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CytRx Corporation

Cardiac safety data support investment case

Update | Pharmaceutical & healthcare | 25 Jun 2015

CytRx released cardiotoxicity data and interim positive efficacy results from the Phase II GBM and combination Phase Ib aldoxorubicin studies. Our focus remains on the ongoing Phase III second-line soft tissue sarcoma (STS) trial, with data expected in H216. While our fundamental view on the drug's potential has not changed, the supplied cardiotoxicity data supports its intended mechanism of action. That is, by acting as a safer form of doxorubicin, aldoxorubicin may displace it in STS and potentially other oncology indications. We have amended our valuation slightly, resulting in an rNPV of $381m (from $375m previously).

CytRx Corporation

Preparing to go solo in the US on aldoxorubicin

Update | Pharmaceutical & healthcare | 31 Mar 2015

As it advances lead candidate aldoxorubicin through clinical trials, CytRx is also planning to commercialise the oncology drug through a specialty sales force in the US, rather than go through traditional biotech drug out-licensing deals in this market. We are revising our assumptions to consider the prospect of CytRx capturing full US aldoxorubicin economics, which raises our rNPV to $375m (from $209m previously).

CytRx Corporation

Aldoxorubicin trials resume as clinical hold lifted

Update | Pharmaceutical & healthcare | 25 Feb 2015

The lifting of a partial clinical hold imposed on aldoxorubicin improves clarity on its future development and enables the firm to maintain its existing timeline projections for the ongoing clinical trials. CytRx is confident its funds on hand should be sufficient to reach top-line data in mid-2016 from its Phase III study in second-line soft tissue sarcoma (STS).

CytRx Corporation

Partial clinical hold a minor setback

Update | Pharmaceutical & healthcare | 10 Dec 2014

Aldoxorubicin's randomised clinical trials (RCTs) were placed under a partial clinical hold following the death of a patient with metabolic acidosis who received the drug on a compassionate-use basis and did not qualify for any of the RCTs. CytRx believes this was the only case of metabolic acidosis out of >250 patients who received the drug to date. While already-enrolled patients can continue receiving the drug, no new patients can be dosed until the hold is lifted. CytRx is amending the protocol to exclude acidosis patients from receiving treatment, and believes its existing trial completion forecasts can be maintained if the hold is resolved promptly.

Simavita

Edison healthcare quarterly: It’s getting personal

Sector Commentary: | Pharmaceutical & healthcare | 30 Jun 2014

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CytRx Corporation

Detailed results on aldoxorubicin presented

Update | Pharmaceutical & healthcare | 12 Jun 2014

Detailed results of the Phase IIb trial of aldoxorubicin in first-line STS patients presented at the annual meeting of ASCO (top-line results were reported in several press releases) continue to show the drug's superior efficacy and safety profile over doxorubicin. The 400-patient, FDA SPA-sanctioned Phase III trial in second-line STS is progressing well with targeted completion of accrual in 2015 and possible top-line readout in 2016, a major value inflection point if the data are positive.

CytRx Corporation

Pivotal trial started

Update | Pharmaceutical & healthcare | 10 Apr 2014

CytRx officially started the pivotal Phase III trial of aldoxorubicin in second-line STS patients in March. Top-line results from the trial could be released in 2016 and mark a major milestone in the company's history. Following the successful $86m financing in February, CytRx also hired aldoxorubicin's inventor and his team to develop more albumin-binding anti-cancer drugs. We estimate its cash should support operations into 2017, beyond the important value inflection point of the Phase III STS data.

TESARO

Edison healthcare quarterly: A boost for allergy immunotherapy

Sector Commentary: | Pharmaceutical & healthcare | 05 Mar 2014

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CytRx Corporation

Trial modification increases the odds of success

Update | Pharmaceutical & healthcare | 23 Jan 2014

The FDA's approval of a protocol change to allow aldoxorubicin to be dosed to progression in the drug's pivotal, SPA-sanctioned, Phase III trial in second-line soft tissue sarcoma (STS) not only underscores the drug's superior safety profile observed in various trials so far, but also increases the drug's probability of success in the trial because drug exposure and treatment duration are typically related to chemotherapy efficacy. We are raising our valuation to $471m from $278m previously to reflect this better than expected progress of the aldoxorubicin development programme.

CytRx Corporation

Aldoxorubicin shines in STS

Update | Pharmaceutical & healthcare | 17 Dec 2013

Aldoxorubicin has demonstrated a statistically significant benefit in terms of progression-free survival (PFS) in the Phase IIb trial in front-line soft tissue sarcoma (STS). The data support Cytrx's plan to undertake a pivotal Phase III trial in second-line STS, which is slated to begin in Q114. We have increased our probability of clinical success rate from 50% to 65% and our valuation rises to $267m, equivalent to $6.8/share (basic) and $6.5/share (fully diluted). Although the shares have risen by c 100% since the data were released, there is upside to our fair value relating to possible positive data from other indications and/or deal(s) with biotech or pharma partners.

CytRx Corporation

Warming up for the main event

Update | Pharmaceutical & healthcare | 18 Nov 2013

Further results from the aldoxorubicin Phase IIb trial in front-line soft tissue sarcoma (STS) support a favourable risk/benefit profile versus doxorubicin. Interim data show that aldox-treated patients have a higher response rate and duration of treatment, which we hope will translate into a clinically meaningful progression-free survival (PFS) benefit. Final PFS data are expected in December. Our rNPV is $176.3m or $4.30/share.

Futura Medical

Edison healthcare quarterly: Immuno-oncology 2: The combos come

Sector Commentary: | Pharmaceutical & healthcare | 06 Nov 2013

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