Alzamend Neuro Soars in First Trading Day

 Alzamend Neuro ALZN, a developer of treatments for neurodegenerative diseases and psychiatric disorders, soared in its first trading day after its IPO but has pulled back from its opening.

Shares of the five-year-old Tampa, Fla., company, which has a treatment for Alzheimer’s disease, on Tuesday opened at $29 and peaked at $33.55. 

Its initial public offering price was $5 a share. The stock recently traded at $14.81.

Alzamend has begun preparing an investigational-new-drug application for AL001, which treats Alzheimer’s, other neurodegenerative diseases and psychiatric disorders, Bloomberg reports. 

The company plans to file the application with the Food and Drug Administration this month.

Alzamend hasn’t earned any revenue. Its loss widened to $3.8 million for the nine months ended Jan. 31 from $3.2 million a year earlier.

https://www.thestreet.com/investing/alzamend-neuro-soars-in-first-trading-day-ipo

Clearside Biomedical Soars; Roth Capital Calls Eye Drug 'Game Changer'

 Clearside Biomedical  (CLSD) - Get Report jumped on Tuesday after the biopharma reported progress in a clinical trial of CLS-AX, a drug for pretreated wet age-related macular degeneration.

The results prompted an analyst to call the treatment "a game changer."

Shares of the Alpharetta, Ga., company at last check were up 46% to $4.41.

Clearside said the initial lowest planned dose of 0.03 mg CLS-AX was well tolerated with no serious adverse events and no drug-related treatment-emergent adverse events observed throughout the study. 

The company said the improvements after receiving an injection of CLS-AX for wet AMD were reflected in the BCVA score, or best corrected visual acuity, with five of six patients each gaining four or more letters.

Roth Capital analyst Zegbeh Jallah reiterated a buy rating and a $9 price target on the company after Clearside unveiled the early safety and efficacy data.

CLS-AX was safe and well-tolerated with no inflammation, allowing for enrollment into Cohort 2, Jallah said in a research note, according to the Fly.

Even "more impressive" were the early efficacy data showing that a single dose of CLS-AX led to best corrected visual acuity improvements, beyond that achieved with "gold standard" Eylea, the analyst said. That makes the Clearside drug a "game changer," Jallah said.

Regeneron Pharmaceuticals  (REGN) - Get Report, which makes Eylea, did not immediately respond to a request for comment. Eylea is Regeneron's first approved drug in 2011 and remains the company's top seller.

In February, Regeneron said Eylea's fourth-quarter U.S. net sales increased 10% to $1.34 billion over the year-earlier total. In May, the company said first-quarter sales of Eylea increased 15% to $1.35 billion.

In April, Regeneron said its Regen-Cov antibody cocktail may work well at treating people who have been exposed to COVID-19 but are not showing symptoms. The company unveiled positive results for Regen-Cov in March.

https://www.thestreet.com/investing/clearside-biomedical-soars-as-eye-treatment-called-game-changer

Aptinyx updates on PTSD treatment program

 Finalizes design for Phase 2b program, which remains on track to commence in 4Q 2021

Corrects statistical analysis from previous exploratory Phase 2 study—no impact on study conclusions or future clinical development plans

Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of nervous system disorders, today announced that it has finalized the design of its Phase 2b program for NYX-783 in patients with post-traumatic stress disorder (PTSD) after having received the minutes from its recent Type C meeting with the U.S. Food and Drug Administration (FDA). The company expects to initiate the Phase 2b program in the fourth quarter of 2021. Aptinyx also announced that, in its preparation for Phase 2b, it identified a statistical error made by the contract research organization (CRO) that performed the statistical analysis of the previously completed exploratory Phase 2 study in PTSD. Accordingly, the company is providing updated statistical analysis for the exploratory Phase 2 study, which has no impact on the study conclusions.

"We are pleased to be moving forward with Phase 2b development of NYX-783 in PTSD and believe that its mechanism of enhancing extinction learning through NMDA receptor modulation has the potential to address the putative underlying pathology of PTSD," said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. "Upon identifying the error in statistical analysis made by the CRO in our previous study, we have moved quickly to reanalyze and release revised statistical analysis. It is important to note that the revised analysis does not impact our conclusions from that study, our confidence in the efficacy and safety profile of NYX-783, or our next steps in its clinical development. We look forward to advancing NYX-783 into Phase 2b starting in the fourth quarter of this year."

https://finance.yahoo.com/news/aptinyx-provides-nyx-783-development-201000880.html

Daiichi Sankyo halts trials of existing drug for COVID-19 treatment

Japan's Daiichi Sankyo Co said on Tuesday it was halting development of an existing drug for the treatment of COVID-19.

Daiichi Sankyo in March started a clinical trial in Japan of an inhaled form of nafamostat mesylate with COVID-19 patients. The company said in a statement it was discontinuing the trial without citing a reason. The Nikkei newspaper reported that there were safety concerns.

Nafamostat is used in the treatment of pancreatitis and has antiviral properties.

https://news.trust.org/item/20210615055559-dx3ae/

5 states had coronavirus infections even before first reported cases: study

 At least seven people in five U.S. states were infected with the novel coronavirus weeks before the states reported their first cases, a large new government study showed, pointing to the presence of the virus in the country as early as December 2019.

Participants who reported antibodies against SARS-CoV-2 were likely exposed to the virus at least several weeks before their sample was taken as the antibodies do not appear until about two weeks of infection, the researchers said.

The samples came from Illinois, Massachusetts, Mississippi, Pennsylvania and Wisconsin, and were part of a study of more than 24,000 samples taken for a National Institutes of Health research program between Jan. 2 and March 18, 2020.

Of the seven samples, three were from Illinois, where the first confirmed coronavirus case was reported on Jan. 24, while the remaining four states had one case each. Samples from participants in Illinois were collected on Jan. 7 and Massachusetts on Jan. 8.

The data suggests the virus was in the U.S. states far from the initial hotspots and areas that were considered its points of entry into the country, the study said. “Data suggest that more rapid and widespread implementation of testing could have allowed us to better realize the spread might have been worse than initially thought, perhaps influencing our level of response,” said Micheal Breen, director of infectious diseases and ophthalmology at GlobalData.

The data backs a Centers for Disease Control and Prevention study that suggested the virus may have been circulating in the United States well before the first COVID-19 case was diagnosed on Jan. 19, 2020.

“This study allows us to uncover more information about the beginning of the U.S. epidemic,” said Josh Denny, a co-author of the study that was published in the journal Clinical Infectious Diseases.

The United States has so far reported 33.6 million cases, according to a Reuters tally.

https://www.cnbc.com/2021/06/15/five-us-states-had-coronavirus-infections-even-before-first-reported-cases-study-says.html

Novavax's COVID-19 Vaccine, Flu Shot Co-administration Preserved Efficacy, Likely 'Viable Strategy'

• Novavax Inc (NASDAQ: NVAX) announced its experimental COVID-19 vaccine remained effective when coadministered with an approved flu shot.

• Researchers are interested in studying coadministration and the associated safety & efficacy of giving multiple vaccines to a person during one visit to ease logistics and help patients catch up on missed vaccinations, especially amid the pandemic.

• The company released the results from a sub-study it conducted as part of its late-stage clinical trial of NVX-CoV2373 in the U.K.

• The 431 participants enrolled in the sub-study received an approved seasonal influenza vaccine, with about half the participants administered NVX-CoV2373, while the rest received a placebo.

• The company said vaccine efficacy was 87.5% compared to 89.8% in the main study.

• Despite the "modest decrease," antibodies against the spike protein were reported as over three-fold higher than levels found in blood samples of people who received both vaccines.

• The news comes hours after Novavax announced that its protein-based COVID-19 vaccine was found to be over 90% effective overall and offered 100% protection against moderate and severe disease in a Phase 3 trial.

https://finance.yahoo.com/news/novavaxs-covid-19-vaccine-flu-100042166.html

Axsome to Seek FDA OK of AXS-14 for Fibromyalgia by End 2022

 Axsome Therapeutics Inc. on Tuesday said it plans to file for U.S. Food and Drug Administration approval of AXS-14 for the management of fibromyalgia by the end of next year.

The New York biopharmaceutical company said a pair of placebo-controlled trials have shown the potential for AXS-14 to improve the symptoms of the debilitating central-nervous-system condition, which currently has limited treatment options.

Axsome said it plans to submit a new drug application for AXS-14 in the fourth quarter of 2022, pending successful completion of manufacturing and other activities related to the product candidate.

https://www.marketscreener.com/quote/stock/AXSOME-THERAPEUTICS-INC-24949017/news/Axsome-Therapeutics-to-Seek-FDA-OK-of-AXS-14-for-Fibromyalgia-by-End-2022-35610568/