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[8-K] Anika Therapeutics Inc Reports Material Event

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

On 30 Jul 2025, Anika Therapeutics (ANIK) filed a Form 8-K (Item 7.01) to furnish a press release (Exhibit 99.1) announcing top-line results from its U.S. pivotal FastTRACK Phase III study of the Hyalofast cartilage-repair scaffold and providing a program update. No financial figures, efficacy data, or regulatory timelines are included in the filing itself; those details reside in the furnished press release, which is not reproduced here. The information is deemed “furnished,” not “filed,” so it is excluded from Exchange Act liability and will not be automatically incorporated into future SEC filings. Apart from the exhibit list, the 8-K contains no additional disclosures under Items 1–6, and there are no financial statements attached.

Positive
  • Reached pivotal milestone: completion and announcement of Phase III topline results for Hyalofast scaffold demonstrate continued pipeline advancement.
Negative
  • None.

Insights

TL;DR: Phase III topline readout signals pipeline progress but no data disclosed, so market impact awaits detailed results.

The completion of a pivotal Phase III trial is a key milestone that could unlock regulatory submissions and drive valuation for a small-cap biotech like Anika. However, because the 8-K only notes that a press release exists—without efficacy, safety, or statistical outcomes—investors cannot gauge whether the readout is favorable. The disclosure structure (Item 7.01 furnished) also suggests management wants flexibility without triggering liability if interpretations later change. Impact: neutral until the actual numbers are examined.

TL;DR: Routine Reg FD filing, minimal legal exposure, signals potential future filings if results are material.

Using Item 7.01 keeps the information outside Section 18 liability, a common approach when companies release scientific data before full peer review. Should the results support an FDA submission, a more detailed 8-K or S-1/A could follow. For now, the company satisfies Reg FD by furnishing the press release, limiting immediate compliance risk. Overall disclosure impact is neutral.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  July 30, 2025

_______________________________

Anika Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware001-1402704-3145961
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

32 Wiggins Avenue

Bedford, Massachusetts 01730

(Address of Principal Executive Offices) (Zip Code)

(781) 457-9000

(Registrant's telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.01 per shareANIKNASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 
 
Item 7.01. Regulation FD Disclosure.

 

On July 30, 2025, Anika Therapeutics, Inc. issued a press release announcing the topline results from its U.S. pivotal FastTRACK Phase III study for Hyalofast cartilage repair scaffold and a program update. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

The information included in this 7.01, including the exhibit attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

(d)   Exhibits.

Exhibit Number Description
   
99.1 Press Release of Anika Therapeutics, Inc. dated July 30, 2025
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 Anika Therapeutics, Inc.
   
  
Date: July 30, 2025By: /s/ Cheryl R. Blanchard        
  Cheryl R. Blanchard
  President and Chief Executive Officer
  

 

FAQ

What did Anika Therapeutics (ANIK) announce on July 30 2025?

It furnished a press release reporting topline results from its U.S. pivotal FastTRACK Phase III study of the Hyalofast cartilage-repair scaffold.

Which SEC form did Anika file for this disclosure?

Anika filed a Form 8-K under Item 7.01 (Regulation FD Disclosure).

Are detailed Phase III efficacy or safety data included in the 8-K?

No. The 8-K only references the press release (Exhibit 99.1); specific data are not included in the filing text.

Does the filing affect Anika’s financial statements?

No financial statements are provided or impacted; Item 9.01 lists only the press-release exhibit.

Is the information deemed "filed" with the SEC?

No. Item 7.01 information is "furnished," so it is not subject to Section 18 liability and is not automatically incorporated into other filings.
Anika Therapeutics Inc

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Drug Manufacturers - Specialty & Generic
Surgical & Medical Instruments & Apparatus
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United States
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