Posts tagged NDA
Titan Pharma in talks with Braeburn about future of Probuphine partnership

Titan Pharmaceuticals (NASDAQ:TTNP) is in discussions with Braeburn Pharmaceuticals about their partnership for the development and commercialization of Probuphine, the first six-month maintenance treatment of opioid dependence. 

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IntelGenx, RedHill Biopharma resubmit RIZAPORT NDA to FDA

IntelGenx (OTCQX:IGXT; TSXV:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg, an oral thin-film formulation of rizatriptan for the treatment of acute migraines.

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HCW ups Verastem price target to $10

Roth Capital Partners reinitiated coverage of Flex Pharma (NASAQ:FLKS) with a “buy” rating and $14 price target. The stock closed at $3.37 on Sept. 6.

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Leerink cuts Intra-Cellular Therapies to MP

Leerink downgraded Intra-Cellular Therapies (NASDAQ:ITCI) to “market perform” from “outperform” and slashed its price target to $10 from $29, following a corporate update highlighting an unusual preclinical safety concern for lumateperone (ITI-007), its atypical antipsychotic for the treatment of schizophrenia. The stock closed at $10.49 on May 1.

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IntelGenx, RedHill RIZAPORT cleared in Luxembourg

IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

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Ladenburg starts Reata at buy

Ladenburg Thalmann launched coverage of Reata Pharmaceuticals (NASDAQ:RETA) with a “buy” rating and price target of $55. The stock closed at $21.21 on April 12.

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Roth upgrades Cempra to buy

Roth Capital Partners upgraded Cempra (NASDAQ:CEMP) to “buy” and maintained its $8 price target after the company announced positive Phase 3 results in the first of two skin infection (ABSSSI) studies with Taksta. The stock was quoted at $4.20 near midday on Feb. 27.

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FDA accepts Adamis NDA resubmission

The FDA has accepted for review Adamis Pharmaceuticals’ (NASDAQ:ADMP) NDA for its Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis. 

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BTIG starts Intra-Cellular Therapies at buy

BTIG launched coverage of Cellular Therapies (NASDAQ:ITCI) with a “buy” rating and $44 price target, saying there is considerable promise for the company’s antipsychotic, ITI-007, in multiple indications. The stock closed at $15.05 on Dec. 21.

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IntelGenx, RedHill license Rizaport in Korea

IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ,:RDHL; TASE:RDHL) have signed an exclusive license agreement with Pharmatronic for the commercialization of Rizaport in South Korea.

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Ladenburg cuts Aradigm price target to $7.50

Ladenburg Thalmann slashed its price target for Aradigm (NASDAQ:ARDM) to $7.50 from $26 but maintained its “buy” rating after the company reported mixed top-line Phase 3 results for Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis (NCF-BE).

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Ladenburg upgrades Repros Therapeutics to buy

Ladenburg Thalmann upgraded Repros Therapeutics (NASDAQ:RPRX) to “buy” from “neutral,” with a new price target of $5.50. The stock closed at $1.93 on Wednesday.

In a new report, analyst Matthew Kaplan writes that Repros has announced positive Phase 2b data for both its oral and vaginal delivery trials, following two, 18-week cycles of treatment with Proellex for the treatment of uterine fibroids.

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Aurinia to begin Phase 3 voclosporin trial in Q2

After an end-of-Phase 2 meeting with the FDA, Aurinia Pharmaceuticals (NASDAQ:AUPH) plans to begin a single Phase 3 clinical trial for voclosporin in the treatment of lupus nephritis (LN).

Aurinia believes the Phase 3 trial, whose design is consistent with the ongoing AURA study, will support a NDA submission.

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Dipexium gets SME designation in Europe

Dipexium Pharmaceuticals (NASDAQ:DPRX) has been granted small and medium enterprise (SME) designation by the European Medicines Agency (EMA). 

The company recently completed its pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2 - with its topical antimicrobial peptide, Locilex, in mild infections of diabetic foot ulcers in the U.S. under a special protocol assessment agreement from FDA. 

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