The EMA has rejected Alzheimer’s drug Leqembi, developed by Eisai and Biogen. Picture Getty
Health & Biotech
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.
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…
| 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 |
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, 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, 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 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.
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.
Health & Biotech
Health & Biotech
Health & Biotech
