ASX healthcare stock Immutep Ltd (ASX: IMM) is surging after the company released a market-sensitive announcement before the open on Monday.
Immutep advised it had a successful meeting with the US Food and Drug Administration (FDA) regarding the design of its Phase 3 trial, TACTI-004, for treating non-small cell lung cancer (NSCLC).
Investors have reacted positively to the update, with the ASX healthcare stock now up more than 3% at the time of writing to 30.5 cents per share. Let's take a closer look.
FDA greenlights Immutep's trial
Immutep announced it received positive feedback from the FDA for its planned TACTI-004 Phase 3 trial.
The trial will evaluate Immutep's eftilagimod alfa (efti) compound, in combination with Merck & Co (NYSE: MRK)'s Keytruda label and standard chemotherapy, as a first-line treatment of metastatic NSCLC.
It will enrol about 750 patients and aims to establish a potential new standard of care in NSCLC treatment.
Etfi is being investigated in several other trials with Keytruda to treat various types of cancers. It has already received "fast track designation" from the FDA, a condition that expedites novel drug compounds through the regulatory process faster than usual.
The FDA's most recent feedback, along with feedback from Spanish regulators, finalises the "preparatory regulatory interactions for the design of the trial", the ASX healthcare stock says.
Christian Mueller, VP of Regulatory and Strategy at Immutep, said the company was delighted with the result.
We are pleased with the FDA's feedback, allowing us to conclude our regulatory preparation for the TACTI-004 trial
This is a key milestone in our late-stage development process for efti. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression
If this trial is successful, it could be a meaningful catalyst for the ASX healthcare stock.
Market reaction and analyst views
The market has responded positively to the update, sending the ASX healthcare stock higher today. This is in stark contrast to its response at the end of June when Immutep announced results from its TACTI-003 trial.
Back then the ASX healthcare stock fell nearly 50%, before making a sharp recovery.
That trial was investigating etfi in another type of carcinoma, also with Merck's Keytruda label. Investors are obviously more pleased from the get-go with today's updates.
Analysts at Wilsons rate the ASX healthcare stock a buy with a price target of $1.13. This suggests an eye-watering 270% upside at the time of writing.
Bell Potter also maintains a speculative buy rating, valuing the stock at 80 cents. Meanwhile, according to CommSec, consensus rates the stock a buy as well.
What's next for this ASX healthcare stock?
The next steps involve initiating the TACTI-004 Phase 3 trial. In the world of biotechnology, research and development, this is where the hard part just begins.
In the last 12 months, Immutep shares are down more than 5%.
