<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0306</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2013-01-29</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001069308</issuerCik>
        <issuerName>Opexa Therapeutics, Inc.</issuerName>
        <issuerTradingSymbol>OPXA</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001359850</rptOwnerCik>
            <rptOwnerName>Seaman Scott B</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>C/O OPEXA THERAPEUTICS, INC.</rptOwnerStreet1>
            <rptOwnerStreet2>2635 TECHNOLOGY FOREST BLVD.</rptOwnerStreet2>
            <rptOwnerCity>THE WOODLANDS</rptOwnerCity>
            <rptOwnerState>TX</rptOwnerState>
            <rptOwnerZipCode>77381</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>1</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <nonDerivativeTable></nonDerivativeTable>

    <derivativeTable>
        <derivativeTransaction>
            <securityTitle>
                <value>Common Stock Warrant (Right to Buy)</value>
            </securityTitle>
            <conversionOrExercisePrice>
                <value>1.21</value>
            </conversionOrExercisePrice>
            <transactionDate>
                <value>2013-01-29</value>
            </transactionDate>
            <deemedExecutionDate></deemedExecutionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>22950</value>
                </transactionShares>
                <transactionPricePerShare>
                    <footnoteId id="F1"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <exerciseDate>
                <value>2013-01-29</value>
            </exerciseDate>
            <expirationDate>
                <value>2018-01-29</value>
            </expirationDate>
            <underlyingSecurity>
                <underlyingSecurityTitle>
                    <value>Common Stock</value>
                </underlyingSecurityTitle>
                <underlyingSecurityShares>
                    <value>22950</value>
                </underlyingSecurityShares>
            </underlyingSecurity>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>22950</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See Footnote</value>
                    <footnoteId id="F2"/>
                </natureOfOwnership>
            </ownershipNature>
        </derivativeTransaction>
    </derivativeTable>

    <footnotes>
        <footnote id="F1">Warrants were issued to all holders of the July 2012 12% Convertible Secured Promissory Notes in exchange for a reduction in the amount of cash collateral held in a controlled account as security for repayment of the Notes.</footnote>
        <footnote id="F2">Held by Alkek &amp; Williams Ventures, Ltd. (&quot;Ventures&quot;).  Chaswil, Ltd. (&quot;Chaswil&quot;) is the investment manager of Ventures and holds voting power and investment power with respect to the Issuer securities held by Ventures. Mr. Seaman is a registered principal of Chaswil and has shared voting power and/or investment power with respect to the Issuer securities held by Ventures. Mr. Seaman disclaims beneficial ownership of the shares held by Ventures except to the extent of any pecuniary interest therein.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ John Ginzler, by Power of Attorney</signatureName>
        <signatureDate>2013-01-31</signatureDate>
    </ownerSignature>
</ownershipDocument>
