There were a couple of big news from the world of biotech this week. Picture Getty
Check Up: Big week in world of biotech after these 2 Nasdaq stocks announce breakthroughs
Health & Biotech
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- Viking Therapeutics doubled after results of weight loss drug trial
- Janux Therapeutics tripled on pancreatic cancer results
- We look at the recent best performing ASX health stocks
There were a couple of big news from the world of biotech this week, both announced on Wednesday.
Nasdaq-listed Viking Therapeutics soared by 120% after trial results show that its obesity drug, VK2735, reduced body weight at the highest dose tested.
Vikings’ trial studied more than 170 patients with obesity or who are overweight. These patients received either different dose sizes of the injectable drug VK2735, or a placebo.
Those who received weekly doses of VK2735 lost up to 14.7% of their body weight from baseline, or 13.1% when adjusted for placebo, after 13 weeks.
Overall, Viking said 88% of patients who received VK2735 had lost weight, compared to only 4% that took the placebo.
Viking Therapeutics is one of several small obesity biotechs hoping to enter the huge $100 billion weigh-loss market that’s so far dominated by Novo Nordisk and Eli Lilly.
Some experts predict that the emergence of these drugs could kill the fast food industry, but others are more pessimistic.
“It’s not going to have an impact on the population unless the drugs get brought down in price,” said Barry Popkin, a professor of nutrition at the University of North Carolina.
“It really needs to be in the hundreds of millions of consumers to have a monster impact. Even if out of 300 million consumers, a million take those drugs, it’s a tiny drop in the bucket for the food industry.”
Janux shares triple in one day
Meanwhile, another Nasdaq-listed stock, Janux Therapeutics, also rocketed on Wednesday, up +230% after the company released promising results for its prostate cancer drug.
In one dosing group, 83% of patients saw their PSA (prostate-specific antigen) levels decline by 50% following treatment with Janux’s drug, JANX007.
Some analysts believe that JANX007 has the potential to be a blockbuster drug and capture the multi-billion-dollar prostate cancer market.
Janux now expects to provide an update on JANX007 doses for expansion in the second half of 2024.
Best performing ASX biotechs over the past month
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| CODE | COMPANY | PRICE | 1 WEEK RETURN % | 1 MONTH RETURN % | 6 MONTH RETURN % | 1 YEAR RETURN % | MARKET CAP |
|---|---|---|---|---|---|---|---|
| NYR | Nyrada Inc. | 0.0830 | 361.11 | 260.87 | 232.00 | -30.83 | $2,964,165 |
| PAA | Pharmaust | 0.3550 | 44.90 | 115.15 | 386.30 | 340.99 | $147,142,287 |
| BP8 | Bph Global | 0.0020 | 0.00 | 100.00 | -20.00 | -84.81 | $3,908,232 |
| IRX | Inhalerx | 0.0400 | 0.00 | 100.00 | -11.11 | -16.67 | $7,590,678 |
| AYA | Artrya | 0.3650 | 28.07 | 65.91 | 1.39 | 4.29 | $28,706,882 |
| HIQ | Hitiq | 0.0260 | 4.00 | 52.94 | 23.81 | -13.33 | $9,147,969 |
| SHG | Singular Health | 0.1250 | 13.64 | 47.06 | 204.88 | 28.87 | $25,395,897 |
| CYP | Cynata Therapeutics | 0.2100 | 16.67 | 44.83 | 55.56 | -33.33 | $37,722,675 |
| ONE | Oneview Healthcare | 0.3400 | -5.56 | 44.68 | 58.14 | 223.81 | $217,557,108 |
| OPT | Opthea | 0.7000 | 17.65 | 42.86 | 23.76 | -11.60 | $457,337,957 |
| PER | Percheron | 0.0820 | 18.84 | 41.38 | 54.72 | -17.17 | $65,812,783 |
| TRI | Trivarx | 0.0380 | 52.00 | 40.74 | 90.00 | 90.00 | $12,854,590 |
| NTI | Neurotech Intl | 0.1175 | 11.90 | 38.24 | 155.43 | 135.00 | $98,437,745 |
| DXB | Dimerix | 0.2300 | -2.13 | 35.29 | 233.33 | 103.54 | $91,841,711 |
| SNT | Syntara | 0.0230 | 4.55 | 35.29 | -42.50 | -48.89 | $27,448,707 |
| IIQ | Inoviq | 0.6950 | 8.59 | 33.65 | -1.42 | 17.80 | $61,192,437 |
| OSL | Oncosil Medical | 0.0080 | -11.11 | 33.33 | -20.00 | -71.87 | $15,796,329 |
| ALA | Arovella Therapeutic | 0.1700 | -5.56 | 30.77 | 269.57 | 466.67 | $154,753,984 |
| RNO | Rhinomed | 0.0400 | 0.00 | 25.00 | -42.86 | -55.56 | $11,340,969 |
| MYX | Mayne Pharma | 6.6400 | 26.00 | 24.11 | 44.03 | 110.79 | $542,773,957 |
| DVL | Dorsavi | 0.0160 | -5.88 | 23.08 | 45.45 | 23.08 | $9,546,586 |
| PNV | Polynovo | 2.1700 | 8.77 | 20.56 | 45.15 | -6.47 | $1,370,112,011 |
| GTG | Genetic Technologies | 0.1200 | 20.00 | 20.00 | -40.00 | -60.00 | $11,426,307 |
| CU6 | Clarity Pharma | 2.7500 | 4.96 | 19.57 | 150.00 | 225.44 | $724,906,678 |
| OIL | Optiscan Imaging | 0.0950 | -4.04 | 18.75 | 31.94 | -1.07 | $79,357,376 |
| MXC | Mgc Pharmaceuticals | 0.3950 | -3.66 | 17.91 | -80.25 | -96.05 | $16,444,362 |
| VLS | Vita Life Sciences.. | 2.1600 | 11.05 | 17.07 | 50.52 | 46.44 | $118,470,301 |
| COV | Cleo Diagnostics | 0.1850 | 2.78 | 15.63 | -9.76 | $13,708,500 | |
| SIG | Sigma Health | 1.1150 | 2.29 | 15.54 | 49.10 | 83.69 | $1,819,530,741 |
| 4DX | 4Dmedical | 0.6900 | 6.98 | 15.00 | 11.29 | 81.58 | $254,074,470 |
| COH | Cochlear | 343.9600 | 4.13 | 14.84 | 29.81 | 51.67 | $22,436,311,782 |
| AVH | Avita Medical | 5.4700 | 5.19 | 14.44 | 8.75 | 48.24 | $331,902,743 |
| NSB | Neuroscientific | 0.0400 | 11.11 | 14.29 | -55.56 | -56.04 | $5,061,170 |
| IDX | Integral Diagnostics | 2.3050 | 2.90 | 13.55 | -26.12 | -15.26 | $553,323,827 |
| MSB | Mesoblast | 0.3000 | 3.45 | 13.21 | -34.76 | -65.98 | $299,525,960 |
| RSH | Respiri | 0.0260 | -10.34 | 13.04 | -10.34 | -45.83 | $27,556,592 |
| AHX | Apiam Animal Health | 0.3600 | 14.29 | 12.50 | -12.20 | -38.46 | $63,901,933 |
| VFX | Visionflex Group | 0.0090 | 12.50 | 12.50 | -10.00 | 0.00 | $11,335,930 |
| IMU | Imugene | 0.1175 | 6.82 | 11.90 | 70.29 | -9.62 | $841,612,524 |
| 1AI | Algorae Pharma | 0.0100 | -9.09 | 11.11 | -28.57 | 6.57 | $18,273,642 |
| NOX | Noxopharm | 0.0720 | 5.88 | 10.77 | 89.47 | -34.55 | $17,534,277 |
| CAJ | Capitol Health | 0.2700 | 3.85 | 10.20 | 17.39 | 1.89 | $287,768,539 |
| RHT | Resonance Health | 0.0550 | 0.00 | 10.00 | -8.33 | 1.85 | $23,685,325 |
| MX1 | Micro-X | 0.1150 | 0.00 | 9.52 | -4.17 | -11.54 | $59,664,343 |
| SDI | SDI | 0.8200 | 7.19 | 9.33 | -7.34 | -13.68 | $90,337,803 |
| MAP | Microbalifesciences | 0.1850 | 2.78 | 8.82 | -44.00 | -51.00 | $71,967,719 |
| MDR | Medadvisor | 0.3150 | 1.61 | 8.62 | 36.96 | 26.00 | $159,461,104 |
| SNZ | Summerset Grp Hldgs | 10.4500 | 1.46 | 8.29 | 16.11 | 21.51 | $2,401,384,166 |
| REG | Regis Healthcare | 3.5900 | 5.28 | 8.13 | 49.58 | 135.41 | $1,074,694,661 |
| TLX | Telix Pharmaceutical | 12.1650 | 7.46 | 7.65 | 16.52 | 85.16 | $3,790,592,582 |
| RAC | Race Oncology | 0.8000 | 4.58 | 7.38 | -8.57 | -61.90 | $127,199,477 |
| FPH | Fisher & Paykel H. | 23.5200 | 6.23 | 7.25 | 14.68 | -0.55 | $13,623,872,701 |
| AHI | Advanced Health | 0.0920 | 0.00 | 6.98 | -56.19 | -2.13 | $22,303,384 |
| ACW | Actinogen Medical | 0.0310 | -16.22 | 6.90 | 14.81 | -64.14 | $74,597,510 |
| PIQ | Proteomics Int Lab | 0.9800 | -4.39 | 6.52 | 20.99 | -0.51 | $125,656,911 |
| CSX | Cleanspace Holdings | 0.3450 | -5.48 | 6.15 | 27.78 | -24.18 | $26,669,577 |
| PAB | Patrys | 0.0090 | 0.00 | 5.88 | 0.00 | -66.67 | $18,517,026 |
| AVR | Anteris Technologies | 17.1000 | 0.65 | 5.62 | -16.59 | -21.20 | $306,733,035 |
| IXC | Invex Ther | 0.0850 | -15.00 | 4.94 | 85.33 | -25.87 | $6,763,846 |
| ECS | ECS Botanics Holding | 0.0230 | -8.00 | 4.55 | 0.00 | -11.54 | $24,348,075 |
| EBR | EBR Systems | 0.7600 | -3.80 | 4.11 | -10.59 | 17.83 | $230,265,569 |
| AT1 | Atomo Diagnostics | 0.0260 | -10.34 | 4.00 | -13.33 | -44.68 | $16,619,260 |
| OCC | Orthocell | 0.4200 | 10.53 | 3.70 | 13.51 | 9.09 | $83,692,290 |
| MVF | Monash IVF Group | 1.4400 | -1.37 | 3.23 | 22.03 | 38.46 | $566,918,692 |
| IME | Imexhs | 0.6500 | 0.00 | 3.17 | 7.44 | 62.50 | $27,772,200 |
| PGC | Paragon Care | 0.2150 | 4.88 | 2.38 | -2.27 | -17.31 | $140,252,318 |
| IMM | Immutep | 0.3425 | -3.52 | 2.24 | 24.55 | 44.96 | $410,147,923 |
| GSS | Genetic Signatures | 0.5100 | 0.00 | 2.00 | 13.50 | -38.57 | $95,106,147 |
| BOT | Botanix Pharma | 0.1775 | -6.58 | 1.43 | -4.05 | 133.55 | $281,418,727 |
| EBO | Ebos Group | 34.3100 | 0.09 | 1.09 | 3.66 | -16.34 | $6,598,805,043 |
| CGS | Cogstate | 1.2300 | -4.65 | 0.41 | -13.38 | -12.77 | $217,639,047 |
| PME | Pro Medicus | 100.2300 | 5.69 | 0.16 | 38.21 | 66.63 | $10,433,841,015 |
| AC8 | Auscann Grp Hlgs | 0.0400 | 0.00 | 0.00 | 0.00 | 0.00 | $17,621,884 |
| AHC | Austco Healthcare | 0.1900 | -5.00 | 0.00 | 11.76 | 46.15 | $58,105,032 |
| ATH | Alterity Therap | 0.0050 | 25.00 | 0.00 | -16.67 | -37.50 | $17,531,019 |
| AVE | Avecho Biotech | 0.0030 | -14.29 | 0.00 | -66.67 | -66.67 | $9,507,891 |
| EPN | Epsilon Healthcare | 0.0240 | 0.00 | 0.00 | -7.69 | 4.35 | $7,208,496 |
| IVX | Invion | 0.0050 | 11.11 | 0.00 | 0.00 | -28.57 | $38,547,193 |
| LBT | LBT Innovations | 0.0150 | 15.38 | 0.00 | 5.01 | -54.06 | $20,173,058 |
| MDC | Medlab Clinical | 6.6000 | 0.00 | 0.00 | 0.00 | 0.00 | $15,071,113 |
| NC6 | Nanollose | 0.0230 | -11.54 | 0.00 | -61.67 | -61.67 | $4,472,166 |
| VHT | Volpara Health Tech | 1.1200 | 0.00 | 0.00 | 38.27 | 48.34 | $284,899,225 |
| RHC | Ramsay Health Care | 50.9300 | 0.28 | -0.29 | 5.18 | -24.68 | $11,694,286,098 |
| EMV | Emvision Medical | 2.0800 | -1.89 | -0.95 | 24.55 | 44.95 | $166,828,220 |
| M7T | Mach7 Tech | 0.6700 | -1.47 | -1.47 | -11.84 | 1.52 | $164,043,912 |
| RMD | ResMed Inc. | 27.8700 | 1.60 | -2.04 | 10.82 | -11.58 | $17,227,976,859 |
| ZLD | Zelira Therapeutics | 0.8500 | -3.41 | -2.30 | -26.72 | -22.73 | $9,645,082 |
| PSQ | Pacific Smiles Grp | 1.4000 | 0.72 | -2.44 | 6.87 | 18.64 | $222,616,804 |
| CSL | CSL | 285.3350 | 1.08 | -2.62 | 8.32 | -4.18 | $137,923,124,874 |
| CYC | Cyclopharm | 1.8000 | -2.70 | -2.70 | -21.74 | 20.00 | $169,373,387 |
| PBP | Probiotec | 2.7500 | -4.18 | -2.83 | 1.85 | 20.09 | $227,705,537 |
| PAR | Paradigm Bio. | 0.3350 | -4.29 | -2.90 | -51.49 | -74.49 | $122,662,461 |
| ANN | Ansell | 23.9900 | 1.52 | -3.03 | 4.40 | -10.75 | $3,011,080,654 |
| VBS | Vectus Biosystems | 0.2900 | -9.38 | -3.33 | -27.50 | -56.72 | $15,164,668 |
| LGP | Little Green Pharma | 0.1400 | 7.69 | -3.45 | -17.65 | -17.65 | $43,513,519 |
| ATX | Amplia Therapeutics | 0.0770 | -2.53 | -3.75 | -3.75 | -9.41 | $15,520,512 |
| 1AD | Adalta | 0.0220 | -4.35 | -4.35 | -4.35 | -45.00 | $9,990,277 |
| GLH | Global Health | 0.1100 | -4.35 | -4.35 | -26.67 | -35.29 | $6,385,449 |
| ENL | Enlitic Inc. | 0.6800 | -3.55 | -5.56 | $53,192,291 | ||
| SOM | SomnoMed | 0.4250 | 1.19 | -5.56 | -47.72 | -62.96 | $38,006,989 |
| FRE | Firebrickpharma | 0.0500 | -1.96 | -5.66 | -82.46 | -74.36 | $8,947,337 |
| PYC | PYC Therapeutics | 0.0790 | -7.06 | -5.95 | 21.54 | 0.00 | $298,629,371 |
| DOC | Doctor Care Anywhere | 0.0630 | -3.08 | -5.97 | 27.27 | -3.08 | $23,098,461 |
| PCK | Painchek | 0.0300 | 0.00 | -6.25 | 0.00 | 15.38 | $43,075,482 |
| AGN | Argenica | 0.5900 | 6.31 | -6.35 | 47.50 | 37.21 | $57,768,477 |
| SHL | Sonic Healthcare | 29.3100 | 0.24 | -7.13 | -8.06 | -10.72 | $13,997,703,183 |
| TRU | Truscreen | 0.0200 | -20.00 | -7.20 | -11.06 | -22.38 | $8,400,507 |
| NXS | Next Science | 0.3200 | -9.86 | -7.25 | -47.97 | -54.61 | $100,634,811 |
| CTQ | Careteq | 0.0240 | -4.00 | -7.69 | -4.00 | -57.71 | $5,888,682 |
| LDX | Lumos Diagnostics | 0.0710 | -6.58 | -7.79 | -32.38 | 36.54 | $36,578,803 |
| AGH | Althea Group | 0.0350 | -5.41 | -7.89 | -16.67 | -30.00 | $13,465,494 |
| IMC | Immuron | 0.0700 | -4.11 | -7.89 | -12.50 | -2.78 | $15,945,884 |
| RHY | Rhythm Biosciences | 0.0980 | -9.00 | -9.00 | -73.31 | -89.35 | $22,114,259 |
| BDX | Bcaldiagnostics | 0.0900 | 0.00 | -9.09 | -21.74 | 45.16 | $22,647,524 |
| NAN | Nanosonics | 2.7400 | -8.67 | -9.87 | -34.76 | -38.57 | $829,752,466 |
| CUV | Clinuvel Pharmaceut. | 14.0900 | -13.72 | -9.97 | -33.85 | -29.51 | $672,707,963 |
| MEM | Memphasys | 0.0090 | 0.00 | -10.00 | -40.67 | -36.72 | $12,309,680 |
| ILA | Island Pharma | 0.0711 | -3.61 | -10.11 | -5.88 | -1.23 | $5,779,163 |
| MVP | Medical Developments | 0.8350 | -15.23 | -10.22 | -23.04 | -42.41 | $75,085,541 |
| CBL | Control Bionics | 0.0420 | -2.33 | -10.64 | -39.52 | -72.61 | $7,168,624 |
| CHM | Chimeric Therapeutic | 0.0250 | 0.00 | -10.71 | -32.43 | -63.24 | $21,033,416 |
| BMT | Beamtree Holdings | 0.2050 | -8.89 | -10.87 | -6.82 | -35.94 | $57,313,804 |
| HGV | Hygrovest | 0.0400 | -14.89 | -11.11 | -20.00 | -42.86 | $9,674,288 |
| EMD | Emyria | 0.0460 | -8.00 | -11.54 | -44.83 | -77.93 | $17,231,582 |
| TRJ | Trajan Group Holding | 1.0150 | -9.38 | -11.74 | -40.29 | -46.30 | $155,260,407 |
| FCG | Freedomcaregrouphold | 0.1500 | -3.23 | -11.76 | $3,582,586 | ||
| ANR | Anatara Ls | 0.0220 | 0.00 | -12.00 | -31.08 | -21.89 | $3,693,662 |
| SPL | Starpharma Holdings | 0.1275 | -1.92 | -12.07 | -8.93 | -77.43 | $53,565,281 |
| AFP | Aft Pharmaceuticals | 3.1000 | -3.43 | -12.18 | -8.01 | -4.62 | $326,134,069 |
| HMD | Heramed | 0.0210 | 10.53 | -12.50 | -71.79 | -83.91 | $6,104,020 |
| RCE | Recce Pharmaceutical | 0.4600 | -4.17 | -13.21 | -32.67 | -18.49 | $92,684,348 |
| EOF | Ecofibre | 0.0950 | 10.47 | -13.64 | -47.22 | -61.22 | $32,962,029 |
| IMR | Imricor Med Sys | 0.5000 | 13.64 | -14.66 | -19.95 | 69.28 | $87,774,472 |
| HLS | Healius | 1.1975 | -14.46 | -14.77 | -50.43 | -53.96 | $918,474,809 |
| IDT | IDT Australia | 0.0890 | -9.18 | -15.24 | 34.85 | 34.85 | $33,742,029 |
| TRP | Tissue Repair | 0.2200 | -2.22 | -15.38 | -16.98 | -6.38 | $12,277,763 |
| CTE | Cryosite | 0.5800 | 0.00 | -15.44 | -3.08 | -19.23 | $28,308,473 |
| PEB | Pacific Edge | 0.0800 | -1.23 | -15.79 | -15.79 | -80.95 | $71,391,878 |
| ACR | Acrux | 0.0570 | 0.00 | -16.18 | 29.55 | -5.00 | $16,531,839 |
| OCA | Oceania Healthc | 0.5400 | -12.90 | -16.28 | -23.94 | -22.86 | $392,752,441 |
| VTI | Vision Tech Inc | 0.2150 | -12.24 | -17.31 | 2.11 | -35.82 | $11,943,675 |
| PTX | Prescient | 0.0470 | 0.00 | -17.54 | -38.16 | -47.78 | $37,044,710 |
| LTP | Ltr Pharma | 0.2700 | -10.00 | -18.18 | $20,417,592 | ||
| EZZ | EZZ Life Science | 0.5100 | 2.00 | -18.40 | -20.31 | 29.11 | $21,993,075 |
| CMP | Compumedics | 0.3250 | 1.56 | -18.75 | 80.56 | 85.71 | $57,577,958 |
| NEU | Neuren Pharmaceut. | 18.6000 | -9.45 | -20.72 | 48.80 | 156.20 | $2,735,385,120 |
| ICR | Intelicare Holdings | 0.0150 | 0.00 | -21.05 | 0.00 | -21.05 | $3,522,367 |
| CAN | Cann Group | 0.0630 | -11.27 | -21.25 | -49.60 | -63.71 | $29,311,301 |
| OSXDA | Osteopore | 0.4000 | -19.19 | -21.57 | -61.90 | -77.53 | $4,131,164 |
| EYE | Nova EYE Medical | 0.2100 | 2.44 | -21.57 | -10.14 | -6.23 | $44,711,630 |
| ARX | Aroa Biosurgery | 0.5725 | -2.97 | -21.58 | -34.20 | -46.24 | $196,696,464 |
| ADR | Adherium | 0.0420 | -2.33 | -22.22 | -30.00 | -20.00 | $14,004,479 |
| HXL | Hexima | 0.0140 | -6.67 | -22.22 | -39.13 | -12.50 | $2,338,555 |
| ALC | Alcidion Group | 0.0430 | -14.00 | -23.21 | -65.60 | -69.29 | $60,411,295 |
| RAD | Radiopharm | 0.0560 | -8.20 | -23.29 | -34.85 | -56.08 | $23,569,685 |
| BIT | Biotron | 0.0720 | -21.74 | -25.00 | 132.26 | 176.92 | $62,257,010 |
| JTL | Jayex Technology | 0.0060 | 0.00 | -25.00 | -33.33 | -40.00 | $1,687,671 |
| RGS | Regeneus | 0.0060 | 0.00 | -25.00 | -33.33 | -50.00 | $1,838,621 |
| UCM | Uscom | 0.0300 | -9.09 | -26.83 | -42.31 | -30.23 | $5,716,007 |
| ACL | Au Clinical Labs | 2.2700 | -20.35 | -27.24 | -20.63 | -36.24 | $526,786,779 |
| UBI | Universal Biosensors | 0.1450 | -9.38 | -27.50 | -42.00 | -49.12 | $30,793,568 |
| CDX | Cardiex | 0.0830 | -31.28 | -31.28 | -42.02 | -63.62 | $20,162,890 |
| TD1 | Tali Digital | 0.0010 | 0.00 | -33.33 | 0.00 | -75.00 | $3,295,156 |
| AMT | Allegra Medical | 0.0290 | 0.00 | -34.09 | -51.67 | -47.27 | $3,468,720 |
| VIT | Vitura Health | 0.1600 | -36.00 | -34.69 | -59.49 | -69.23 | $89,260,437 |
| IPD | Impedimed | 0.0840 | 1.20 | -35.38 | -53.33 | 40.00 | $161,864,634 |
| CVB | Curvebeam Ai | 0.2150 | -2.27 | -36.76 | -48.19 | $46,994,569 | |
| IBX | Imagion Biosys | 0.0820 | -4.65 | -54.44 | -86.33 | -91.46 | $2,742,310 |
| ME1 | Melodiol Glb Health | 0.0075 | -46.43 | -65.91 | -94.64 | -97.12 | $1,973,088 |
NYR jumped by 400% on Wednesday after the company’s lead Brain Injury Program drug candidate, NYR-BI03, demonstrated strong efficacy in reducing injury in a preclinical animal study.
The study showed a significant neuroprotective signal, providing strong evidence of efficacy for the drug.
Conducted in collaboration with UNSW Sydney, the study involved 16 test animals, which were treated with either NYR-BI03 or vehicle, 30 minutes following induced brain injury, with treatment conducted for 72 hours via continuous intravenous infusion.
The MRI brain imaging results showed that a statistically significant neuroprotection was achieved when animals received NYR-BI03 treatment.
On average, NYR-BI03 therapy rescued 42% of the brain injury in the penumbra region seen in animals receiving vehicle.
Nyrada will now move on to Phase I clinical trial in humans, which is scheduled for the second half of the 2024 calendar year.
PharmAust has successfully completed a pre-IND meeting with the US Food and Drug Administration (FDA).
A path has now been outlined to potentially receive an accelerated and full approval of its lead drug monepantel, for the treatment of motor neurone disease/amyotrophic lateral sclerosis (MND/ALS).
PharmAust will initiate requirements requested by FDA in preparation to open an IND application for its adaptive Phase 2/3 clinical study.
Separately, PharmAust has engaged globally renowned experts in MND/ALS and formed a scientific advisory board (SAB).
The SAB will provide expert advice for the development of monepantel to treat MND/ALS. The SAB will also support the planning stages for PharmAust’s adaptive Phase 2/3 clinical study.
BPH has recently entered into two new agreements with the China Tobacco group, for the sale and distribution of bird’s nest products via China Tobacco’s outlets in the City of Guangzhou in China for calendar year 2024.
The principal terms of the agreements include: Commencement date 1 January 2024 with a term 12 months.
Products to be supplied include: pure bird’s nest 50g box, and bird’s nest drink.
Guangzhou is at the heart of the Guangdong-Hong Kong-Macau Greater Bay Area, the most populous built-up metropolitan area in the world.
InhalerX has been rising despite revenue falling by 95% for the full year. But investors have been happy after the company announced a new focus in its biotech program.
InhalerX said that following pre-IND meeting feedback from the US FDA in March last year, the company undertook a detailed and careful evaluation process, which has resulted in the decision to promote BTcP (Breakthrough Cancer Pain) as the primary indication of focus for the proposed Phase 2 trial of IRX211.
IRX explained that there are many aspects that make BTcP a more attractive acute pain candidate versus CRPS (Complex Regional Pain Syndrome), its previous focus.
This includes BTcP’s well-established condition compared to the paroxysmal pain episodes in CRPS.
An Australian provisional patent application for the treatment of BTcP was filed at the Australian Patent Office on 21 December 2023.
HIQ announced it has executed an agreement with UK Sports Institute (UKSI), the United Kingdom’s high-performance sports institute, to supply its concussion management technology across the UK’s elite sports ecosystem, expanding the company’s global footprint.
Under the deal, the UKSI will implement HITIQ’s CSX concussion management platform across 25 National Governing Body Sports Programs, onboarding 1,050 athletes.
The current agreement is through to 31 March 2025, with UKSI holding an option to extend the agreement for a further year. The financial implication of the deal is not material, says HitIQ.
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