in the shares over the coming year. (See SRNE stock analysis on TipRanks).
Related News:
Gilead’s Kite Gets FDA Nod For Tecartus Blood Cancer Treatment
Moleculin Pops 33% On Anti-Viral Activity For Potential Covid-19 Treatment
Upcoming Phase 2 COVID-19 Trial Marks Key Milestone for Sorrento (SRNE); Analyst Says ‘Buy’
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.
Shares in Gilead dropped 2.5% to $73.64 at the close of trading on July 24 trimming the year-to-date advance to about 13%. The $81.07 average price target implies 10% upside potential in the shares in the coming 12 months. (See Gilead stock analysis on TipRanks).
Related News:
Gilead Pours $300M Into Tizona’s Cancer Immunotherapy Pipeline
NuVasive Spikes 5% After-Hours On Sharp Procedure Rebound
Acadia Plunges 12% As Depressive Study Misses Goals; Analyst Says Buy