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Palatin Technologies, IncNYSEMKT
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  • Thu, Dec. 1, 8:56 AM
    • Nano cap Palatin Technologies (NYSEMKT:PTN) is off 29% premarket on increased volume in response to the pricing of its public offering of stock and warrants. The company intends to sell 25,384,616 shares of common stock and warrants to purchase up to 12,692,310 shares of common at a combined price of $0.65 per unit. The five-year warrants are immediately exercisable at $0.80 per common share.
    • Yesterday's close was $0.8167.
    | Thu, Dec. 1, 8:56 AM | 14 Comments
  • Wed, Nov. 30, 4:45 PM
    • Palatin Technologies (NYSEMKT:PTN) commences a public offering of stock and warrants. Prices, volumes and terms have yet to be announced.
    • Shares are down 28% after hours on robust volume.
    | Wed, Nov. 30, 4:45 PM | 42 Comments
  • Tue, Nov. 15, 7:33 AM
    | Tue, Nov. 15, 7:33 AM | 16 Comments
  • Wed, Nov. 2, 10:51 AM
    • Nano cap Palatin Technologies (PTN +5.3%) spiked almost 55% before retracing on the news that it is exploring a possible sale. It has retained Greenhill & Co. to advise after receiving multiple offers from interested suitors.
    • Palatin's lead product candidate is bremelanotide, in development for the on-demand treatment of female sexual dysfunction in premenopausal women with hypoactive sexual desire disorder (HSDD). Its key advantage over Valeant Pharmaceuticals' (VRX -8.2%) Addyi (filbanserin) is that women who have consumed alcohol can use it.
    • Valeant bought the company that developed Addyi, Sprout Pharmaceuticals, for $1B but the drug has struggled to gain traction due to, in large part, its contraindication with alcohol because of the risk of fainting.
    | Wed, Nov. 2, 10:51 AM | 74 Comments
  • Wed, Oct. 26, 11:00 AM
    • With the aim of clarifying the requirements to approve drugs to treat women with sexual desire dysfunction, the FDA issued draft guidance yesterday for drug developers. The guidance focuses on conditions of low sexual interest, desire and/or arousal that lead to distress or interpersonal difficulty in women, including female sexual interest/arousal disorder (FSIAD), hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD).
    • To prove efficacy, the agency maintains its requirement of two randomized pivotal trials. Each study should include at least 24 weeks of blinded treatment to demonstrate the onset and persistence of effect. The agency also recommends a placebo run-in period to gather baseline data and assess the likelihood that the participants will adhere to the proposed dosing regimen. Suggested primary endpoints include the change from baseline in the number of satisfying sexual events (SSEs), the level of sexual interest or desire, the level of sexual arousal and the level of distress.
    • The FDA has approved only one such drug thus far, Valeant Pharmaceuticals' (VRX -0.9%) Addyi (flibanserin), which it acquired via its $1B takeover of Sprout Pharmaceutics last year. Sales have been tepid, however, due to the lack of effect in many women and the unwanted side effect of the risk of fainting due to low blood pressure. Women are advised to avoid consuming alcohol in order to minimize the effect, a significant negative.
    • Nano cap Palatin Technologies (PTN +0.6%) has a candidate in late-stage development, bremelanotide, that it says has demonstrated no adverse events in women who have consumed alcohol. Phase 3 data are expected by year end.
    • Previously: Valeant's $1B investment in female libido pill off to a slow start (Nov. 17, 2015)
    | Wed, Oct. 26, 11:00 AM | 38 Comments
  • Tue, Sep. 20, 8:23 AM
    • Palatin Tech (PTN +10.9%) FY16 results: Revenues: $0; R&D Expense: $43.1M (+75.2%); SG&A: $6.2M (+8.8%); Operating Loss: ($49.3M) (-185.0%); Net Loss: ($51.7M) (-192.1%); Loss Per Share: ($0.33) (-120.0%); Quick Assets: $9.4M (-65.6%).
    • Shares up 2% premarket.
    • No guidance given.
    | Tue, Sep. 20, 8:23 AM | 1 Comment
  • Tue, Sep. 20, 7:33 AM
    • Palatin Tech (NYSEMKT:PTN): FQ4 EPS of -$0.09 misses by $0.03.
    • Cash and cash equivalents of $8M
    • Press Release
    | Tue, Sep. 20, 7:33 AM | 1 Comment
  • Tue, May 17, 9:43 AM
    • Palatin Technologies (PTN +1.8%) FQ3 results: Revenues: $0; R&D Expense: $10.7M (+40.8%); SG&A: $1.4M (+27.3%); Operating Loss: ($12.1M) (-39.1%); Net Loss: ($12.7M) (-38.0%); Loss Per Share: ($0.08) (-14.3%); Quick Assets: $23.1M (-15.4%); CF Ops: ($33.7M).
    • No guidance given.
    | Tue, May 17, 9:43 AM
  • Tue, May 17, 2:06 AM
    • Palatin Tech (NYSEMKT:PTN): FQ3 EPS of -$0.08 in-line.
    | Tue, May 17, 2:06 AM | 3 Comments
  • Fri, Feb. 26, 9:13 AM
    • Results from a Phase 1 safety study of Palatin Technologies' (NYSEMKT:PTN) bremelanotide demonstrated no adverse events in healthy subjects who also consumed alcohol. The data were presented in a Research Podium Session at the International Society for the Study of Women's Sexual Health annual meeting in Charleston, SC.
    • The company is developing bremelanotide, administered via subcutaneous injection, for on-demand treatment of female sexual dysfunction in premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD). Studies have shown bremelanotide starts working within 30 - 60 minutes after administration and remains effective for ~eight hours.
    • The only FDA-approved drug for the treatment HSDD is Valeant Pharmaceuticals' (NYSE:VRX) Addyi (flibanserin), which carries a black box warning against consuming alcohol while on the medication due to the risk of developing severe hypotension and syncope (fainting). This is a negative since, well, many women would like to consume alcohol before/after being intimate.
    • Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-MSH, a melanocortin agonist. The melanocortin system plays a key role in sexual function as well as pigmentation, inflammation and energy homeostasis. Top-line data from a Phase 3 study in HSDD should be available in Q3.
    • Previously: Palatin hits enrollment target in two late-stage studies of female sexual dysfunction product candidate (Dec. 10, 2015)
    | Fri, Feb. 26, 9:13 AM | 22 Comments
  • Tue, Feb. 16, 8:46 AM
    • Palatin Technologies (PTN) FQ2 results: Revenues: $0; R&D Expense: $11.3M (+162.8%); SG&A: $1.36M (-4.2%); Operating Loss: ($12.6M) (-647.8%); Net Loss: ($13.2M) (-571.4%); Loss Per Share: ($0.08) (-366.7%); Quick Assets: $33.4M (+22.3%).
    • No guidance given.
    | Tue, Feb. 16, 8:46 AM
  • Tue, Feb. 16, 7:32 AM
    • Palatin Tech (NYSEMKT:PTN): FQ2 EPS of -$0.08 misses by $0.01.
    | Tue, Feb. 16, 7:32 AM
  • Mon, Feb. 8, 1:30 PM
    • The USPTO issues a Notice of Allowance to Palatin Technologies (PTN -4.3%) for its Patent Application No. 14/313,258 covering methods of treating female sexual dysfunction utilizing the formulation and dose of bremelanotide used in its ongoing Phase 3 studies and commercialization, once approved. When issued, the patent should be effective until November 2033.
    • Top-line results from the Phase 3s are expected in Q3. If successful, a New Drug Application (NDA) will be filed in H1 2017.
    • Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-MSH, a melanocortin agonist. The melanocortin system plays a key role in sexual function as well as pigmentation, inflammation and energy homeostasis. Its value proposition versus Valeant Pharmaceuticals' (VRX +0.6%Addyi (flibanserin) is the avoidance of hypotension and syncope (temporary loss of consciousness) when combined with alcohol.
    • In an earlier study, the most common bremelanotide-related adverse events were facial flushing, nausea and headache.
    | Mon, Feb. 8, 1:30 PM | 1 Comment
  • Dec. 10, 2015, 10:33 AM
    • Palatin Technologies (PTN +2.9%) achieves full enrollment in two clinical trials evaluating bremelanotide for the treatment of female sexual dysfunction. The two trials, based mainly in the U.S., will randomize ~1,100 postmenopausal women with hypoactive sexual desire disorder (HSDD) to receive subcutaneous bremelanotide as an on-demand, as-needed treatment or placebo. Top-line data are expected in Q3 2016.
    • Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-MSH, a melanocortin agonist. The melanocortin system plays a key role in sexual function as well as pigmentation, inflammation and energy homeostasis. Its value proposition versus Valeant Pharmaceuticals' (VRX +0.6%) Addyi (flibanserin) is the avoidance of hypotension and syncope (temporary loss of consciousness) when combined with alcohol.
    • In an earlier study, the most common bremelanotide-related adverse events were facial flushing, nausea and headache.
    • Previously: Sprout's good fortune stoking Palatin Tech; shares up 15% premarket (Aug. 20)
    • Previously: Valeant's $1B investment in female libido pill off to a slow start (Nov. 17)
    | Dec. 10, 2015, 10:33 AM | 7 Comments
  • Nov. 12, 2015, 7:46 AM
    • Palatin Tech (NYSEMKT:PTN): FQ1 EPS of -$0.08 in-line.
    | Nov. 12, 2015, 7:46 AM
  • Sep. 21, 2015, 7:33 AM
    • Palatin Tech (NYSEMKT:PTN): FQ4 EPS of -$0.09 misses by $0.03.
    | Sep. 21, 2015, 7:33 AM | 4 Comments