<SEC-DOCUMENT>0001714899-21-000087.txt : 20210823
<SEC-HEADER>0001714899-21-000087.hdr.sgml : 20210823
<ACCEPTANCE-DATETIME>20210823202557
ACCESSION NUMBER:		0001714899-21-000087
CONFORMED SUBMISSION TYPE:	4
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210819
FILED AS OF DATE:		20210823
DATE AS OF CHANGE:		20210823

REPORTING-OWNER:	

	OWNER DATA:	
		COMPANY CONFORMED NAME:			Ho Carole
		CENTRAL INDEX KEY:			0001724605

	FILING VALUES:
		FORM TYPE:		4
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38311
		FILM NUMBER:		211198285

	MAIL ADDRESS:	
		STREET 1:		C/O DENALI THERAPEUTICS INC.
		STREET 2:		151 OYSTER POINT BLVD., 2ND FLOOR
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080

ISSUER:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Denali Therapeutics Inc.
		CENTRAL INDEX KEY:			0001714899
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				463872213
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	BUSINESS ADDRESS:	
		STREET 1:		161 OYSTER POINT BLVD.
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080
		BUSINESS PHONE:		(650) 866-8548

	MAIL ADDRESS:	
		STREET 1:		161 OYSTER POINT BLVD.
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080
</SEC-HEADER>
<DOCUMENT>
<TYPE>4
<SEQUENCE>1
<FILENAME>wf-form4_162976473844672.xml
<DESCRIPTION>FORM 4
<TEXT>
<XML>
<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0306</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2021-08-19</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001714899</issuerCik>
        <issuerName>Denali Therapeutics Inc.</issuerName>
        <issuerTradingSymbol>DNLI</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001724605</rptOwnerCik>
            <rptOwnerName>Ho Carole</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>C/O DENALI THERAPEUTICS INC.</rptOwnerStreet1>
            <rptOwnerStreet2>161 OYSTER POINT BLVD.</rptOwnerStreet2>
            <rptOwnerCity>SOUTH SAN FRANCISCO</rptOwnerCity>
            <rptOwnerState>CA</rptOwnerState>
            <rptOwnerZipCode>94080</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>1</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle>Chief Medical Officer</officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2021-08-19</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>S</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>1402</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>49.31</value>
                    <footnoteId id="F2"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>D</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>165917</value>
                    <footnoteId id="F3"/>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See footnote</value>
                    <footnoteId id="F4"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2021-08-19</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>S</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>1144</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>49.91</value>
                    <footnoteId id="F5"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>D</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>164773</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See footnote</value>
                    <footnoteId id="F4"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>25000</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See footnote</value>
                    <footnoteId id="F6"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>77792</value>
                    <footnoteId id="F3"/>
                    <footnoteId id="F7"/>
                    <footnoteId id="F8"/>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">Shares sold to satisfy the tax obligations by the reporting person in connection with the settlement of previously vested restricted stock units.</footnote>
        <footnote id="F2">The sale price reported in column 4 of Table I represents the weighted average sale price of the shares purchased ranging from $48.79 to $49.78 per share. Upon request by the Commission staff, the Issuer, or a security holder of the Issuer, the Reporting Person will provide full information regarding the number of shares sold at each separate price.</footnote>
        <footnote id="F3">Reflects the issuance of shares to the Rohatgi-Ho Family 2009 Revocable Trust in connection with the vesting of 5000 restricted stock units held by the Reporting Person.</footnote>
        <footnote id="F4">The shares are held of record by the Rohatgi-Ho Family 2009 Revocable Trust, for which Reporting Person serves as trustee.</footnote>
        <footnote id="F5">The sale price reported in column 4 of Table I represents the weighted average sale price of the shares purchased ranging from $49.80 to $50.10 per share. Upon request by the Commission staff, the Issuer, or a security holder of the Issuer, the Reporting Person will provide full information regarding the number of shares sold at each separate price.</footnote>
        <footnote id="F6">The shares are held of record by The Rohatgi-Ho Irrevocable GST Trust for the benefit of the Reporting Person's children.</footnote>
        <footnote id="F7">Includes 75,906 restricted stock units.</footnote>
        <footnote id="F8">Includes 410 shares acquired pursuant to the Issuer's Employee Stock Purchase Plan purchased on June 1, 2021.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Tyler Nielsen, by power of attorney</signatureName>
        <signatureDate>2021-08-23</signatureDate>
    </ownerSignature>
</ownershipDocument>
</XML>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
