(RTTNews) – As another week comes to a close, let’s take a look back at some of the stories that made headlines in the pharma space, and look ahead to what’s in store in the coming week.
Tilray Inc. (TLRY) made its debut on the Nasdaq Global Select Market on July 19, becoming the first cannabis company to go public on a U.S. major stock exchange. The shares have gained as much as 87% from the listing price of $17.
Mersana Therapeutics Inc. (MRSN) lost more than 30% of its value this week, following a partial clinical hold on its phase I trial of cancer drug candidate XMT-1522. The partial clinical hold was imposed by the FDA on July 19 after a patient death in the trial.
For Agios Pharmaceuticals Inc. (AGIO), it was a pleasant surprise when the FDA approved Tibsovo (Ivosidenib) for treating relapsed or refractory acute myeloid leukemia patients with an IDH1 mutation on July 20, one month ahead of the agency’s expected decision date.
Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
1. Lannett Co. (LCI)
The FDA decision on Lannett Co.’s (LCI) Numbrino Cocaine HCl, a proprietary local topical anesthetic with a nasal indication, due July 21, is awaited.
The NDA for Numbrino Cocaine HCl was submitted under 505(b)(2) regulatory pathway, and it is the Company’s first NDA submission to include full clinical trial studies.
The Company believes that Numbrino Cocaine HCl, if approved, may have broad applicability across a number of medical specialties, including Ears, Nose and Throat (ENT), Dermatologists, Obstetrics and Gynecology (OB-GYNs), Ophthalmologists, Emergency-Room (ER) physicians, oral surgeons, Proctologists, Veterinarians, Neurologists, Urologists, pain specialists, Oncologists, Hematologists and Podiatrists.
LCI closed Friday’s trading at $12.35, down 3.52%.
2. GlaxoSmithKline plc (GSK)
An FDA panel is slated to review GlaxoSmithKline’s (GSK) supplemental Biologics License Application seeking approval of Mepolizumab as an add-on to maintenance treatment for patients with eosinophilic chronic obstructive pulmonary disease on July 25, 2018.
Mepolizumab is already approved for use in the U.S., EU, Japan and a number of other countries worldwide under the brand name Nucala as an add-on maintenance treatment for eosinophilic asthma patients.
As recently as December 2017, the FDA expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
Sales of Nucala were Ã‚Â£344 million in 2017 compared to Ã‚Â£236 million in 2016.
GSK closed Friday’s trading at $41.87, up 2.90%.
3. Biogen (BIIB)
Biogen is focused on developing innovative therapies for people living with serious neurological and neurodegenerative diseases.
Early this month, the Company announced positive topline results from a phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease.
The final analysis at 18 months of the 856 patient Phase II clinical study in early Alzheimer’s disease demonstrated statistically significant slowing in clinical decline and reduction of amyloid beta accumulated in the brain.
Watch out for…
New analysis from a phase Ib study of Aducanumab, an investigational anti-amyloid beta antibody therapy for mild cognitive impairment (MCI) due to Alzheimer’s disease and mild dementia due to Alzheimer’s disease, dubbed PRIME, are expected to be presented on July 22 at the Alzheimer’s Association International Conference.
Two phase III trials of Aducanumab, dubbed ENGAGE and EMERGE, are underway. The trials are testing the safety and efficacy of Aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.
BIIB closed Friday’s trading at $358.71, up 0.17%.
4. Clearside Biomedical Inc. (CLSD)
Clearside Biomedical Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases.
Initial topline results from the Company’s pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveits, dubbed PEACHTREE, were reported on March 5, 2018, which sent the stock up as much as 69% that day.
According to the trial results reported in March, the trial met the primary endpoint, demonstrating statistically significant improvement in proportion of patients gaining 15 or more letters in visual acuity. All the secondary endpoints were also achieved in the trial.
Watch out for…
Data from the PEACHTREE trial are expected to be presented on Wednesday, July 25 at the 2018 American Society of Retina Specialists Annual Meeting.
CLSD closed Friday’s trading at $10.00, up 0.10%.
5. Indivior PLC (INVVY.OB)
The FDA is due to announce on July 28, 2018 whether it will approve Indivior’s RBP-7000 Risperidone monthly depot for the treatment of schizophrenia.
RBP-7000 is a novel extended-release product using the ATRIGEL delivery system for the subcutaneous administration of Risperidone once every month for the treatment of schizophrenia.
In September 2017, DURECT Corp. (DRRX) assigned certain of its U.S. patent rights on RBP-7000 to Indivior under a patent purchase agreement.
Under the terms of the agreement, Indivior made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based upon approval of RBP-7000, as well as quarterly earn-out payments.
INVVY.OB closed Friday’s trading at $22.35, down 1.32%.
6. INSYS Therapeutics Inc. (INSY)
The FDA decision on INSYS Therapeutics’ New Drug Application for a novel formulation of Buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain is expected on July 28, 2018.
On May 22, 2018, an expert panel convened by the FDA had voted not to recommend approval of Buprenorphine.
The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
INSY closed Friday’s trading at $7.83, down 5.55%.
7. Theravance Biopharma Inc. (TBPH)
Theravance is a diversified biopharmaceutical company having one approved drug Vibativ, and a couple of drug candidates in clinical testing.
Vibativ is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, and hospital-acquired and ventilator-associated bacterial pneumonia.
Watch out for…
Data from an exploratory phase IIa study of TD-9855 in patients with symptomatic neurogenic orthostatic hypotension (nOH) is expected by the end of this month.
Neurogenic orthostatic hypotension, or NOH for short, results from a deficient release of norepinephrine, the neurotransmitter used by autonomic nerves to send signals to the blood vessels and the heart. NOH is characterized by a chronic and often debilitating drop in blood pressure upon standing, lightheadedness, dizziness, blurred vision and syncope (fainting).
TBPH closed Friday’s trading at $25.90, down 1.48%.
8. Denali Therapeutics Inc. (DNLI)
Denali is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases.
The Company’s most advanced core programs include LRRK2 inhibitor program to address Parkinson’s disease and RIPK1 inhibitor program to address Alzheimer’s disease and Amyotrophic lateral sclerosis (ALS).
The two most advanced product candidates in the LRRK2 program are DNL201 and DNL151.
DNL201 is currently in a Phase 1 clinical trial in healthy volunteers in the United States, and DNL151 is currently in a Phase 1 clinical trial in healthy volunteers in the Netherlands.
The most advanced product candidate in the RIPK1 inhibitor program is DNL747, which is currently in a Phase 1 clinical trial in healthy volunteers in the Netherlands.
Watch out for…
Top line data from the phase I trial of DNL201 in healthy volunteers, due in the first half of 2018, is awaited.
DNLI closed Friday’s trading at $13.46, down 3.86%.
9. Ra Pharmaceuticals Inc. (RARX)
Ra Pharma is a clinical-stage biopharmaceutical company focused on developing drugs for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.
The Company’s lead drug candidate is RA101495 that is being developed for convenient self-administered subcutaneous injection for the treatment of paroxysmal nocturnal hemoglobinuria, Myasthenia Gravis, and renal indications such as atypical hemolytic uremic disorder (aHUS) and lupus nephritis.
Watch out for…
Data from a phase 1b clinical trial of RA101495 SC in atypical hemolytic uremic disorder, due mid-2018, is awaited.
RARX closed Friday’s trading at $11.17, up 2.10%.
10. CorMedix Inc. (CRMD)
CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease.
The Company’s lead product candidate is Neutrolin, a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently. It is approved as a CE Marked medical device in Europe, but is not approved in the U.S. yet.
Watch out for…
A phase III trial of Neutrolin in hemodialysis patients with central venous catheters, dubbed LOCK-IT-100, is underway. The Company anticipates Data Safety Monitoring Board Review of the LOCK-IT-100 study in July 2018.
CRMD closed Friday’s trading at $0.28, up 3.70%.
11. Bellerophon Therapeutics Inc. (BLPH)
Bellerophon is a late-stage biotherapeutics company.
The Company is developing INOpulse delivery system for the treatment of patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD).
Watch out for…
A phase III INOvation-1 study evaluating INOpulse in patients with pulmonary arterial hypertension is underway. Readout of the interim analysis of this trial due mid-2018 is awaited, with top-line data from the full study anticipated around the end of 2018.
BLPH closed Friday’s trading at $2.62, down 1.87%.
12. Altimmune Inc. (ALT)
Altimmune is a clinical-stage immunotherapeutics company having three clinical product candidates in its pipeline namely, NasoVAX, a phase II seasonal influenza vaccine candidate, HepTcell, a phase I immunotherapeutic candidate for the potential cure of chronic hepatitis B, SPARVAX-L, a phase II Anthrax vaccine, and NasoShield, a next generation Anthrax vaccine, under phase I study.
Watch out for…
Safety and immunogenicity data from phase I study of single dose NasoShield anthrax vaccine are expected in early 3Q, 2018.
ALT closed Friday’s trading at $0.40, up 11.08%.
13. Spring Bank Pharmaceuticals Inc. (SBPH)
Spring Bank Pharma is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers.
The Company’s lead product candidate is Inarigivir, also known as SB 9200, under Phase 2a trial, for the treatment of HBV, dubbed ACHIEVE.
The phase 2a trial has 4 monotherapy dosing regimens of SB 9200 namely, 25mg, 50mg, 100mg and 200mg followed by Viread for the treatment of chronic hepatitis B virus (HBV).
The Company has already reported results from the 24-week trial of both the 25mg and 50mg cohorts of Part A of the ongoing phase II ACHIEVE trial.
Watch out for…
Top-line results from the third monotherapy cohort (100mg) of the ACHIEVE trial due mid-2018, are awaited.
SBPH closed Friday’s trading at $12.56, up 0.96%.
14. Progenics Pharmaceuticals Inc. (PGNX)
On July 30, 2018, Progenics will know whether or not its drug candidate Azedra gets the FDA blessing.
Azedra, a radio-therapeutic, is proposed for the treatment of patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.
If approved, analysts expect Azedra to rake in peak sales of between $200 million and $300 million.
PGNX closed Friday’s trading at $8.26, down 1.55%.