FDA Snubs CHMA, NICE Is Nice With PTCT, RXII To Effect Reverse Split

(RTTNews) - BeiGene Ltd.'s (BGNE) initial data from an ongoing phase I clinical trial of BGB-283 in patients with BRAF or KRAS/NRAS-mutated cancers has demonstrated that treatment with single-agent BGB-283 is well tolerated with a favorable safety profile, and can result in durable responses in a range of cancers with mutations in BRAF and KRAS.

At the time of the data cutoff, among 29 evaluable patients, one patient receiving the 40 mg starting dose of BGB-283 had a confirmed complete response (CR), two patients receiving 20 mg or 30 mg starting dose had a confirmed partial response (PR), and 15 patients had a stable disease (SD) including one patient with an unconfirmed PR, according to the company.

BGNE closed Friday's trading at $31.92, up 2.01%.

In a huge disappointment, Chiasma Inc. (CHMA) on Friday was issued a complete response letter for Mycapssa, the company's drug candidate proposed for the maintenance treatment of adult patients with acromegaly.

Chiasma is reviewing the FDA communication and plans to provide an additional update before market open on Monday, April 18, 2016.

CHMA closed Friday's trading at $10.17, up 1.35%.

Enanta Pharmaceuticals Inc., (ENTA) announced Saturday that in ongoing phase II studies, dubbed SURVEYOR-1 and SURVEYOR-2, in patients with any of genotypes 1 through 6 of hepatitis C virus, AbbVie's (ABBV) investigational once-daily regimen of ABT-493 and ABT-530, without ribavirin, demonstrated high sustained virologic response rates after 8 or 12 weeks post-treatment.

BT-493 is Enanta's second protease inhibitor being developed in combination with ABT-530, AbbVie's NS5A inhibitor.

ENTA closed Friday's trading at $31.49, down 0.41%.

Presenting updated results of its phase I clinical trials of investigational product Entrectinib, Ignyta Inc. (RXDX) on Sunday said that there was tumor regression in 20 out of the 25 patients in the study who would meet the eligibility criteria for phase II clinical trial.

While 19 out of 24 patients with extracranial solid tumors had a confirmed RECIST response, representing a 79% overall response rate, 1 patient with an astrocytoma had evidence of substantial tumor regression by volumetric measurement, says the company.

The phase 1 clinical trials included the ALKA-372-001 study and the STARTRK-1 study, both of which were designed to determine the maximum tolerated dose and/or recommended phase 2 dose (RP2D), as well as preliminary anti-cancer activity, of single agent Entrectinib in patients with solid tumors.

RXDX closed Friday's trading at $8.11, down 3.34%.

Loxo Oncology Inc.'s (LOXO) new results from its phase I dose-escalation trial of LOXO-101 has revealed consistent efficacy of LOXO-101 in patients with TRK gene fusions, independent of tumor type.

The company noted that the data update also provides an encouraging snapshot of response durability, particularly at the recommended phase II dose of 100mg twice-daily.

As of the March 25, 2016 data cutoff date, 43 patients with solid tumors refractory to standard therapy had been enrolled and treated, including seven patients with cancers harboring TRK gene fusions. Five of six evaluable patients with TRK fusion cancers achieved confirmed RECIST partial responses and all six demonstrated significant tumor regression.

LOXO closed Friday's trading at $25.92, down 0.80%.

Shares of PTC Therapeutics Inc. (PTCT) were up 43% on Friday, following NICE's recommendation on Translarna for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD). The agency expects to finalize the draft guidance next month.

Translarna was approved by the European Commission in August 2014 to treat nmDMD and is currently available to patients in 23 countries through either expanded access programs or commercial sales. Its list price is approximately £220,000 per year.

For the full year 2015, Translarna generated $33.7 million in net product sales compared to $0.7 million in the prior year.

Last October, the company was asked by NICE to provide results of a confirmatory study of Translarna and further justification for the cost of the drug.

The New Drug Application for Translarna, which was submitted to the FDA on a rolling basis in January of this year, was refused to be filed by the U.S. regulatory agency on February 23, 2016.

PTCT closed Friday's trading 43.18% higher at $8.92.

RXi Pharmaceuticals Corp. (RXII) is all set to implement a 1-for-10 reverse stock split on April 18, 2016 in order to satisfy the $1.00 per share minimum bid price requirement of regaining compliance with the Nasdaq.

The company has time until May 2, 2016 to regain compliance with the Nasdaq Stock Market's minimum bid price requirement, and, to regain compliance, RXi Pharmaceuticals common stock must have a minimum bid price per share of at least $1.00 for 10 consecutive business days.

RXII closed Friday's trading at $0.26, down 1.22%. In after-hours, the stock was up 11.50% to $0.29.