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CDNA, OCUL Soar On Prelim Q3 Revenue, Lilly Seeks EUA For LY-CoV555 In COVID-19, ALKS On Watch

biotech oct08 lt

Today's Daily Dose brings you news about the third-quarter preliminary revenue results of CareDx and Ocular Therapeutix; Lilly pursuing emergency use authorization for LY-CoV555 in high-risk COVID-19 patients, and dual government support for TLC in developing a COVID-19 therapy.

Read on…

1. Alkermes' ALKS 3831 to Face FDA Panel Tomorrow

The briefing documents for the Oct. 9, 2020, joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review Alkermes plc's (ALKS) New Drug Application for ALKS 3831 have been released.

Alkermes' ALKS 3831, a once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder is scheduled to be reviewed by the FDA panels on October 9.

The final decision on ALKS 3831 is expected on November 15, 2020.

ALKS closed Wednesday's trading at $16.94, up 6.01%.

2. CareDx Soars On Preliminary Q3 Revenue Results

Shares of CareDx Inc (CDNA) were up over 15% in extended trading Wednesday, following encouraging preliminary unaudited revenue for the three months ended September 30, 2020.

CareDx offers testing services, products, and digital healthcare solutions along the pre-and post-transplant patient journey.

The company expects revenue for the third quarter of 2020 to be approximately $53.0 million, an increase of 57% compared with $33.8 million in the third quarter of 2019. Analysts polled by Thomson Reuters have a consensus revenue estimate of $44.68 million for the quarter.

The company is slated to report Q3 financial results early next month.

CDNA closed Wednesday's trading at $43.86, up 1.83%. In after-hours, the stock was up 15.09% at $50.48.

3. Lilly Seeks EUA for LY-CoV555 Monotherapy in High-Risk COVID-19 Patients

Eli Lilly and Co. (LLY) has submitted an initial request for emergency use authorization for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.

A phase II study, evaluating a combination of Lilly's SARS-CoV-2 neutralizing antibodies, LY-CoV555 and LY-CoV016, in patients with mild to moderate COVID-19 illness, dubbed BLAZE-1, is underway. The BLAZE-1 trial involves three arms - the monotherapy arm of LY-CoV555, the combination arm of LY-CoV555 and LY-CoV016, and the placebo arm.

The monotherapy arm of the trial is studying three doses of LY-CoV555 - 700 mg, 2800 mg, and 7000 mg and the combination arm is testing LY-CoV555 2800 mg plus LY-CoV016 2800 mg.

The data from an interim analysis of the monotherapy arm of the BLAZE-1 trial, reported last month, revealed that the prespecified primary endpoint, i.e., the change from baseline in viral load at day 11, was met at the 2800 mg dose level.

The data from a new interim analysis of the BLAZE-1 clinical trial, reported Wednesday, showed that combination therapy of LY-CoV555 and LY-CoV016 reduced viral load, symptoms and COVID-related hospitalization and emergency room visits.

Lilly expects to submit a request for emergency use authorization for the combination therapy of LY-CoV555 and LY-CoV016 in November, with biologics license application submission expected as early as the second quarter of 2021.

LLY closed Wednesday's trading at $148.96, up 3.35%.

4. Ocular Therapeutix Catches Eye

Shares of Ocular Therapeutix Inc. (OCUL) touched a new high of $10.95 yesterday, thanks to the impressive revenue growth in the third quarter ended September 30, 2020.

Ocular derives revenue from DEXTENZA, which is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery, and ReSure Sealant, used in sealing clear corneal incisions following cataract surgery.

Yesterday, the company released preliminary third-quarter 2020 total net product revenue figures, which fall in the $5.8 to 5.9 million range, representing a greater than 250 % sequential increase over the second quarter. The net product revenue in the third quarter of 2019 was $0.8 million.

Analysts polled by Thomson Reuters expect the company to report revenue of $4.2 million for the quarter.

The company is scheduled to report Q3 financial results on November 5.

OCUL closed Wednesday's trading at $10.82, up 28.66%.

5. TLC Gets Dual Government Support in Developing COVID-19 Therapy

Taiwan Liposome Company, Ltd. (TLC) had a double dose of good news for its investors yesterday, sending the stock soaring over 36%.

The company has secured approval both in Taiwan and Australia to conduct a phase I clinical trial of TLC19 Hydroxychloroquine Liposome Inhalation Suspension for COVID-19.

The Australian government offers a financial rebate of 40% or more on clinical trial spending under the Research & Development tax incentive program, noted the company.

Commenting on the developments, George Yeh, President of TLC, said, "We very much look forward to launching TLC19's Phase 1 trial with the support of experienced, high-quality partners in Taiwan as well as in Australia, which has an efficient and globally recognized regulatory environment with the bonus of government incentives and benefits and is a great place to conduct clinical trials for time-sensitive projects like TLC19".

The phase I blinded study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteers.

TLC closed Wednesday's trading at $5.94, up 36.55%.

6. Stocks That Moved On No News

Chimerix Inc. (CMRX) closed Wednesday's trading at $3.02, up 19.84%.

Orchard Therapeutics plc (ORTX) closed Wednesday's trading at $3.02, up 19.84%.

Milestone Scientific Inc. (MLSS) closed Wednesday's trading at $1.86, up 16.25%.

Xtant Medical Holdings Inc. (XTNT) closed Wednesday's trading at $1.30, down 15.03%.

Aytu BioScience Inc. (AYTU) closed Wednesday's trading at $1.16, down 12.78%.

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