Moderna: Euro Meds Agency OKs covid booster for immunocompromised

 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the European Medicines Agency (EMA) has authorized a third dose of the Moderna COVID-19 vaccine (Spikevax) given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.

"We recognize the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease. It is promising to see recent trials demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in this important population," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain committed to helping to end the COVID-19 pandemic with our mRNA vaccine."

A growing number of studies have shown the benefit of a third dose of COVID-19 vaccine in immunocompromised subjects. In particular, a recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo1. In the study, the third dose was generally well tolerated.

https://finance.yahoo.com/news/moderna-announces-european-medicines-agency-132100453.html

Prometheus started at Outperform by Oppenheimer

 Target $35

https://finviz.com/quote.ashx?t=RXDX&ty=c&ta=1&p=d

Aditxt to Acquire AiPharma, Rights Holder of Antiviral Tablet Avigan

 Phase 3 clinical trial of Avigan/Reeqonus for treatment of COVID-19 completed enrollment of more than 1,200 patients in the U.S., Mexico and Brazil with topline results expected in less than 60 days

Aditxt, Inc. ("Aditxt") (Nasdaq: ADTX), a biotech innovation company with a mission to improve the health of the immune system, today announced it has entered into a transaction agreement to reach a definitive agreement by the end of November 2021 to acquire a subsidiary ("AiPharma") of AiPharma Global Holdings LLC ("AiPharma Global") which is to own all of the assets of AiPharma Global, a company focused on discovering, developing and commercializing antiviral therapies across a broad spectrum of infectious diseases.

AiPharma Global is a biopharmaceutical company that holds directly, or through its affiliates worldwide (excluding Japan), exclusive rights to Avigan/Reeqonus/Qifenda and all formulations of favipiravir, a broad spectrum oral antiviral drug that targets COVID-19 and other infectious diseases. The binding agreement follows Aditxt’s prior announcement on August 25, 2021 to acquire the company and Aditxt’s funding of a bridge loan to AiPharma Global in the amount of $6.5 million.

The acquisition, if completed, will form a business segment for Aditxt that is focused on the monitoring and treatment of infectious diseases. Key terms of the agreement include: an increase in the amount of permitted borrowings under the secured loan from Aditxt to AiPharma Global by $8.5 million resulting in total availability of $15 million, as well as Aditxt issuing such number of shares of common stock that yields 65% of the number of Aditxt’s outstanding shares calculated as of September 30, 2021 to be issued only upon closing of the transaction.

https://finance.yahoo.com/news/aditxt-signs-transaction-agreement-acquire-124500511.html

Guardant Starts Study of Blood Test to Predict Recurrence in Early-Stage Cancers

 1,000-patient prospective study in 11 solid tumors will monitor ctDNA levels up to five years

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal™ liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types.

"For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "This study is exciting because it will evaluate the first blood-only minimal residual disease (MRD) assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care."

The study will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies (COBRA, ACT-3, PEGASUS) evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer.

"Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers," said Helmy Eltoukhy, Guardant Health Co-CEO. "The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes."

https://finance.yahoo.com/news/guardant-health-initiates-oracle-study-120500999.html

Coherus eyes marketing go-ahead after positive on-body injector trial

  UDENYCA® On-Body Injector (OBI) Achieved Both Pharmacokinetic and Pharmacodynamic Bioequivalence in Randomized Clinical Trial

- Coherus plans to seek U.S. marketing authorization for the UDENYCA® OBI in 2022

Coherus BioSciences, Inc. (“the Company”; Nasdaq: CHRS) today announced positive results from a randomized, open-label, crossover study assessing the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of UDENYCA® (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed UDENYCA® pre-filled syringe (PFS). The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). No new safety signals were observed. The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of UDENYCA®: OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks.

Coherus plans a 2022 submission to the United States Food and Drug Administration (FDA) of a prior approval supplement to seek marketing authorization for the UDENYCA® OBI and anticipates a standard 10-month review period. Coherus expects commercial launch of the UDENYCA® OBI directly post approval.

https://finance.yahoo.com/news/coherus-announces-positive-results-udenyca-120000038.html

Ocugen: Opportunity abounds

 Ocugen's selling point to investors is its COVID vaccine candidate Covaxin. Ocugen partnered with India's Bharat Biotech for the commercialization of the vaccine in Canada and the United States. The two companies reported fairly strong overall efficacy and safety results for the vaccine last July. Covaxin is already in use in India via an Emergency Use Authorization in the country, with over 45 million doses being administered to date. Ocugen and Bharat Biotech are reportedly working with regulators to secure approvals for the vaccine in both Canada and the United States.

Aren't vaccine players old news? Big vaccines developers have probably had their day in the sun from this particular catalyst. But the truth is that there will be a real need for COVID vaccines for a long time to come. So while Ocugen's vaccine surely won't be a mega-blockbuster, it could post decent sales in the years to come. Despite its latecomer status, for example, Wall Street still thinks this vaccine might generate around $260 million per year in sales by 2025. That's a respectable revenue stream for a company with a market cap of approximately $1.4 billion at the time of this writing.

Ocugen is still a clinical-stage biotech without a reliable revenue stream, and a lot can go wrong while Covaxin's regulatory process plays out. As such, this speculative biotech is probably only a great buy for investors who are comfortable with heavy levels of risk. 

https://www.fool.com/investing/2021/10/04/2-best-biotech-stocks-to-buy-in-october/

Biohaven: Prelim 3Q2021 Net Product Revenue For Nurtec

  NURTEC® ODT achieved preliminary net product revenue of approximately $136 million for the third quarter of 2021

- Launch to date net product revenue for NURTEC ODT is approximately $336 million with over 1,000,000 prescriptions filled since initial product launch in March 2020

- NURTEC ODT is now the market leader for new oral migraine therapies and currently accounts for approximately 61% of new-to-brand prescriptions (NBRx) for oral CGRP-targeting drugs

https://finance.yahoo.com/news/biohaven-announces-preliminary-3q2021-net-113000769.html