Announcement • Jun 21
Lannett Company, Inc. Files Form 15 Lannett Company, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.001per share. Announcement • Jan 26
Lannett Company, Inc. to Report Q2, 2023 Results on Feb 01, 2023 Lannett Company, Inc. announced that they will report Q2, 2023 results After-Market on Feb 01, 2023 Announcement • Jan 05
Lannett Company Provides Development Update on Biosimilar Insulin Products On January 4, 2023, Lannett Company, Inc. provided an update on the clinical advancement and development of its biosimilar insulin aspart and biosimilar insulin glargine products. Lannett is developing both products with its strategic alliance partner, the HEC Group of companies (HEC). The company said results from the study of Lannett/HEC biosimilar insulin aspart versus US NovoLog® (the reference biologic) indicated the products were highly comparable when animals were dosed with equal quantities of the drugs via subcutaneous route. Data from the study will be submitted to the FDA as part of the company's request, expected in the first half of calendar 2023, for a Biosimilar Biological Product Development (BPD) Type II meeting. The company also said that analysis of the pivotal trial results for its biosimilar insulin glargine continues, though it now anticipates top-line data to be available by the end of February 2023. Board Change • Dec 29
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 2 highly experienced directors. Independent Director Melissa Rewolinski was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 27
Lannett Company, Inc. to Report Q1, 2023 Results on Nov 02, 2022 Lannett Company, Inc. announced that they will report Q1, 2023 results After-Market on Nov 02, 2022 Announcement • Oct 22
Lannett Company, Inc. Receives FDA Approval to Manufacture Numbrino® at Seymour Plant Lannett Company, Inc. announced that it has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino®, the company's branded topical anesthetic product, at its main plant in Seymour, Indiana. The company previously manufactured Numbrino and other liquid drug products at its Carmel, New York plant, which it sold in March of this year as part of a restructuring and cost reduction plan. Crew noted that at the time of the sale of the Carmel plant the company said the buyer would support production of certain Lannett products for a period of up to 18 months. Now, the company's team will only need such production support for less than 10 months - a remarkably expeditious time frame by prevailing industry standards. Announcement • Sep 01
Lannett Company, Inc. Announces Subject Dosing Complete for Pivotal Clinical Trial of Biosimilar Insulin Glargine Lannett Company, Inc. announced that subject dosing has been completed in the pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies. No serious adverse events have thus far been reported. Announcement • Aug 20
Lannett Company, Inc. to Report Q4, 2022 Results on Aug 24, 2022 Lannett Company, Inc. announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Aug 24, 2022 Announcement • Jun 02
Lannett Company, Inc. Provides Update on Pivotal Clinical Trial for Biosimilar Insulin Glargine Lannett Company, Inc. provided an update on its ongoing pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). Crew added that if the study is successful, the company anticipates filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus Solostar in early 2023 and potentially launching the product in the first half of 2024. Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Announcement • Jun 01
Lannett Company Receives Notice from the NYSE Accepting the Company's Plan for NYSE's Listed Company Manual On March 4, 2022, Lannett Company, Inc. (the "Company") received notice on March 2, 2022 (the "First Notice") from the New York Stock Exchange (the "NYSE") that it was not in compliance with the continued listing standard set in Section 802.01B of the NYSE's Listed Company Manual (the "LCM") because the Company's average market capitalization was less than $50 million over a consecutive 30 trading-day period and the most recently reported stockholders' equity of the Company was also less than $50 million. Also, as previously disclosed in the Company's Current Report on Form 8-K filed with the SEC on March 18, 2022 ("March 18, 2022 Form 8-K"), the Company received a second notice on March 14, 2022 (the "Second Notice") from the NYSE that it was not in compliance with the continued listing standard set in Section 802.01C of the LCM because the average closing price of the Company's Common Stock was less than $1.00 per share over a consecutive 30 trading-day period. Investors should refer to the March 18, 2022 Form 8-K for further details on the Second Notice. The Company notified the NYSE on March 28, 2022 that it intends to cure the deficiency and re-gain compliance. The Company submitted a plan within 45 days of receipt of the First Notice setting definitive action it is and will be taking to bring it into conformity with Section 802.02B of the LCM within 18 months. On May 26, 2022, the Company received notice from the NYSE that the NYSE has accepted the Company's plan. The NYSE will be performing quarterly reviews during the 18 months from the Company's receipt of the First Notice for compliance with the goals and initiatives as outlined in the Company's plan. Failure to satisfy the requisite goals or initiatives may result in the Company being subject to NYSE trading suspension at that time. The Company is required to achieve the minimum continued listing standards of either average global market capitalization over a consecutive 30 trading-day period of $50 million or total stockholders' equity of $50 million at the completion of the 18-month plan period, and failure to achieve any of the minimum requirements at the end of the 18 month period may result in the Company being suspended by the NYSE, which may make an application to the SEC to delist the Company's Common Stock. Announcement • May 05
Lannett Company, Inc. Revises Earnings Guidance for the Fiscal Year 2022 Lannett Company, Inc. revised earnings guidance for the fiscal year 2022. For the year, the company expects net sales $335 million to $350 million, from $335 million to $360 million. Announcement • Mar 30
Lannett Company, Inc. Initiates Pivotal Clinical Trial for Biosimilar Insulin Glargine Lannett Company, Inc. announced that it has initiated the pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies. As previously reported, the pivotal trial is being conducted at the same site, using the same overall clinical design, as the previously completed first human volunteer pilot study. The first study, which the FDA reviewed, suggested that the Lannett/HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints. The pivotal trial uses clinical material produced at commercial scale from a large, new dedicated insulin facility, which will be used to supply the US market. Announcement • Feb 05
Lannett Company, Inc. Revises Earnings Guidance for the Fiscal Year 2022 Lannett Company, Inc. revised earnings guidance for the fiscal year 2022. For the year, the company expects net sales to be in the range of $335 million to $360 million, down from $370 million to $400 million and net loss to be in the range of $166.4 million to $158.0 million. Announcement • Jan 28
Lannett Company, Inc. to Report Q2, 2022 Results on Feb 03, 2022 Lannett Company, Inc. announced that they will report Q2, 2022 results After-Market on Feb 03, 2022 Announcement • Jan 22
Lannett Announces FDA Completes Review of Investigational New Drug Application for Biosimilar Insulin Glargine Lannett Company, Inc. announced that the U.S. Food and Drug Administration has notified the company that they have completed the safety review of the Investigational New Drug application for biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies, and concluded that the company may proceed with the proposed clinical investigation. The company said it anticipates the pivotal clinical trial to commence by March 2022 and be completed by early 2023. Board Change • Jan 05
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 3 experienced directors. 3 highly experienced directors. Independent Director Melissa Rewolinski was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Board Change • Dec 21
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 3 experienced directors. 3 highly experienced directors. Independent Director Melissa Rewolinski was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Dec 21
Lannett Announces Submission of Investigational New Drug (Ind) Application for Biosimilar Insulin Glargine Lannett Company, Inc. announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). Crew noted that the pivotal trial will be conducted at the same site and use the same clinical design as the previously completed first human volunteer pilot study. That first study, which the FDA reviewed, suggested that the Lannett/HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints. Submission of the IND kicks off the final regulatory process before Lannett starts the pivotal trial. As part of that process, the company has also recently received approval from the South Africa Health Products Regulatory Authority (SAHPRA) to conduct the trial in South Africa. The trial site has experience with clinical insulin trials and has been used by other innovator firms for their insulin clinical trials. 