Today’s Daily Dose brings you news about NGM Biopharma’s phase II NASH study results, Moderna’s Coronavirus program, COCRYSTAL’s focus on COVID-19 coronavirus and norovirus, Lipocine’s update on the New Drug Application of TLANDO, growing woes of Mallinckrodt, and Takeda Pharma’s date with FDA, among others.
Shares of COCRYSTAL PHARMA INC. (COCP) jumped over 160% on Monday, following a license agreement with Kansas State University Research Foundation to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of Norovirus and Coronavirus infections.
The agreement enables Cocrystal to secure an exclusive, royalty-bearing right and license to certain antiviral compounds for humans covered by KSURF’s patents. (KSURF is Kansas State University Research Foundation).
Cocrystal intends to pursue research and development of the antiviral compounds, including preclinical and clinical development.
“This license agreement opens several development opportunities for us to expand the broad utility of our platform to address significant viruses for which there are unmet medical needs, particularly the COVID-19 coronavirus and norovirus,” commented Dr. Sam Lee, President of Cocrystal.
COCP closed Monday’s trading at $1.33, up 166.53%. In after-hours, the stock gained another 27.82% and was at $1.70.
Shares of Enlivex Therapeutics Ltd. (ENLV) gapped open 32% above the prior day’s close after the Company announced that it is initiating a plan to increase its manufacturing capacity of Allocetra, in preparation for potential treatment of Coronavirus (COVID-19) patients with organ failure.
Allocetra is an experimental therapy being investigated for the treatment of patients with organ failure associated with sepsis, a syndrome whose lethal pathophysiology – cytokine storm followed by organ failure – is similar to that of the coronavirus (COVID-19).
As previously announced, the Company is slated to initiate a phase I/II clinical trial of Allocetra for sepsis and a phase II /III trial of Allocetra for the prevention of GvHD in patients who undergo bone-marrow transplantations this year.
However, towards the closing of the trade, the shares took a hit after the Company announced it has entered into definitive agreements with certain institutional investors for the purchase in a registered direct offering of an aggregate of 1 million ordinary shares of the Company at a purchase price of $8.00 per share.
The gross proceeds to the Company from the offering, slated to close on February 26, are expected to be $8.0 million.
ENLV closed Monday’s trading at $8.73, down 6.33%.
GlaxoSmithKline plc’s (GSK) supplemental New Drug Application seeking approval of Zejula for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer has been accepted for review by the FDA.
The application is being reviewed under the FDA’s Real-Time Oncology Review pilot program.
Zejula is currently approved in the U.S. as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status. It is also approved as a treatment for women with advanced ovarian cancer, following three or more chemotherapy regimens.
Zejula came under GlaxoSmithKline’s fold, following the acquisition of TESARO Inc. in January 2019. Sales of Zejula were £229 million in the period from the date of acquisition till December 31, 2019.
GSK closed Monday’s trading at $41.92, down 2.69%.
Lipocine Inc. (LPCN) is all set to submit its New Drug Application for TLANDO, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, this quarter.
TLANDO had been rejected thrice by the FDA – in June 2016, citing deficiencies related to the dosing algorithm for the proposed label, in May 2018 too, saying that the product could not be approved in its current form, and in November 2019, citing the failure of the efficacy trial to meet three secondary endpoints for maximal testosterone concentrations (“Cmax”).
LPCN closed Monday’s trading at $0.77, up 67.39%.
Shares of Mallinckrodt Public Limited Company (MNK) took a hit, following a report by the Wall Street Journal that the Company is considering a possible Chapter 11 bankruptcy filing owing to opioid litigation pressure.
Mallinckrodt is one of the many companies named in the National Prescription Opiate Litigation, which accuses the companies of grossly misrepresenting the risks of long-term use of prescription opioids and failing to properly monitor suspicious orders of those prescription drugs, all of which have led to the current opioid epidemic.
MNK closed Monday’s trading at $4.17, down 18.55%.
Moderna Inc. (MRNA) announced that it has shipped the first batch of mRNA-1273, the Company’s vaccine against the novel coronavirus, COVID-19, for the planned phase I study in the U.S.
mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
The Company said that it has shipped the vials of mRNA-1273 to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).
Moderna’s portfolio of mRNA development candidates, including mRNA-1273, is manufactured at its Norwood manufacturing facility.
As per the latest update by the WHO, China has reported a total of 77,362 cases of COVID-19, including 2,618 deaths.
MRNA closed Monday’s trading at $18.59, up 1.97%. In after-hours, the stock was up 18.34% at $22.
NGM Biopharmaceuticals Inc.’s (NGM) 24-week placebo-controlled cohort of phase II study of 1 mg Aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis with stage 2 or 3 liver fibrosis has yielded positive results.
According to the preliminary topline results, treatment with Aldafermin 1 mg resulted in a fibrosis improvement of more than or equal to 1 stage with no worsening of NASH in 38% of patients compared to 18% in the placebo arm. In the Aldafermin treatment arm, 24% of patients achieved the endpoint of resolution of NASH with no worsening of liver fibrosis compared to 9% of placebo patients.
Moreover, 22% of patients in the Aldafermin treatment arm versus 0% in the placebo arm achieved the composite endpoint of both fibrosis improvement and resolution of NASH, which was statistically significant, added the Company.
A phase II/III clinical study of 0.3 mg, 1 mg and 3 mg of Aldafermin compared to placebo in patients with biopsy-confirmed NASH and F2-F3 liver fibrosis, dubbed ALPINE, is underway, with data expected in the first half of 2021.
NGM plans to initiate a phase IIb study of Aldafermin in NASH patients with F4 liver fibrosis and well-compensated cirrhosis, dubbed ALPINE 4, in the first half of 2020.
NGM touched a new high of $22.95 on Monday, before closing at $18.87, up 16.55%.
Takeda Pharmaceutical Co. Ltd.’s (TAK) supplemental New Drug Application for ALUNBRIG has been accepted for priority review by the FDA, with a decision date set for June 23, 2020.
The Company is seeking to expand the use of ALUNBRIG as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
ALUNBRIG is currently approved in more than 40 countries, including the U.S., Canada and the European Union, for the treatment of people living with ALK+ metastatic NSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.
TAK closed Monday’s trading at $18.28, down 2.71%.
United Therapeutics Corp.’s (UTHR) phase III study of Tyvaso Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease has met its primary efficacy endpoint.
In the phase III study, dubbed INCREASE, Tyvaso increased six-minute walk distance by 21 meters versus placebo after 16 weeks of treatment. This is the first pivotal clinical trial to demonstrate a benefit in patients with pulmonary hypertension associated with interstitial lung disease, the Company noted.
Tyvaso is already approved by the FDA for the treatment of pulmonary arterial hypertension. The Company plans to seek revised labeling for the drug that reflects the outcome of the INCREASE study by mid-2020.
The drug generated sales of $110.8 million in the third quarter of 2019 compared to $107.8 million in the year-ago quarter.
The Company is slated to report its fourth-quarter and full-year 2019 financial results before the market opens on Wednesday, February 26, 2020.
UTHR closed Monday’s trading at $115.35, up 7.84%.
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