Tag: Biotechnology

Release – Ocugen, Inc. to Present at Chardan’s 6th Annual Genetic Medicines Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Markt Data on OCGN

September 29, 2022

MALVERN, Pa., Sept. 29, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen, will participate in an in-person fireside chat at the Chardan 6th Annual Genetic Medicines Conference being held October 3-4, 2022 in New York, NY.

Details regarding Dr. Musunuri’s fireside chat are as follows:

Event: Chardan 6th Annual Genetic Medicines Conference
Date: October 4, 2022
Time: 8:30 – 8:55 a.m. ET
Location: Westin Grand Central Hotel
Webcast: Live Fireside Chat

A live video webcast beginning at 8:30 a.m. ET on the day of the presentation will be available on the events page of the Ocugen investor site. The webcast replay will be archived for 90 days following the event.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com 

Ocugen (OCGN) – Nasal COVID-19 Vaccine Licensed For Development

Posted on by aweinsoff@channelchek.com


Thursday, September 29, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Vaccine For Protection and Prevention of Transmission.  Ocugen has licensed a nasally administered COVID-19 vaccine from Washington University.  Preclinical models show the vaccine produces a strong immune response in the tissues of the nasal passages and respiratory tract where the SARS-CoV-2 virus enters the body and first colonizes.  This strong local immunity could potentially stop both infection and transmission.  Ocugen plans to develop the vaccine as a “universal booster” for protection against current and future strains. 

The Vaccine Has Been Licensed For Other Territories.  Ocugen’s partner for Covaxin, Bharat Biotech (India), has also licensed the vaccine from Washington University and received Emergency Use authorization for India.  We see this as positive sign for regulatory approval in the US and other territories.  Ocugen plans to begin discussions with the FDA to determine the clinical requirements for approval.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Ocugen Announces Agreement With Washington University in St. Louis for Commercialization of Intranasal COVID-19 Vaccine in U.S., Europe, and Japan

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

September 28, 2022

  • Ocugen’s intranasal candidate is one of the world’s most advanced intranasal COVID-19 vaccines
  • Intranasal vaccine is designed to curb virus transmission and confer protective immunity

MALVERN, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the company has entered into an exclusive license agreement with Washington University in St. Louis, MO for the rights to develop, manufacture and commercialize its proprietary, intranasally delivered COVID-19 vaccine in the United States, Europe, and Japan. This vaccine is already authorized for emergency use in India and is an important addition to Ocugen’s COVID-19 vaccine portfolio.

“Washington University’s COVID-19 nasal vaccine technology has been shown to induce strong mucosal immunity with potential to reduce SARS-CoV-2 infection, transmission, and the emergence of new variants,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “As the effort to end the pandemic focuses on effective booster options, Ocugen is excited about the potential for this vaccine to be a universal booster, regardless of previous COVID-19 vaccination history. We look forward to working with U.S., European, and Japanese regulators to expedite development.”

Ocugen’s intranasal vaccine candidate is a recombinant, replication-deficient, adenovirus-vectored vaccine with a prefusion stabilized spike protein. As a mucosal vaccine delivered through the intranasal route, we believe it has potential to generate rapid local immunity in the nose, mouth, upper airways, and lungs where SARS-CoV-2 enters and affects the body most. This is particularly important during times of peak transmission. In addition, intranasal delivery provides an alternative to those who are hesitant to receive injectable vaccines.

“In recent months we have seen COVID-19 continue to spread—despite high levels of vaccination the U.S., Europe, and Japan have achieved,” said Michael S. Diamond, MD, PhD, co-inventor of the nasal vaccine technology and the Herbert S. Gasser Professor and a professor of medicine, of molecular microbiology and of pathology & immunology at Washington University School of Medicine. “Because the vaccine can be delivered directly into the nose, it is specifically designed to block infection at the portal of virus entry, and we believe it may help prevent transmission as well as provide protection against new COVID-19 variants.”

Dr. Diamond developed the vaccine with David T. Curiel, MD, PhD, the Distinguished Professor of Radiation Oncology at Washington University School of Medicine.

Ocugen intends to work closely with U.S. government agencies tasked with pandemic preparedness and response to initiate clinical trials and manufacture the intranasal vaccine, as well as pursue funding and investment options.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including, but not limited to, statements related to the planned clinical and regulatory development of our intranasal vaccine candidate, the anticipated benefits of our intranasal vaccine candidate and our plans to pursue government funding and establish domestic manufacturing for our intranasal candidate. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

Release – Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

MALVERN, Pa., Sept. 16, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 148,800 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 40,092 shares of common stock to five newly hired team members. The stock options and RSUs were granted as of September 16, 2022, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have a ten-year term and have an exercise price of $2.17 per share, which was the closing price of Ocugen’s common stock on the grant date. The stock options and RSUs vest in equal annual installments over a three-year period starting on the one-year anniversary of the grant date, subject to the applicable new employee’s continued service with Ocugen through the applicable vesting dates. The stock options and RSUs were granted outside of Ocugen’s 2019 Equity Incentive Plan.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

MustGrow Biologics Corp. (MGROF) – A Progress Update

Posted on by cpatches


Friday, September 16, 2022

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A Look-in on Programs. Yesterday, MustGrow announced the update on the Company’s biological programs with various partners Sumitomo, Bayer, Janssen PMP, and NexusBioAg. The update includes the soil biofumigation, postharvest food preservation, and bioherbicide of the Company’s mustard-derived technology.

Soil Biofumigation. Data regarding efficacy continue to remain positive, as the Company recently extended the program with Sumitomo that we highlighted in August. Sumitomo is working with MustGrow and the EPA in the registration approval process in the U.S. along with registration in Mexico. In Chile, the country approved an Experimental Use permit and registration work has commenced. Bayer has shown positive results in laboratory and greenhouse studies, and has new trials underway and further studies planned for Europe, Asia, and Africa.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

With New Health Research Mandate Billions To Be Made Available

Posted on by cpatches
Image: Public Domain (Pexels)

ARPA-H: High-Risk, High-Reward Health Research is the Mandate of New, Billion-Dollar US Agency

A new multibillion-dollar federal agency was created with a goal of supporting “the next generation of moonshots for health” in science, logistics, diversity and equality. And the agency now has it’s first leader, as President Joe Biden announced Renee Wegrzyn as director of the Advanced Research Projects Agency for Health, or ARPA-H, on Sept. 12, 2022.

Since the announcement of the intention to establish ARPA-H two years ago, this new agency has sparked interest and questions within both academia and industry.

This article was republished  with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Tong Sun, Assistant Dean of Translational Health Sciences, University of Washington.

I have been a director of innovation-driven health institutes for decades and have worked with many of the government agencies that fund science. I and many of my colleagues hope ARPA-H will become an agency that can quickly turn scientific discoveries into real-world advances to detect, prevent and treat diseases like cancer, diabetes and Alzheimer’s. But questions still remain surrounding how it will work and what makes it different from other government-funded agencies such as the National Institutes of Health and the National Science Foundation.

What is ARPA-H?

ARPA-H is the newest entity established within the National Institutes of Health. ARPA-H was explicitly set up as an independent agency within NIH, in theory allowing it to benefit from the NIH’s vast scientific and administrative expertise and resources while still being nimble and forward-thinking.

ARPA-H was inspired by and modeled after the Defense Advanced Research Projects Agency, or DARPA, to rapidly develop cutting-edge technologies. DARPA is small compared to other federal research and development agencies, but has long been hugely successful. It played a critical role in spawning many technologies ranging from the internet to GPS, and even funded Moderna to develop mRNA vaccine technology in 2013.

ARPA-H is not the only DARPA spinoff. In 2006, the federal government created the Intelligence Advanced Research Projects Activity to tackle difficult challenges in the intelligence community, and in 2009, the Advanced Research Projects Agency for Energy was launched. Though its budget is small compared to the Department of Energy, ARPA-E has been incredibly effective in funding ambitious research into fighting climate change. By funding ambitious mid- and long-term projects, IARPA, ARPA-E and now ARPA-H are meant to operate in between slow, government-funded basic research and short-term, profit-driven private sector venture capital.

ARPA-H is modeled after the Defense Advanced Research Projects Agency, which played a key role in developing many modern technologies, including personal computers. Tim Colegrove (Wikimedia Commons)

How Will the Agency Function?

Biden wants ARPA-H to replicate the success of DARPA, but in the health care realm, by providing “leadership for high-risk, high-reward biomedical and health research to speed application and implementation of health breakthroughs equitably.”

Established federal agencies like the NIH and the National Science Foundation prefer to fund more basic research and less risky projects compared to the high-risk, high-reward, applied science approach of DARPA. If ARPA-H wants to achieve the success of its predecessor, it will need to operate differently from NIH and NSF.

DARPA employs about 100 program managers who are “borrowed” from academia or industry for three to five years. These managers travel across the nation to meet with scientists and experts in different fields in order to generate ideas and start projects. These managers make funding decisions and work closely with their funded teams to overcome problems, but will cut funding if teams cannot deliver promised milestones on time. Many DARPA projects don’t produce spectacular successes, yet they pushed the boundaries of science and technology.

Many years ago, I had the privilege of working with a DARPA program manager alongside numerous experts in various scientific and medical fields. After several months of meetings, the program manager came up with the idea to develop “fracture putty” – a puttylike material that could be applied to the shattered bones of a wounded soldier in the battlefield. The material would support weight, prevent infection, expedite healing and bone regeneration and eventually dissolve away. The program launched in 2008, and our team of chemists, nanomaterials experts, bioengineers, mathematical modelers and surgeons was one of the funded teams in this program.

President Joe Biden appointed Renee Wegrzyn, a former DARPA project manager and biotech industry expert, to lead ARPA-H. Image: Renee Wegrzyn (@rwegrzyn)

Who is the New Director?

Wegrzyn holds a Ph.D. in molecular biology and bioengineering from Georgia Tech. She is currently a vice president of business development at Ginkgo Bioworks, a U.S. biotech company. Wegrzyn spent four and half years as a program manager in DARPA’s Biological Technologies Office, where she managed projects that focused on using genetic engineering and gene editing for biosecurity and public health. She also worked for another DARPA-inspired agency, Intelligence Advanced Research Projects Activity.

At this moment, we don’t know yet the exact plan and progress in hiring APPA-H program managers and where APAR-H’s headquarters will be located. Several cities have expressed interest.

What Should People Look for as ARPA-H Gets Started?

DARPA is driven by talented, ambitious and risk-taking program managers. They are the ones who generate ideas and turn lofty goals into executable projects. It will be interesting to see how many and what kind of program managers ARPA-H hires in its early days, as these decisions will give an indication of which areas within health care the agency will be prioritizing.

I’ll also be watching to see how well ARPA-H and its program managers work within the NIH, which has an unbelievable depth of resources and expertise in all health care related fields that ARPA-H can tap into. But the NIH has very different funding mechanisms and culture from DARPA.

The final question is money. Biden wants US$6.5 billion in funding for ARPA-H, and he’s only gotten $1 billion from Congress so far. This is its first, biggest challenge. Finding political unity for funding may have to be this new agency’s first big breakthrough if it is to reach its goals.

Release – Ocugen Announces Publication of a Comprehensive Review of BBV152 in Frontiers in Immunology

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

September 14, 2022

  • Data include the persistence of immune responses and protection against variants of concern, especially Delta and Omicron
  • Ocugen has North American commercialization rights for BBV152, commercialized as COVAXIN™

MALVERN, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the publication “A comprehensive review of BBV152 vaccine development, effectiveness, safety, challenges, and prospects” appeared in Frontiers in Immunology. BBV152, commercialized as COVAXIN™, is developed and manufactured by Ocugen’s partner Bharat Biotech, a global leader in vaccine innovation based in Hyderabad, India. BBV152 is currently authorized by the World Health Organization, authorized under Emergency Use Authorization in 28 countries, and accepted as a COVID-19 vaccine to travel into over 85 countries. It is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

This review by Dotiwala and Upadhyay provides a detailed analysis of the immunogenicity, safety, and efficacy of BBV152—a whole virus inactivated vaccine and an important tool in the fight to control the COVID-19 pandemic. Additionally, BBV152 has a broader impact on public health, as it induces high neutralization efficacy against different SARS-CoV-2 variants of concern.

“Unfortunately, the COVID-19 pandemic is not yet over, despite the introduction of effective vaccines and a greater understanding of COVID-19 pathogenesis and transmission dynamics,” said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine, Translational Medicine & Human Genetics, University of Pennsylvania, and Ocugen Vaccine Scientific Advisory Board member. “This study demonstrates durability through immune memory and a broader immune response with BBV152 and provides further evidence that additional vaccine options—including those built on a traditional vaccine platform—are needed.”

Findings include:

  • 77.8% and 93.4% protection from symptomatic COVID-19 disease and severe symptomatic COVID-19 disease respectively.
  • Studies in pediatric populations show superior immunogenicity (geometric mean titer ratio of 1.76 compared to an adult) with a seroconversion rate of >95%.
  • Reactogenicity and safety profiles were comparable across all pediatric age groups between 2-18 yrs.

The study concludes that BBV152 is a suitable alternative to mRNA vaccines.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

Why Biotech May Finish out 2022 Very Strong

Posted on by cpatches
Image Credit: Jason Mrachina (Flickr)

The Reasons Biotech is Gaining Ground on the Field

Similar to their watching a horse race, with a sense that their horse is starting to come from behind and may even be moving toward the front of the pack, biotech investors are leaning over the rail, watching their sector’s increased pace. This week biotechs, as measured by the ETF $XBI, crossed above its 200-day moving average – only last week the biotech sector’s momentum took it above its 50-day moving average. Does this technical indicator demonstrate the growing strength will continue, or does this indicate that it may be approaching overbought?

Technical analysis is not usually clear on this; below, we look for clues in the sector’s fundamentals to better handicap its chances.

Source: Koyfin

Pace of Deals

In 2021, the overall healthcare sector experienced record merger and acquisition activity. The first half of 2022 also had significant activity; however, at $92.4 billion in value and 481 deals announced, the pace of activity was down 51% from the same period in 2021. This may feel slow but is well ahead of the pre-pandemic pace for these companies.  For example, it’s a 37% increase from the first half of 2020. This could be seen as fundamentally positive for a sector that is trading below its 2021 levels and even below the second half of 2020. 

One catalyst for this continued high pace of deals which may even help accelerate it, is that big pharmacies are flush with cash. This cash serves them best if invested in the next generation of medicine or valuable patent. Fortunately for big pharma, small and mid-sized biotech companies are more likely now to form financial partnerships, agree to merger arrangements, or be outright purchased in order to help with their need for cash to continue operations.

This dynamic is easy to understand; there is less money flowing into the smaller incubator-type companies than the big pharmaceutical companies that have had money pouring in from generous pandemic-related government contracts. These small companies, many working on what may be life-changing science, rarely have sizeable sales. Sales and revenue come after the final phase of testing, FDA approval, and marketing. A small biotech company that sees its research and development possibly making a difference a few years from now, but is currently burning through capital at a pace where it may only last another 12 months, might welcome partnership or acquisition talks with a cash-rich suitor.

News of any injection of cash or capital in these smaller biotechs is usually an event that pushes the price up by percentage points in a short period of time. A full buyout can do much more.

XBI provides exposure to US biotech stocks, as defined by GICS, from a universe that invests across the market-cap spectrum. The fund equal-weights its portfolio, which in turn emphasizes small- and micro-caps and greatly reduces single-name risk. Thus, the weighted-average market-cap is much smaller than some competitors. Unlike other funds in this segment, XBI is a pure biotech play, with relatively small pharma overlap. The index is rebalanced quarterly.  – FactSet

Put yourself in the position of big pharma in 2022 into 2023. Your firm may now be sitting on a huge war chest thanks to the pandemic. This is now being eroded by high inflation. Management’s role is to use resources to provide value to shareholders. In the meantime, biotech is well-priced and motivated to talk.

And then the clock is always ticking on patent cliffs for big pharma. They may be very amenable to shop for acquisition targets as they look out at the expiration of patent rights and the exclusive protection those patents provide. Analysts estimate the top-ten pharmaceutical manufacturers have more than 46 percent of their revenues at risk between 2022 and 2030. Behemoths like Bristol Myers Squibb, Pfizer and Merck will be among the most exposed over the next decade.

Take Away

Watching a thoroughbred that was lagging behind the pack find an opening and begin to gain ground on those around it is exciting. When you have money on the horse, it’s even more enjoyable. The performance of the biotech sector was far behind other industries for much of this year. Moving into fall it has been outperforming its own average and many other investment areas.

There are fundamentals in play that could keep this strength going. What’s more is that these factors have little to do with the overall market, which many now fear

This challenge may catalyze M&A in the industry as large firms look to recoup lost revenue streams and invest in patents.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.nasdaq.com/articles/consolidation-case-for-biotech-etf-bbh

https://www.jdsupra.com/legalnews/big-pharma-firms-return-to-the-deal-6580128/

Release – Axcella Therapeutics to Participate in the H.C. Wainwright Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on AXLA

September 12, 2022 at 8:00 AM EDT

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 12, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will participate in a fireside chat and one-on-one meetings at the H.C. Wainwright Global Investment Conference taking place September 12 – 14, 2022 both virtually and in-person in New York City.

Details for the fireside chat are as follows:

Date:Tuesday, September 13, 2022
Time:10:30 am Eastern Time
Webcast:https://journey.ct.events/view/6604fa89-69be-476a-b518-b615e1ac7fb6

The conference call webcast will be accessible in the Investors & News section on the company’s website at www.axcellatx.com. An archive of the webcast replay will be available on the Company’s website for up to 90 days.

To request a one-on-one in-person or virtual meeting, please register here.

Internet Posting of Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and NASH. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005400/en/

Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

Cocrystal Pharma (COCP) – Influenza Program Update

Posted on by cpatches


Monday, September 12, 2022

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Cocrystal Has Reported Progress In Its Influenza Program.  Cocrystal has reported Phase 1 data and plans for a Phase 2a  trial for CC-42344, its oral drug for seasonal and pandemic influenza.  The drug is an inhibitor of the enzyme PB2 (polymerase basic 2), a subunit of the RNA polymerase required for the replication cycle of the virus.  This early point of action could make it effective against all strains of influenza.

Phase 1 Data Confirmed Once-Daily Dosing.  In July 2022, Cocrystal announced pharmacokinetic data from its Phase 1 trial. The single ascending-dose stage met its goals, confirming administration on a once-daily basis.  Patient enrollment continues in the multiple ascending dose portion.  The company plans to present the study data at a medical meeting later in the year.


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Release – Baudax Bio to Present at the 24th Annual H.C. Wainwright Healthcare Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BXRX

September 08, 2022 4:05pm EDT

MALVERN, Pa., Sept. 08, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on innovative products for acute care settings, today announced that Gerri Henwood, the Company’s President and Chief Executive Officer, will present at the 24th Annual H.C. Wainwright Healthcare Conference, taking place in New York, New York on Wednesday, September 14, 2022 at 3:00 p.m. Eastern Time.

A webcast of the presentation will be available on the “Events” page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The webcast will be archived on the company’s website for 90 days following the event.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Source: Baudax Bio, Inc.

Released September 8, 2022

Release – Ocugen CSO to Participate in 3rd Annual Gene Therapy for Ophthalmic Disorders Conference

Posted on by cpatches

Research, News, and Market Data on OCGN

MALVERN, Pa., Sept. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Company’s Chief Scientific Officer, Arun Upadhyay, PhD, will be among the featured speakers at the 3rd Annual Gene Therapy for Ophthalmic Disorders conference, which is being held Sept. 13-16 in Danvers, Massachusetts.

Details regarding Dr. Upadhyay’s presentation are as follows:

Event:3rd Annual Gene Therapy for Ophthalmic Disorders Conference
Topic:Highlighting the Modifier Gene Therapy Approach for the Treatment of Retinitis Pigmentosa
Date:September 14, 2022
Time:9:15 a.m. ET
Location:DoubleTree by Hilton Boston North Shore, Danvers, Mass.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Release – Avivagen Announces Publication of Peer-Reviewed Article in Food and Chemical Toxicology Journal

Posted on by cpatches

Research, New, and Market Data on VIVXF

Publication of this Scientific Paper on the Safety of Oxidized Beta Carotene  is a milestone on the path to broader regulatory clearance to market and sell OxC-beta™ Products in the U.S. and supports wide-spread adoption of the technology around the world

Ottawa, ON /Business Wire/ September 7, 2022 /– Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that its scientific paper entitled “Safety and uptake of fully Oxidized Beta Carotene” (the active ingredient in the company’s OxC-beta™ product line) has been published in the Journal of Food and Chemical Toxicology. A link to the article is provided below.

“With any innovative product, adoption and uptake require a robust understanding of the benefits and safety of that product and necessitate significant scrutiny. Avivagen has been working tirelessly to showcase the multiple, compelling use cases of OxC-beta and concurrent proven safety. This new peer reviewed publication, one of now ten such publications on OxC-beta, represents the cumulative work on the attractive safety profile of our product. This pioneering work by Dr. Graham Burton, co-founder of Avivagen, and his team lays important groundwork to seek further regulatory approvals for OxC-beta in the U.S. and around the world, for multiple use cases and with strong, proven scientific underpinnings expected by our end market customers.”, said Kym Anthony, Avivagen CEO.  “We look forward to sharing these results with existing and new customers and providing this to regulatory bodies around the world as we look to further expand our access to large markets.”

Please refer to the full content of the peer-reviewed publication on the “Safety and uptake of fully oxidized Beta Carotene” by following the link below: https://www.sciencedirect.com/science/article/pii/S0278691522005853

About OxC-beta™ Technology
β-carotene has been primarily recognized for the health benefits it provides when it is transformed into vitamin A by biochemical reaction with oxygen in the body. Avivagen discovered that spontaneous oxidation of β-carotene produces a mixture of oxidation compounds other than vitamin A that also provide important health benefits. The mixture of β-carotene oxidation compounds, OxC-beta, a product developed by Avivagen, contains neither β-carotene or vitamin A, indicating its health benefits stem uniquely from the oxidation compounds themselves. Incorporation of OxC-beta into products for livestock, companion animal and humans show a range of practical benefits. A peer reviewed paper just published in the prestigious Food and Chemical Toxicology journal (https://doi.org/10.1016/j.fct.2022.113387) has reported that OxC-beta has a very high margin of safety and the discovery that the natural counterpart of OxC-beta is present at significant levels in mouse tissues and blood. A standard toxicology study conducted in rats established a No Observed Adverse Effect Level that is several thousand-fold higher than the level of supplementation with OxC-beta used in livestock, companion animals and humans. These findings are highly significant in establishing the safety of OxC-beta with respect to regulatory approvals of the product in various major jurisdictions.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about β-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.

Statements set out in this news release relating to the potential positive impacts expected to arise from the publication of the above referenced article, the possibility for further regulatory approvals and expanded use cases for Avivagen’s products, the future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.