After spending most of the year under relentless selling pressure, the biotech stock has suddenly sprung back to life.

At the time of writing, Immutep shares are rocketing 89.74% to 7.4 cents in afternoon trade.

Trading volumes have also lifted well above recent averages, showing how quickly sentiment has shifted on the update.

The rebound looks even more significant because the shares had still been down about 82% in 2026 before today's rally.

That leaves this as one of the market's biggest turnarounds of the week.

Here's what got investors moving back into the stock.

FDA grants a valuable rare disease designation

According to the release, Immutep has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for eftilagimod alfa in soft tissue sarcoma.

Soft tissue sarcoma is a rare cancer with limited treatment options, which makes this a positive step for its long-term commercial potential.

The FDA program offers regulatory support, tax credits, fee waivers, and up to seven years of US exclusivity if approved.

The FDA's decision was backed by positive Phase II trial results, where efti was used with radiotherapy and Merck's Keytruda in soft tissue sarcoma patients.

The trial's 38 evaluable patients delivered a 51.5% major pathological response rate. That was comfortably ahead of the 35% target set by the study and well above historical benchmarks.

Chief executive Marc Voigt said the designation could help support a direct move into a late-stage study after the company completes its ongoing review of the discontinued TACTI-004 program.

Why the rally is so aggressive

The share price reaction makes more sense in the context of what happened last month.

Immutep shares were smashed after its flagship Phase III lung cancer trial was discontinued following an interim futility review.

That update effectively wiped out the company's biggest near-term value driver and crushed confidence in the lead program.

With investor sentiment already heavily damaged, today's update has been enough to trigger a strong rebound.

Investors now have another pathway to focus on, while the orphan designation also strengthens the sarcoma program's long-term commercial appeal.

Foolish takeaway

I think today's move shows the market had pushed Immutep too low after the lung cancer setback.

The sarcoma program now gives investors a new reason to stay interested, especially with FDA support making the commercial upside more attractive.

The key from here is whether management can turn this momentum into a credible late-stage development pathway.

The post Why this ASX biotech stock just rocketed 89% today appeared first on The Motley Fool Australia.

After entering a trading halt on Monday, 9 March, Immutep shares resumed trading last Friday. And by the time the closing bell sounded, the Immutep share price had crashed a very painful 88.6%.

Investors were overheating their sell buttons on the day, after the ASX 300 healthcare stock reported that the Phase III lung cancer study of its eftilagimod alfa (efti) product had been discontinued.

"We are very disappointed and surprised with the outcome of the futility analysis, in light of efti's performance in every other clinical trial," Immutep CEO Marc Voigt said at the time.

On Monday, bargain hunters swooped in, sending the Immutep share price up 35.6% by close. But a lot of those gains evaporated again on Tuesday, with shares closing the day down a sharp 16.4%.

See what I mean about a 'decidedly wild ride'?

Now, here's what's happening today.

ASX 300 healthcare stock slides again

The Immutep share price is slumping again today, down 1.9% in morning trade at 5.1 cents. That sees the share price down 87.3% since exiting the trading halt last week, as investors appear to have lost confidence in the company's outlook.

Today's fall comes despite the company announcing positive results this morning from the first-in-human Phase I study in healthy participants evaluating IMP761.

According to the release, IMP761 is a first-in-class LAG-3 agonist antibody that enhances the physiological inhibitory function of LAG-3 on T-cell receptor signalling, potentially suppressing pathogenic T cell responses in autoimmune diseases.

(Quite a mouthful, I know!)

The ASX 300 healthcare stock reported that the single ascending dose portion of the study has been successfully completed. The drug was well tolerated across all dose levels, with no safety concerns or dose-limiting toxicities observed.

The study is now progressing in the multiple ascending dose portion, which is evaluating pharmacokinetics and safety across two dose levels. Immutep expects to complete this stage of the study in the third quarter of calendar year 2026.

What did management say?

Commenting on the new trial results that have yet to lift the ASX 300 healthcare stock today, Immutep chief scientific officer Frederic Triebel said:

IMP761 continues to show a clear immunosuppressive effect in healthy participants challenged with a foreign antigen in an intra-dermal reaction, with durable inhibition of T-cell–mediated responses after a single administration.

These first-in-human findings support our mechanistic aim of selectively silencing pathogenic, self-antigen–specific memory T cells via LAG–3 agonism and provide the basis for dose levels to be tested in a future phase II trial in patients with autoimmunity.

Immutep said it will present the results of the phase I trial at the European Alliance of Associations for Rheumatology annual congress in London on 4 June.

The post Down 87% since Thursday, why is this ASX 300 healthcare stock sliding again today? appeared first on The Motley Fool Australia.

Let's see what the broker is saying about these speculative stocks.

Immutep Ltd (ASX: IMM)

Immutep is a clinical-stage biopharmaceutical company focused on developing novel LAG3 immunotherapy for cancer and autoimmune disease.

Its shares were sold off this month after its lead drug, Efti, failed the futility analysis in its global Phase 3 trial in non-small cell lung cancer. Bell Potter notes that this "is a bitterly disappointing and surprising outcome considering the strength of the company's prior Phase 1 and Phase 2 lung cancer data."

As a result, it has downgraded its shares to a speculative hold rating with a 7 cents price target (from 65 cents). It said:

We downgrade to a Hold recommendation and $0.07 valuation. We tentatively estimate IMM will end up with ~$60m of cash (4c/sh) following wind-down of the global Phase 3 trial and other Efti development activities, assuming no repayments to Dr Reddy's are necessary.

In addition to cash, IMM retains the earlier-stage IMP761 asset which it will continue to progress for treating autoimmune conditions. The early stage of IMP761's development (no data in patients) leads us to exclude any material contribution from our valuation at this time.

Oneview Healthcare PLC (ASX: ONE)

Another ASX healthcare stock that Bell Potter has been looking at is Oneview.

Its Care Experience Platform (CXP) is a unified set of digital tools in a single bedside solution that connects patients, families, and care teams with services, education, and information during hospital stays.

Bell Potter is positive on the company's growth outlook and has put a speculative buy rating and 45 cents price target on its shares. It said:

There is no change to our earnings estimates but we have reduced our DCF valuation by c.10% to $0.45/sh following FX appreciation and share count adjustments. We assume c.20% annual growth in live endpoints from FY26e-FY28e to drive our FY28e U. EBITDA breakeven expectation.

Given ONE's track record, this is no small feat. In the face of improving thematics and the need for hospitals to utilise efficiency tools to plug the operating impact of nurse shortages, we remain cautious ahead of more consistent performance on conversion and financial performance.

PYC Therapeutics Ltd (ASX: PYC)

Finally, PYC is a clinical-stage biotechnology company that is developing multiple drug candidates for rare inherited diseases.

Bell Potter notes that "following a Type D meeting with the FDA, PYC provided key elements of the Phase 3 trial design for its novel drug candidate, VP-001."

And thanks to its recent $600 million capital raise, PYC has the benefit of >$700 million in cash, with runway into at least 2030 according to the broker. As a result, Bell Potter believes the company is "incredibly well capitalised to execute over the next several years on its clinical development programs without having to come back to investors for additional capital."

For this reason, it has put a speculative buy rating and $2.30 price target on its shares. It said:

There are no changes to our BUY (spec.) recommendation or $2.30/sh valuation. The catalysts most likely to drive enthusiasm include additional RP11 readouts from the Phase 1/2 trial (expected Q4 CY26), clinical data in patients in the PKD trial (CY27 to CY28), and any potential licensing partnerships for the ophthalmology programs.

The post How does Bell Potter rate these ASX healthcare stocks? appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

CAR Group Limited (ASX: CAR)

The CAR Group share price is down 3% to $24.47. The catalyst for this has been the auto listings company's shares going ex-dividend this morning for its latest payout. Last month, CAR Group released its half-year results and declared a partially franked interim dividend of 42.5 cents per share. Eligible shareholders can now look forward to receiving this dividend next month on 13 April.

Immutep Ltd (ASX: IMM)

The Immutep share price is down a massive 89% to 4.4 cents. Investors have been selling this late-stage biotechnology company's shares after it released an update on the TACTI-004 Phase III study. Immutep revealed that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol. The company's CEO, Marc Voigt, said: "We are very disappointed and surprised with the outcome of the futility analysis, in light of efti's performance in every other clinical trial. […] We are currently conducting a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the program."

Northern Star Resources Ltd (ASX: NST)

The Northern Star share price is down over 17% to $22.10. This morning, this gold miner downgraded its production guidance for FY 2026 a second time. Northern Star advised that it has been impacted by weaker-than-planned milling performance at the KCGM operation and reduced mining productivity across several operating areas. It now expects FY 2026 production to come in above 1.5 million ounces. This compares to its most recent guidance of 1.6 million to 1.7 million ounces, which was downgraded from 1.7 million to 1.85 million ounces.

Syrah Resources Ltd (ASX: SYR)

The Syrah Resources share price is down 28% to 17.25 cents. This has been driven by news that the US International Trade Commission (ITC) has reached a final negative determination in an antidumping and countervailing duty investigation. It was looking into whether graphite active anode material (AAM) imports into the United States from China are materially retarding the establishment of a domestic AAM industry. Syrah believes the decision may "delay AAM sales from the Vidalia AAM facility and limit near-term demand growth for AAM produced in the United States and Balama natural graphite as feedstock for natural graphite AAM facilities outside China."

The post Why CAR Group, Immutep, Northern Star, and Syrah Resources shares are sinking today appeared first on The Motley Fool Australia.

In morning trade, the ASX biotech stock is down a massive 93% to 2.8 cents.

Why is this ASX biotech stock having a day to forget?

Investors have been rushing to the exits in their droves on Friday after the late-stage biotechnology company released an update on the TACTI-004 Phase III study.

TACTI-004 is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with Merck & Co's anti-PD-1 therapy, KEYTRUDA, and chemotherapy.

It is being evaluated as a first-line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations.

Patients were being randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study's dual primary endpoints were progression-free survival and overall survival.

What's the latest?

This morning, the ASX biotech stock revealed that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

This followed a review of the available safety and efficacy data.

In response to the IDMC's recommendation, Immutep advised that enrolment in the study will be halted and the company will implement an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations.

Commenting on the news, the ASX biotech stock's CEO, Marc Voigt, said:

We are very disappointed and surprised with the outcome of the futility analysis, in light of efti's performance in every other clinical trial. We would like to thank the patients, investigators, and clinical teams who contributed to this important study. We are currently conducting a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the program.

Is it game over?

The company advised that despite this massive setback, it remains focused on advancing its pipeline of therapies including efti.

Following the discontinuation of TACTI-004, Immutep now anticipates its cash runway will be extended well beyond the previously guided timeframe of the second quarter of 2027, which was set prior to the trial's cessation.

It intends to provide an updated outlook on its revised cash runway and will reassess capital allocation priorities once operational assessments and a full analysis of the study data have been finalised.

The post Game over? ASX biotech stock crashes 90% on big bad news appeared first on The Motley Fool Australia.

Before being placed on ice, shares in the cancer immunotherapy developer finished Friday's session up 3.95% to 39.5 cents.

Despite that gain, the stock has had a softer start to the year and remains around 5% lower in 2026.

Let's take a look at what is happening with this ASX healthcare share.

Trading halt ahead of important clinical update

According to the release, Immutep requested that its shares be paused while it prepares to release a significant update to the market.

The pause relates to an upcoming update on the company's Phase III TACTI 004 clinical trial.

Management said the move is designed to ensure trading does not occur on an uninformed basis while the company prepares its announcement.

Immutep stated that the trading halt will remain in place until the earlier of an announcement being released or the commencement of trading on 11 March 2026.

Investors are now waiting for the company to disclose the results of the interim analysis.

What the clinical trial is testing

Immutep is an Australian biotechnology company developing new treatments that help the immune system fight cancer and other diseases.

Its lead drug candidate is called eftilagimod alpha. The treatment works by stimulating the body's immune system so it can better recognise and attack cancer cells.

The company is currently running a late-stage Phase III clinical trial known as TACTI 004, also called the KEYNOTE F91 study.

This trial is testing eftilagimod alpha alongside Keytruda, a widely used cancer treatment developed by pharmaceutical giant Merck.

The study focuses on patients with advanced head and neck cancer that has either returned or spread to other parts of the body.

As part of the trial, researchers are carrying out what is known as a futility analysis. This is an interim check to see whether the treatment appears likely to deliver positive results.

If the early data suggest the trial is on the right track, the study will continue. If not, researchers may decide it is unlikely to meet its goals.

Because this is a Phase III study, it is one of the final stages of clinical testing. The outcome of this analysis could have a major impact on Immutep's future.

What investors will be watching

Biotech shares often react strongly to clinical trial updates, particularly when they involve late-stage studies.

If the futility analysis indicates the trial should continue, it could strengthen investor confidence in Immutep's development pipeline.

However, if the results are disappointing, the market could react negatively.

The post Why the Immutep share price is halted today appeared first on The Motley Fool Australia.

Shares in the clinical-stage biotech company closed yesterday trading for 38 cents. In morning trade on Friday, shares are changing hands for 37.25 cents apiece, down 2%.

For some context, the ASX 300 is down 1.5% at this same time.

With today's slide factored in, Immutep shares are up 12.9% over the past year and up 43.3% since 8 December.

Shares got a big lift on 9 December after the company revealed that it had entered into a strategic collaboration and exclusive licensing agreement with Indian-based global pharmaceutical company, Dr. Reddy's.

Here's what's catching ASX investor attention today.

ASX 300 healthcare share hits trial milestone

This morning, Immutep announced that it had achieved a key milestone in its TACTI-004 Phase III trial.

That trial is evaluating its eftilagimod alfa (efti) product in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer.

As for that milestone, the ASX 300 healthcare share said it has now achieved 50% of the patient enrolment target for the cancer trial, with 378 patients now taking part globally.

Looking ahead, Immutep said it expects to complete futility analysis in the first quarter of calendar year 2026.

It expects patient enrolment to complete in the third quarter, with enrolment reported to be continuing at a "robust pace". The company noted that more than 140 clinical sites are now activated across 27 countries.

What did management say?

Commenting on the enrolment achievement for the ASX 300 healthcare shares, Immutep CEO Marc Voigt said:

The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer.

Our team continues to work hard to bring this innovative cancer immunotherapy to market and looks forward to delivering on additional important upcoming milestones ahead, including the futility analysis in the first quarter and completing patient enrolment in the third quarter this year.

Voigt said that the combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in patients with advanced/metastatic non-small cell lung cancer, which is one of the largest and deadliest indications in oncology.

Immutep is aiming to expand the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival.

The post Up 43% since December, ASX 300 healthcare share announces milestone achievement appeared first on The Motley Fool Australia.

At the time of writing, the Immutep share price is down 2.95% to 42.7 cents.

That short-term dip comes despite a solid year for investors. Immutep shares are still up almost 30% over the past 12 months, as the company continues to make progress across its drug development programs.

So, why is the share price falling today?

A big partnership deal moves closer to cash

The biggest news from the quarter was Immutep's new partnership with global drug company, Dr Reddy's Laboratories.

Under the deal, Dr Reddy's will develop and sell Immutep's lead cancer drug, eftilagimod alfa (efti), in most global markets. Immutep will retain full rights in the US, Europe, Japan, and Greater China.

In return, Immutep received an upfront payment of about $30 million in January. The company could also receive up to $528 million in future milestone payments if the drug is successfully developed and approved. Immutep would also earn royalties on any future sales.

Cancer trials continue to show progress

Immutep's main focus remains its late-stage lung cancer trial, which is testing efti alongside Keytruda and chemotherapy.

The company said patient enrolment continues at a steady pace, with more than 38% of the required patients now enrolled across sites in 27 countries. Management said the trial remains on track.

Earlier-stage trials have also delivered encouraging results. In one lung cancer study, response rates were higher than typically seen with standard treatments, even in harder-to-treat patients.

Immutep also reported positive data from a soft tissue sarcoma trial, where the drug showed signs of shrinking tumours and activating the immune system.

Outside of cancer, the company shared early positive results from a new autoimmune disease program, which could open the door to future growth.

A strong cash position supports the next phase

Looking at the numbers, Immutep finished the quarter with $99.1 million in cash and term deposits.

After receiving the upfront payment from Dr Reddy's in January, that figure increased to around $129.3 million.

Management said this gives the company enough funding to operate well into the second quarter of FY27, even before factoring in any future milestone payments.

Immutep spent $9.4 million on operations during the quarter, mainly to support its clinical trials.

Why the share price dipped anyway

Expectations were already high following Immutep's recent run.

With no major new trial results released on the day, some investors appear to have taken profits, pushing the share price slightly lower.

Even so, Immutep's update showed steady progress, a major commercial partnership, and a strong cash position.

The post This ASX biotech just smashed its quarterly update. So why are its shares falling? appeared first on The Motley Fool Australia.

The biotechnology company said in a statement to the ASX on Monday morning that the "single-ascending dose escalation" portion of the phase one clinical trial of its compound, IMP761, had completed the 2.5 and 7mg per kg dosing levels, "with continued positive safety and efficacy data".

As the company said:

IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose-dependent immunosuppressive effects with IMP761 was observed with significant, long-last inhibition of the three T-cell mediated intradermal reactions to a strong foreign antigen at day 2, 9 and 23.

Key milestone for the company

Immutep's Chief Scientific Officer, Dr Frederic Triebel, said the results were encouraging.

He went on to say:

We are excited to see IMP761 having a long-term immunosuppressive effect after a single injection. A solid pharmacokinetic/pharmacodynamic relationship has now been established between 1 and 7mg per kg with eight participants per group to cover the variability of the responses. This novel immunotherapy's significant level of immune suppression combined with its favourable safety provide proof of concept data in its potential to silence the dysregulated T cells at the epicentre of many autoimmune diseases. Encouragingly our clinical progress with IMP761 has corresponded with increased external interest in the program.

Various ailments in focus

Immutep said the LAG-3 "immune checkpoint" has been identified as a promising therapeutic target for many autoimmune diseases, including rheumatoid arthritis, type 1 diabetes, and multiple sclerosis.

It went on to say:

IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large, increasingly prevalent disorders, each of which represent multi-billion dollar markets. By enhancing the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells, IMP761 is designed to target the cause of autoimmune diseases and restore balance to the immune system. LAG-3 expression on activated T cells demonstrates high specificity for disease sites, especially in regions characterised by chronic inflammation. This distinct characteristic of the LAG-3 immune checkpoint suggests IMP761 may enable a more targeted therapeutic approach with fewer adverse effects compared to other treatments.

Immutep said the clinical trial would continue, with further updates expected in the first half of calendar 2026, including a potential presentation of the trial data at a major medical conference.

The company's shares were 0.7% lower at 39.3 cents on the news on Monday morning.

Immutep was valued at $582.1 million at the close of trade on Friday.

The post Clinical trial of potential diabetes and arthritis treatment delivers positive results appeared first on The Motley Fool Australia.

That's because Bell Potter believes the signing of an "impressive deal" could be the catalyst to sending its shares materially higher.

Which small cap ASX stock?

The stock that Bell Potter is bullish on is Immutep Ltd (ASX: IMM).

It is a clinical-stage biopharmaceutical company that is developing a novel LAG-3 (lymphocyte activation gene-3) immunotherapy for cancer and autoimmune disease.

Its core technology is based on the LAG3 protein, which is a key mediator of the immune system.

Immutep's lead drug candidate, eftilagimod alpha (efti), is currently undergoing clinical trials in five different oncology indications.

What is the broker saying?

Bell Potter was very pleased to see the small cap ASX stock sign an exclusive license agreement with Dr Reddy's Laboratories (NYSE: RDY). This is for the development and commercialisation of its lead asset Efti in all countries outside North America, Europe, Japan and China.

As part of the deal, Immutep will receive US$20 million (A$30 million) upfront, US$350 million (A$528 million) in potential development and commercial milestones, and double-digit royalties on net sales.

Commenting on the deal, the broker said:

We view this as an impressive deal that provides: (1) financial and industry validation from a credible pharma company in Emerging Markets, (2) significant non-dilutive cash in the form of A$30m upfront plus potential milestones, (3) leaves the commercial rights to the most lucrative US, EU and Japanese markets (>90% of market value) unencumbered for future licensing/M&A opportunities, and (4) could spur other industry parties (most obviously clinical collaborator Merck) to more actively engage for rights to the US and EU markets.

Big potential returns

According to the note, the broker has responded to the update by retaining its speculative buy rating on the small cap ASX stock with an improved price target of 60 cents (from 46 cents).

Based on its current share price of 32 cents, this implies potential upside of almost 90% for investors over the next 12 months.

Commenting on its recommendation, Bell Potter said:

We have updated forecasts to include contributions from the Dr Reddy's deal in FY26 and FY27. The deal sets a precedent for the de-risked global valuation of Efti to be closer to ~US$7b excluding royalties, a large premium to the closing market cap of $472m. There is clear multi-fold upside potential for IMM should it succeed through the current Phase 3 lung cancer trial in a NSCLC market valued at US$12b/yr in the US alone. We maintain our BUY (speculative) recommendation and valuation is increased to $0.60/sh after increasing licensing revenue forecasts.

The post Broker says this small cap ASX stock can rise ~90% following 'impressive deal' appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

Brightstar Resources Ltd (ASX: BTR)

The Brightstar Resources share price is up over 1% to 46 cents. This morning, this gold explorer released positive results from reverse circulation (RC) drilling at the Bull Oak and Havilah deposits, which are part of the Sandstone Hub. Brightstar's managing director, Alex Rovira, commented: "These results from our Sandstone Hub continue illustrate the significant potential growth to our existing MRE. All of these drillholes, at both Havilah and Bull Oak, targeted zones outside of the existing resource and confirmed significant mineralisation in these areas."

Immutep Ltd (ASX: IMM)

The Immutep share price is up 24% to 31.75 cents. Investors have been buying this late-stage immunotherapy company's shares following the release of a promising announcement after the market close on Monday. Immutep has entered into a strategic collaboration and exclusive licensing agreement with Dr. Reddy's Laboratories for the development and commercialisation of Eftilagimod Alfa (efti) in all countries outside North America, Europe, Japan, and Greater China. The agreement will see Immutep receive an upfront payment of US$20 million (~A$30.2 million). It will also be eligible to receive potential regulatory development and commercial milestone payments of up to US$349.5 million (~A$528.4 million), as well as double-digit royalties on commercial sales in these markets.

Pilbara Minerals Ltd (ASX: PLS)

The Pilbara Minerals share price is up 2% to $4.11. This may have been driven by a broker note out of Morgan Stanley. It notes that increasing use of energy storage systems due to the AI boom is driving demand for lithium. Given its strong organic growth opportunities, the broker feels that it is well-placed to benefit from any improvements in lithium prices.

Race Oncology Ltd (ASX: RAC)

The Race Oncology share price is up 8% to $2.89. This follows news that the oncology company has received and accepted an offer of a private placement from a supportive group of existing sophisticated shareholders. The company notes that the proceeds will fund the HARNESS-1 Phase 1a/b non-small cell lung cancer trial of RC220 in combination with Tagrisso. Race Oncology's CEO, Dr Daniel Tillett, commented: "Race Oncology is extremely grateful to the shareholders who approached us to ensure that the HARNESS-1 trial is started without delay. We are blessed to have such supportive shareholders who share our belief in the potential of RC220 to transform cancer patients' lives."

The post Why Brightstar Resources, Immutep, Pilbara Minerals, and Race Oncology shares are roaring higher appeared first on The Motley Fool Australia.

The surging stock in question is clinical-stage biotech company Immutep Ltd (ASX: IMM).

Immutep shares closed yesterday trading for 25.5 cents. In early morning trade on Tuesday, shares are changing hands for 32.5 cents apiece, up 27.5%.

This outperformance follows news of a new strategic collaboration.

Here's what's happening.

ASX 300 healthcare share surges on global expansion potential

Investors are piling into Immutep shares today after the ASX 300 healthcare share reported that it has entered into a strategic collaboration and exclusive licensing agreement with an Indian-based global pharmaceutical company, Dr. Reddy's.

The agreement is for the development and commercialisation of Immutep's Eftilagimod Alfa (efti) cancer treatment in all countries outside North America, Europe, Japan, and Greater China.

The ASX 300 healthcare share will retain its rights on efti in those markets. Immutep also retains all its global manufacturing rights for efti across all markets. The company will supply the product to Dr. Reddy's in the licensed markets.

Immutep describes efti as a novel immunotherapy with the potential to set a new standard of care in combination with pembrolizumab (Keytruda) and chemotherapy as first-line therapy for non-small cell lung cancer.

The company highlighted that efti is also being investigated in other indications, including head and neck cancer, breast cancer, and soft tissue sarcoma.

Under the agreement with Dr. Reddy's, Immutep will receive an upfront payment of US$20 million (AU$30.2 million). The company said it may also receive potential regulatory development and commercial milestone payments of up to US$349.5 million, as well as double-digit royalties on commercial sales in these markets.

What did management say?

Commenting on the collaboration sending the ASX 300 healthcare share rocketing today, Immutep CEO Marc Voigt said, "This agreement with Dr. Reddy's marks a significant milestone for Immutep and further validates the potential of efti."

Voigt continued:

Dr. Reddy's proven capabilities and reach in the licensed markets make them an ideal partner to maximise the impact of our innovation and serve a large number of patients across the globe.

Additionally, this partnership allows us to capture significant value for efti in the licensed markets, while retaining full rights in key markets such as North America, Europe, and Japan, and ensures we remain very well-positioned for future value creation.

M.V. Ramana, CEO Branded Markets Dr. Reddy's, noted, "This collaboration marks our continuous efforts to deliver first-in-class and innovative therapies for cancer treatment."

Ramana added:

Through this agreement, we look forward to leveraging our expertise and strong market access to advance the development and commercialisation of this promising cancer therapy in the licensed markets.

The post Guess which ASX 300 healthcare share is rocketing 28% on global expansion news appeared first on The Motley Fool Australia.

Shares in the clinical-stage biotech company closed on Friday trading for 30.5 cents. In morning trade on Monday, shares are changing hands for 30.75 cents apiece, up 0.8%.

For some context, the ASX 300 is down 0.1% at this same time.

With today's boost factored in, this sees Immutep shares up 33.7% since 12 September.

Here's what's grabbing investor interest this morning.

ASX 300 healthcare share lifts on positive conference coverage

This morning, Immutep, which focuses on treating cancer and autoimmune diseases, announced that positive data from its EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany.

According to the release from the ASX 300 healthcare share:

The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study's prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis.

Dr Katarzyna Kozak, who shared the data at ESMO, said, "The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial's primary endpoint in resectable soft tissue sarcoma."

Kozak added:

These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti's unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas.

Commenting on the potential demand this may imply for the ASX 300 healthcare share, Immutep CEO Marc Voigt said, "There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy."

What else did Immutep announce?

In a separate announcement today, the ASX 300 healthcare share reported that Dr Akin Atmaca, Head of the Thoracic Oncology at UCT-University Cancer Center in Frankfurt, Germany, also presented promising data at ESMO.

Atmaca detailed data from Immutep's investigator-initiated INSIGHT-003 trial.

According to the release:

In this multi-centre study, the novel combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy (carboplatin/pemetrexed) has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.

Immutep's Voigt said, "We are increasingly confident that efti can set a new standard of care as first line treatment for non-small cell lung cancer patients through our pivotal TACTI-004 Phase III trial, supported by strong data from multiple clinical trials evaluating efti in lung cancer including INSIGHT-003."

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Wilsons Advisory's healthcare analysts believe Immutep Ltd (ASX: IMM) may be one such stock.

Immutep bills itself as a "late stage" biotech company that is developing novel immunotherapies for cancer and autoimmune diseases, as it explains on its website.

The company is a pioneer in the understanding and advancement of therapeutics related to lymphocyte activation gene-3 (LAG-3), a cell surface molecule that plays a vital role in regulating the immune system. Immutep's diversified product portfolio harnesses LAG-3's ability to stimulate the immune response to fight cancer or modulate it to combat autoimmune diseases.

New research collaboration to kick off

Immutep announced earlier this week that it had struck a research collaboration agreement with the George Washington University Cancer Centre to evaluate one of its compounds, neoadjuvant efti.

A Phase II trial will evaluate the compound in up to 50 patients, treating them for early-stage breast cancer initially with the compound alone and later in combination with chemotherapy.

Immutep Chief Executive Officer Marc Voigt said in a statement to the ASX that the trial would "help us cost-efficiently expand our clinical pipeline for neoadjuvant efti in areas of high unmet need".

Our belief is this novel immune system activator can play a meaningful role in metastatic settings and in the ongoing expansion of immunotherapy into neoadjuvant settings to fight cancer.  

Wilsons analysts said they maintained their overweight rating on Immutep and had a risked price target of $1.20 per share, well above the current price of 25 cents.

Immutep continues to impress with pipeline optionality and the potential of efti in earlier lines of treatment. The announcement of this investigator-initiated trial is the second of its kind, demonstrating both the desire for and the opportunity of efti to move into earlier lines of treatment and into the neoadjuvant setting.

Trial results to be released soon

Wilsons also noted that data from the first trial of efti in the neoadjuvant setting would be presented at an upcoming conference in mid-November.

As well as being trialled for its efficacy against breast cancer, Immutep said efti was also being evaluated for a variety of solid tumours, including non-small cell lung cancer and head and neck squamous cell carcinoma.

Immutep's market capitalisation is currently about $370 million.

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Shares in the clinical-stage biotech company closed Friday at 29.5 cents. In morning trade on Monday, they are changing hands for 30.5 apiece, up 3.4%. This sees the ASX 300 healthcare stock up 33.6% since hitting a one-year closing low of 22.5 cents on 16 April.

For some context, the ASX 300 is just about flat today and up 7.8% since 16 April.

Today's outperformance for Immutep shares follows on promising clinical cancer treatment trial results.

Here's what's happening.

ASX 300 healthcare stock leaps on cancer treatment progress

The Immutep share price is marching higher after the company reported that its Phase II trial evaluating its eftilaginod alpha (efti) treatment in combination with radiotherapy plus Merck & Co's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint.

The ASX 300 healthcare stock reported that the novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS.

According to the release, tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.

STS is an orphan disease with high unmet medical needs and a poor prognosis for patients. According to the American Cancer Society, the number of new STS cases in 2025 in the United States is around 13,520, with approximately 5,420 deaths.

The trial's investigators at the Maria Skłodowska-Curie National Research Institute of Oncology, the national reference centre for STS in Poland, intend to present detailed results from the latest study at an upcoming medical meeting.

What did management say?

Commenting on the clinical trial results helping boost the ASX 300 healthcare stock today, medical oncologists Katarzyna Kozak and Paweł Sobczuk at MSCNRIO, said:

It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma.

These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy.

The oncologists added, "There remains a very high unmet need in this aggressive orphan cancer indication, and we look forward to presenting detailed results at a medical meeting later this year."

Immutep share price snapshot

Despite the big lift since April's one-year lows, with today's intraday boost factored in, shares in the ASX 300 healthcare stock remain down 33% since this time last year.

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In morning trade, the ASX 300 stock is up 11% to 31 cents.

Why is this ASX 300 stock rocketing?

Investors have been bidding the late-stage immunotherapy company's shares higher after it released an update on the INSIGHT-003 trial.

INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF. The study is evaluating a triple combination therapy in front-line non-small cell lung cancer (NSCLC) patients consisting of Efti administered subcutaneously in conjunction with Keytruda and chemotherapy delivered intravenously.

Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer.

According to the release, the company achieved a 60.8% response rate and 90.2% disease control rate as of the data-cut off date of 6 May 2025.

The ASX 300 stock highlights that ~92% of all evaluable patients have a programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) <50%, including 43% with PD-L1 below 1 (TPS <1%), which represents an area of high unmet need.

It also notes that data demonstrates a significant improvement in response rates compared to historical controls, and safety continues to be favourable.

Rising confidence

The ASX 300 stock's CEO, Marc Voigt, was very pleased with the data and believes it could be driving a new standard of care. He commented:

Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy.

In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two thirds of the 1L NSCLC patient population, is very encouraging.

Additional data from INSIGHT-003 is planned for presentation at a medical conference later this year. Investors will no doubt be hoping that this data is equally positive.

Following today's gain, the ASX 300 stock is up 30% since this time last month. Though, it is still down by the same margin on a 12-month basis.

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The soaring stock in question is clinical-stage biotech company Immutep Ltd (ASX: IMM).

Immutep shares closed on Friday at 27 cents apiece. In morning trade on Monday, shares leapt to 32.25 cents, up 19.4%. After some likely profit-taking, shares are changing hands for 31.5 cents each at the time of writing, up 16.7%.

Here's what's grabbing investor interest today.

ASX All Ords share rockets on trial results

Investors are piling into the ASX All Ords share after Immutep announced promising survival results have been achieved in a head and neck cancer trial.

The biotech company said there was "an excellent median overall survival" (OS) of 17.6 months in Cohort B of its TACTI-003 Phase IIb trial.

This part of the Phase II study was reported to evaluate Immutep's eftilagimod alfa (efti) treatment in combination with Merck & Co's anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma patients with PD-L1 expression below 1.

(Quite a mouthful, I know!)

The ASX All Ords share noted that the patients in the trial represent a treatment population with high unmet medical needs.

Immutep also highlighted that efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals. The company said this safety and the latest OS data "build on the encouraging high overall response rate", with multiple complete responses achieved through the immunotherapies' combination.

What did management say?

Commenting on the promising trial results sending the ASX All Ords share flying higher today, Immutep CEO Marc Voigt said, "We are excited to see this strong survival benefit for head and neck cancer patients with such cold tumours."

Voigt added:

Combining these two complementary immunotherapies has led to a 7-fold increase in response rates and a more than doubling of median overall survival as compared to historical results from anti-PD-1 monotherapy.

Driving durable responses that translate into clinically meaningful survival holds tremendous promise for these patients in need of more tolerable and efficacious therapies.

Voigt said there remains a "high unmet need" for the patients enrolled in the trial, "due to the lack of an approved immunotherapy-only treatment regimen and a lack of competitor trials with chemotherapy-free approaches targeting this patient population".

And likely helping spur investor interest in the ASX All Ords share today, Voigt concluded:

Given the strength of the efficacy and safety results generated to date with efti in combination with pembrolizumab, we will meet with regulators to discuss next steps and potential paths to approval.

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Shares in the clinical-stage biotech company closed yesterday trading for 35.5 cents. In earlier trade, shares were changing hands for 38.5 cents apiece, up 8.5%. After some likely profit-taking, shares are currently trading for 37.7 cents each, up 6.2%.

For some context, the ASX 300 is up 0.4% at this same time.

This outperformance comes following the release of promising new clinical trial data.

Here's what we know.

What did the ASX 300 healthcare stock report?

Investors are bidding up the ASX 300 healthcare stock after the company announced positive clinical results from Cohort B of its TACTI-003 Phase IIb trial.

The trial is evaluating the efficacy of Immutep's Efti product used in combination with Merck & Co's Pembrolizumab in difficult-to-treat head and neck cancer patients with negative PD-L1 expression.

(Quite a mouthful, I know!)

Immutep noted that the latest data shows strong overall survival, progression-free survival, and durability from the novel combination of treatments.

The complete response rate increased to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectively.

ASX 300 investors also look to be reacting positively, with Immutep reporting that the median overall survival has not yet been reached, and the 12-month overall survival rate is 67%. Both were said to be "well above" historical controls.

The treatment was also continuing to be well tolerated among the patients in the trial.

What did management say?

Commenting on the trial results sending the ASX 300 healthcare stock soaring today, Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation Trust said:

The new survival and durability data, coupled with increasing complete responses, build on the strong response rates already established with this novel IO combination in head and neck squamous cell cancers with PD-L1 CPS.

Immutep CEO Marc Voigt added:

Despite the significant progress of cancer immunotherapy over the past decade and the positive change in the therapeutic landscape it has brought to bear, head and neck cancer patients with PD-L1 expression of less than one continue to have limited treatment options that all include chemotherapy.

We believe this data is an encouraging step in the right direction towards potentially bringing a new approach to this underserved population, representing up to 20% of patients with this difficult disease.

Looking to the next steps for the ASX 300 healthcare stock, the company said it will continue to follow the maturing data from the TACTI-003 trial while engaging with regulatory authorities for potential commercial paths forward.

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Over the last 12 months, Immutep shares have gained just under 5%. That compares to an almost 18% gain posted by the All Ords over this same period.

Though that underperformance could change if the biotech company achieves further successes with its cancer treatment trials. Or, if the ASX All Ords stock becomes a takeover target in 2025.

Is Immutep a likely takeover candidate for 2025?

Asked which company in his portfolio could be an acquisition target, Antares Equities' portfolio manager, Andrew Hamilton, named Immutep (courtesy of The Australian Financial Review).

Hamilton said the ASX All Ords stock's "key asset is Efti, an immunotherapy drug with a unique mechanism of action that theoretically makes it highly synergistic with other immunotherapies as well as with chemotherapy and radiotherapy".

He noted that Efti "has had a succession of very strong data in a number of different types of cancers including lung cancer, head and neck cancer and breast cancer".

So, why does this make the ASX All Ords stock a potential takeover target?

According to Hamilton:

When used in combination with Merck's Keytruda, the world's biggest-selling drug last year with sales of US$25 billion, Efti appears to double the number of patients for whom Keytruda is beneficial.

Efti's patents extend to the mid-2030s whereas Keytruda's patent in the US expires in 2028, at which time Merck will face much cheaper generic competition eroding sales of a drug that makes up 40% of their total revenue.

But it's not just Merck. Many of the largest global drug companies are facing significant patent cliffs before 2030 which, we think, makes a drug with Efti's enormous potential revenue and quality data very appealing.

What's the latest from the ASX All Ords stock and Efti?

The most recent trial updates on Immutep's eftilagimod alpha product (Efti) were released on 14 November.

At the time, the ASX All Ords stock announced positive data from its Phase I trial evaluating Efti used in combination with pembrolizumab and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer patients.

Project lead Salah-Eddin Al-Batran called the trial results "very encouraging".

According to Al-Batran:

The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging.

On the same day, Immutep updated the market on its Phase II trial of Efti, which was used in combination with radiotherapy and pembrolizumab for patients with soft tissue sarcoma.

Management noted that preliminary analysis of the 21 patients available for primary endpoint assessment showed that "the triple combination therapy demonstrates significant efficacy in the neoadjuvant setting for resectable STS".

The ASX All Ords stock closed up 9.7% on the day.

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The small cap ASX biotechnology share fell 3% to finish the session at 33 cents.

But its shares may not be trading at those levels for long if one leading broker is to be believed.

What is being said about this small cap ASX share?

Analysts at Bell Potter have been looking over a recent data update and were pleased with what they saw. Commenting on the INSIGHT-003 trial, the broker said:

IMM have provided a data update from the Phase 1 trial called INSIGHT-003 evaluating Efti in combination with Keytruda + chemo in first-line non-small cell lung cancer (1L NSCLC) patients. We consider the data to be a strong update and provides further support heading into the pivotal Phase 3 trial starting in the next few months using the same treatment regimen in a similar patient population.

Bell Potter highlights that the median survival data was strong and was a key highlight from the release. It adds:

A key highlight was the 32.9 months median survival for the first 21 patients, roughly 11 months longer than the 22.0 months observed for a similar patient group in the historical Keytruda + chemo Phase 3 trial (KEYNOTE-189). Additionally, the first 21 subjects showed favourable outcomes relative to the historical phase 3 trial in terms of (1) median progression-free survival (mPFS) of 12.7m vs. 9.0 months; and (2) 24- month survival rate of 81% vs 46%.

Big potential returns

According to the note, the broker has held firm with its speculative buy rating and 70 cents price target on the small cap ASX share.

This implies massive potential upside of 111% for investors over the next 12 months.

To put that into context, a $500 investment would be worth approximately $1,050 by this time next year if Bell Potter is on the money with its recommendation.

The broker acknowledges that there's still a lot of work to be done, but that the early signs are positive. It concludes:

While INSIGHT-003 is a relatively small trial lacking a head-to-head control arm, the data so far looks promising and provides added confidence in the upcoming Phase 3 trial (n=750) utilising the same treatment regimen. First-line NSCLC is one of the most lucrative oncology indications, and while the Ph3 will be a multi-year trial, there are futility and interim readout events along the way to maintain interest.

There are no changes to our forecasts after this data update. We maintain our BUY (spec.) recommendation and $0.70 valuation. Upcoming readouts in the next 12 months include: (1) further head & neck Ph2 data (Cohort B update on 12-Dec-2024, Cohort A survival data 2025); (2) Ph1 results with autoimmune drug candidate in healthy volunteers; and (3) Ph2 breast cancer results using the 90mg dose (having potential relevance for the Ph3 dose in 1L NSCLC).

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