LumiraDx to start trading on Nasdaq

 CA Healthcare Acquisition Corp announced today that it entered a merger agreement with LumiraDx that will take the company public.

London-based LumiraDx, a point-of-care diagnostics developer, will merge with CAHC with the combination reflecting a value of $5 billion for Lumira’s existing equity, according to a news release. Since its founding, LumiraDx has raised $700 million in equity capital, including investments from Morningside Ventures, U.S. Boston Capital Corporation, The Bill & Melinda Gates Foundation, Petrichor Healthcare Capital Management and others.

Among LumiraDx’s point-of-care diagnostic offerings is its high-sensitivity COVID-19 antigen test, which has been used by the NHS in the UK and has FDA emergency use authorization in the U.S. It also offers POC tests for COVID-19 antibodies, INR and D-Dimer, all of which are available in Europe.

Under the terms of the transaction, all current LumiraDx shareholders will retain the entirety of their existing holdings in the combined company, with additional capital from the CACH’s cash held in trust. Together with the new financing commitments and cash from operations, the cash will support increasing production, continued R&D activities and commercial and manufacturing expansion.

CEO Ron Zwanziger and other co-founders of LumiraDx will lead the company, while its existing board and governance principles will not change. Once the transaction closes, LumiraDx and its common shares are expected to trade on Nasdaq under the LMDX ticker.

The companies expect the transaction to close in the late stages of the second quarter or early part of the third quarter this year, subject to approval from securityholders and customary closing conditions. Both companies’ boards approved the merger.

“LumiraDx is at the tipping point of driving a transformation in diagnostic testing. This new public recognition will solidify our already growing presence in the point of care testing market,” Zwanziger said in the release. “COVID-19 has demonstrated how important it is to have rapid and highly accurate diagnostic tests, at mass scale, and available everywhere. It has validated the performance of our Platform and enabled us to partner with governments, health systems, retail chains and other customers to expand testing across community care settings both in high and low-and middle-income countries. This access to increased testing will change the way care pathways are currently practiced, improving patient outcomes and saving human lives.”

“LumiraDx’s next-generation point of care solutions provide a significant opportunity for our shareholders,” added CAHC chairman & CEO Larry Neiterman. “Ron and his management team have decades of entrepreneurial success in innovative diagnostics businesses and the LumiraDx Platform and testing menu offer healthcare providers and other customers major advantages over traditional central labs.

“LumiraDx has a clear strategy for addressing the large and underpenetrated testing market to increase next-generation POC market share. In the near-term, demand for fast, low-cost COVID-19 tests is driving strong and transformational growth for LumiraDx’s solutions.”

https://www.massdevice.com/lumiradx-to-start-trading-on-nasdaq/

Applied DNA, Northwell Set SARS-CoV-2 Mutation, Variant Tracking Program

 Offers Valuable Real-Time Surveillance of SARS-CoV-2 Mutations and VoCs-

- Program Powered by Applied DNA’s Mutation-targeted qPCR Assays and NGS Platform -

- Program Data Potentially Relevant to COVID-19 Vaccine and Therapeutics Developers, Precision Medicine -

Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and Northwell Health (Northwell) today announced their entry into a pro bono Material Transfer Agreement (MTA) that establishes a real-time surveillance program for the tracking and identification of SARS-CoV-2 mutations and variants of concern (VoCs) in Northwell’s COVID-positive specimens (the "Program"). Under the Program, de-identified positive COVID-19 specimens supplied by Northwell are being screened for SARS-CoV-2 mutations found in currently known VoCs using Applied DNA’s Linea™ COVID-19 Assay Kit ("Assay Kit") and Selective Genomic Surveillance™ (SGS™) Mutation Panel. The Program currently has the analysis of over 2,000 samples underway, with early results from approximately 360 samples showing that approximately 80% of specimens tested on the Company’s qPCR assays contain one or more mutations. Data generated from the Program will enable Northwell to make more efficient use of costly and time-consuming next-generation sequencing (NGS) necessary to conclusively identify specific VoCs and their subsequent descendants. Aggregate data from the Program that could influence vaccine or booster design, antibody therapies, or drug development may be monetized by either party under a revenue-share structure. The Program also provides valuable SARS-CoV-2 mutation data to support the continued validation of the Company’s SGS Mutation Panel. An Applied DNA-authored white paper on SGS of SARS-CoV-2 will be available for publication shortly.

https://finance.yahoo.com/news/applied-dna-northwell-health-establish-110000859.html

Biohaven Crushes Forecasts; What's Next For Its Blockbuster Hopeful?

 Biohaven Pharmaceutical's (BHVN) first-quarter pre-announcement for sales of migraine treatment Nurtec ODT crushed Wall Street's expectations Wednesday, leading BHVN stock to surge.

During the quarter, Nurtec ODT — orally disintegrating tablets — generated $43.8 million in sales, Biohaven said. That handily beat Bloomberg's estimate for $27.2 million, Mizuho Securities analyst Difei Yang said in a report to clients.

Nurtec ODT launched recently as an acute migraine treatment. But analysts expect the Food and Drug Administration to approve it as a migraine prevention drug later this quarter. That should help differentiate Nurtec ODT from the multitude of migraine products on the market.

"In addition, Nurtec ODT uptake should benefit from the country 'reopening,' given the product launched during the heart of the Covid pandemic," Yang said. "We continue to forecast peak Nurtec ODT sales exceeding $2.7 billion."

https://www.investors.com/news/technology/bhvn-stock-pops-migraine-drug-sales-crush-estimates/

AIM ImmunoTech: Positive Interim Safety Data in Phase 1 of Potential Prophylaxis or Treatment for COVID

 AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is a critical step in the company’s ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.” AIM is the sponsor and is funding the clinical study.

The study protocol calls for the enrollment of eight healthy subjects in each of four Cohorts to receive Ampligen. In addition, two healthy subjects in each Cohort will receive placebo, for a total of 40 healthy subjects. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. This study will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The protocol design is for subjects in Cohort 1 to receive 75 μg of Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a matching placebo.

“AIM is pleased with the positive results in this first cohort. This Phase 1 safety study is designed to test the parameters of Ampligen’s intranasal tolerance before commencing a Phase 2 study. While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1.” said AIM CEO Thomas K. Equels.

AIM will continue to provide interim updates on the clinical trial.

https://www.biospace.com/article/releases/aim-immunotech-announces-positive-safety-data-in-first-cohort-of-phase-1-clinical-study-investigating-intranasal-administration-of-ampligen-as-a-potential-prophylaxis-or-treatment-for-covid-19-and-other-respiratory-viral-diseases/

Healthcare platform Agilon targets valuation of up to $9 billion in U.S. IPO

 Agilon Health is aiming for a valuation of up to $9 billion in its initial public offering (IPO), the healthcare platform said on Wednesday, joining a clutch of companies looking to cash in on the record run in U.S. capital markets.

The company said it planned to raise more than $1 billion in its IPO by selling 46.6 million shares at a price range of $20 and $23 per share.

Founded in 2016, Agilon health provides a care platform for primary care physicians.

The company will list on the New York Stock Exchange under the symbol “AGL,” it said in a filing.

JP Morgan, Goldman Sachs and BofA are among the underwriters for the offering.

https://www.reuters.com/article/us-agilon-health-ipo/healthcare-platform-agilon-aims-to-raise-over-1-billion-in-u-s-ipo-idUSKBN2BU1HP

Rigel Announces Closing of Strategic Collaboration with Lilly

 Rigel Pharmaceuticals, Inc.. (Nasdaq: RIGL) today announced the successful closing of its license agreement with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976. Rigel and Lilly entered a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.  Pursuant to the collaboration, Lilly will also lead all clinical development of penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

The agreement is effective as of March 27, 2021 and Rigel has received the $125 million upfront cash payment due under the terms of the agreement from Lilly. Additional details about the collaboration can be found in Rigel's Form 8-K filed with the Securities and Exchange.

https://www.biospace.com/article/releases/rigel-announces-closing-of-strategic-collaboration-with-lilly/

India's Serum Institute asks government for $403M to up AstraZeneca vaccine output

 

The Serum Institute of India, the world's biggest vaccine manufacturer, has asked the government for a grant of 30 billion rupees ($402.97 million) to increase its capacity to make AstraZeneca's COVID-19 vaccine.

It is seeking the money to ramp up monthly production to more than 100 million doses by the end of May, the government said in a statement on Wednesday, noting output was currently around 65-70 million doses a month.

The company is making vaccine doses for dozens of mainly poorer countries, though it has supplied Britain, Canada and Saudi Arabia due to AstraZeneca production issues elsewhere.

About 90% of the 86 million doses India has administered since mid-January have come from the institute, with the rest accounted for by a domestic vaccine developed by Bharat Biotech, which is also struggling to boost output.

Some Indian states have complained of a vaccine shortage even though immunisations are currently limited to front-line workers and people aged over 45, or 400 million of India's 1.35 billion people.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-India-s-Serum-Institute-asks-government-for-403-million-to-boost-AstraZeneca-vac-32905296/