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DRRX Plunges On Psoriasis Trial Data, INCY Fails GRAVITAS-301 Test, AGRX Abuzz

pharma 062017 02jan20 lt

Today's Daily Dose brings you news about Agile Therapeutics' strengthened commercial leadership team; DURECT's decision to discontinue the development of DUR-928 in mild to moderate plaque psoriasis; Novan's disappointing molluscum contagiosum trial results; Incyte's acute graft-versus-host disease trial results and Innate Pharma's regulatory catalyst that drove the stock to a new 52-week high.

Read on…

Agile Therapeutics Inc. (AGRX) has appointed Kimberly Whelan as Vice President of Market Access and filled two additional positions to further strengthen its finance and marketing capabilities. Charles Grass, CMA, has been named Senior Director, Finance and Matthew Riley has been named Product Manager.

The Company's lead product candidate, Twirla, awaits the FDA decision on February 16, 2020.

AGRX closed Thursday's trading at $2.97, up 18.80%.

Shares of DURECT Corp. (DRRX) plunged more than 30% on Thursday, following disappointing results from its phase IIa clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis.

DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator's Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses, DURECT noted.

The Company will no longer be pursuing the development of topical DUR-928 in psoriasis.

James Brown, President and CEO of DURECT said, "With the recently announced positive results from our Phase 2a alcoholic hepatitis trial, our focus moving forward with DUR-928, will be on completing the NASH trial in the first half of this year and initiating the Phase 2b AH trial in the middle of the year."

The Company successfully completed the phase IIa clinical trial of DUR-928 in patients with alcoholic hepatitis last August.

Near-term Catalyst:

On January 16, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee is scheduled to review DURECT's resubmitted New Drug Application for POSIMIR, a post-operative pain relief depot.

POSIMIR, a nonopioid, locally-acting analgesic, is designed to be administered directly into the surgical site to deliver the anesthetic bupivacaine for up to three days after surgery.

The FDA had issued a Complete Response Letter for POSIMIR in February 2014.

DRRX closed Thursday' trading at $2.61, down 31.18%. In after-hours, the stock was up 2.49% to $2.68.

Incyte Corp.'s (INCY) phase III study evaluating Itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease did not meet the primary endpoint of improving overall response rate at Day 28.

In the trial, dubbed GRAVITAS-301, Itacitinib in combination with corticosteroids was compared against placebo plus corticosteroids.

Near-term Catalyst:

The Company's New Drug Application for Pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements is under priority review by the FDA, with a decision expected on May 30, 2020.

INCY closed Thursday's trading at $85.97, down 1.55%. In after-hours, the stock fell 10.08% to $77.30.

Shares of Innate Pharma SA (IPHA) touched a new 52-week high of $8.24 in intraday trading on Thursday, following the European Medicines Agency's acceptance of the Marketing Authorization Application for Lumoxiti.

In-licensed from AstraZeneca, Lumoxiti was approved by the FDA in September 2018.
Lumoxiti is indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

IPHA closed Thursday's trading at $7.30, up 13.53%.

Novan Inc.'s (NOVN) phase III program with SB206 for the treatment of molluscum contagiosum has failed to achieve statistically significant results for the primary endpoint of efficacy.

The phase III program, dubbed B-SIMPLE, consists of two trials namely, B-SIMPLE1 and B-SIMPLE2, evaluating SB206 for the treatment of molluscum in 707 patients aged 6 months and older, with a 2:1 (active: vehicle) randomization.

However, the Company noted that multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for SB206.

The phase III B-SIMPLE program is ongoing, with full efficacy and safety data, including the prospectively planned safety evaluation ongoing through Week 24, targeted to be available by March 2020.

NOVN closed Thursday's trading at $3.11, down 1.58%. In after-hours, the stock was down 72.67% to $0.85.

Pulmatrix, Inc. (PULM) has entered into a licensing and development agreement with Johnson & Johnson's (JNJ) Lung Cancer Initiative.

Through the agreement, the Lung Cancer Initiative gains an option to access Pulmatrix's portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception. A phase Ib study of the Company's lead in-licensed inhibitor RV1162/PUR1800 in stable COPD patients is underway.

Under the terms of the agreement, the Lung Cancer Initiative will pay a $7.2 million upfront payment and an additional $2 million milestone payment upon completion of the ongoing Phase 1b study of RV1162/PUR1800 in stable COPD patients, on-track for year-end 2020.

If the Lung Cancer Initiative exercises the option on RV1162/PUR1800 and the portfolio of these kinase inhibitors, Pulmatrix is eligible for up to $91 million in additional development and commercial milestones, as well as royalty payments.

PULM closed Thursday's trading at $1.62, up 88.37%.

Trillium Therapeutics Inc. (TRIL) in an SEC filing dated December 31, 2019, reveals that Morgan Stanley has acquired a 5.9% stake in the Company.

The Company's lead program is intravenous administration of TTI-621, which is in phase I clinical trial for advanced hematologic malignancies, and solid tumors and mycosis fungoides.

TRIL closed Thursday's trading at $1.49, up 44.66%. In after-hours, the stock lost 2.68% to $1.45.

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