• 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

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
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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.