Abbreviated New Drug Application,
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Estradiol valerate,
ANDA,
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Generic drug,
IQVIA BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.
Key Points:
- BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.
- ANI’s Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel®.
- The current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA, a leading healthcare data and analytics provider.
- "The approval and launch of Estradiol Gel, 0.1%, mark an important milestone for ANI, as this is the first topical gel approved from our R&D and manufacturing site in New Jersey.
Retrieved on:
Thursday, August 24, 2023
To schedule a 1x1 meeting with the Company, please contact [email protected] at H.C. Wainwright.
Key Points:
- To schedule a 1x1 meeting with the Company, please contact [email protected] at H.C. Wainwright.
- The live and archived webcast will be accessible from the Company’s website at www.anipharmaceuticals.com , under the Investors section under Events and Presentations.
- The replay of the webcast will be accessible for 90 days.
Retrieved on:
Wednesday, August 23, 2023
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Covetrus BAUDETTE, Minn., Aug. 23, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the addition of Matthew J. Leonard, R.Ph. to its Board of Directors. Mr. Leonard brings more than 35 years of experience as an accomplished leader and innovator within the pharmaceutical industry. This appointment is effective immediately.
Key Points:
- -- Mr. Leonard has significant expertise in pharmacy benefits management, health insurance, and specialty and retail pharmacy --
BAUDETTE, Minn., Aug. 23, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the addition of Matthew J. Leonard, R.Ph.
- Mr. Leonard brings more than 35 years of experience as an accomplished leader and innovator within the pharmaceutical industry.
- “We are delighted to add Matthew (Matt) Leonard to our Board of Directors.
- “On the heels of a record quarter and with ANI’s compelling growth trajectory, it’s an exciting time to join the Board.
Retrieved on:
Wednesday, August 9, 2023
ANI,
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Patient,
Rheumatology,
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Tourism,
IQVIA,
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Generic,
Others -- Generics, Established Brands and Others reported net sales of $92.2 million, representing year-over-year growth of 44.9% --
Key Points:
- “The second quarter of 2023 was another strong quarter for ANI, across all areas of the business.
- The Company is proud to report record net revenues and adjusted non-GAAP EBITDA and raise full-year 2023 guidance for the second quarter in a row.
- Second Quarter and Recent Business Highlights:
Revenues for our lead asset, Cortrophin Gel, totaled $24.3 million for the second quarter of 2023.
- Sales of generic pharmaceuticals products, established brands and others grew 44.9% year-over-year in the second quarter of 2023.
BAUDETTE, Minn., July 31, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its second quarter 2023 financial results on Wednesday, August 9, 2023, prior to the market open.
Key Points:
- BAUDETTE, Minn., July 31, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its second quarter 2023 financial results on Wednesday, August 9, 2023, prior to the market open.
- Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:
The live and archived webcast of the presentation will be accessible from the Company’s website at www.anipharmaceuticals.com , under the Investors section under Events and Presentations.
Key Points:
- The live and archived webcast of the presentation will be accessible from the Company’s website at www.anipharmaceuticals.com , under the Investors section under Events and Presentations.
- The replay of the webcast will be accessible for 90 days.
- To schedule a 1x1 meeting with the Company, please contact Corporate Access at Jefferies.
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Guggenheim Partners ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the “Company”) today announced the closing of its previously announced underwritten public offering.
Key Points:
- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the “Company”) today announced the closing of its previously announced underwritten public offering.
- A total of 2,183,545 shares of its common stock were sold at a public offering price of $39.50 per share, inclusive of the exercise in full of the underwriters’ option to purchase an additional 284,810 shares of common stock.
- The gross proceeds of the offering to the Company are approximately $86.25 million, before deducting the underwriting discounts and commissions and offering expenses.
- The securities described above were offered by ANI pursuant to a shelf registration statement on Form S-3 (File No.
Biotechnology,
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Abbreviated New Drug Application,
CGT,
ANI,
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RLD,
Alendronic acid,
Anders,
Food,
Pharmaceutical industry,
IQVIA ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.
- Methsuximide Capsules has been granted 180-day Competitive Generic Therapy (CGT) Exclusivity, and Alendronate Sodium Oral Solution is eligible for CGT Exclusivity upon launch.
- ANI’s Methsuximide Capsules are the generic version of the Reference Listed Drug (RLD) Celontin® Capsules and ANI’s Alendronate Sodium Oral Solution is the generic version of the RLD Fosamax® Oral Solution.
- "The FDA approval and launch of Methsuximide Capsules and Alendronate Sodium Oral Solution represent our ability to drive generics business growth through superior new product launch execution.
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Guggenheim Partners ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the "Company") today announced the pricing of its previously announced underwritten public offering of 1,898,735 shares of its common stock at a public offering price of $39.50 per share.
Key Points:
- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the "Company") today announced the pricing of its previously announced underwritten public offering of 1,898,735 shares of its common stock at a public offering price of $39.50 per share.
- The gross proceeds of the offering to the Company are expected to be $75 million, before deducting the underwriting discounts and commissions and other offering expenses.
- In addition, ANI granted the underwriters a 30-day option to purchase up to an additional 284,810 shares of common stock at the public offering price, less underwriting discounts and commissions.
- The closing of the offering is expected to occur on or about May 16, 2023, subject to the satisfaction of customary closing conditions.
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Cayman Islands Directors Registration and Licensing Law, 2014 ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI”) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
Key Points:
- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI”) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
- All of the shares to be sold in the offering will be offered by ANI.
- The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
- In addition, ANI intends to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock offered in the public offering.
