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ATRS

By mell following x   2017 Nov 3, 7:37am 2,157 views   24 comments   watch   sfw   quote     share    


Just received CRL from FDA for XYOSTED, their injectable testosterone, price crashed from almost $4 to sub $2. 50MM+ sales and rising, possible approval of generic epi-pen version in partnership w/ TEVA (ATRS supplies injectors). Risks are possible dilution (already bloated share count) if turnaround to profitability is delayed too much, otherwise this should slowly churn towards profitability within the next 1-2 years. Any movement on the CRL without the requirement of additional trials or approval of TEVAs generic epi-pen will send this soaring. Market cap just below 300MM, target market cap 700MM-1bln.

#investing
1   mell   ignore (2)   2018 Feb 14, 3:48pm   ↑ like (0)   ↓ dislike (0)   quote   flag        

AMAG just got approval in partnership with ATRS for Makena injection. up $20-30% from it's sub $2 lows. Good stock going forward. More news to come as they meet with FDA 02/21 wrt Xyosted CRL.
2   HEYYOU   ignore (21)   2018 Feb 14, 6:19pm   ↑ like (0)   ↓ dislike (0)   quote   flag        

Real men sweat testosterone!
3   mell   ignore (2)   2018 Mar 5, 11:16am   ↑ like (1)   ↓ dislike (0)   quote   flag        

Would like to put ATRS back on the radar. They had a relatively confident presentation today and many possible catalysts are looming such as update on FDA meeting wrt XYOSTED (update should come within the next few weeks) as well as TEVA generic EpiPen launch news this year (which ATRS is partnered with supplying the injectors). Could be a great year for this biotech turning towards profitability, currently trading around $2.20.
4   mell   ignore (2)   2018 May 11, 9:41pm   ↑ like (1)   ↓ dislike (0)   quote   flag        

Still in this (from the low $2s), accumulated sizable position, swing-trading around the core. $2.50 now, looking for a double, or at least $4. Best case scenario XYOSTED approval (September) and generic Epipen approval (TEVA partnered with ATRS) could bring $10. Downside $2, hardly lower, since they already have growing earnings with their currently approved products. Currently there's a shortage of Epipens, so the FDA could approve TEVA's generic version soon.
5   mell   ignore (2)   2018 May 12, 2:12pm   ↑ like (1)   ↓ dislike (0)   quote   flag        

https://www.foodallergy.org/about/media-press-room/food-allergy-research-education-calls-on-fda-to-act-swiftly-on-reported

"Expedite the FDA’s review of the Abbreviated New Drug Application from Teva Pharmaceuticals for approval of its proposed AB-rated generic epinephrine, using Antares Pharma Inc’s Vibex®auto-injector."
6   Patrick   ignore (1)   2018 May 12, 6:17pm   ↑ like (2)   ↓ dislike (0)   quote   flag        

I have 5000 shares, bought at $2.37 about a month ago. Up more than 6%, but happy to ride out whatever happens for a few years. I need a little excitement so I have something to watch every day. Most of my other stocks are pretty boring.
7   TwoScoopsOfSpaceForce   ignore (4)   2018 May 12, 6:42pm   ↑ like (1)   ↓ dislike (0)   quote   flag        

I'll gonna go in for a couple of thousand...
8   Patrick   ignore (1)   2018 May 12, 7:08pm   ↑ like (1)   ↓ dislike (0)   quote   flag        

Now we can all watch this thing and comment. Should have some entertainment value at least.
9   mell   ignore (2)   2018 May 12, 7:23pm   ↑ like (0)   ↓ dislike (0)   quote   flag        

lol made decent bank last year with my picks, but now the peer pressure is on! Betting big on this, that epipen shortage needs to be dealt with rather swiftly. And while the ways of the FDA can be rather mysterious I do think they may get moving on this soon ;)
10   Patrick   ignore (1)   2018 May 12, 7:25pm   ↑ like (2)   ↓ dislike (0)   quote   flag        

Don't worry, I accept the risk of my bet. No one made me do it.
11   mell   ignore (2)   2018 May 17, 9:41am   ↑ like (1)   ↓ dislike (0)   quote   flag        

Train has left the station, @TwoScoopsOfDragonEnergy you're in? Scoops and Patrick, enjoy the ride ;)
12   TwoScoopsOfSpaceForce   ignore (4)   2018 May 17, 9:52am   ↑ like (1)   ↓ dislike (0)   quote   flag        

Thanks for the reminder @mell. Just wrote the broker. Just in for a thousand bucks, I got a baby ready to drop out any second so I'm keeping some cash around.
13   mell   ignore (2)   2018 May 31, 8:41am   ↑ like (0)   ↓ dislike (0)   quote   flag        

$2.70 this am. Looking good here my fellow Antarians.
14   mell   ignore (2)   2018 Jun 13, 7:51am   ↑ like (2)   ↓ dislike (0)   quote   flag        

$2.95. Chart looks terrific.
16   mell   ignore (2)   2018 Aug 14, 9:34am   ↑ like (2)   ↓ dislike (0)   quote   flag        

Crossed 3, basing in the 3.20 range now. Steady as she goes.
17   mell   ignore (2)   2018 Aug 16, 6:45pm   ↑ like (0)   ↓ dislike (0)   quote   flag        

Teva just got approval for first generic epipen. Atrs supplies the injectors. Large float so there will be swings but should eventually approach $4 before pdufa date for xysoted Approval changes are very high IMO which would make this easily pass $5 but since nothing is certain with the fda the pdufa run up may be an opportunity to derisk and take gains. LT though I see this becoming profitable either way so I'll continue holding a sizeable chunk - I trimmed down and took some gains from a 200k+ share position - and swing around the core. $5 options look interesting as well.
18   mell   ignore (2)   2018 Aug 16, 8:20pm   ↑ like (1)   ↓ dislike (0)   quote   flag        

https://finance.yahoo.com/news/antares-pharma-announces-fda-approval-205450510.html

"
EWING, N.J., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) (“Antares”) today announced that the U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries, Ltd.’s (“Teva”) epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Our partner Teva filed an Abbreviated New Drug Application (ANDA) seeking FDA approval of the product as a generic substitute of Mylan’s branded product EpiPen®. Teva’s drug-device combination product utilizes the Antares Pharma VIBEX® device and has been approved with an AP rating, defined as a therapeutically equivalent injectable aqueous solution and therefore fully substitutable to the EpiPen at the pharmacy.

“We are extremely pleased with the FDA’s decision to approve Teva’s ANDA for the first and only fully substitutable generic version of Mylan’s branded EpiPen, the most widely used epinephrine auto injector on the market,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. “This approval means patients living with severe, sometimes life-threatening allergic reactions, (anaphylaxis), who require immediate access to life-sparing epinephrine should have access to a generic alternative. We and our partner Teva worked diligently together to obtain the approval of this very complex drug/device rescue pen combination product utilizing our VIBEX auto injector platform and we look forward to Teva making it commercially available to patients.”

Antares previously entered into an exclusive License, Development and Supply Agreement with Teva for an epinephrine auto injector product to be marketed in the U.S. Pursuant to the agreement, Antares is responsible for supply of the device which will be sold to Teva at cost plus margin. Teva is responsible for commercialization and distribution of the final product for which Antares will receive royalties on net sales.

About Antares Pharma

Antares Pharma, Inc. is a specialty pharmaceutical company focused on the development and commercialization of self-administered parenteral pharmaceutical products using advanced drug delivery auto injection technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in advanced stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva) and AMAG Pharmaceuticals, Inc. Antares Pharma’s proprietary products include OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company has developed an investigational new drug for testosterone replacement therapy called XYOSTED™, currently under active review at the FDA with a PDUFA date of September 29, 2018.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: market acceptance of Teva’s generic epinephrine auto-injector product and future revenue from the same; timing and successful development of the rescue pen with Pfizer and FDA approval and future revenue from the same; successful completion of the transaction with Ferring International Center, S.A.; the Company’s ability to resolve the deficiencies identified by the FDA in the Complete Response Letter for XYOSTED™, FDA approval of the Company’s NDA for XYOSTED™ and future market acceptance and revenue for XYOSTED™; future market acceptance and revenue from Makena® subcutaneous auto injector; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
"
19   mell   ignore (2)   2018 Aug 16, 8:25pm   ↑ like (0)   ↓ dislike (0)   quote   flag        

Btw. Buffet upped his stake in Teva just days before. Likely one or more birdies involved ;)

https://seekingalpha.com/news/3383569-buffet-ups-teva-stake-43m-shares
20   mell   ignore (2)   2018 Aug 21, 7:07am   ↑ like (2)   ↓ dislike (0)   quote   flag        

$3.60. You're welcome.
21   Patrick   ignore (1)   2018 Aug 21, 7:26am   ↑ like (2)   ↓ dislike (0)   quote   flag        

Looking good, thanks!
22   mell   ignore (2)   2018 Oct 1, 4:29am   ↑ like (0)   ↓ dislike (0)   quote   flag        

https://finance.yahoo.com/news/antares-receives-fda-approval-xyosted-110000270.html

"
Antares Receives FDA Approval of Xyosted™ (Testosterone Enanthate) Injection for Testosterone Replacement Therapy in Adult Males
GlobeNewswire•October 1, 2018
A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy

EWING, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) today announced the approval of XYOSTED™ (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED™ is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector. XYOSTED™ has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).

“Today’s FDA approval of XYOSTED is a significant milestone for Antares. XYOSTED expands our branded portfolio of combination drug/device products and continues to highlight our passion and commitment to providing high quality therapies that improve patient care,” said Robert F. Apple, President and Chief Executive Officer of the Company. “XYOSTED, the first subcutaneous auto injector product designed for testosterone replacement therapy will soon be available for adult males diagnosed with a deficiency or absence of endogenous testosterone. Published data from the XYOSTED phase three studies have shown our product to be easy to use and virtually pain free while providing steady testosterone levels.” He concluded, “We believe XYOSTED significantly enhances a testosterone deficient patient’s option for treatment, and I am proud of our team’s success in developing and bringing to market this novel product. We will now begin the process of onboarding sales representatives and expect to make XYOSTED available to patients before the end of this year.”

Jed C. Kaminetsky, MD, a urologist at University Urology Associates, Medical Director of Manhattan Medical Research, clinical assistant professor of urology at New York University School of Medicine and principal investigator in the XYOSTED pivotal studies said, “A once-weekly, at-home, subcutaneously administered testosterone product represents an exciting new treatment option for men suffering from hypogonadism.” He continued, “The subcutaneous dosing of XYOSTED also removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits. XYOSTED has been clinically shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio.”

XYOSTED enters the testosterone replacement therapy market where approximately 6.5 million retail prescriptions were filled in 2017, according to data from Symphony Health Solutions. The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products.
[...]
"
23   mell   ignore (2)   2018 Oct 1, 7:15am   ↑ like (0)   ↓ dislike (0)   quote   flag        

Still a good price here - LT over > $5 - $10.
24   mell   ignore (2)   2018 Oct 2, 10:21am   ↑ like (1)   ↓ dislike (0)   quote   flag        

$3.80. Who's making money today raise your hands ;)




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