XLRN's DART Misses Mark, RGLS Makes Cuts In Pipeline, FDA Snubs CHRS

(RTTNews) - Today's Daily Dose brings you news about Acceleron Pharma's disappointing renal cell carcinoma trial results; Aimmune's PALISDE progress; reverse stock split of CEL-SCI; the FDA rejection of Coherus' biosimilar candidate; promising trial results of GTX's drug candidate in postmenopausal women with stress urinary incontinence and Regulus' shrinking pipeline.

Read on...

Shares of Acceleron Pharma Inc. (XLRN) were down over 5% in extended trading on Monday, following the failure of its phase II study of Dalantercept in advanced renal cell carcinoma.

In the phase II study, dubbed DART, Dalantercept plus Axitinib did not achieve its primary endpoint of demonstrating a statistically significant increase in progression-free survival in advanced renal cell carcinoma patients.

Based on the lack of efficacy, the Company is discontinuing the development of Dalantercept.

XLRN closed Monday's trading at $28.23, down 2.79%. In after-hours, the stock was down another 5.24% to $26.75.

Aimmune Therapeutics Inc. (AIMT) on Monday announced that in its ongoing phase III trial of AR101 for desensitization of patients with peanut allergy, over 97 percent of patients currently on study have completed up-dosing.

The study, dubbed PALISADE, is designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. A total of 554 peanut-allergic patients, ages 4-49, were randomized to receive either AR101 or placebo for approximately six months of up-dosing followed by six months of maintenance therapy, according to the Company.

The final study visits will be completed around year-end 2017, and top line data are expected to be available in the first quarter of 2018.

AIMT closed Monday's trading at $17.70, up 0.11%.

Bio-Rad Laboratories Inc. (BIO) has received FDA clearance for its BioPlex 2200 Syphilis Total & RPR assay, a novel one-step universal testing method to aid in the diagnosis of syphilis infection.

Commenting on the development, John Hertia, Bio-Rad President, Clinical Diagnostics Group, said, " The addition of the BioPlex 2200 Syphilis Total & RPR assay broadens our expanding BioPlex 2200 System infectious disease menu while offering laboratories a simplified approach to syphilis testing, and it is adaptable to any testing algorithm used by a laboratory."

BIO closed Monday's trading at $221.73, down 2.45%.

CEL-SCI Corp. (CVM) is all set to implement a 1-for-25 reverse split on June 15, 2017.

The exercise price for the warrants that trade under the symbol CVM WS will be adjusted from $1.25 to $31.25 and 25 warrants will be required to purchase one share. The exercise price of all other outstanding warrants and options, as well as the shares issuable upon the exercise of the outstanding warrants and options, will also be proportionately adjusted, the Company said.

CVM closed Monday's trading $0.09, down 7.62%.

The FDA has refused to approve Coherus Biosciences Inc.'s (CHRS) product candidate CHS-1701, a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta.

Amgen's Neulasta is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy. The drug generated sales of $4.65 billion in sales for Amgen last year.

In its complete response letter to Coherus, the FDA has requested for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and has also sought certain additional manufacturing related process information. The regulatory agency has not made any request for a patient study.

CHRS closed Monday's trading at $15.75, down 23.73%.

Fibrocell Science Inc.'s (FCSC) gene therapy candidate for the treatment of moderate to severe localized scleroderma FCX-013 has been granted Rare Pediatric Disease Designation by the FDA.

The Rare Pediatric Disease Designation augments the Orphan Drug Designation previously granted by the FDA to FCX-013 for the treatment of localized scleroderma, which includes linear scleroderma.

The Company expects to submit an investigational new drug application for FCX-013 to the FDA in the fourth quarter of 2017.

FCSC closed Monday's trading at $2.88, up 15.20%.

Shares of GTx Inc. (GTXI) jumped more than 99% on Monday, following positive preliminary results from its ongoing Phase 2 Proof-of-Concept trial of Enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence.

The clinical findings from the first seven patients enrolled in the study following their completion of treatment revealed that:

-- Each of the women treated with Enobosarm showed a clinically significant reduction in incontinence episodes per day -- Reductions in incontinence episodes were sustained well beyond the stopping of study drug at Week 12 -- Women reported improved quality of life in the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index and -- Reported adverse events were minimal with none above Grade I.

GTXI closed Monday's trading at $6.15, up 99.03%.

Shares of Regulus Therapeutics Inc. (RGLS) fell more than 16% on Monday, following the Company's decision to discontinue the development of RG-101, an investigational treatment of chronic hepatitis C virus infection.

The FDA placed a clinical hold on RG-101 last July after Regulus reported a second serious adverse event of jaundice in a HCV patient with end-stage renal disease on dialysis enrolled in its phase I US study - 117 days after receiving a single dose of RG-101.

The Company said it is also pulling the plug on RGLS5040 for cholestatic disease, based on a positioning of the compound with respect to the competitive landscape coupled with the results from repeat pharmacology studies as part of IND-enabling work.

Separately, Regulus has been informed by AstraZeneca about the termination of clinical development program for AZD4076 (RG-125), which is under phase I/IIa trial, for the treatment of NASH in Type 2 Diabetes/Pre-diabetes.

Regulus and AstraZeneca entered into an agreement in 2015 to discover, develop and commercialize microRNA therapeutics under which AZD4076 (RG-125) was jointly identified and selected as a clinical candidate in April 2015 by AstraZeneca. Now that AstraZeneca has decided to halt the development of AZD4076 (RG-125), the rights to this compound will revert to Regulus.

RGLS closed Monday's trading at $1.17, down 16.07%.

Seres Therapeutics Inc. (MCRB) has initiated a phase III trial of SER-109 in patients with multiply recurrent C. difficile infection.

The study, dubbed ECOSPOR III, is expected to enroll approximately 320 patients with multiply recurrent C. difficile infection, randomized 1:1 to either SER-109 or placebo.

The ECOSPOR III trial was initially a phase II study. But based on recent interactions with the FDA, ECOSPOR III has been now designated a phase III trial.

The initiation of the SER-109 Phase 3 ECOSPOR III study triggers a $20 million milestone payment under the Company's previously announced development and commercialization collaboration agreement with Nestlé Health Science.

MCRB closed Monday's trading at $10.49, up 5.75%.

Zosano Pharma Inc's (ZSAN) additional data from its pivotal Phase 2/3 study of M207 as an acute treatment for migraine, dubbed ZOTRIP, has revealed a favorable tolerability profile for the compound.

Previously, the Company reported that a 3.8mg dose of M207 achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours. In addition, the 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours.

ZSAN closed Monday's trading at $1.36, down 9.33%.