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FOMX Soars On Acne Trial Data, GLPG Abuzz, ACRX To Face FDA Panel In Oct.

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Today's Daily Dose brings you news about AcelRx Pharma's regulatory catalyst in October; positive acne trial results of Foamix; Galapagos' rheumatoid arthritis trial results; trading halt in OPKO and Viveve Medical's progress in stress urinary incontinence studies.

Read on...

AcelRx Pharmaceuticals Inc.'s (ACRX) New Drug Application for DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings in adult patients is scheduled to be reviewed by an FDA panel on October 12.

The regulatory agency's final decision on DSUVIA is set for November 3, 2018.

If approved, the Company believes that DSUVIA will provide a novel non-invasive treatment option for moderate-to-severe acute pain in medically supervised settings.

ACRX closed Tuesday's trading at $3.25, unchanged from the previous day's close.

Shares of Foamix Pharmaceuticals Ltd. (FOMX) were up more than 56% in extended trading on Tuesday, following positive topline results of its third phase III clinical trial of FMX101 for the treatment of moderate-to-severe acne.

The trial, dubbed FX2017-22, met both co-primary endpoints of absolute change from baseline in inflammatory lesion count at Week 12, and Investigator Global Assessment treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.

The safety profile of FMX101 was found to be consistent with that determined from the two prior phase III studies namely, FX2014-04 and FX2014-05, noted the Company. Now that the third phase III acne trial has concluded, the Company is now in position to finalize its efforts to submit its first NDA.

If approved, FMX101 would be the first topical minocycline product available for patients in the United States, according to the Company.

FOMX closed Tuesday's trading at $5.92, down 3.27%. In after-hours, the stock was up 56.76% to $9.28.

Gilead Sciences Inc. (GILD) and Galapagos NV (GLPG) announced that their phase III study of Filgotinib in adults with moderately-to-severely active rheumatoid arthritis achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12.

The trial, dubbed FINCH 2, evaluated Filgotinib 100 mg and 200 mg doses, and both the doses achieved the primary end points and all key secondary efficacy endpoints, including low disease activity and clinical remission.

GLPG closed Tuesday's trading at $102.74, up 5.52%. In after-hours, the stock was up 7.07% to $110.00.

KemPharm Inc.'s (KMPH) oral human abuse potential clinical trial of serdexmethylphenidate (KP415 Prodrug) has yielded positive topline results.

Results from the trial indicate that the prodrug component of KP415 may have lower abuse potential compared to Focalin XR, a schedule II controlled substance, even when serdexmethylphenidate is administered at oral doses up to 1.5 times higher than Focalin XR on a molar basis.

The results from the final human abuse potential trial, which will evaluate the abuse potential of SDX via the intranasal route, are expected soon. Results from the intranasal HAP trial are expected to be the final component of the NDA for KP415 with the FDA, which remains on track for submission to the FDA in the first quarter of 2019.

KMPH closed Tuesday's trading at $4.85, down 7.18%.

Trading in common stock of OPKO Health Inc. (OPK) continues to be halted and will remain so until the Company responds to Nasdaq's request for information related to the previously reported lawsuit filed by the U.S. Securities and Exchange.

On September 7, trading was halted in OPKO Health, following a lawsuit filed by the SEC against OPKO, its CEO and Chairman, Dr. Phillip Frost, and Frost Gamma Investments Trust, an entity affiliated with Dr. Frost, alleging violations of the Securities Act, the Exchange Act and rules promulgated thereunder.

Portola Pharmaceuticals Inc.'s (PTLA) Prior Approval Supplement filing for the large-scale Generation 2 manufacturing process for Andexxa has been accepted by the FDA, with a decision date set for December 31, 2018.

If approved, the Prior Approval Supplement will allow for the broad commercial launch of Andexxa in the United States.

Andexxa was approved on May 3, 2018 under the FDA's Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

PTLA closed Tuesday's trading at $28.79, up 3.49%.

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's supplemental Biologics License Application for Praluent, outlining a proposed update to the Prescribing Information to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events has been accepted for review by the FDA - with a decision date set for April 28, 2019.

Praluent is approved for the treatment of patients with heterozygous familial hypercholesterolemia or atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

REGN closed Tuesday's trading at $393.77, down 0.32%.

Theravance Biopharma Inc. (TBPH) and Mylan N.V. (MYL) will be presenting new data from the Phase 3 YUPELRI inhalation solution clinical program at the European Respiratory Society (ERS) International Congress on September 16.

The presented data will highlight chronic obstructive pulmonary disease (COPD) exacerbation rates observed in the Phase 3 clinical program of YUPELRI in patients with moderate to very severe COPD.

YUPELRI is a novel investigational once-daily nebulized LAMA under FDA review for the treatment of moderate to very severe COPD, with a decision date set for November 13, 2018.

TBPH closed Tuesday's trading at $28.37, down 0.35%.

Viveve Medical Inc. (VIVE) has submitted an Investigational Device Exemption to the FDA for authorization to begin LIBERATE-U.S., a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of the Company's proprietary, cryogen-cooled monopolar radiofrequency (CMRF) technology for the improvement of stress urinary incontinence (SUI) in women.

The Company already has two ongoing multicenter stress urinary incontinence registration studies including LIBERATE-International trial initiated in Canada in August 2018.

VIVE closed Tuesday's trading at $3.19, up 6.33%.

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