An expert review published in the medical journal, The Lancet, reccomends that a booster shot for COVID-19 is not needed at this stage of the pandemic.

The report concluded that even for the Delta variant, the vaccine efficacy is high enough and that boosters woud not be appropriate.

Meanwhile, vaccine developer Novovax is conducting a trial in Australia to test its combined flu and COVID-19 vaccine. The trial wil be conducted across 12 sites, and results are expected in the first half of 2022.

To the ASX, and the biotech scene is well and truly alive as ASX companies are rapidly making progress into international markets.

During the month, there has been a handful FDA-related news as Australian-based companies attempt to launch their products globally.

Adherium (ASX:ADR) announced a US FDA 510(k) approval that allows the company to market its Hailie Sensor, for use in monitoring Asthma and Chronic Obstructive Pulmonary Disease (COPD).

The Hailie Sensors are devices that attach to a patient’s asthma or medication inhaler to allow caregivers to provide advanced patient monitoring.

Skin-focused biotech company Acrux Limited (ASX:ACR) has submitted an Abbreviated New Drug Application (ANDA) to the US FDA for its generic version of Dapsone Gel 5%, used to treat acne.

The FDA has in turn notified Acrux that the submission is sufficiently complete to be accepted for review.

Meanwhile, oncology-focused Telix Pharma (ASX:TLX) said the US FDA has accepted its Investigational New Drug Application to undertake a clinical trial of the company’s investigational kidney cancer therapy, TLX250.

The primary endpoint of the trial is to determine the efficacy of combining immunotherapy with TLX250, versus the current standard of care alone.

Best and worst performing health stocks in August

Code Company Price %Mth %Yr MktCap
RAP Resapp Health Ltd 0.091 102 -21 $ 76,468,539.85
HXL Hexima 0.37 61 21 $ 40,926,619.06
MXC MGC Pharmaceuticals 0.064 52 178 $ 142,408,520.04
LBT LBT Innovations 0.145 49 4 $ 41,921,698.78
IDT IDT Australia Ltd 0.6125 46 231 $ 142,716,801.15
VBS Vectus Biosystems 1.7 43 91 $ 54,447,277.68
IHL Incannex Healthcare 0.385 40 613 $ 432,095,433.12
PXS Pharmaxis Ltd 0.145 38 79 $ 63,517,438.46
IMU Imugene Limited 0.4 38 789 $ 2,210,531,407.61
AT1 Atomo Diagnostics 0.285 33 -22 $ 116,476,746.05
MEB Medibio Limited 0.009 29 -18 $ 13,462,961.24
PGC Paragon Care Limited 0.34 28 113 $ 113,191,572.82
DXB Dimerix Ltd 0.3 28 -59 $ 75,792,232.21
NSB Neuroscientific 0.36 26 44 $ 50,932,433.27
AVE Avecho Biotech Ltd 0.02 25 150 $ 36,722,330.52
EZZ EZZ Life Science 0.51 24 $ 5,940,000.00
RHY Rhythm Biosciences 1.14 23 688 $ 217,665,085.05
GSS Genetic Signatures 1.645 21 -15 $ 227,937,057.37
UBI Universal Biosensors 0.92 18 171 $ 159,951,164.40
BDX Bcaldiagnostics 0.2 18 $ 25,647,679.59
IPD Impedimed Limited 0.1225 17 73 $ 186,919,051.75
TLX Telix Pharmaceutical 6.71 16 272 $ 1,850,265,790.56
ONT 1300 Smiles Limited 8 14 27 $ 189,427,072.00
MX1 Micro-X Limited 0.295 13 64 $ 131,014,995.90
KZA Kazia Therapeutics 1.4 13 51 $ 185,573,092.60
OVN Oventus Medical Ltd 0.1125 13 -58 $ 27,798,551.53
1AD Adalta Limited 0.096 12 -4 $ 23,292,059.91
VHT Volpara Health Tech 1.215 10 -6 $ 306,650,758.82
IMM Immutep Ltd 0.545 10 153 $ 472,262,154.56
SUD Suda Pharmaceuticals 0.055 10 25 $ 25,002,639.27
PTX Prescient Ltd 0.225 10 263 $ 138,470,420.62
MEM Memphasys Ltd 0.068 10 -41 $ 50,971,849.96
RCE Recce Pharmaceutical 0.975 8 -39 $ 176,384,514.71
ALC Alcidion Group Ltd 0.39 8 169 $ 403,506,585.02
ONE Oneview Healthcare 0.395 8 867 $ 162,474,469.88
VLS Vita Life Sciences.. 1.21 8 25 $ 63,972,923.58
CYP Cynata Therapeutics 0.545 8 -38 $ 80,951,275.61
CAJ Capitol Health 0.4175 7 64 $ 428,237,467.48
CGS Cogstate Ltd 1.825 7 179 $ 297,318,695.40
AMT Allegra Orthopaedics 0.24 7 33 $ 25,070,208.72
GTG Genetic Technologies 0.008 7 -11 $ 73,808,721.14
S66 Star Combo 0.34 6 1 $ 45,802,239.46
SDI SDI Limited 1.03 6 45 $ 121,242,840.60
ADR Adherium Ltd 0.018 6 -47 $ 40,452,633.24
PAR Paradigm Bio. 1.935 5 -23 $ 441,960,655.91
RAC Race Oncology Ltd 3.29 5 322 $ 499,717,706.62
DOC Doctor Care Anywhere 0.79 5 $ 149,210,439.51
OPT Opthea Limited 1.345 5 -51 $ 477,364,815.76
ADO Anteotech Ltd 0.21 5 250 $ 423,634,218.94
PSQ Pacific Smiles Grp 2.51 5 40 $ 398,954,845.00
ACR Acrux Limited 0.13 4 -28 $ 36,829,701.22
MVF Monash IVF Group Ltd 0.985 3 68 $ 381,842,143.20
ANP Antisense Therapeut. 0.175 3 103 $ 106,278,123.46
ATX Amplia Therapeutics 0.2 3 43 $ 24,964,268.00
ACW Actinogen Medical 0.093 2 245 $ 149,450,269.23
CDY Cellmid Limited 0.052 2 -42 $ 9,933,819.68
MMJ MMJ Group Hlds Ltd 0.08 1 -15 $ 18,626,272.79
IVX Invion Ltd 0.014 0 27 $ 77,553,592.13
NC6 Nanollose Limited 0.1 0 43 $ 14,868,636.80
IMC Immuron Limited 0.16 0 -43 $ 36,359,455.36
ICS ICSGlobal Limited 0.575313 0 18 $ 6,054,604.94
ALT Analytica Limited 0.002 0 0 $ 9,227,602.26
AHK Ark Mines Limited 0.034 0 0 $ 1,778,919.95
JHC Japara Healthcare Lt 1.38 0 263 $ 368,801,312.64
M7T Mach7 Tech Limited 1.01 0 0 $ 242,492,158.90
CYC Cyclopharm Limited 1.66 -1 19 $ 155,469,080.30
NEU Neuren Pharmaceut. 2.2 -1 86 $ 246,407,432.20
PBP Probiotec Limited 2.15 -1 17 $ 168,696,322.90
SOM SomnoMed Limited 2.31 -1 28 $ 190,346,424.50
PAA Pharmaust Limited 0.088 -2 -35 $ 27,888,289.70
OIL Optiscan Imaging 0.22 -2 120 $ 144,973,991.47
RNO Rhinomed Ltd 0.37 -3 363 $ 86,295,104.88
MDC Medlab Clinical Ltd 0.175 -3 13 $ 59,880,742.43
PYC PYC Therapeutics 0.15 -3 4 $ 461,234,284.94
AHC Austco Healthcare 0.145 -3 86 $ 41,207,397.90
4DX 4Dmedical Limited 1.53 -3 5 $ 323,881,432.65
BWX BWX Limited 4.91 -4 4 $ 784,635,005.18
JTL Jayex Technology Ltd 0.025 -4 -40 $ 4,849,983.14
BOT Botanix Pharma Ltd 0.075 -4 38 $ 72,985,655.55
CHM Chimeric Therapeutic 0.33 -4 $ 70,920,574.40
BIT Biotron Limited 0.0535 -4 -49 $ 37,202,433.79
BPH BPH Energy Ltd 0.063 -5 62 $ 41,889,921.51
APH AP Hemp Ltd 0.31 -5 107 $ 24,147,942.53
ATH Alterity Therap Ltd 0.0305 -5 -32 $ 72,206,237.34
CBL Control Bionics 0.695 -5 $ 34,225,016.08
PAB Patrys Limited 0.039 -5 202 $ 71,315,996.70
GLH Global Health Ltd 0.455 -5 102 $ 27,738,602.08
MVP Medical Developments 3.85 -5 -31 $ 264,391,933.12
HCT Holista CollTech Ltd 0.058 -6 -6 $ 15,970,247.05
PIQ Proteomics Int Lab 1.06 -7 96 $ 113,150,065.63
BXN Bioxyne Ltd 0.028 -7 115 $ 17,924,071.14
CDX Cardiex Limited 0.061 -8 3 $ 57,414,365.61
OSP Osprey Med Inc 0.012 -8 -52 $ 30,789,363.34
OSL Oncosil Medical 0.048 -8 -64 $ 38,272,478.11
CPH Creso Pharma Ltd 0.12 -8 233 $ 144,187,677.84
ARX Aroa Biosurgery 1.005 -8 -21 $ 345,281,444.16
CTE Cryosite Limited 0.405 -8 125 $ 19,767,873.02
NTI Neurotech Intl 0.046 -8 229 $ 30,660,041.54
OCC Orthocell Limited 0.485 -8 18 $ 90,764,481.05
SHG Singular Health 0.24 -9 $ 16,820,305.32
CAN Cann Group Ltd 0.2825 -9 -34 $ 89,627,520.77
LDX Lumos Diagnostics 1.125 -9 $ 171,924,512.89
AC8 Auscann Grp Hlgs Ltd 0.091 -9 -43 $ 39,649,239.90
PCK Painchek Ltd 0.05 -9 -47 $ 57,722,044.75
ZLD Zelira Therapeutics 0.038 -10 -33 $ 44,041,949.74
RGS Regeneus Ltd 0.075 -10 -58 $ 23,068,915.59
PNV Polynovo Limited 2 -11 -7 $ 1,322,776,088.00
VTI Vision Tech Inc 0.955 -11 -63 $ 22,453,725.00
NYR Nyrada Inc. 0.28 -11 37 $ 33,798,282.93
BNO Bionomics Limited 0.1725 -12 28 $ 176,679,430.20
ILA Island Pharma 0.34 -12 $ 15,244,823.93
BD1 Bard1 Life Sciences 1.31 -12 56 $ 123,652,467.40
RSH Respiri Limited 0.081 -12 -63 $ 59,995,785.57
LSH Lifespot Health Ltd 0.088 -12 159 $ 15,162,026.13
EPN Epsilon Healthcare 0.145 -12 -48 $ 27,942,507.61
TRU Truscreen 0.056 -13 $ 20,320,510.17
SCU Stemcell United Ltd 0.014 -13 17 $ 15,128,149.54
AGH Althea Group 0.2575 -13 -56 $ 78,214,983.38
NXS Next Science Limited 1.315 -13 3 $ 258,355,951.25
DVL Dorsavi Ltd 0.02 -13 0 $ 7,028,651.44
CMP Compumedics Limited 0.395 -13 4 $ 69,979,364.46
1ST 1St Group Ltd 0.016 -13 -47 $ 6,793,870.45
EYE Nova EYE Medical Ltd 0.39 -15 24 $ 56,765,978.49
LCT Living Cell Tech. 0.011 -15 -27 $ 6,285,850.79
NOX Noxopharm Limited 0.49 -16 58 $ 144,138,247.50
EXL Elixinol Wellness 0.105 -16 -34 $ 33,121,454.73
IBX Imagion Biosys Ltd 0.067 -19 -26 $ 72,092,716.76
RHT Resonance Health 0.105 -22 -28 $ 48,389,458.01
FFC Farmaforce Ltd 0.051 -23 -27 $ 6,664,729.98
ZNO Zoono Group Ltd 0.475 -23 -78 $ 76,812,283.76
OSX Osteopore Limited 0.3025 -24 -45 $ 24,581,907.00
TD1 Tali Digital Limited 0.032 -30 23 $ 29,820,985.25
PAL Palla Pharma Ltd 0.25 -31 -65 $ 42,097,422.38
MDR Medadvisor Limited 0.25 -31 -40 $ 90,577,752.24
ICR Intelicare Holdings 0.094 -33 -69 $ 5,050,566.26

 

Digital health tech ResApp Health (ASX:RAP) was the best performer for the month, with its stock price having more than doubled.

The stock has been on the rise since announcing the expansion of its COVID-19 clinical program in India, as it aims to develop a smartphone-based algorithm to instantly screen for COVID-19.

Resapp has also recently received a regulatory approval in Indonesia for its smartphone-based respiratory diagnostic test, ResAppDx.

Hexima’s (ASX:HXL) stock price has been rising since announcing the approval of a Chinese patent for its prescription topical treatment, pezadeftide (HXP124), for onychomycosis.

After raising $5m and floating itself on the ASX in December, Hexima is currently preparing to conduct a Phase IIb clinical trial for HXP124 in Australia and New Zealand, starting in Q2 of 2022.

MGC Pharma (ASX:MXC) has been rising since announcing that India has approved an import licence for its phytomedicine, CimetrA. Additionally, the UK government has also approved an import licence for CannEpil, its cannabis-based drug to treat epilepsy.

Artificial intelligence (AI)-based medtech company LBT Innovations (ASX:LBT) has been surging after clinical results from the evaluation of the APAS device was published in the Journal of Clinical Microbiology, by The Johns Hopkins Hospital.

The Automated Plate Assessment System (or APAS) is based upon LBT’s intelligent imaging and machine learning software, and remains the only US FDA-cleared AI technology for automated imaging, analysis and interpretation of culture plates following incubation.

 

At Stockhead we tell it like it is. While MGC Pharma is a Stockhead advertiser, it did not sponsor this article.