(RTTNews.com) - The week that just rolled by was a mixed bag in terms of regulatory and clinical trial results - with some stocks vaulting to new highs on positive news and some cratering in response to the negative news.
Zafgen Inc. (ZFGN) gained 38% in the week and touched a new high, propelled by positive phase II clinical trial data of ZGN-1061 in patients with type 2 diabetes. Gemphire Therapeutics Inc. (GEMP) was another notable winner, with the stock soaring as much as 118%, on the back of encouraging results from its phase IIb trial of Gemcabene in severe hypertriglyceridemia patients.
In contrast, Arsanis Inc. (ASNS) lost 80% of its value in the week, following its decision to discontinue a phase II trial of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients as the trial was unlikely to meet primary efficacy endpoints.
Similarly, Aquinox Pharmaceuticals Inc. (AQXP) tanked nearly 83%, following the failure of its phase III trial of oral Rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS).
On the regulatory front, while GW Pharmaceuticals plc (GWPH) secured the FDA approval for Epidiolex to treat two severe forms of epilepsy, Pain Therapeutics Inc.'s (PTIE) investigational pain drug Remoxy ER failed to win the FDA panel backing. PTIE lost 75% of its share price in the week.
Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
1. Alkermes plc (ALKS)
The FDA decision on Alkermes' Aripiprazole Lauroxil NanoCrystal Dispersion, an investigational product designed to help patients get started with schizophrenia drug is due on June 30, 2018.
Aripiprazole lauroxil, which is Aristada, is an injectable atypical antipsychotic approved in four doses and three dosing durations for the treatment of schizophrenia (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks, and 1064 mg once every two months).
Once in the body, Aristada converts to Aripiprazole. Oral Aripiprazole should be administered for 21 consecutive days in conjunction with the first injection of Aristada.
Aripiprazole Lauroxil NanoCrystal Dispersion, which uses the Company's proprietary NanoCrystal technology, is designed to provide extended-release Aripiprazole lauroxil in a formulation that uses a smaller particle size than Aristada. This enables faster dissolution, and would lead to more rapid achievement of therapeutic levels of Aripiprazole.
If approved, Aripiprazole Lauroxil NanoCrystal Dispersion in conjunction with a single oral dose of 30 mg Aripiprazole will provide an alternative to the 21 day oral Aripiprazole regimen with the first dose of Aristada.
ALKS closed Friday's trading at $41.16, up 0.88%.
2. Novo Nordisk A/S (NVO)
Novo Nordisk is a global healthcare company focused on developing drugs to treat diabetes and other serious chronic conditions like adult growth hormone deficiency.
Watch out for...
Data from a phase II study in prepubertal growth hormone deficient (GHD) children evaluating weekly treatment with once-weekly Somapacitan versus daily injections of Norditropin, dubbed REAL 3, due this quarter, is yet to be reported.
NVO closed Friday's trading at $46.12, up 1.41%.
3. Acorda Therapeutics Inc. ( ACOR )
Acorda Therapeutics is a biopharmaceutical company marketing two approved products namely AMPYRA and QUTENZA, and has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease and multiple sclerosis.
The lead drug candidate in the pipeline is INBRIJA, an investigational treatment for people with Parkinson's living with OFF periods, or the re-emergence of Parkinson's symptoms. INBRIJA is under FDA review, with a decision expected on October 5, 2018.
Watch out for...
Data from a phase II trial of BTT1023 as a treatment for primary sclerosing cholangitis (PSC), due this quarter, is pending.
PSC is a rare, chronic disease that damages the bile ducts over time, leading to accumulation of bile in the liver, eventually resulting in liver failure.
ACOR closed Friday's trading at $28.70, up 3.99%.
4. Celsion Corp. (CLSN)
Celsion is an oncology drug development company.
The Company's lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer. Also in the pipeline is an immunotherapy candidate, GEN-1, currently in Phase I/II development for the localized treatment of ovarian cancer, dubbed OVATION II.
Last year, the Company reported impressive results from its phase Ib dose escalating clinical trial combining GEN-1 with neoadjuvant chemotherapy for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer followed by interval debulking surgery, dubbed OVATION I.
Watch out for...
Final progression-free survival data from the OVATION I Study due this month is yet to be reported.
CLSN closed Friday's trading at $2.95, down 4.84%.
5. NewLink Genetics Corp. (NLNK)
NewLink Genetics is a clinical stage biopharmaceutical company with a wide range of immuno-oncology portfolio candidates.
The Company's lead product candidate is Indoximod, which is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications.
Watch out for...
Updated data from a phase I study of Indoximod in combination with radiation and chemotherapy for children with newly-diagnosed diffuse intrinsic pontine glioma (DIPG) is slated to be presented on July 1, 2018. DIPG is a type of primary, high grade brain tumor in children.
NLNK closed Friday's trading at $4.76, down 1.24%.
6. Zogenix Inc. (ZGNX)
Zogenix is a pharmaceutical company developing therapies for the treatment of rare central nervous system disorders like Dravet syndrome and Lennox-Gastaut syndrome.
The lead product candidate is ZX008, a low-dose fenfluramine liquid solution.
The Company reported positive top-line results from its first pivotal phase III trial of ZX008 in Dravet Syndrome, dubbed Study 1, in September 2017.
In Study 1, ZX008 as an adjunctive therapy at a dose of 0.8 mg/kg/day achieved statistically significant convulsive seizure reduction in children and young adults with Dravet syndrome.
Dravet syndrome is a rare form of childhood epilepsy with life threatening consequences, having limited treatment options.
Watch out for...
Top-line data from a second phase III trial of ZX008 as an adjunctive therapy in children and young adults with Dravet Syndrome, dubbed Study 1504, are expected late June/early July.
ZGNX closed Friday's trading at $44.20, up 2.20%.
Read the original article on RTTNews (http://www.rttnews.com/2909908/an-ear-to-the-pharma-6-stocks-to-watch-alks-zgnx-acor.aspx)
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