Pharma and Biotech companies on the move in April
Below we take a look at 10 companies that were on the move in April and the reasons driving the move.
Cyclopharm Limited (ASX: CYC): CYC is an innovative nuclear medicine company whose shares have been rallying through the year, as the FDA commences its 6-month review process for Technegas. Approval from the FDA will create an immediate addressable market of USD$180 million p.a. in the diagnosis of Pulmonary Embolism (PE). This excludes the potentially larger market for Technegas application for indications beyond PE, including the diagnosis and management of chronic obstructive pulmonary disease, lung cancer, asthma and long COVID. Technegas is currently available in over 64 countries, however the US represents the single largest market for Technegas.
The Company recorded revenues of $23 million in FY23, up 31% compared to the previous year. Europe and Canada represents the largest source of sales. US approval would provide the next stage for the Company’s growth. Technegas has the potential to generate substantial revenue over the years.
CYC’s product is clearly competitive. Post approval, which is looking likely, the Company should see significant uptake of its product, in turn leading to the share price continuing to rally. The Company plans to provide imaging products beyond PE, for diseases such as COPD, which is also a multi-billion market. Management has indicated that it will continue to invest in a strong product cycle on the back of the initial release.
Beyond the Nasdaq news, the Company has been seeing positive news come out for its Paxalisib drug, which is in an adaptive Phase 2/3 of study. The potential for the glioblastoma drug remains highly positive, and should the Company get past phase-3, the market for glioblastoma remains wide open. Furthermore, the market is expected to grow 8%-9%p.a. until 2030, which means that if the drug were to get to market, the revenue potential is significant.
Another drug candidate is EVT801, which has similar properties to Avastin a well-known cancer inhibitor drug. The drug works by inhibiting VEGFR3, and would be used as an adjunct therapy to current cancer therapies. The potential for the drug in providing a wide range of immunoncology therapy, makes the drug, which is currently in phase 1 clinical trials, potentially highly lucrative. It remains to be seen where how the drug trials will progress from here.
“This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States,” - Dr. Christian Behrenbruch, Managing Director and CEO at Telix. “Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.”
In late 2022, AVR received clearance from the FDA for a feasibility study for DurAVR to evaluate the safety and feasibility of the DurAVR THV system in the treatment of subjects with symptomatic severe native aortic stenosis. The FDA designated the heart valve as a Category B device, which permits the device to be sold during the study. The study will commence in early-2023 and pave the way for a clinical trial in 2024.
The Company raised $35 million from an equity fundraising initiative issuing 1.458 million shares at $24 each. The proceeds will be used for clinical development of the Company’s 3D single piece aortic valve.
Arovella Therapeutics Limited (ASX: ALA): ALA shares were up 70.5% in April on the back of developments with the Company’s iNKT cell therapy platform. ALA is one of the few companies globally developing an iNKT cell therapy platform and is the only company developing a CAR targeting DKK1-peptide.
Pre-clinical data on the Company’s lead candidate, ALA-101 (CAR19-iNKT cells), indicated that ALA-101 has the potential to be a novel off-the-shelf therapy to treat CD-19 expressing leukemias and lymphomas. ALA-101 is dual targeting, with the cells targeting CD19 and CD1d. CD19 is an antigen expressed on B cells in leukemias and lymphomas and is a known target for CAR-T cell therapies, while CD1d is expressed on several tumour types including lymphoma and myeloma. In a mouse tumour model, ALA-101 showed an enhanced tumour killing response with the CAR19-iNKT cells resulting in a significant regression of tumour cells after three days while all other treatments observed tumour cell persistence. After 90 days, only mice treated with CAR19-T cells or CAR19-iNKT cells remained alive with 1.5x more mice treated with CAR19-iNKT cells remaining alive after 90 days. The results from the animal models were promising and provide the platform for ALA to progress to clinical trials.
Cardiex Limited (ASX: CDX): CDX shares rose on the back of FDA approval for its CONNEQT Pulse vascular biometric monitor. The device includes the market leading SphygmoCor. The device is expected to have significant clinical and consumer applications, allowing physicians to gain comprehensive insight into cardiovascular disease. The standalone nature of the device makes it far easier than the Company’s previous device, and that should play a key role as it looks to expand. Heart disease diagnostics is a multi-billion dollar market globally, and the product could see significant revenue flow, once the product is rolled-out.
IDT Australia Limited (ASX: IDT): In late March, IDT unveiled that its license has been upgraded to manufacture injectable medicine allowing the Company to make advanced therapies for clinical trials where there currently is a short supply. The updated licence unlocks a further $6 million in potential sales.
IDT shares were up 32.8% in the month of April.
The PXS CEO stated - “The agreement with the FDA to expand the patient population in the ongoing phase 2 study to include those patients currently on a JAK inhibitor is an important step forward in realising the benefits of lysyl oxidase inhibition for all myelofibrosis patients and in maximising the commercial opportunity for PXS‐5505. We are already in discussion with the existing trial site investigators who have welcomed the opportunity to extend the patient population for the study and anticipate significantly accelerated recruitment.”
This article was written by Parth Pala.
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