(RTTNews.com) - We are in the middle of second-quarter earnings season, with many of the pharma giants having reported better-than-expected results and issuing an upbeat outlook.
For the first time, sales of Merck & Co.'s (MRK) blockbuster cancer drug Keytruda have outpaced its rival Opdivo, developed by Bristol Myers, by logging $1.67 billion during the second quarter compared to $1.63 billion recorded by Opdivo.
Pfizer Inc. (PFE) reported strong second quarter results and lifted its EPS guidance while lowering its revenue outlook for the full-year. The drug giant touched a new 52-week high of $40.66 in intraday trading on Friday.
Health Insurance Innovations Inc. (HIIQ), Tandem Diabetes Care Inc. (TNDM), Molina Healthcare Inc. (MOH), Progenics Pharmaceuticals Inc. (PGNX), Illumina Inc. (ILMN) and DexCom Inc. (DXCM) are some of the other biotech stocks that hit new highs on the back of strong second quarter results.
However, not everything was hunky-dory in the pharma space in the week. Intersect ENT Inc. (XENT) lost nearly 15% of its stock price, following mixed second quarter results and a lackluster outlook.
Nobilis Health Corp. (HLTH), Capital Senior Living Corp. (CSU) and MannKind Corp. (MNKD) are some of the other stocks in the healthcare sector that touched new lows on disappointing second quarter financial results.
Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
1. Alnylam Pharmaceuticals Inc. (ALNY)
The New Drug Application for Patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis is under priority review by the FDA, with a decision expected on August 11, 2018.
Patisiran is developed by Alnylam Pharmaceuticals, using Arbutus Biopharma's Lipid Nanoparticle (LNP) delivery technology. Successful approval of Patisiran will trigger a royalty entitlement to Arbutus from Alnylam.
Credit Suisse analyst Alethia Young expects Patisiran sales to peak by 2023 at $1.5 billion.
Tegsedi, a drug developed by Akcea and Ionis Pharmaceuticals, for the similar indication, hereditary transthyretin amyloidosis, is under FDA review with a decision expected on October 6, 2018. Tegsedi was approved in the European Union as recently as July 11, 2018.
ALNY closed Friday's trading at $91.65, down 3.75%.
2. BioLineRx Ltd. (BLRX)
BioLine is a clinical-stage biopharmaceutical company focused on oncology and immunology.
A phase III study, evaluating the safety, tolerability and efficacy of BL-8040 and granulocyte colony-stimulating factor (G-CSF) compared to placebo and G-CSF, for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in multiple myeloma patients, dubbed GENESIS, is underway.
The study has a lead-in period for dose confirmation, which includes 10-30 patients.
Watch out for...
Results from the lead-in part of the GENESIS study in stem-cell mobilization for autologous transplantation due mid-year 2018, are awaited.
BLRX closed Friday's trading at $0.87, down 0.68%.
3. Insmed Inc. (INSM)
Insmed is a clinical-stage biopharmaceutical company developing therapies for patients with rare diseases.
Watch out for...
An FDA panel is scheduled to review the Company's New Drug Application seeking approval of ALIS for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex on August 7, 2018.
ALIS or Amikacin liposome inhalation suspension is an investigational drug comprising the antibiotic Amikacin in Insmed's proprietary liposomal technology formulation.
The FDA decision on ALIS is expected to be announced on September 28, 2018.
Nontuberculous Mycobacterial (NTM) lung disease is a rare and serious disorder, with patients experiencing a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. If approved, ALIS will be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States.
INSM closed Friday's trading at $26.15, down 6.87%.
4. Pain Therapeutics Inc. (PTIE)
The FDA's final word on Pain Therapeutics Inc.'s (PTIE) investigational pain drug Remoxy ER is slated for August 7, 2018.
Remoxy ER is a long-acting abuse-resistant version of oxycodone, a powerful narcotic painkiller, formulated with Durect Corp.'s (DRRX) ORADUR technology.
Remoxy is bioequivalent to Purdue Pharma's Oxycontin, meaning the two drugs provide similar levels of oxycodone in people when used as intended.
Last year, Oxycontin brought home sales of $1.94 billion, according to Symphony Health Solutions.
In June an FDA panel had voted 14 to 3 against the approval of Remoxy ER. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
The New Drug Application for Remoxy had been rejected thrice by the FDA - i.e., in December 2008, June 2011, and September 2016.
PTIE closed Friday's trading at $2.36, down 1.26%.
5. Paratek Pharmaceuticals Inc. (PRTK)
Paratek Pharma is a biopharmaceutical company focusing on drugs that target infectious disease and other difficult to treat conditions.
The Company's lead drug candidate is an antibiotic called Omadacycline for serious community acquired infections where resistance is of concern.
Watch out for...
An FDA panel is scheduled to review the New Drug Applications for once-daily, oral and intravenous Omadacycline on August 8, 2018.
Omadacycline is proposed for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The FDA decision on Omadacycline is expected in early October 2018.
PRTK closed Friday's trading at $9.80, down 0.51%.
6. 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 $9.02, down 7.01%.
7. Regeneron Pharmaceuticals Inc. (REGN)
The FDA is slated to announce its decision on Regeneron Pharma's supplemental Biologics License Application for a 12-week dosing interval of EYLEA Injection in patients with wet age-related macular degeneration on August 11, 2018.
For wet AMD, the current recommended dose for EYLEA is 2 mg administered by injection in the eye every two months (eight weeks) following three initial monthly (every four weeks) injections. EYLEA may also be dosed once per month.
The global annual net sales of Eylea in 2017 were $5.93 billion, up 14% over 2016.
REGN closed Friday's trading at $394.88, down 0.53%.
8. Strongbridge Biopharma plc (SBBP)
Strongbridge is a rare disease biopharmaceutical company with commercial and late-stage product portfolio.
Watch out for...
The top-line results from a phase III trial of investigational drug RECORLEV in endogenous Cushing's syndrome, dubbed SONICS, due to be reported in mid-2018, are awaited.
SBBP closed Friday's trading at $5.65, down 2.59%.
9. TRACON Pharmaceuticals (TCON)
TRACON is a clinical stage biopharmaceutical company developing novel targeted therapeutics for cancer and wet age-related macular degeneration.
The Company's lead drug candidate is TRC105 for the treatment of angiosarcoma, under phase III trial called TAPPAS. The interim analysis to determine the final sample size and eligible population for the trial is expected to be conducted in the second half of 2018.
Watch out for...
A phase 1/2 trial of TRC253 for the treatment of prostate cancer that was in-licensed from Janssen is underway. This trial is designed to determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels.
An update regarding the completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer, due in mid-2018, is pending.
TCON closed Friday's trading at $2.50.
10. Vertex Pharmaceuticals Inc. (VRTX)
The FDA is slated to announce its decision on Vertex Pharma's New Drug Application seeking approval of Lumacaftor in combination with Ivacaftor in patients with cystic fibrosis who are two to five years of age on August 7, 2018.
The combination of Lumacaftor and Ivacaftor is already approved by the FDA under brand name Orkambi for the treatment of the underlying cause of cystic fibrosis in patients 6 years and older with two copies of the F508del mutation in their CFTR gene.
Orkambi is a blockbuster drug, and it generated annual revenue of $1.32 billion last year, up from $979.6 million in 2016. The drug had sales of $665 million in the first half of 2018.
VRTX closed Friday's trading at $174.54, down 1.88%.
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