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CRSP Falls On Clinical Hold, PFE Gets FDA Nod, ARWR To Report Data In Nov.

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Today's Daily Dose brings you news about clinical hold on CRISPR's CTX001 for sickle cell disease; new findings from ContraVir's pre-clinical study of CRV431 in a hepatocellular carcinoma mouse model; positive data from Gilead's psoriatic arthritis study; FDA approval for expanded use of Pfizer's Xeljanz and Sage Therapeutics' upcoming regulatory catalyst.

Read on…

Akers Biosciences Inc. (AKER) has been granted a 180-day extension to meet minimum bid price requirement for continued inclusion on the Nasdaq Capital Market.

The Company was notified on November 28, 2017, of being non compliant with the Bid Price Requirements for its common stock, and was afforded an initial 180 calendar days to regain compliance.

On May 29, 2018, the Company announced its decision to withdraw its initial 510(k) application for PIFA Chlamydia, a rapid diagnostic test device for chlamydia infection, in order to re-evaluate its options with regards to this product development opportunity, sending the stock down over 33% that day.

AKER closed Wednesday's trading at $0.32, down 16.51%. In after-hours, the stock was up 24.39% to $0.40.

Arrowhead Pharmaceuticals Inc. (ARWR) has completed enrollment and dosing of all 5 planned cohorts of healthy adult volunteers in the single-ascending dose portion of its ongoing Phase 1/2 study of ARO-HBV, being developed for patients with chronic hepatitis B virus infection.

The Company expects to present initial clinical data on ARO-HBV in November.

ARWR touched a new 52-week high of $11 in intraday trading on Wednesday before closing at $10.89, up 5.73%.

Shares of CRISPR Therapeutics AG (CRSP) were down 14% in extended trading on Wednesday, following the FDA's clinical hold on the planned initiation of a phase I/II trial of CTX001 in the U.S. in adult patients with sickle cell disease.

CTX001 is being co-developed by CRISPR Therapeutics and Vertex Pharmaceuticals (VRTX).

CRISPR and Vertex have to resolve some questions raised by the FDA with regard to the investigational New Drug Application for CTX001 before they can go-ahead with the phase I/II trial.

CTX001 is an investigational, gene-edited autologous hematopoietic stem cell therapy for patients suffering from ß-thalassemia and sickle cell disease. The planned initiation of a Phase 1/2 trial of CTX001 in Europe in adult patients with transfusion dependent ß-thalassemia is unchanged, and the companies expect to initiate the trial in the second half of 2018.

CRSP closed Wednesday's trading at $73.59, up 6.79%. In after-hours, the stock was down 14.39% to $63.00.

ContraVir Pharmaceuticals Inc. (CTRV) announced new findings from a preclinical study of CRV431, a cyclophilin inhibitor.

According to the findings, CRV431 reduced the number of liver tumors in a hepatocellular carcinoma mouse model by 44% and reduced the overall tumor burden by 56% compared to the vehicle control. Importantly, 25% of CRV431-treated mice had no liver tumors at the end of the 10 week study, whereas all vehicle-treated mice had at least five tumors per liver, added the Company.

CTRV closed Wednesday's trading at $1.88, unchanged from the previous day's close. In after-hours, the stock was up 0.53% to $1.89.

Gilead Sciences Inc. (GILD) and Galapagos NV's (GLPG) phase II study of Filgotinib in 131 adults with moderate to severe psoriatic arthritis, dubbed EQUATOR, has met the primary endpoint.

The primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20 percent improvement score (ACR20) was significantly higher for Filgotinib compared to placebo - i.e., the ACR20 response was 80 percent for Filgotinib versus 33 percent for placebo.

The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo (ACR50: 48 percent for filgotinib versus 15 percent; ACR70: 23 percent versus 6 percent).

Separately, Gilead and Galapagos also announced that an independent Data Monitoring Committee conducted a planned interim futility analysis of the Filgotinib Phase 2b/3 ulcerative colitis study, named SELECTION, after 350 patients completed the induction period in the Phase 2b portion of the study.

The DMC recommended that the study proceed into Phase 3 as planned at both the 100 mg and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients.

Galapagos is to receive a $15 million payment from Gilead for progression into phase III of the phase IIb/III SELECTION trial.

GLPG closed Wednesday's trading at $100.14, up 2.11%.

The FDA has approved the expanded use of Pfizer Inc.'s (PFE) Xeljanz for the treatment of adult patients with moderately to severely active ulcerative colitis.

Ulcerative colitis is a chronic inflammatory bowel disease that affects over 900,000 adults in the U.S.

Xeljanz, an oral Janus kinase (JAK) inhibitor, is already indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and adult patients with active psoriatic arthritis.

The global annual sales of Xeljanz totaled $1.35 billion in 2017, up from $927 million in 2016.

PFE closed Wednesday's trading at $36.05, up 0.98%.

Syndax Pharmaceuticals Inc. (SNDX) and Nektar Therapeutics (NKTR) have entered into a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar's NKTR-214 in combination with Syndax's Entinostat in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 (programmed death receptor-1) agent.

A phase Ib/II trial evaluating the combination of Entinostat with NKTR-214 in patients with PD-1 refractory melanoma is all set to be started, and Syndax will be responsible for conducting the study.

Additional financial details and other terms of the agreement are under wraps.

SNDX closed Wednesday's trading at $9.11, up 0.22%.

Sage Therapeutics' (SAGE) New Drug Application for an intravenous formulation of brexanolone (SAGE-547) for the treatment of postpartum depression has been accepted for review by the FDA - with a decision expected on December 19, 2018.

If approved, brexanolone IV would be the first medication indicated for the treatment of postpartum depression and would be Sage Therapeutics' first commercial product.

SAGE closed Wednesday's trading at $154.54, up 1.79%.

The FDA has finally approved TherapeuticsMD Inc.'s (TXMD) TX-004HR, branded as IMVEXXY, an applicator-free vaginal estradiol softgel.

IMVEXXY is indicated for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women.

Related Reading

FDA Greenlights TXMD's Imvexxy; Stock Up In Early Trade

TXMD closed Wednesday's trading at $6.06, down 5.75%.

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