FDA Nod For MRK, All Eyes On AGTC, ACTION Boosts APLT

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Today's Daily Dose brings you news about Applied Therapeutics' ACTION-Galactosemia trial results, FDA approval of Merck's Keytruda for yet another indication, Verastem's a global licensing agreement with Chugai Pharma and SCYNEXIS' FURI study results.

Read on…

Shares of Applied Genetic Technologies Corp. (AGTC) climbed more than 12% in extended trading on Wednesday, following an announcement that the Company will be releasing interim six-month data from the expansion group, and an update of enrollment for its ongoing Phase 1/2 clinical trial in patients with X-linked Retinitis Pigmentosa on January 9, 2020.

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Keep an Eye on AGTC, Stock up Over 40% In A Month

AGTC closed Wednesday's trading at $4.16, down 2.58%. In after-hours, the stock was up 12.98% to $4.70.

Shares of Applied Therapeutics Inc. (APLT) touched an all-time high of $40.14 in intraday trading on Wednesday, following positive topline results from the pivotal phase II portion of the phase I/II study of AT-007 in adult Galactosemia patients, dubbed ACTION-Galactosemia.

Galactosemia is a devastating rare pediatric metabolic disease that affects how the body processes a simple sugar called galactose, and for which there is no known cure or approved treatment available.

In August 2019, the Company announced data from the healthy volunteer portion of the ACTION study, demonstrating that AT-007 was well tolerated, with no drug-related adverse events or dose-limiting toxicities.

The results reported from the phase II portion of the study demonstrated that AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol vs placebo in adult Galactosemia patients. Galactitol is an aberrant toxic metabolite of galactose, formed by Aldose Reductase in Galactosemia patients.

The Company expects to file for regulatory approval of AT-007 for Galactosemia in the second half of 2020.

APLT touched an all-time high of $40.14 in intraday trading on Wednesday, before closing at $35.18, up 34.48%.

Clovis Oncology Inc. (CLVS) is slated to report fourth-quarter and full-year 2019 financial results on February 24, 2020.

The product revenue of the Company's flagship drug Rubraca is expected to be $38.3 million to $39.3 million for the fourth quarter of 2019 compared to $37.6 million for Q3 2019 and $30.4 million for Q4 2018.

For full-year 2019, Rubraca product revenue is anticipated to be in the range of $142.0 million to $143.0 million compared to $95.4 million in 2018.

Rubraca is approved in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, and for adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

CLVS closed Wednesday's trading at $10.77, up 27.21%.

The FDA has approved Merck's (MRK) KEYTRUDA for yet another indication - this time, as a monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Keytruda, which received its initial approval in September 2014 for advanced melanoma, is also indicated for non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

The drug fetched an annual revenue of $7.17 billion for Merck in 2018 and $7.97 billion in the first nine months of 2019.

MRK closed Wednesday's trading at $88.60, down 0.67%.

SCYNEXIS Inc. (SCYX), on Wednesday, announced positive results from its second interim efficacy analysis of the ongoing phase III open-label FURI study, demonstrating oral Ibrexafungerp's ability to treat patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains in the hospital setting.

The positive results of the first interim analysis of the FURI study were reported last January.

According to the study results, oral Ibrexafungerp showed clinical benefits in 83% of patients (34 out 41), with 23 patients achieving a complete or partial response and 11 patients a stable disease response. Of the 41 treated patients, only six did not respond to Ibrexafungerp treatment and one patient was considered indeterminate.

SCYX closed Wednesday's trading at $1.05, up 16.67%.

Shares of Verastem Inc. (VSTM) jumped more than 35% on Wednesday, following a global licensing agreement with Chugai Pharmaceutical Co., Ltd.

The agreement entitles Verastem to obtain worldwide development and commercialization rights to the RAF/MEK inhibitor CH5126766 (CKI27) from Chugai currently under development for the treatment of KRAS mutant solid tumors.

Verastem will make an upfront payment of $3 million and pay royalties to Chugai.

CH5126766 in combination with Verastem's lead candidate Defactinib is currently the subject of a clinical study (Phase I followed by expansion cohorts) with the expansion cohorts now ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). This clinical study of the Defactinib/CH5126766 combination is supported by the single-agent phase II studies of Defactinib in KRAS mutant NSCLC and CH5126766 in KRAS mutant NSCLC and LGSOC.

VSTM closed Wednesday's trading at $1.72, up 36.51%. in after-hours, the stock was up another 5.81% to $1.82.

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