Check Up: Europe delivers blow to Alzheimer’s research; and recent ASX health stock winners

The decision by the EMA to reject Alzheimer’s drug, Leqembi, is a major setback for sufferers.

The EMA has rejected Alzheimer’s drug Leqembi, developed by Eisai and Biogen. Picture Getty

• The EMA has rejected the Alzheimer’s drug Leqembi, developed by Eisai and Biogen

• There is one ASX-listed company that collaborates with Eisai

• We take a look at the best performing ASX health stocks in the past month

In a major blow for Alzheimer’s research, the European Medicines Agency (EMA) has just rejected a groundbreaking drug called Leqembi, developed by Eisai and Biogen.

This decision is a major hurdle for the drug’s approval in Europe, where it could have been used to treat the 6.9 million people suffering from Alzheimer’s.

Leqembi, known scientifically as lecanemab, had already gained approval in the US, where it is generating substantial revenue.

The drug was designed to slow the progression of Alzheimer’s by targeting amyloid plaques in the brain.

Despite showing promise by reducing cognitive decline in clinical trials, the EMA raised concerns about rare but severe side effects, including brain swelling that can lead to serious complications.

The EMA committee ultimately ruled that while Leqembi can slow cognitive decline, the side effects – though rare – are serious and might outweigh the benefits given the drug’s limited impact.

Eisai, the Japanese pharmaceutical company behind Leqembi, expressed disappointment and plans to request a re-evaluation of the decision.

The company, along with Biogen, hopes that the EMA could reverse its decision, especially as Leqembi has already been approved in several countries besides the US, including Japan and China.

Experts suggest that the decision might be revisited as more real-world data becomes available.

Historically, around 40% of negative EMA decisions are overturned after further review.

This means there’s still hope that Leqembi could still eventually be approved in Europe.

Eisai's ASX connection

Separately, and unrelated to the EMA decision, Eisai has been collaborating with the Australian company Cogstate (ASX:CGS) since 2019 to advance digital cognitive assessment tools.

Central to this collaboration is the Cogstate Brief Battery (CBB), a scientifically validated digital tool that allows users to self-assess cognitive functions such as memory and attention.

In countries like the US, Europe, Australia, and Canada, the CBB is known as “Cognigram” and is used by healthcare professionals to help diagnose conditions such as mild cognitive impairment and dementia.

In April this year, Cogstate announced that it has amended its global agreement with Eisai to distribute these digital cognitive assessment technologies.

The agreement lets Cogstate keep working with Eisai, and also explore new ways to help create a system that ensures Alzheimer’s patients get the right treatment when they need it.

“The Amended Global License Agreement provides Cogstate with clear rights in respect of all intellectual property,” said Cogstate’s CEO, Brad O’Connor.

“This will allow Cogstate to explore additional opportunities for identification of the first signs of cognitive impairment in the community.

“We are also eager to explore whether there is an extended role for Cogstate in the identification of patients that may benefit from new Alzheimer’s treatments.”

Now to the ASX…

How ASX biotechs performed over the past month

Oncosil Medical (ASX:OSL)

OncoSil, a company focused on developing treatments for pancreatic cancer, successfully arranged for a $2.7 million investment from an Australian institutional investor.

This deal involves issuing new shares at a price of $0.007 each.

OncoSil’s CEO, Nigel Lange, pointed out that this new investment shows investors really believe in the company’s future.

He said that the additional funds will bolster OncoSil's efforts to enhance its distribution network and increase monthly sales revenue.

The investment will result in the issuance of approximately 386 million new shares, each accompanied by an option that can be exercised until June 2025.

Zelira Therapeutics (ASX:ZLD)

Zelira, a company known for developing cannabis-based medicines, has made important progress with its HOPE autism drug program after a successful meeting with the US Food and Drug Administration (FDA).

The FDA provided a positive response to Zelira's preliminary questions this month, offering clear guidance on treating irritability in autism patients with Phelan-McDermid syndrome and Smith-Magenis syndrome.

The meeting, which included experts from iNGENu CRO, helped refine the design for a Phase 1 study involving healthy volunteers.

The FDA's feedback will assist Zelira in preparing for the next steps, including submitting for Investigational New Drug (IND) approval.

Zelira has also announced that it has obtained patents for its HOPE 1 and HOPE 2 drug formulations from both the Australian and US patent authorities, aimed at treating symptoms related to Autism Spectrum Disorder.

The new patents has significantly boosted Zelira's patent portfolio.

Cleanspace (ASX:CSX)

CleanSpace, a company that makes respiratory protection equipment, recently shared its unaudited sales update for the year ending June 30.

The company reported preliminary sales of $15.7 million, marking a 30% increase from the previous year and a 33% rise in the second half of the year.

This growth continues a strong trend seen over the past 18 months and aligns with CleanSpace’s goal of 30% annual revenue growth. The company has achieved consistent revenue growth over the last four half-year periods.

CleanSpace has performed exceptionally well in Europe and has also seen significant growth in Asia Pacific and North America during the second half of the year.

Around 97% of the company’s revenue now comes from industrial sectors, reflecting a shift from its previous focus on healthcare markets.

A key driver of this growth has been the launch of new technology. In April, CleanSpace introduced CleanSpace WORK, its lightest powered respirator, designed for small businesses and tradespeople.

Alcidion (ASX:ALC)

Alcidion jumped over 20% last week after announcing that it has been chosen as the preferred supplier for North Cumbria Integrated Care (NCIC) NHS Foundation Trust’s new Electronic Patient Record (EPR) system, following a rigorous competitive tender process.

This selection marks a significant milestone in Alcidion’s relationship with NCIC, expanding upon its existing collaboration where Alcidion’s Patient Administration System (Silverlink PCS) has been instrumental in meeting operational needs.

Located in the north of the UK, NCIC serves approximately half a million people across multiple hospitals and community health facilities.

The Trust is an integral part of the North East and North Cumbria Integrated Care System, collaborating closely with primary care networks and support services.

Alcidion will deploy its comprehensive Miya Precision platform, integrating a suite of solutions including the Silverlink PCS already operational within the Trust.

Memphasys (ASX:MEM)

Meanwhile, fertility-focused biotech company, Memphasys, has updated the market on its product development and clinical trial progress.

Memphasys says it has achieved repeat commercial sales in Japan and witnessed multiple successful live births in both Japan and India.

Securing exclusive distribution agreements for Japan, Canada, and New Zealand through Vitrolife Group subsidiaries were keys to its strategic expansion into key global markets, the company said.

Japan, representing approximately 14.5% of the global IVF market, remains a pivotal focus area for Memphasys despite the current absence of insurance reimbursement for its flagship Felix System.

Meanwhile, progress in the clinical trial of the Felix System has gained momentum throughout the June quarter.

Key trial phases, including the “Swim-up” and Density Gradient Centrifugation (DGC), are advancing steadily, with the trial expected to conclude by the end of the current calendar year.

Following completion, Memphasys plans to promptly analyse results and submit regulatory filings to the Therapeutic Goods Administration (TGA).

Memphasys also says it’s prioritising its Oxidative Stress Measurement System, recognising its potential to revolutionise reproductive health diagnostics by offering unique product differentiation.

The company is currently finalising a study to establish baseline levels and thresholds for oxidative stress, crucial for evaluating reproductive performance.

CODE	COMPANY	PRICE	1 MONTH RETURN %	6 MONTH RETURN %	1 YEAR RETURN %	MARKET CAP
OSL	Oncosil Medical	0.014	238%	104%	10%	$45,408,286
ZLD	Zelira Therapeutics	0.590	111%	-32%	-66%	$6,808,293
HXL	Hexima	0.019	73%	12%	6%	$3,173,753
CSX	Cleanspace Holdings	0.430	72%	30%	30%	$32,885,859
ALC	Alcidion Group	0.079	68%	49%	-37%	$103,370,438
SOM	SomnoMed	0.400	58%	4%	-39%	$86,443,301
MEM	Memphasys	0.011	57%	10%	-27%	$15,210,230
AYA	Artrya	0.340	55%	58%	36%	$24,398,238
LDX	Lumos Diagnostics	0.047	52%	-37%	-25%	$25,027,959
TRP	Tissue Repair	0.375	50%	53%	34%	$22,674,316
CVB	Curvebeam Ai	0.235	47%	-15%	0%	$51,385,908
CAN	Cann Group	0.040	43%	-49%	-70%	$17,746,234
OCA	Oceania Healthc	0.705	41%	9%	-1%	$499,719,411
PCK	Painchek	0.038	41%	15%	23%	$65,433,167
ATX	Amplia Therapeutics	0.085	37%	9%	3%	$23,582,231
EOF	Ecofibre	0.041	37%	-59%	-76%	$15,533,830
SNT	Syntara	0.032	33%	68%	-36%	$35,820,953
TRI	Trivarx	0.032	28%	33%	7%	$14,168,199
IMC	Immuron	0.110	25%	45%	43%	$22,799,835
AVH	Avita Medical	3.020	25%	-40%	-45%	$202,250,585
VBS	Vectus Biosystems	0.095	23%	-68%	-81%	$5,054,999
IDT	IDT Australia	0.135	23%	32%	104%	$57,994,343
ICR	Intelicare Holdings	0.017	21%	6%	55%	$5,092,494
UCM	Uscom	0.018	20%	-56%	-62%	$4,488,201
TRU	Truscreen	0.019	19%	-16%	-22%	$10,499,231
OPT	Opthea	0.415	19%	-3%	-18%	$510,904,266
IXC	Invex Ther	0.071	18%	-13%	43%	$5,260,769
ALA	Arovella Therapeutic	0.165	18%	10%	237%	$173,542,984
IMM	Immutep	0.345	17%	-1%	12%	$501,151,240
AHC	Austco Healthcare	0.210	17%	11%	20%	$75,761,356
GLH	Global Health	0.140	17%	27%	-18%	$8,126,935
SNZ	Summerset Grp Hldgs	10.000	16%	3%	0%	$2,349,071,351
SDI	SDI	0.905	15%	24%	3%	$106,978,977
ANR	Anatara Ls	0.048	14%	129%	38%	$9,258,899
CU6	Clarity Pharma	6.130	13%	153%	591%	$1,988,300,823
ACW	Actinogen Medical	0.070	13%	122%	100%	$200,366,502
NXS	Next Science	0.265	13%	-27%	-52%	$77,422,462
MAP	Microbalifesciences	0.180	13%	0%	-41%	$85,091,876
RSH	Respiri	0.029	12%	12%	-28%	$33,249,532
RMD	ResMed Inc.	32.180	11%	11%	-4%	$19,994,724,476
VIT	Vitura Health	0.095	10%	-61%	-81%	$52,980,388
1AI	Algorae Pharma	0.011	10%	10%	-31%	$15,186,553
OCC	Orthocell	0.390	10%	-3%	-1%	$79,544,191
CBL	Control Bionics	0.057	10%	24%	-20%	$10,562,199
IMR	Imricor Med Sys	0.580	9%	-3%	36%	$146,381,998
DVL	Dorsavi	0.012	9%	0%	-8%	$7,382,130
EBO	Ebos Group	32.540	9%	-7%	-7%	$6,270,894,550
PTX	Prescient	0.041	8%	-28%	-45%	$33,018,112
GSS	Genetic Signatures	0.770	8%	57%	29%	$174,460,565
CTQ	Careteq	0.014	8%	-44%	-54%	$3,556,781
PNV	Polynovo	2.635	8%	38%	67%	$1,780,800,498
LBT	LBT Innovations	0.015	7%	0%	-12%	$23,482,754
IIQ	Inoviq	0.600	7%	17%	-29%	$64,511,871
EYE	Nova EYE Medical	0.235	7%	-12%	-7%	$54,917,586
EBR	EBR Systems	1.115	6%	62%	30%	$354,330,390
MDR	Medadvisor	0.530	6%	83%	141%	$291,788,273
BOT	Botanix Pharma	0.365	6%	115%	181%	$678,764,171
FPH	Fisher & Paykel H.	29.350	6%	32%	30%	$17,026,669,497
MVF	Monash IVF Group	1.355	5%	-5%	11%	$520,162,511
ARX	Aroa Biosurgery	0.630	5%	2%	-31%	$216,850,935
CSL	CSL	309.040	5%	4%	16%	$149,465,236,552
NOX	Noxopharm	0.069	5%	3%	92%	$20,164,419
SHL	Sonic Healthcare	27.470	4%	-15%	-21%	$13,081,400,185
AHX	Apiam Animal Health	0.360	4%	18%	-31%	$67,132,472
BDX	Bcaldiagnostics	0.130	4%	43%	86%	$46,448,313
COH	Cochlear	344.900	4%	14%	44%	$22,491,373,868
NAN	Nanosonics	3.100	4%	5%	-35%	$921,113,458
CGS	Cogstate	1.160	4%	-15%	-16%	$200,665,109
AGN	Argenica	0.810	4%	43%	116%	$95,249,790
TRJ	Trajan Group Holding	1.055	3%	-5%	-43%	$160,587,970
ANN	Ansell	27.280	3%	11%	13%	$3,968,216,925
MVP	Medical Developments	0.405	3%	-51%	-64%	$36,248,192
PGC	Paragon Care	0.450	2%	109%	96%	$744,887,425
LGP	Little Green Pharma	0.097	2%	-28%	-48%	$29,270,779
IME	Imexhs	0.500	2%	-22%	-17%	$22,996,135
PAR	Paradigm Bio.	0.260	2%	-31%	-72%	$90,946,964
NTI	Neurotech Intl	0.071	1%	-21%	25%	$71,217,201
HLS	Healius	1.515	1%	8%	-44%	$1,067,366,916
SIG	Sigma Health	1.288	1%	30%	70%	$2,096,947,983
TLX	Telix Pharmaceutical	18.765	1%	61%	67%	$6,465,252,992
PSQ	Pacific Smiles Grp	1.910	1%	32%	32%	$300,811,953
AMT	Allegra Medical	0.029	0%	-6%	-50%	$3,468,720
VLS	Vita Life Sciences..	2.280	0%	20%	54%	$128,026,316
BP8	Bph Global	0.003	0%	-40%	-76%	$1,189,924
IRX	Inhalerx	0.025	0%	25%	-29%	$4,744,174
JTL	Jayex Technology	0.001	0%	-89%	-90%	$281,279
AC8	Auscann Grp Hlgs	0.040	0%	0%	0%	$17,621,884
PIQ	Proteomics Int Lab	0.880	0%	-9%	10%	$115,282,392
PAB	Patrys	0.007	0%	-22%	-30%	$14,402,131
PAA	Pharmaust	0.195	0%	0%	141%	$97,223,911
MDC	Medlab Clinical	6.600	0%	0%	0%	$15,071,113
VFX	Visionflex Group	0.004	0%	-45%	-52%	$11,667,965
ATH	Alterity Therap	0.004	0%	-33%	-43%	$21,281,344
EPN	Epsilon Healthcare	0.024	0%	0%	9%	$7,208,496
NSB	Neuroscientific	0.040	0%	18%	-60%	$5,784,195
DOC	Doctor Care Anywhere	0.068	0%	5%	11%	$24,931,673
SPL	Starpharma Holdings	0.095	0%	-37%	-71%	$38,763,024
FCG	Freedomcaregrouphold	0.145	0%	-12%	0%	$3,463,167
EMD	Emyria	0.041	0%	-20%	-62%	$16,973,060
COV	Cleo Diagnostics	0.340	0%	143%	0%	$26,112,000
AHI	Advanced Health	0.092	0%	7%	-52%	$22,733,170
ACL	Au Clinical Labs	2.495	-1%	-18%	-21%	$496,511,677
M7T	Mach7 Tech	0.635	-2%	-9%	-34%	$153,188,065
AFP	Aft Pharmaceuticals	2.800	-2%	-17%	-17%	$293,625,528
LTP	Ltr Pharma	0.765	-2%	135%	0%	$54,916,281
BMT	Beamtree Holdings	0.225	-2%	5%	-2%	$63,588,514
PME	Pro Medicus	140.110	-2%	38%	102%	$14,429,430,195
REG	Regis Healthcare	4.260	-2%	30%	91%	$1,264,346,660
EZZ	EZZ Life Science	1.798	-3%	188%	213%	$79,499,628
MSB	Mesoblast	0.963	-3%	263%	-12%	$1,147,493,035
CUV	Clinuvel Pharmaceut.	14.890	-3%	-4%	-19%	$730,634,810
RHC	Ramsay Health Care	45.935	-3%	-9%	-20%	$10,322,868,517
ENL	Enlitic Inc.	0.135	-4%	-81%	0%	$10,232,902
VTI	Vision Tech Inc	0.130	-4%	-43%	-41%	$7,154,741
1AD	Adalta	0.025	-4%	4%	9%	$14,890,588
4DX	4Dmedical	0.500	-4%	-19%	-32%	$209,368,343
CAJ	Capitol Health	0.303	-4%	21%	29%	$319,814,249
AT1	Atomo Diagnostics	0.024	-4%	4%	-20%	$14,701,653
MX1	Micro-X	0.079	-5%	-25%	-34%	$44,201,886
RGT	Argent Biopharma	0.285	-5%	-19%	-91%	$13,795,597
CHM	Chimeric Therapeutic	0.019	-5%	-27%	-51%	$18,397,170
RAD	Radiopharm	0.036	-5%	-50%	-61%	$37,012,422
ADR	Adherium	0.017	-6%	-65%	-70%	$12,895,859
PEB	Pacific Edge	0.078	-6%	-22%	-42%	$63,329,446
UBI	Universal Biosensors	0.140	-7%	-26%	-44%	$41,729,441
IDX	Integral Diagnostics	2.460	-8%	24%	-19%	$563,848,413
MYX	Mayne Pharma	4.320	-8%	-18%	-9%	$362,416,467
CYC	Cyclopharm	1.550	-8%	-13%	-34%	$172,262,118
OIL	Optiscan Imaging	0.215	-9%	176%	162%	$179,598,273
HGV	Hygrovest	0.042	-9%	-14%	-7%	$9,043,356
IMU	Imugene	0.052	-9%	-50%	-48%	$389,510,119
EMV	Emvision Medical	1.960	-9%	6%	58%	$172,558,266
ACR	Acrux	0.062	-10%	-11%	22%	$18,024,445
NEU	Neuren Pharmaceut.	19.110	-10%	-20%	47%	$2,478,345,958
RHT	Resonance Health	0.053	-10%	-4%	6%	$23,685,325
CMP	Compumedics	0.300	-10%	-23%	76%	$55,131,027
DXB	Dimerix	0.455	-11%	107%	532%	$239,537,011
ECS	ECS Botanics Holding	0.015	-12%	-32%	-38%	$19,328,244
IVX	Invion	0.004	-13%	-13%	-42%	$23,115,863
RHY	Rhythm Biosciences	0.054	-13%	-56%	-88%	$13,424,225
ONE	Oneview Healthcare	0.345	-14%	35%	47%	$232,914,852
IPD	Impedimed	0.062	-14%	-52%	-70%	$123,408,729
ILA	Island Pharma	0.066	-14%	-22%	-26%	$8,366,628
HIQ	Hitiq	0.018	-14%	6%	-10%	$6,333,209
RAC	Race Oncology	1.555	-15%	130%	18%	$276,008,469
FRE	Firebrickpharma	0.045	-15%	-12%	-77%	$8,788,803
CYP	Cynata Therapeutics	0.250	-15%	79%	72%	$46,705,083
NC6	Nanollose	0.021	-16%	-5%	-62%	$3,612,134
BIT	Biotron	0.031	-16%	-67%	15%	$27,970,671
SHG	Singular Health	0.082	-16%	-13%	116%	$17,988,059
PER	Percheron	0.071	-16%	18%	31%	$63,108,148
AVE	Avecho Biotech	0.003	-17%	-29%	-58%	$7,923,243
CDX	Cardiex	0.059	-17%	-51%	-65%	$17,356,300
AVR	Anteris Technologies	15.150	-17%	-6%	-28%	$291,218,087
AGH	Althea Group	0.019	-17%	-51%	-58%	$7,701,316
OSX	Osteopore	0.047	-18%	-51%	-77%	$5,746,914
CMB	Cambium Bio	0.400	-20%	-50%	-60%	$4,772,402
PYC	PYC Therapeutics	0.095	-21%	26%	66%	$443,277,924
RCE	Recce Pharmaceutical	0.465	-23%	-8%	-34%	$104,229,565
NYR	Nyrada Inc.	0.043	-26%	87%	-14%	$8,746,018
HMD	Heramed	0.016	-30%	-6%	-78%	$12,031,747
TD1	Tali Digital	0.001	-33%	0%	0%	$3,295,156
ME1	Melodiol Glb Health	0.002	-33%	-100%	-100%	$1,215,473
CTE	Cryosite	0.750	-40%	12%	25%	$35,630,981
GTG	Genetic Technologies	0.044	-41%	-60%	-82%	$6,252,942
IBX	Imagion Biosys	0.048	-44%	-73%	-92%	$1,819,821

Originally published as Check Up: Europe delivers blow to Alzheimer’s research; and recent ASX health stock winners