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Monday, August 5, 2019

Roche Tecentriq shows positive effect in advanced bladder cancer

Results from a Phase 3 clinical trial, IMvigor130, evaluating Roche’s (OTCQX:RHHBY) Tecentriq (atezolizumab) plus platinum-based chemo in treatment-naive patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) showed a treatment benefit compared to chemo alone.
Specifically, patients receiving Tecentriq + chemo experienced a statistically significant reduction in the risk of cancer progression or death compared to patients receiving only chemo.
Overall survival also appeared to favor the Tecentriq group but the data are not yet mature.
No new safety signals were observed.
There are four ongoing late-studies assessing Tecentriq alone or in combination with other medicines in early and advanced bladder cancer.
The FDA granted accelerated approval to use Tecentriq as initial treatment in patients with advanced bladder cancer in April 2017. Full approval will be contingent on the successful outcomes of the late-stage studies.
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Abiomed up on continuation of current reimbursement for Impella heart pump

Abiomed (NASDAQ:ABMD) is up 3% premarket on light volume in reaction to its disclosure that that the present level of Medicare reimbursement for its Impella heart pump for certain procedures will be maintained for fiscal year 2020 (October 1, 2019 – September 30, 2020).
A draft of new payment levels released in April proposed lower rates.
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Krystal Biotech EPS misses by $0.05

Krystal Biotech (NASDAQ:KRYS): Q2 GAAP EPS of -$0.37 misses by $0.05.
Cash, cash equivalents and short-term investments of $195.5M.
Press Release
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Intra-Cellular to submit additional preclinical data; FDA date delay to Dec 27

Per FDA feedback, Intra-Cellular Therapies (NASDAQ:ITCI) will submit additional preclinical data to the FDA related to its marketing application seeking approval for lumateperone for the treatment of schizophrenia. The additional results constitute a major amendment to the filing so the agency’s action date has been extended three months to December 27 to allow for review.
The company believes that the additional data should be sufficient to address the FDA’s questions.
Management hosted a conference call this morning at 8:30 am to discuss the matter.
On July 24, the company announced that the agency canceled the planned advisory committee meeting to allow for the full review of the new information. Shares initially sold off on the news.
Shares were up 13% premarket on light volume.
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Heron Therapeutics EPS in-line, beats on revenue

Heron Therapeutics (NASDAQ:HRTX): Q2 GAAP EPS of -$0.63 in-line.
Revenue of $36.7M (+112.1% Y/Y) beats by $5.27M.
Shares +1% PM.
Press Release
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Premarket analyst action, Aug. 5

Alphatec Holdings (NASDAQ:ATEC) initiated with Overweight rating and $7 (46% upside) price target at Piper Jaffray.
Healthcare Trust (NYSE:HTA) upgraded to Outperform with a $30 (11% upside) price target at SMBC Nikko.
GlycoMimetics (NASDAQ:GLYC) downgraded to Hold with a $6 (34% downside risk) price target at Jefferies after its lead drug failed a late-stage study. Downgraded to Hold at SunTrust and Neutral at Piper. Shares down 52% premarket.
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Eagle Pharma launches development plan to support fulvestrant NDA

Eagle Pharmaceuticals (NASDAQ:EGRX) announces a clinical development plan to support the submission of a NDA for its fulvestrant formulation.
Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the FDA for the treatment of advanced hormone-related breast cancers.
In March and June 2019, Eagle and FDA, mutually agreed to a clinical program that could provide an efficient approval pathway for the Company’s fulvestrant formulation.
The main goal of the clinical research program is to determine if the unique properties of fulvestrant formulation will result in greater inhibition of estrogen receptors, potentially leading to improved efficacy outcomes, including lower disease progression rates, compared to current treatment options.
Eagle intends to begin a pilot study shortly in healthy female volunteers to evaluate the pharmacokinetics and safety of its novel formulation.
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