ANI Pharmaceuticals Inc News - ANIP

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Form S-8 - Securities to be offered to employees in employee benefit plans

ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

ANI Pharmaceuticals’ CEO Nikhil Lalwani Named EY Entrepreneur Of The Year® 2024 New Jersey Award Winner

PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

ANI Pharmaceuticals to Further Expand Rare Disease Business through Acquisition of Alimera Sciences

Conference call scheduled for today at 8:30 a.m. ET Strengthens Rare Disease segment as largest driver of...

Form 144 - Report of proposed sale of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

ANI Pharmaceuticals to Present at the 2024 Jefferies Global Healthcare Conference

BAUDETTE, Minn., May 29, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

Form 4 - Statement of changes in beneficial ownership of securities

silvr_surfr 14 hours ago

Thank you JTFM. The trademarks are a good tell for who are the players.

Nice to see that we are green on a red day for the market. Hopefully, we can put the 50's behind us. Here is a bullish technical analysis I recently found:

Technical Analysis

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Just the facts maam 2 days ago

SIlvr, fyi, neither Organon, Merck or ANIP have a trademark pending with the "sexual dysfunction" listed in the Good and Services.

However, AbbVie, Abbott Labs, Teva and Pfizer all do.

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Just the facts maam 2 days ago

In treating HSDD alone, I would say Organ would be a good fit but when looking at most of the other potential indications for testosterone, I think Merk would be interested in the additional indications.

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silvr_surfr 3 days ago

Thank you JTFM. The dates are very telling. Doesn't it make sense that it would get executed through their Organon spin off? Pill Plus would also have a home here.

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Just the facts maam 3 days ago

It all makes sense now. Merck is almost definitely the partner.

ANIP announce the agreement to acquire Corti from Merck on September 21, 2015.

Corti announcement

The following day ANIP obtains Confidential Treatment Order extending to filings associated to Libigel up to March 31, 2020.

CT order to 2020

Looks like there was a gap between March 31, 2015 and September 22, 2015 where a CT order was not in place.

CT order expires March 31, 2015

Hard to argue that the Corti deal with Merck was not tied to Libigel.

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Just the facts maam 3 days ago

Thanks Silvr, regarding the NYT story, it takes longer but you can read it through the source code. The text gets broken up by code for links etc... But it is readable.

Nothing in there regarding CV or BC benefits. It laments the lack of an FDA approve testosterone for women, while men have 31 options.

Here is an interesting excerpt They are intrigued by the fact that women have testosterone receptors all over the body — including the heart, brain, muscles and bones — which suggests that it is linked to the health of these organs, Dr. Davis said, but we aren’t sure yet why or how.

They say that testosterone is effective in approximately 50 % of women in treating HSDD . Mainly because there are so many other variables which may cause HSDD. For best results they recommend testosterone along with seeing a sex therapist. Interestingly they recommend obtaining a testosterone base line trying to see where the levels are in relation to when a patient was more sexually active. Maybe more related to the level of deviation as they age.

Personally, this may be true for HSDD, but I believe in the end getting to the average premenopausal range will drive the reduction in CV and BC events. If so, it could create a market in premenopausal women, as well.

They still advise against pellets and compounded testosterone, recommending a testosterone gel.

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silvr_surfr 3 days ago

The New York Times has a recent article about female testosterone, but it is behind a paywall. Don't know if it is positive or negative.

Testosterone Therapy

More interestingly, Pfizer is now in the game. They are a big API supplier, but could there be something else?

Health Answers from Pfizer

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Just the facts maam 4 days ago

Correction the dosage form for Inzirqo is powder for suspension , not oral solution.

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silvr_surfr 6 days ago

Cool. Did not see that. Merck is a likely partner given the Cortrophin relationship. They have to be happy with the deal we struck with them on that.

There is sure a lot going on with this sleepy little company of ours.

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Just the facts maam 6 days ago

Silvr, I find it interesting that in the "Case Parties" section near the top of the docket, they list Christina B. VAVALA of Polsinelli PC as an attorney but do not state who they represent. Could it be the silent partner? Maybe just a coincidence, but Polsinelli PC seem to have a good relationship with Merck having recently hired some of Merck's lawyers and represented Merck in both the Vioxx and Nuvaring litigations.

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silvr_surfr 6 days ago

I saw that, but it only says a letter was sent to the judge. Not sure if this was at the request of the judge, or if they are responding to something from CGON. It could also be something we initiated, but it does not make sense then why the new Farnan brother was added for personal injury claims. I guess we will know soon enough. Things will get interesting leading up to the July trial.

I still believe the $200M offering CGON did out of the blue was to settle this, but it is telling that a couple of months later there is no settlement.

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Just the facts maam 6 days ago

Silvr, if you look at the February 4th docket entry, it looks like they going towards mediation.

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silvr_surfr 6 days ago

Yet another new lawyer, Joseph J. Farnan, joined our CGON lawsuit team. Looks like we have all of the Farnan brothers now which comprises almost all of the firm. What makes his addition noteworthy is that he is a personal injury guy. ANIP stated they would be seeking personal injuries so maybe there is a there there, Here's his bio:

Joseph J. Farnan

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Just the facts maam 6 days ago

I agree, this is definitely the most private,, publicly traded company. Two NDAs down and one to go.

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silvr_surfr 6 days ago

Wow, thank you JTFM. I have never heard of a company not disclosing good news like this. It is also another branded entry which I don't think is a coincidence. I hope any deal is worth our while since the stock has had a miserable year while the company has performed well.

The Guggenheim Conference was a yawner. I don't get why they are spending so much time doing these events when you can just read the powerpoint deck. So many conferences with institutional investors and notihng to show for it in the stock price. Get a clue Nikhil.

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Just the facts maam 6 days ago

Thanks for the update Silver.

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Just the facts maam 6 days ago

ANIP is now sitting two NDA approvals. On January 28, 2025 Novitium's INZIRQO oral solution of Hydrochlorothiazide was approved.

Approval

To approved drugs and just presented at Guggenheim, yet crickets.

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silvr_surfr 6 days ago

Thanks JTFM. I have been out of pocket for a while.

There continues to be lots happening with the CGON lawsuit:

a) Another pro hac vice attorney (Robert Isakson) added to our team (1/27)
b) We will be deposing Morgan Stanley (led the CGON IPO) in March
c) We sent a letter to the judge responding to a question about mediation - not sure if this was initiated by him or CGON (2/5)

With all of the attorneys and documents, this must be costing a fortune. Glad to see that we are in it to win it. Still suspect that we have a partner.

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Just the facts maam 2 weeks ago

The last FDA approval posted on their site is from January 22, 2025. As a rule the FDA try to post the day after an approval. Is this one of the impacts of Trump's broad actions? If so, we are in the dark as we await a decisions on two NDAs. It is bad enough that ANIP is withholding info on Tezruly, and the other NDAs. This could make it even easier for them to hold back info.

Approvals

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big bambino 2 weeks ago

Can someone advise me on a situation of a stock I own. Tried speaking with Merrill and only came away more confused. I have shares in GNS @ $.56. now my portfolio shows GNSRT @$.078.

Genius Files Rights Offering to Fund Bitcoin Purchases
January 22, 2025
12:35 PM ETPublished January 22, 2025 12:35 PM Eastern Time
MT Newswires

12:35 PM EST, 01/22/2025 (MT Newswires) -- Genius Group (GNS) said Wednesday it filed a registration statement for up to 90 million subscription rights and an equal amount of shares issuable on the exercise of the rights.

The company said it will distribute one transferable right to buy a share for $0.50 apiece against each ordinary share held to shareholders at no charge.

Net proceeds will be used to buy Bitcoin for the company's Bitcoin Treasury, Genius Group said.

The rights offering expires on Feb. 14, unless extended, according to the company.

Shares of Genius Group were down nearly 6% in recent trading.

Price: 0.64, Change: -0.04, Percent Change: -5.88

MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.

Does this mean I can purchase an additional 19,000 @.50, or cash in the additional shares for .068. Is this correct. Would appreciate any guidance as this is 10x's over my pay grade🤣

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Just the facts maam 3 weeks ago

Transactions like Millennium acquiring 561,251 shares at $54.16 on January 14, 2025 is what keeps ANIP's PPS artificially low. Imagine what PPS would have climbed to had it been open market buys. They now own 5.2% of ANIP.

Millennium acquisition of shares

I expect other's are also trying to get in.

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Just the facts maam 3 weeks ago

Checking over ANIP's corporate presentation, I see that they project Acth therapy (Corti and Acthar HP) to increase by $127 to $131 million in 2024 . Looks like ANIP captured approx.67% of the increase. Even better is that Lalwani stated that they have figured out the process to get the drug to those who may benefit most from it.

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silvr_surfr 3 weeks ago

Wow, I did not realize he was the former President/\Chairman of the Board for Endo/Par. It is hard to believe all of the high fives were referencing the quarterly results. Something "great", "amazing", and "awesome" happened at the conference. Wonder how long we will have to wait to find out.

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Just the facts maam 3 weeks ago

Thanks Silvr, Campinelli obviously has close ties to Samy and Stephen Carey from their time at PAR. Looking at his bio on the Bourne Partners, ANIP is somewhat mirroring his growth strategy for PAR, except it is going beyond generics. A company that was acquired for $1.2 Billion and with a few smaller acquisitions sold for $8.2 billion three year later. TPG who owned PAR made 6.5 X their initial investment in the deal.

Paul’s leadership drove the company to significantly increased total revenue. During his tenure, Par and Endo acquired Michigan-based JHP Pharmaceuticals, established a business office in London to serve as Par’s entry point into the European generics market, and completed its acquisition of an active pharmaceutical ingredients (API) facility located in Chennai, India. Paul also shaped the company’s strategic focus on organic growth through investments in hard-to-produce generic assets and technologies, a highly specialized branded business, and a concentration on differentiated and intelligent product selection.

I still think any finalization on a deal will be contingent on an FDA approval for testosterone. A PDUFA update sure would be nice.

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silvr_surfr 3 weeks ago

Here's a brand new article from Dr. Susan Davis. She is highlighting other benefits of testosterone besides hsdd:

Not Just Sex:

Only the abstract is available. I believe her articles to date have emphasized that testosterone is only to be used for hdd following the published menopause guidelines. Is this a change for her? Regardless, it helps our cause.

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silvr_surfr 3 weeks ago

Thanks for finding this JTFM. They were telling us the truth, but their meetings were obviously not in public.

I looked at who commented on Nikhil's post and there are some very fascinating connections:

Kurt Nielsen is the President of Pharmaceuticals International, LLC. When you search his name with testosterone you find that his company makes testosterone cypionate injection for Wilshire Pharmaceuticals

PII Testosterone

Paul Campinelli - Bourne Partners. I have already spoken about the link between our company and this.

Mario DI Giacomo - President Steroids and Highly Potent Products BU at Axplora and Managing Director Farmabios SpA. They are an API supplier of testosterone.

Perhaps the gang got together to finalize the testosterone deal, There was a congratulations from the Bourne partner so that might mean that the deal was made.

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Just the facts maam 3 weeks ago

Thanks BB.

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Just the facts maam 3 weeks ago

Thanks Silvr, Lalwani made a post on Linkedin about the JPM conference. Looks like Chad Gassert also attended. They may have been on a business development trip.

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silvr_surfr 4 weeks ago

Thanks big bambino, Patrick Walsh is a busy guy.

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big bambino 4 weeks ago

A news story "Alcami Announces CEO Transition" for ANIP from PR Newswire was triggered at 1/13/2025 11:12 AM.

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silvr_surfr 4 weeks ago

Thanks for the updates JTFM. I was not available to listen this time. A team-building shopping trip is a good explanation as any for them first saying the business development guy would be there, then just Mary Pao and then neither of them shows up.

Here is a favorable article from Zachs. They sure bounce around, but it is a good read for anyone having any doubts about our future, even without all of the hidden assets we have been discussing.

Zachs Research on ANIP

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Just the facts maam 4 weeks ago

So Mary Pao was not at JP Morgan to present. Maybe she was there as part of company shopping/partnering trip.

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Just the facts maam 4 weeks ago

Listened to JP Morgan presentation. No mention of Tezruly or other NDAs.

They want to send the message that hey are now and will be predominantly a rare disease company with support from a complex generic business.

It almost looks like they will sell or out licence the NDAs and use the funds to finance rare disease growth. I am ok with this but why the secrecy.

Unlike other CEO's lalwani will not give peak sales estimates but speaks patient numbers that can possibly benefit from Corti. Good to hear that acute gouty arthritis has an addressable patient population of 300,000. This iworks out to an addressable market of over $2 billion. How much of the addressable market ANIP can capture remains to be seen, but even 10% is $200 million in sales for the one indication.

Maybe we find out more this week.

Brusselsspirit 4 weeks ago

Truist maintains a Hold rating. Never seen such a strange context for a stock...

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Just the facts maam 4 weeks ago

Forbes article "Three Under-The-Radar Growth Stocks Poised To Double In 2025" list ANIP as on of the three stocks. I commented giving info regarding Tezruly and the other two NDA's not factored into ANIP current revenue estimates for 2025.

Article

Hopefully, Forbes will help get ANIP some traction.

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Just the facts maam 4 weeks ago

I agree the numbers look strong and Lalwani once again left lots on the table. He has to be bound by some type of disclosure restrictions. If there is deal to be announced at the JPM Conference it would be by the larger partner. AbbVie does not present until the 15th. I have also seen deals announced a week or two after the conference, to avoid competing with all the other pharma news.

I did like seeing 14% growth in Corti revenue over Q3 almost $60 million in Q4.

Hopefully, some has done their homework and ask Lalwani for an update on Tezruly and the other two NDAs. If Lalwani repeats the following, as he did to Oren Linvat of H.C. Wainwright:

"So, Oren, on the 505B2s, we will share more when we have meaningful updates to give. But there's no linkage between the litigation spend and the launch of 505B2 products. But we will share updates on that when there are material. "

Hopefully, they follow up with:

What do you mean by meaningful? And when can we expect a meaningful update?.

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silvr_surfr 4 weeks ago

Thanks JTFM. Looks like we won't be getting a deal announcement. It is strange that they are essentially communicating Q4 results. The numbers look very strong so hopefully we see the stock price react accordingly and get far way from this 52 week low.

I suspect Mary Pao's presentation will focus on the "research" areas called out in the deck and will not be talking about testosterone. This company is such the mystery given they are silent on so many things. I guess we will have to read the 10Q to see if it provides any info. Our share price has suffered ever since the shorts took their 2M position. Hopefully, we get some news that will put them on their heels. Perhaps we saw some covering today given the high volume.

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Just the facts maam 4 weeks ago

ANIP posted their presentation for the JP Morgan Healthcare Conference. No mention of Tezruly or other NDA's.

They must be selling or out-licencing them. Leaving it to to buyer to make announcement(s).

If ANIP is intending on marketing Tezruly, their strategy sure questions their motto "Serving Patients, Improving Lives".

Presentation

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big bambino 4 weeks ago

--Alcami Corporation, a leading contract development and manufacturing organization, today announced the resignation of Bill Humphries. In addition to his duties at Alcami, he currently serves as Chairman of ANI Pharmaceuticals, Inc., Chairman of MedPharm, and is an Operating Partner at Ampersand Capital Partners. Alcami's private equity ownership includes.

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Roddy4 4 weeks ago

Can anybody explain why every time the announce results that apparently seems good , SP declines 2/3%?

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Roddy4 4 weeks ago

Can anybody explain why every time the announce results that apparently seems good , SP declines 2/3%?

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Just the facts maam 1 month ago

Thanks Silvr.

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Just the facts maam 1 month ago

Thanks Silvr, hard to say how it will play out. There are reasons to settle out for both, but good reasons not to settle.

I would not be surprised if CGON screwed up in some of their out-licensing deals and lowered their royalty rate to the point where all the royalty money they receive would go to ANIP. I doubt they included ANIP in the licencing agreement.

If they are being bought out, they will buyout ANIP's stake in the drug. If not. I think they eventually go back to the terms of the agreement and pay ANIP's legal fees. This way, in the event that the FDA does not approve the drug, they have not thrown away their money.

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silvr_surfr 1 month ago

I follow the progress of our "Pill Plus". It is a mystery here too since the reporting on the European Union clinical trial is not clear and Pantarhei Biosciences appears to have closed its doors. Here is a very recent paper highlighting the negative impact the standard hormonal contraceptives have on several bone metabolism markers:

COC Impact on Bone Metabolism Markers

If there is a deal in the works, it will be interesting to see if our rights to this product are included. Pantarhei Biosciences closing suggests that it will.

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silvr_surfr 1 month ago

We are deposing CGON again later this month on the 23rd. My guess is that this will be to address items uncovered during discovery. Good to see the pressure being kept on.

This also suggests that a settlement has not occurred. CGON did the offering so there is more than $200M available. Wonder if we said no. Regardless, it seems bullish that we are back in front of them with hopefully some meaty discovery findings.

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Just the facts maam 1 month ago

Interesting, Silvr.

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Just the facts maam 1 month ago

Thanks Silvr, this would make diagnosing low testosterone much more efficient.

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silvr_surfr 1 month ago

Revvity is the renamed Perkin Elmer company after they spun out part of it to focus on diagnostics. Interestingly, Ampersand Capital (Patrick Walsh) sold one of their portfolio companies to Perkin Elmer in 2021.Is this just a coincidence or part of a larger strategic plan?

The razor/blade strategy fits here since you sell the product (the razor) and then you also sell the upfront and ongoing tests to maintain the product's use.

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silvr_surfr 1 month ago

Sorry, could not resist. Here may be another piece of the puzzle - the first FDA approved automated test for free testosterone. The testing range and indications appear appropriate for women which has been an issue up to this point.

Revvity Automated Free Testosterone Test

This could also have been one of the things that "they" have been waiting for. Doctors will need these tests run to prescribe the product. It also looks like a more practical alternative to the liquid chromatography/mass spec currently recommended.. The automation should also reduce the costs.

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ANI Pharmaceuticals Inc (ANIP)

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ANIP News

Form S-8 - Securities to be offered to employees in employee benefit plans

ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

ANI Pharmaceuticals’ CEO Nikhil Lalwani Named EY Entrepreneur Of The Year® 2024 New Jersey Award Winner

ANI Pharmaceuticals to Further Expand Rare Disease Business through Acquisition of Alimera Sciences

Form 144 - Report of proposed sale of securities

Form 144 - Report of proposed sale of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

ANI Pharmaceuticals to Present at the 2024 Jefferies Global Healthcare Conference

Form 4 - Statement of changes in beneficial ownership of securities

ANIP Discussion

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Professional-Grade Tools, for Individual Investors.

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Form S-8 - Securities to be offered to employees in employee benefit plans

ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

ANI Pharmaceuticals’ CEO Nikhil Lalwani Named EY Entrepreneur Of The Year® 2024 New Jersey Award Winner

ANI Pharmaceuticals to Further Expand Rare Disease Business through Acquisition of Alimera Sciences

Form 144 - Report of proposed sale of securities

Form 144 - Report of proposed sale of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

ANI Pharmaceuticals to Present at the 2024 Jefferies Global Healthcare Conference

Form 4 - Statement of changes in beneficial ownership of securities

ANIP Discussion

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