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APLS Soars On PNH Data, ADXS On Track, TYME In Deal With Eagle, CVM On Watch

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Today's Daily Dose brings you news about Apellis Pharma's PEGASUS study results; Advaxis' progress with ADXS-504 in prostate cancer; CEL-SCI Corp's stock offering and Tyme's strategic collaboration with Eagle Pharma.

Read on…

Shares of Apellis Pharmaceuticals Inc. (APLS) hit a new high on Tuesday, following positive results from the Company's phase III study evaluating Pegcetacoplan in adults with paroxysmal nocturnal hemoglobinuria, or PNH.

PNH is a rare disease in which red blood cells break down earlier than they should.

In the study, dubbed PEGASUS, Pegcetacoplan was compared against Alexion Pharmaceuticals' Soliris (Eculizumab) in patients with PNH. Pegcetacoplan met the study's primary efficacy endpoint, demonstrating superiority to Soliris with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16.

At week 16, Pegcetacoplan-treated patients had an adjusted mean hemoglobin increase of 2.4 g/dL from a baseline of 8.7 g/dL, compared to Soliris-treated patients who had a change of -1.5 g/dL from a baseline of 8.7 g/dL.

Pegcetacoplan also showed promising results in key secondary endpoints - by meeting non-inferiority on transfusion avoidance and absolute reticulocyte count and showing positive trends on lactate dehydrogenase (LDH) and fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue score.

The Company noted that all patients in the trial have entered the 32-week open-label Pegcetacoplan treatment period.

In other news, the Company announced that it has commenced an underwritten public offering of 7 million shares of its common stock. The underwriters will have a 30-day option to purchase up to an additional 15% of the shares of the common stock sold in the public offering.

APLS touched a new high of $42.48 in intraday trading on Tuesday, before closing at $38.73, up 28.29%.

Advaxis Inc. (ADXS) has been given the go-ahead by the FDA to conduct a phase I clinical study of ADXS-504, the Company's ADXS-HOT candidate for prostate cancer.
ADXS-HOT is the Company's off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.

ADXS-503, the Company's ADXS-HOT drug candidate in non-small cell lung cancer, is under a phase I/II trial, with immune response data anticipated later this quarter.

ADXS closed Tuesday's trading at $1.30, up 21.50%.

AzurRx BioPharma Inc. (AZRX) is slated to make a presentation at the Biotech Showcase conference in San Francisco at the Hilton San Francisco Union Square Hotel on January 13, 2020.

The Company's lead drug candidate is MS1819-SD recombinant lipase. A phase II clinical trial of MS1819-SD in combination with standard porcine enzyme replacement therapy (PERT) for patients with cystic fibrosis who suffer from severe exocrine pancreatic insufficiency is underway.

Preliminary data from the study is expected in early 2020.

AZRX closed Tuesday's trading at $1.32, up 25.71%.

CEL-SCI Corporation (CVM) announced the full exercise of the over-allotment option granted to the underwriters with respect to 90,959 additional shares of common stock, in connection with its previously announced underwritten public offering of 606,395 million shares.

The total gross proceeds from the offering are about $6.325 million.

A phase III trial of the Company's lead drug candidate Multikine in head and neck cancer is underway, with results expected to be reported soon. It is the largest phase III study in the world for the treatment of head and neck cancer.

CVM closed Tuesday's trading at $8.61, down 3.69%.

Tyme Technologies Inc. (TYME) and Eagle Pharmaceuticals Inc. (EGRX) have formed a U.S. strategic collaboration focused on the co-promotion of TYME's lead CMBT candidate oral SM-88 in advanced cancers, which is in pivotal trials.

CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells' protein synthesis, leading to a breakdown of cancer's key defenses and cell death.

The agreement entitles TYME to receive an initial $20 million upfront a second $20 million milestone payment upon achieving primary endpoints in pivotal trial results or approval of a cancer indication in the U.S. for SM-88.

In return, Eagle will receive 10 million restricted shares of TYME's common stock at $2.00 per share.

Eagle Pharmaceuticals will undertake 25% of the promotional sales effort for SM-88 in the U.S. oncology market and receive 15% of the net U.S. revenues of SM-88, and TYME will be responsible for the remaining promotional effort. TYME will also be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. TYME retains the remaining 85% of net U.S. revenues and reserves the right to repurchase Eagle's co-promotion right for $200 million.

TYME closed Tuesday's trading at $1.75, up 13.64%.

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