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Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:

The Daily Biotech Pulse: Moderna Seeks FDA Approval For COVID-19 Shot For Children 2-6, Tax Disclosure For Amgen, Fast Track Tags For SQZ Biotech, Timber Pharma Candidates

Why Are Statera Biopharma Shares Surging Today

Immune Therapeutics Inc

Imunon Inc

<ul>
<li>Statera Biopharma Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stab#NASDAQ">STAB</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/10/ac29295284/statera-biopharma-announces-signing-of-a-binding-mou-with-holobeam-technologies-to-gain-access-to" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">signed a binding</a>&nbsp;Memorandum of Understanding with&nbsp;Holobeam Technologies Inc.</li>
<li>Holobeam offers holographic medical imaging and therapeutic technologies for early cancer detection, treatment, and other diseases using Holographic Energy Teleportation (HET) technology.&nbsp;</li>
<li>Under the terms of the MOU, Statera will acquire a 25% interest in Holobeam for access to their technology and assist in targeting Statera drugs specifically to the site of cancer in concentrations that would not be possible under normal dosing.&nbsp;</li>
<li>The MOU provides an exclusivity period of sixty (60) days for negotiating and finalizing a definitive agreement.</li>
<li>Michael Handley, President &amp; Chief Executive Officer of Statera, said, &quot;Holobeam&#39;s technology also has the potential to precisely deliver focused energy to the tumor cells, thus making them more susceptible to therapeutic intervention.&quot;</li>
<li>In April,&nbsp;Statera Biopharma&nbsp;entered into a non-binding term sheet with&nbsp;Immune Therapeutics Inc&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/imun#OTC">IMUN</a>) to sell its naltrexone and met-enkephalin rights.</li>
<li>Under the anticipated terms, Statera will receive an&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/04/26864918/why-are-statera-biopharma-shares-surging-today" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">initial $2 million upfront payment</a>&nbsp;and 5% of the issued and outstanding stock of Immune Therapeutics.&nbsp;</li>
<li>Price Action:&nbsp;STAB shares are down 13.50% at $0.19 during the premarket session on the last check Tuesday.</li>
</ul>

Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:
<h1>Stocks In Focus</h1>
<h1>Moderna Seeks FDA Emergency Use Nod For COVID-19 Shot In Kids 2-6</h1>
Moderna Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/ac26863133/moderna-files-for-authorization-of-its-covid-19-vaccine-in-young-children-six-months-to-under-six" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">submitted a request for FDA emergency use authorization</a>&nbsp;(EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 6 years of age.&nbsp;
The requests are based on a 25 &mu;g two-dose primary series of mRNA-1273.
The EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna is also currently studying booster doses for all pediatric cohorts.
<h1>Amgen Hit By Bombshell Tax Disclosure&nbsp;</h1>
Amgen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>) says that earlier this month the company received a notice of deficiency from the Internal Revenue Service centered on 2013 to 2015.&nbsp;
The agency seeks to increase Amgen&#39;s taxable income for the period by an amount that&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/n26852927/amgen-reports-first-quarter-2022-financial-results" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">would result in an additional federal tax of approximately $5.1 billion</a>&nbsp;plus interest.&nbsp;
In addition, the notice proposes penalties of roughly $2 billion.
The notice is similar to the adjustments Amgen received from the IRS for the 2010 to 2012 period.&nbsp;
<h1>Y-MAbs Therapeutics&#39; CEO Exits, Expects FY22 Danyelza Sales of Up To $50M</h1>
Y-mAbs Therapeutics Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ymab#NASDAQ">YMAB</a>) CEO and board member Claus Moller&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/g26852910/y-mabs-announces-executive-management-changes-and-provides-2022-revenue-guidance-and-financial-upd" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">has stepped down</a>&nbsp;from his position effective immediately.&nbsp;
Thomas Gad, the company&#39;s founder, chairman and president, has assumed the interim CEO and board member role.&nbsp;
The company posted preliminary Q1 FY22 Danyelza sales of $10.5 million, with a $45-$50 million full-year revenue guidance.
<h1>Cara, Vifor&#39;s Kapruvia Scores European Approval</h1>
The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/b26859409/kapruvia-approved-by-european-commission-for-the-treatment-of-moderate-to-severe-pruritus-in-hemod" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">European Commission has approved</a>&nbsp;Vifor Pharma AG&nbsp;and&nbsp;Cara Therapeutics Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cara#NASDAQ">CARA</a>) Kapruvia (difelikefalin) for pruritus (itchy skin) associated with chronic kidney disease&nbsp;in adult hemodialysis patients.&nbsp;
The FDA approved the treatment in August 2021.
<h1>SQZ Biotech Receives Fast Track Tag For&nbsp;Lead Cancer Cell Therapy</h1>
The FDA has&nbsp;<a class="editor-rtfLink" href="https://www.businesswire.com/news/home/20220427006000/en/SQZ-Biotechnologies-Receives-FDA-Fast-Track-Designation-for-its-Lead-Cell-Therapy-Candidate-for-the-Treatment-of-HPV16-Tumors" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">granted Fast Track Designation</a>&nbsp;to&nbsp;SQZ Biotechnologies&#39;&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/sqz#NYSE">SQZ</a>) lead cell therapy candidate, SQZ-PBMC-HPV, for HPV16+ advanced or metastatic solid tumors.
The cell therapy is being evaluated in a Phase 1/2 clinical trial.
Shares are trading 17% higher at $3.24 during the premarket session.
Click&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/fda-biotech#historical" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">here&nbsp;</a>to access Benzinga&#39;s FDA Calendar.
<h1>AnaptysBio Posts Topline Data From ANB032 Study In Healthy Volunteers</h1>
AnaptysBio Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anab#NASDAQ">ANAB</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/g26853723/anaptysbio-announces-positive-anb032-anti-btla-agonist-top-line-phase-1-data-and-provides-pipeline" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">announced topline data</a>&nbsp;from a Phase 1 trial of ANB032, an anti-BTLA agonist antibody.&nbsp;
Topline data demonstrated favorable safety, tolerability, and rapid and sustained pharmacokinetics and pharmacodynamic profile, supporting the advancement of ANB032 into subsequent patient trials.
ANB032 was generally well-tolerated&nbsp;and no dose-limiting toxicities were observed.
<h1>AstraZeneca&#39;s Ultomiris Scores FDA Approval For Rare Neuromuscular Disease</h1>
The&nbsp;<a class="editor-rtfLink" href="https://www.astrazeneca.com/media-centre/press-releases/2022/ultomiris-approved-in-the-us-for-adults-with-generalised-myasthenia-gravis.html" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">FDA has approved</a>&nbsp;AstraZeneca Plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) Ultomiris (ravulizumab-cwvz) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor&nbsp;antibody-positive.&nbsp;&nbsp;
The approval was based on positive results from the CHAMPION-MG Phase 3 trial. Ultomiris was superior to placebo on a patient-reported scale that assesses patients&#39; abilities to perform daily activities.
gMG is a rare, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.
<h1>Statera Biopharma, Immune Therapeutics Ink Pact For Low Dose Naltrexone Rights</h1>
Statera Biopharma Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stab#NASDAQ">STAB</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/g26853375/statera-biopharma-and-immune-therapeutics-inc-announce-strategic-agreement-for-rights-to-low-dose-" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">entered into a non-binding term sheet</a>&nbsp;with Immune Therapeutics Inc (OTC: <a class="ticker" href="https://www.benzinga.com/stock/imun#OTC">IMUN</a>) to sell its naltrexone and met-enkephalin rights.
Statera will receive an initial $2-million upfront payment and 5% of the issued and outstanding stock of Immune Therapeutics.&nbsp;
Additionally, Statera will receive milestone-based payments. Potential indication payments will include asthma, multiple sclerosis, HIV&nbsp;and chemotherapy. This transaction can generate over $400 million in non-dilutive payments to Statera.
Shares are up 62.7% at 34 cents during the premarket session.
<h1>Sio Gene Therapies Ditches Two Remaining Programs, Seeks Buyer(s)</h1>
Sio Gene Therapies Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/siox#NASDAQ">SIOX</a>)&nbsp;<a class="editor-rtfLink" href="https://www.globenewswire.com/news-release/2022/04/27/2430731/0/en/Sio-Gene-Therapies-Provides-Corporate-Update.html" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">will terminate its licensing agreement</a>&nbsp;with the University of Massachusetts to develop and commercialize gene therapy product candidates, including AXO-AAV-GM1 and AXO-AAV-GM2, for GM1 gangliosidosis and GM2 gangliosidosis, respectively.
The company announced that it plans to explore and review a range of strategic alternatives in parallel.
The Sio held cash and&nbsp;cash equivalents of approximately $64 million at March 31.&nbsp;
Shares are down 38.6% at 37 cents&nbsp;during the premarket session.
<h1>Opiant Pharma&#39;s Nasal Nalmefene Non-Inferior To Nasal Naloxone In Opioid Overdose</h1>
Opiant Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/opnt#NASDAQ">OPNT</a>)&nbsp;<a class="editor-rtfLink" href="https://www.globenewswire.com/news-release/2022/04/27/2430661/37234/en/Opiant-Pharmaceuticals-Announces-Positive-Topline-Results-from-Head-to-Head-Pharmacodynamic-Study-Comparing-OPNT003-Nasal-Nalmefene-to-Nasal-Naloxone.html" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">announced topline results</a>&nbsp;from a pharmacodynamic study for OPNT003, nasal nalmefene for opioid overdose.
OPNT003 met the primary endpoint of non-inferiority to nasal naloxone.
A preliminary analysis of the 50 subjects completing the study found that treatment with OPNT003 produced nearly twice the reversal of respiratory depression than produced by nasal naloxone at 5&nbsp;minutes.&nbsp;
<h1>Timber Pharma TMB-001 Scores FDA Fast Track Tag For Skin Scaling Disorder</h1>
The FDA has granted Fast Track designation to&nbsp;Timber Pharmaceuticals Inc&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/tmbr#NYSE">TMBR</a>) TMB-001, topical isotretinoin formulated for X-linked recessive ichthyosis and autosomal recessive congenital ichthyosis lamellar ichthyosis.
Congenital ichthyosis is a group of rare genetic keratinization disorders that lead to dry, thickened&nbsp;and scaling skin.&nbsp;
Timber expects to launch a pivotal Phase 3 ASCEND trial for TMB-001 within 60 days.
Shares are up 0.72% at 46 cents during the premarket session.
<h1>Abbvie, Plexium Collaborate For Protein Degradation Therapies In Neurological Conditions</h1>
Plexium Inc&nbsp;and&nbsp;AbbVie Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abbv#NYSE">ABBV</a>) have&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/n26864338/abbvie-and-plexium-enter-into-multi-target-strategic-collaboration-to-develop-and-commercialize-ta" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">entered into an exclusive strategic collaboration</a>&nbsp;to develop and commercialize novel Targeted Protein Degradation therapeutics for neurological conditions.&nbsp;
Plexium will conduct preclinical research activities for the collaboration targets, after which AbbVie has the option to select programs for additional research and development activities.&nbsp;
Specific deal terms were not disclosed.
<h3>On The Radar</h3>
<h3>Earnings</h3>
<ul>
<li>Merck &amp; Co Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>)&nbsp;(Before Market Open).</li>
<li>CureVac BV&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cvac#NASDAQ">CVAC</a>) (Before Market Open).</li>
<li>Sanofi SA&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) (Before Market Open).</li>
<li>NovoCure Limited&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nvcr#NASDAQ">NVCR</a>) (Before Market Open).</li>
<li>Eli Lilly And Co&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lly#NYSE">LLY</a>) (Before Market Open).</li>
<li>Alnylam Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alny#NASDAQ">ALNY</a>) (Before Market Open).</li>
<li>Gilead Sciences Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gild#NASDAQ">GILD</a>) (After Market Close).</li>
</ul>

<ul>
<li>Statera Biopharma Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stab#NASDAQ">STAB</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/04/g26853375/statera-biopharma-and-immune-therapeutics-inc-announce-strategic-agreement-for-rights-to-low-dose-" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">entered into a non-binding term sheet</a>&nbsp;with&nbsp;Immune Therapeutics Inc&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/imun#OTC">IMUN</a>) to sell its naltrexone and met-enkephalin rights.</li>
<li>The transaction is contingent upon the negotiation of a definitive agreement and satisfaction of several closing conditions, including a contingency on Immune Therapeutics financing.</li>
<li>Under the anticipated terms, Statera will receive an initial $2 million upfront payment and 5% of the issued and outstanding stock of Immune Therapeutics.&nbsp;</li>
<li>Also See:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/04/26611976/coeptis-therapeutics-intends-to-acquire-stateras-tlr5-agonist-platform" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Coeptis Therapeutics Intends To Acquire Statera&#39;s TLR5 Agonist Platform</a>.</li>
<li>Additionally, Statera will receive milestone-based payments. Potential indication payments will include asthma, multiple sclerosis, HIV, and chemotherapy. This transaction can generate over $400 million in non-dilutive payments to Statera.</li>
<li>Price Action:&nbsp;STAB shares are up 75.1% at $0.37&nbsp;during the premarket session on the last check Thursday.</li>
</ul>

<a href="https://www.globenewswire.com/Tracker?data=k71vffR-OOrWROGyymJqFGcp3nGDHs9wwVQDByQamB4m-e5DANYmQxYerMHrdIjmdv86I-nVzusKqtvwSmiPTwhY9KLAfY5r0r01IsBsWsrsdB7rBL8MMSUBFacdIc_PGrNHtmzChm2teAwTpoC1fMp4VqfyAudSTj70MEfpx7q8Ia4LZsWXwTNg0fDMO3oq9NBT-qgOnIVm6IcUB9TNDVQdpHbDWc3SAwYKddhC4vA06_Y8-yeMDkjKU1tI6p0-GPhD2fkx1Euo9gFqcNMvwqfoQpaim9NfnTgUGInqTtZpiTRAIRscCph6DeB1qJAP" target="_blank">Statera Biopharma</a>&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/STAB#NASDAQ">STAB</a>) (the &quot;Company&quot;), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, announced today that the Company entered into a non-binding term sheet with respect to a strategic agreement with&nbsp;<a href="https://www.globenewswire.com/Tracker?data=u8YNRBQy77v9QluiXnzchU6KHElmgrcEQqWtczOXWVa-FQ8MQXruGSHnvEVM7TTivBWKRdyJzh5oDISzt2xz894h0RBZB4StDpyVml-pyt8=" target="_blank">Immune Therapeutics</a>, Inc. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/IMUN#OTC">IMUN</a>), a drug development and commercialization company, to sell Statera&#39;s rights to naltrexone and met-enkephalin. The transaction is contingent upon negotiation of a definitive agreement and satisfaction of a number of closing conditions, including a contingency on Immune Therapeutics financing. 
&nbsp;
&quot;The agreement with Immune will enable us to strengthen our financial position with a transaction that has the potential to produce significant non-dilutive cashflow to fund our other programs. For instance, Statera is beginning to chart a new course in the immunotherapy field by pursuing molecules that act on Toll-like Receptor pathways similar to Naltrexone,&quot; said Michael K. Handley, President and Chief Executive Officer of Statera Biopharma. &quot;It also will help advance our new product candidates for treatment of a variety of immune-related diseases that have no cure.&quot;
Under the anticipated terms of the agreement, Statera will receive an initial&nbsp;$2 million&nbsp;upfront payment and&nbsp;5%&nbsp;of the issued and outstanding stock of Immune Therapeutics. Additionally, Statera will receive payments for achievement of revenue-based milestones, new indications and royalties, Crohn&#39;s disease and COVID-19 indications and regulatory approvals, as well as any other payments from Immune Therapeutics in exchange for Statera&#39;s rights to any product containing low-dose naltrexone as an active ingredient. Potential indication payments will include asthma, multiple sclerosis, HIV and chemotherapy. In aggregate, this transaction has the ability to generate over&nbsp;$400 million&nbsp;in non-dilutive payments to Statera.
&quot;Statera&#39;s naltrexone assets will be a great addition to our immune-modulation products and immunotherapy technologies,&quot; said Kevin Phelps, CEO, Immune Therapeutics. &quot;We believe that they can significantly enhance our ability to combat chronic, life‐threatening diseases and bring hope to millions of patients and their families.&quot;

Statera Biopharma And Immune Therapeutics Inc. Announce Strategic Agreement For Rights To Low Dose Naltrexone

Immunic Therapeutics And Vital Therapies Complete Transaction Creating Nasdaq-Listed Company Targeting Chronic Inflammatory And Autoimmune Diseases; Vital Therapies Trading To Commence On Nasdaq Capital Market Under Symbol 'IMUX' On April 15

Immune Therapeutics Inc (IMUN) "Immune Therapeutics", through its fully owned subsidiary, TNI Biotech International, today announced the dosing of the first patient with Lodonal™ (Once-daily Oral Treatment) for the 90-Day bridging clinical trial of Immune Therapeutics' proprietary patented therapy (Lodonal™) as an adjunct treatment for HIV/AIDS and opportunistic infections.
The Bridging Trial has met all parameters of the Nigerian Trial Clinical Research Health [NTCR] &amp; Nigerian Health Research Ethics Committee [NHREC] as confirmed on their official website and stated below: 89519615
A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised. The primary objective of this clinical trial is to confirm that LODONAL has a beneficial effect on the immune system of patients in Nigeria with a compromised immune system (refer to Inclusion/Exclusion Criteria). This will be determined by: The number of subjects with CD4 count stabilization (less than 10% change from baseline mean values) or 25% increase in CD4 counts on LODONAL compared to observation group from baseline to Days 30, 60 and 90. 2015-03-31
<a href="http://nctr.nhrec.net/search.php?search=lodonal&amp;submit=Search" title="http://nctr.nhrec.net/search.php?search=lodonal&amp;submit=Search">http://nctr.nhrec.net/search.php?search=lodonal&amp;submit=Search</a>
Dr. Abayomi Oni, Principal Investigator and Lead Consultant on this trial at State Hospital Asubiaro, stated "I am excited about the possibility of Low Dose Naltrexone (Lodonal™) being of immense benefit to our local population of patients with HIV/AIDS in Osun State, Nigeria as has been proven with other populations."
AIDS is a chronic, potentially life-threatening condition caused by the human immunodeficiency virus (HIV). By damaging your immune system, HIV interferes with your body's ability to fight the organisms that cause disease. NAFDAC determined that using Lodonal™ as an immune adjunct could provide a tremendous catalyst in enhancing the resistance to the proliferation of HIV/AIDS virus. This 90-Day bridging trial simply provides the verification and legitimization of this precept on this population. Upon completion of this trial, Lodonal™ will be available and could provide positive solutions to millions of HIV/AIDS sufferers. 
"With the total population in Africa of 1.111 billion (2013) and the incidence and prevalence of HIV and other non-HIV immune compromised states, Lodonal™, being affordable, well tolerated and efficacious in boosting the immune status of individuals at risk is novel and revolutionary. Early deaths due to opportunistic infections would be reduced thereby increasing the labor force in the continent which is essential to the much-awaited economic boom in Africa!" said Dr. Richards Afonja, MD, of American Hospitals and Resorts. 
The bridging trial for Lodonal™ is a single center 90-Day, double-blind, placebo-controlled trial. The trial has enrolled over 200 patients consisting of a one a day oral treatment with Lodonal™ or placebo, followed by a 60-day open label extension in which all participants will receive Lodonal™. The superiority of Lodonal™ vs. placebo during the double blind period will be evaluated in terms CD4 count (primary endpoint), while key secondary endpoints include the reduction in the number of opportunist infections and improvements in the quality of life measures.
"The start of this bridging trial for HIV/AIDS is marking the accomplishment of a critical milestone for Immune Therapeutics," said Noreen Griffin, CEO of Immune Therapeutics. "We are grateful for the opportunity to launch Lodonal™ in Nigeria via this trial, as well as the support we have received from the medical community in Nigeria." 
There's no cure for HIV/AIDS, but there are medications that can dramatically slow disease progression. These drugs have reduced AIDS deaths in many developed nations. But HIV/AIDS continues to decimate populations worldwide. It is such a devastating health challenge that the US Department of State through its PEPFAR [Presidential Emergency Program for AIDS Recovery] program provides emergency assistance for more than 21 partners, one of which is Nigeria. We believe LDN could be an answer; LDN is safe, easy to administer and affordable. 
President &amp; CEO GB Pharma Holdings, Dr. Gloria B. Herndon, said " Nigeria has once again assumed its leadership position by undertaking a bridging trial that will allow Lodonal™ to be available to its population and ultimately the rest of Africa. This will revolutionize the concept of health security in Africa by providing an immune booster that offers solutions that are non evasive and reactive. After my forty-five [45] years experience in Africa, this initiative has the potential of being the most far reaching and impactful I have yet to witness.

Press Releases

Immune Therapeutics Inc, Announces The Official Publication Announcement of The NAFDAC Approved 90-Day Bridging Trial of Lodonal With HIV/AIDS Patients

Biostax signs collaboration agreement with Immgenuity to pursue remission in HIV

Biostax Launches Growth Funding Round to Revitalize Affordable Healthcare

Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH, NAFLD and AIH

Biostax Corp. Signs Collaboration Agreement with Immgenuity, Inc. to Pursue Remission in HIV

Biostax Corp Announces the Passing of Esteemed Director, H. Louis Salomonsky

IMMUNE THERAPEUTICS INC by Immune Therapeutics, Inc.