Dismay Over Novavax Vague Timelines for Covid Vaccine

 Novavax Inc. shares dropped Monday after a Washington Post report said the biotech may not seek emergency use authorization for its closely-watched Covid-19 vaccine until June at the earliest -- a delay that spooked investors on top of manufacturing concerns.

The drug developer will not publish results from a highly-anticipated study of the vaccine until the end of the month, according to the report, which is weeks later than many on Wall Street anticipated. The biotech, which has soared more than 4,000% since the start of 2020, tumbled as much as 9.9% as the article removed an immediate catalyst for the stock.

Investors fear there may be issues beyond just a simple delay in the vaccine’s results that may be preventing it from filing for emergency use. The company also needs to reach an agreement with U.S. regulators over issues for an assay, which helps check the quality of its vaccines, the report said. That could cause the delay to drag on longer.

Representatives for Novavax did not immediately respond to an email inquiry for comment on the Washington Post story.

“These are growing pains and I would remind investors this will be a three horse race basically between Moderna, BioNTech-Pfizer and Novavax,” B. Riley analyst Mayank Mamtani said by telephone. “This is a great entry point for investors,” Mamtani, who rates shares at a buy and has a Street-high price target of $365, added.

While Novavax and vaccine developing peers were hit last week by concerns surrounding a U.S.-backed effort to waive patent protection for Covid-19 vaccines, Monday’s news flow was less cut and dry. As Novavax headed toward its lowest close in two months, peer BioNTech SE rallied as much as 10% after raising its Covid-19 vaccine sales forecast to $15.1 billion for this year.

Novavax is due to report quarterly results after the bell Monday, and analysts will be paying close attention to any comments on the delayed timelines for the Covid-19 vaccine. Earlier the biotech published positive results from a combination trial of its Covid-19 vaccine candidate and its seasonal flu vaccine in hamsters.

https://finance.yahoo.com/news/novavax-slumps-muddy-covid-19-154032029.html

Indian COVID Strain Declared 'Global Concern' As Data Show It's Vaccine-Resistant

 During the WHO's Monday press conference, Maria Van Kerkhove, the scientist in charge of the agency's COVID-19 response, declared that COVID-19 variant B.1.617, which was first isolated in India and is believed to be driving that country's brutal second wave, is a "variant of global concern".

There's apparently some new data that's presently being peer-reviewed which shows that B.1.617 is indeed more transmissible than earlier strains of the virus.

"There is some available information to suggest increased transmissibility," Van Kerkhove said.

Though examples of every major mutant strain have been discovered across India, local public health authorities have been growing increasingly concerned about B.1.617, suspecting that the variant strain might be even more infectious than B.1.1.7, the mutant strain otherwise known as "the Kent Strain", after the part of the UK where it was first identified. 

Over the weekend, the Indian Express reported that the B.1.617 variant was been found to be driving much of the spread in the outbreak in Odisha, comprising roughly 50% of cases reported. Interestingly, not a single sample of the UK variant B.1.1.7 or the triple-mutant B.1.618 (which was recently found to be more prevalent in West Bengal) has been found in Odisha, suggesting that the original India strain is spreading the fastest.

B.1.617 is also the dominant variant in India’s hardest-hit state, Maharashtra.

Dr. Kerkhove explained that the WHO's data appears to support the conclusion that B.1.617 is not only more infectious, but also resistant to vaccinations, as a surprising number of patients who have already been fully vaccinated have been found to be infected with the strain.

Meanwhile, shortly after the press conference concluded, the FT reported that a new study showing that B.1.617 has "modest ability" to avoid antibodies elicited by the Pfizer jab, though an extensive vaccination campaign is likely to reduce transmissions, a study has found. The B.1.6.1.7 variant, one version of which was elevated to a "variant of concern" by Public Health England last week, first emerged in the state of Maharashtra in late 2020 or early 2021 and has spread throughout India and to at least 40 countries.

The variant includes mutations that appear to make it more transmissible and less susceptible to vaccines than the virus that first emerged in Wuhan last year.

One such mutation "confers partial evasion" of antibodies generated by the Pfizer vaccine, according to a paper — which has yet to be peer-reviewed — but is set to be published this week by researchers from India, South Africa, Japan and the UK.

Ravindra Gupta, professor of clinical microbiology at the University of Cambridge and one of the study’s authors, told a press conference on Monday the variant discovered in India has mutations that "enable immune escape" and that "we should be assuming it’s as transmissible" as the one first identified in the UK. To be sure, the vaccines "will still protect against severe disease,” he added.

While it might not seem like it at first, this is actually good news for Pfizer. Though it's definitely bad news for humanity.

https://www.zerohedge.com/covid-19/indian-covid-strain-declared-global-concern-data-show-its-vaccine-resistant 

Are Coronavirus Vaccine Boosters Inevitable?

 Moderna (NASDAQ:MRNA) says it is developing vaccines against the coronavirus variants "out of an abundance of caution." But as Fool.com contributors Brian Orelli and Keith Speights discuss in this video from Motley Fool Live, recorded on April 12, the need for vaccines against the variants appears inevitable.

Brian Orelli: In Moderna's press release, it says, and I'm quoting here, "Out of an abundance of caution, Moderna is also pursuing a clinical development strategy against the emerging variants," which we already knew that. But I just found it curious. First off, with the coronavirus variants, have we reached a point where we're doing this just in case it's needed? Then do you want to give us a timeline on the potential booster shots in advance?

Keith Speights: Obviously Moderna doesn't think that we're beyond that point of moving forward out of an abundance of caution. It is kind of funny the wording they use in some of their press releases, but aside from that wording, putting it aside, I think the drug makers are legitimately continuing to explore the best approach to providing protection against new variants.

As for the timelines for potential booster shots, for Moderna, the National Institute of Health, NIH, is testing a booster dose of a modified version of Moderna's vaccine. They expect to be fully enrolled in this study by the end of April. So just a few weeks from now. Moderna has publicly stated that it expects to have a booster shot available by the end of 2021. Moderna has gone on the record projecting when they think they'll have this booster shot available.

It's a little different story with Pfizer (NYSE:PFE). Pfizer and BioNTech (NASDAQ:BNTX) are testing a third dose of their existing vaccine. In late February, the two companies said that they were also talking with regulatory authorities about the potential for advancing a modified version of their vaccine that specifically targets these variants in the clinical testing. But I haven't seen an update from Pfizer or BioNTech on this testing effort, haven't seen any specific timelines about the booster shots from either company.

I think though that just based on what we do know, I think that Pfizer could be a little ahead of Moderna with the testing of a third dose of its existing vaccine and probably a little behind with testing of a modified vaccine that's specific to these variants. So we'll just see how this plays out.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

Brian Orelli, PhD has no position in any of the stocks mentioned. Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.

https://www.fool.com/investing/2021/05/10/are-coronavirus-vaccine-boosters-inevitable/

Heron upcoming events with earnings

  Labelling Discussions with the FDA are Underway for HTX-011; Prescription Drug User Fee Act (PDUFA) Goal Date is May 12, 2021 

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced financial results for the three months ended March 31, 2021 and highlighted recent corporate updates.

Recent Corporate Updates

Acute Care Franchise

• New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a PDUFA goal date of May 12, 2021.

• Initiation of Expanded Phase 2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain: In March 2021, Heron initiated the expanded Phase 2 clinical study in patients undergoing bunionectomy with HTX-034, Heron's next-generation product for the treatment of postoperative pain.

• NDA for HTX-019 Planned in Late 2021 for Prevention of PONV in Adults: In the Phase 1 bioequivalence study, HTX-019 32 mg as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of postoperative nausea and vomiting (PONV). A 505(b)(2) NDA for HTX-019 for PONV in adults is planned for late 2021.

Oncology Care Franchise

• 2021 Net Product Sales: For the three months ended March 31, 2021, oncology care franchise net product sales were $20.0 million, compared to $25.4 million for the same period in 2020. The Coronavirus Disease 2019 (COVID-19) pandemic reduced cancer screening procedures and new patient treatment starts in 2020 resulting in fewer clinic anti-emetic administrations during the first quarter of 2021 compared to the prior year and last quarter. Heron is assisting Community Oncology Alliance with its campaign to get patients back into screening. With the greater availability of COVID-19 vaccines and the declining rates of infection, Heron believes that the number of patients receiving cancer treatment will begin to return to normal levels.

• Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the oncology care franchise of $130 million to $145 million.

"We have no outstanding questions on the pending NDA and are currently in labelling discussions with the FDA, as we prepare for the anticipated commercial launch of HTX-011 in the U.S.," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "For the oncology care franchise, we expect the market to pick up in the second quarter and we recently signed a large, multi-year contract for CINVANTI that will help increase net product sales throughout 2021."

https://finance.yahoo.com/news/heron-therapeutics-announces-financial-results-123000089.html

Soligenix Plummets As Will Not Pursue Rolling US Submission For HyBryte

 

• Soligenix Inc (NASDAQ: SNGX) shares dropped during premarket after the company said it would not pursue a rolling marketing application submission for HyBryte (SGX301). Instead, it plans to submit the NDA in the first half of 2022.
• The decision follows the company's discussions with the FDA regarding the HyBryte application submission.
• Based on the discussions and given delays in manufacturing, in part caused by the global COVID-19 pandemic, Soligenix has decided to drop the rolling NDA submission at this time to provide additional supportive data for inclusion in the NDA filing.
• The company sees potential FDA approval adjusted to the first half of 2023.
• Recently, confirmatory data from its Phase 3 FLASH study was presented at the Society for Investigative Dermatology (SID) Virtual Meeting.
• The presented data demonstrated the ability of HyBryte to treat both patch and plaque disease, including generating complete disease responses, while being associated with fewer and less severe adverse events than other currently approved skin-directed therapies for cutaneous T-cell lymphoma. 
• HyBryte (SGX301 or synthetic hypericin) is a novel photodynamic therapy utilizing safe, visible light to treat cutaneous T-cell lymphoma. 

https://www.benzinga.com/general/biotech/21/05/21031590/soligenix-stock-plummets-after-it-announces-not-to-pursue-rolling-us-application-submission-for-h

Precipio Launches New Test for AML with 4-hour turnaround

 Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that it has launched a new, four-hour Acute Myeloid Leukemia (AML) HemeScreen panel to specifically determine the genetics of this aggressive, acute form of leukemia. When physicians are armed with the genetic character of the disease, they can rapidly and precisely select the most effective targeted therapeutic.

Beyond the important clinical utility and substantial impact to patient care described below, this panel is expected to increase revenues to Oncology Physician Office Laboratories (POLs) by approximately 10% (subject to patient volume), and is expected to similarly increase Precipio’s revenues from existing and future Oncology POL and other laboratory customers who incorporate this panel into their operations.

The addition of this panel further demonstrates the potential of HemeScreen and the POL model, whereby an existing installed customer base, as well as Precipio, benefit from the continued development and introduction of new panels by Precipio’s R&D team.

https://finance.yahoo.com/news/precipio-launches-hemescreen-panel-aml-143000386.html

Allergan Aesthetics to Acquire Soliton, Expand Body Contouring

 Acquisition adds Rapid Acoustic Pulse technology platform for improvement in appearance of cellulite in the buttocks and thighs 

Allergan Aesthetics, an AbbVie company (NYSE: ABBV) and Soliton (NASDAQ: SOLY) today announced a definitive agreement under which Allergan Aesthetics will acquire Soliton and RESONICTM, its Rapid Acoustic Pulse device which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The acquisition of Soliton expands and complements Allergan Aesthetics' Body Contouring treatment portfolio which includes CoolSculpting® Elite.

The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite. In clinical trial data submitted to the FDA, after a single treatment session RESONICTM demonstrated significant improvement and strong patient satisfaction with 92.9 percent of subjects agreeing or strongly agreeing their cellulite appeared improved.

https://finance.yahoo.com/news/allergan-aesthetics-acquire-soliton-expanding-123000839.html