u/TwongStocks

>The CRL is based on the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025. Unicycive understands that the FDA has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process of the resubmitted NDA. The NDA for OLC had been resubmitted based on Unicycive’s belief of continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the deficiencies identified in the Company’s CRL related to the compliance status of the vendor. The FDA did not express any concerns about the third-party manufacturer’s progress and no additional issues were raised by the FDA at the Type A meeting.

https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter

It's been a while since I've seen the Agency issue a CRL due to a lack of a facility inspection. Not since the Covid era, when travel restrictions impacted a lot of inspections. I would love to see the CRL, to see if there is any hint as to why the 3rd party facility wasn't inspected. But unfortunately, the FDA hasn't published any CRLs since Makary left. The most recent CRL on the FDA website is Abbvie's April 22nd CRL.

As previously reported, on February 18, 2026, Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), received a letter from the Listing Qualifications Staff (the “Nasdaq Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that Nasdaq staff had determined to delist the Company’s common stock, par value $0.01 per share (the “Common Stock”) from the Nasdaq Capital Market because it failed to maintain a minimum bid price of $1.00 per share for 30 consecutive business days, in violation of Nasdaq Listing Rule 5550(a)(2).

On June 26, 2026, the Company received a letter from the Nasdaq Staff notifying the Company that, because the closing bid price of the Company’s common stock had been at $1.00 per share or greater for the ten consecutive business days between June 11, 2026 - June 25, 2026, the Company had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market and that this matter is now closed.

https://www.sec.gov/ix?doc=/Archives/edgar/data/1649989/000110465926078337/tm2619105d1_8k.htm

JMG was previously suspended by the SEC in January. NYSE kept JMG halted after the SEC trading suspension expired, and will now delist them.

>As a result of the U.S. Securities and Exchange Commission issuing a temporary trading suspension in the Company’s securities (https://www.sec.gov/files/litigation/suspensions/2026/34-104613.pdf), NYSE Regulation halted trading in the Company’s ordinary shares on January 15, 2026 and has now determined that the Company’s ordinary shares are not suitable for continued listing pursuant to Sections 1001, 1002(e), and 1003 of the NYSE American Company Guide (the “Guide”).

https://www.businesswire.com/news/home/20260612158356/en/NYSE-American-to-Commence-Delisting-Proceedings-Against-JM-Group-Limited-JMG

TCGL was previously suspended by the SEC in February. NYSE kept TCGL halted after the SEC trading suspension expired and will now delist them.

>As a result of the U.S. Securities and Exchange Commission issuing a temporary trading suspension in the Company’s securities (https://www.sec.gov/files/litigation/suspensions/2026/34-104763.pdf), NYSE Regulation halted trading in the Company’s Class A ordinary shares on February 2, 2026 and has now determined that the Company’s Class A ordinary shares are not suitable for continued listing pursuant to Sections 1001, 1002(e), and 1003 of the NYSE American Company Guide (the “Guide”).

https://www.businesswire.com/news/home/20260612788736/en/NYSE-American-to-Commence-Delisting-Proceedings-Against-TechCreate-Group-Ltd.-TCGL

NYSE has made their move. Now we wait and see if any of the NASDAQ stocks that were also suspended by the SEC will also be delisted.

>It appears to the Securities and Exchange Commission that the public interest and the protection of investors require a suspension in the trading of the securities of Happy City Holdings Limited (“HCHL”) (CIK No. 0002046656), a holding company incorporated in the British Virgin Islands and headquartered in Hong Kong, because of potential manipulation in the securities of HCHL effectuated through recommendations made to investors by unknown persons via social media to purchase and/or hold the securities of HCHL, and to send screenshots documenting their transaction, which appear to be designed to artificially inflate the price and trading volume of the securities of HCHL. As of June 10, 2026, the common stock of HCHL is listed on the Nasdaq Capital Market under the symbol “HCHL.” The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed company.

https://www.sec.gov/files/litigation/suspensions/2026/34-105675.pdf

The SEC trading suspension is from 4:00 AM ET on June 12, 2026, through 11:59 PM ET on June 26, 2026. The SEC is allowed to place trading suspensions for a maximum of 10 trading days.

However, none of the companies that have been placed in SEC trading suspensions since Sept 2025 have resumed trading yet. NASDAQ and NYSE have maintained trading halts after the SEC trading suspensions expired.

HONG KONG, June 03, 2026 (GLOBE NEWSWIRE) -- TJGC Group Limited (Nasdaq: TJGC) (the "Company") today announced that The Nasdaq Stock Market LLC ("Nasdaq") has advised the Company that trading in its ordinary shares, which was halted on May 15, 2026 under halt code "T12 — Additional Information Requested by Nasdaq," will resume at certain time after 10:00 a.m. Eastern Time on June 3, 2026.

The halt was imposed by the Nasdaq Listing Qualifications Department (the "Staff") under Nasdaq Listing Rule 5250(a) pending the Company's response to information requests relating to recent trading activity in the Company's ordinary shares and to the Company's registered follow-on offering that closed on April 16, 2026 (the "Follow-On Offering"). The Company submitted written responses to the Staff on May 18, 2026 and May 19, 2026. After the Company furnished its Report on Form 6-K dated May 21, 2026 announcing the 1-for-3 reverse stock split of its ordinary shares (the "Reverse Stock Split"), the Staff issued a further information request, to which the Company responded on May 26, 2026. Following its review of the Company's responses, the Staff has advised the Company that it has no further questions at this time.

Recent trading activity and the Follow-On Offering. Based on its internal review, the Company is not aware of any undisclosed corporate development, material non-public information, or other Company-specific event that would explain the recent trading activity in its ordinary shares. The Company believes the increase in price and volume that began on or around April 15, 2026 most likely reflects publicly available information regarding the Follow-On Offering, including the U.S. Securities and Exchange Commission's declaration of effectiveness of the Company's registration statement on Form F-1 and the Company's announcement of the entry into related securities purchase agreement and closing of the Follow-on Offering.

https://www.globenewswire.com/news-release/2026/06/03/3306151/0/en/TJGC-Group-Limited-Announces-Resumption-of-Trading-on-Nasdaq.html

• No Clinical Safety or Efficacy Concerns Currently Identified 
• Agency Feedback Primarily Focused on CMC-Related Requests
• Company Plans Prompt Response and Submission of Requested Information
• Company is Well Capitalized with Nearly $30 Million Cash on Hand

KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

The response identified specific Chemistry, Manufacturing and Controls (CMC) information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing issues raised.

“We are encouraged that the FDA’s response was limited to specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301,” said Cingulate CEO Shane J. Schaffer. “Our immediate priority is to complete the CMC work already underway with our manufacturing partner; we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission. Importantly, we have nearly $30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027.”

https://www.cingulate.com/news-releases/news-release-details/cingulate-receives-complete-response-letter-fda-ctx-1301

Company plans to resubmit BLA to the FDA in June 2026

ISELIN, N.J.,May 26, 2026(GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced that theU.S. Food and Drug Administration(FDA) has granted the appeal following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs(OND). The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD). As a result,Outlook Therapeutics expects to resubmit the ONS-5010/LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) in June 2026.

The Company engaged in the FDR process after its recent Type A meeting with the Division of Ophthalmology (Division) and Officeof Specialty Medicine (OSM) related to the December 30, 2025 Complete Response Letter (CRL) for the BLA for ONS-5010/LYTENAVA™.

In its formal response, OND determined that the results of the NORSE TWO trial, together with confirmatory evidence including NORSE EIGHT, natural history, and mechanistic and pharmacodynamic data, establish substantial evidence of effectiveness for LYTENAVA™ for the treatment of nAMD. The response directs the Division and OSM to work with Outlook Therapeutics to reach an agreement on final labeling. As indicated in the formal decision, it is anticipated that this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission.

>“We appreciate the opportunity to engage with the FDA through the FDR process,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Agency’s action on our appeal provides a clear path forward toward U.S.approval.”

Mr. Jahr added, “Importantly, we are extremely grateful for the continued support and confidence of our stakeholders throughout this process. I would especially like to thank our team for their tireless efforts, resilience and unwavering commitment throughout what was a rigorous and highly demanding process. Their persistence and professionalism were instrumental in achieving this successful outcome. We have remained resolute that patients deserve additional FDA-approved options for the treatment of nAMD and look forward to receiving an approval decision for ONS-5010/LYTENAVA™.”

If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab supported by an FDA-approved manufacturing process, FDA-approved labeling, as well as robust pharmacovigilance.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-wins-appeal-following-formal-dispute

NEW YORK, May 19, 2026 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market*®* (Nasdaq: NDAQ) announced that trading is halted in TJGC Group Limited (Nasdaq: TJGC) for additional information requested from the company. Nasdaq halted TJGC at 18:50:47 on May 15, 2026; the last closing price of the company’s ordinary shares was $2.19. 

Trading will remain halted until TJGC Group Limited has fully satisfied Nasdaq’s request for additional information.

https://www.globenewswire.com/news-release/2026/05/19/3297601/6948/en/Nasdaq-Halts-TJGC-Group-Limited.html

Unlike some other stocks with lengthy halts, there is currently no SEC suspension on TJGC. Just the NASDAQ T12 halt. NASDAQ's press release does not specify the reason for the halt.

• Chiesi agreed to acquire KalVista Pharmaceuticals for $27.00 per share in cash, representing an equity consideration of approximately $1.9bn
• Acquisition adds to Chiesi’s rare immunology portfolio the first oral, on-demand therapy for hereditary angioedema, strengthening Chiesi’s long-term commitment to people living with rare conditions 
• Transaction expected to close in Q3 2026

https://www.chiesi.com/en/media-hub/press-releases/chiesi-group-to-acquire-kalVista-pharmaceuticals-expanding-its-global-rare-disease-portfolio